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NCT Number: NCT07830836

Physiotherapy and Osteopathic Treatment for Pain in the Cervical and Lumbar Spine and Temporomandibular Joints

Study Summary: Effectiveness of Physiotherapy and Osteopathy in Treating Spinal and Temporomandibular Joint Pain About the Study and Its Objective This study is conducted by Artur Hołodniuk, MSc, a physiotherapist and academic lecturer. The primary goal of the project is to evaluate the effectiveness of various manual and physical techniques in treating pain in the spine (cervical and lumbar regions) and the temporomandibular joints (TMJ). The therapy aims to reduce muscle tension, improve mobility, and alleviate symptoms associated with conditions such as discopathy or degenerative changes.

Who Can Benefit from Participation?

The project is addressed to individuals struggling with:

pain and stiffness in the neck and lower back, pain in the masseter and temporal muscles, limited jaw mobility, as well as headaches and gluteal pain, tension resulting from a sedentary lifestyle or physical strain. Phase One: Comprehensive Diagnostics

Before therapy begins, each participant undergoes a series of modern and safe measurements for a multi-dimensional health analysis:

Myotomy: An objective assessment of selected muscle tension. Stabilometric Platform: Analysis of body posture and balance control. Jaw Grip Strength: Checking the functional performance of the stomatognathic system.

Diaphragm Research Belt: Evaluating respiratory and stabilizing functions of the diaphragm.

Fukuda Test: Assessing vestibular function and spatial orientation. Questionnaires: Standardized tools to determine pain intensity, sleep quality, and the impact of symptoms on daily life.

Phase Two: Applied Treatment Methods

The study utilizes six main forms of support, tailored individually to the patient's needs:

General Osteopathic Treatment (GOT): A holistic manual approach involving gentle joint mobilizations and soft tissue work to restore the body's functional balance and range of motion.

Visceral Therapy: Precise, gentle manual work with the internal organs of the chest and abdomen to improve their mobility and reduce tensions transmitted to the spine.

Pulsed Magnetic Field: 30-minute treatments using low-frequency fields to achieve analgesic, anti-inflammatory, and edema-reducing effects.

Positional Placement: Adopting specifically selected body positions using bolsters or pillows to offload painful structures and promote relaxation.

External Stabilization: The use of a cervical collar or lumbar corset for temporary stabilization and offloading of the spine, protecting tissues while preventing secondary muscle weakness.

Safety and Contraindications

All applied techniques are non-invasive. Before starting, the therapist conducts a detailed interview to exclude contraindications, such as:

acute inflammation, infections with fever, fresh injuries, or fractures, active cancer or advanced osteoporosis, electronic implants like pacemakers (specifically for magnetic field therapy), high-risk pregnancy. Possible Reactions: Following therapy, temporary reactions may occur, such as fatigue, tissue tenderness, sleepiness, or a short-term increase in pain, which typically subside quickly.

Important Information for Participants Voluntary Participation: Participation is entirely voluntary. You may withdraw at any stage without providing a reason.

Insurance: Participants are covered by appropriate civil liability insurance for the duration of the study.

Privacy: Personal data (name, age, weight) is protected and used solely for identification purposes within the research project.

Contact Information

Individuals interested in participating or seeking further clarification may contact the lead researcher directly:

Phone: 796 947 765 E-mail: [email protected]

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Key information

About this study

Physiotherapeutic and Osteopathic Management in Pain Complaints of the Cervical and Lumbar Spine and in the Temporomandibular Joints

Detailed project description

Study assumptions Pain of the spine, both in the cervical and lumbar regions, as well as in the temporomandibular joints, is one of the most common reasons why patients report to primary care physicians, physiotherapists, and osteopaths. It is estimated that as many as 70-80% of the population experience at least one episode of spinal pain during their lifetime, and many of these cases concern acute pain, appearing suddenly and significantly limiting functioning. In contrast, symptoms of temporomandibular joint disorders, including pain, affect about 5-12% of people worldwide [1-3].

Acute spinal pain, although often transient, may lead to chronicity of symptoms, absence from work, decreased quality of life, and significant social and economic costs. Particularly important are the actions taken in the first phase of symptoms, which influence the pace of recovery and the risk of recurrence. In clinical practice, various methods of treatment of acute painful dysfunctions are used, including: manual therapy (including structural and visceral osteopathy), physical therapy modalities (e.g., magnetic field therapy), and conservative methods (semi-rigid orthopedic collar Ortel C2 Plus Thuasne, lumbosacral orthosis LB3000 Orliman) [4-6].

There are many studies devoted to chronic spinal pain and temporomandibular joint pain, whereas the acute phase is analyzed much less frequently, even though it is often crucial for the further course of treatment. It is also worth noting that many current therapeutic methods are based mainly on the experience and intuition of specialists, rather than on unequivocal scientific evidence [7-9].

Physiotherapeutic therapy offers a comprehensive approach to pain treatment, based on the principle of interrelationships between structure and function. Osteopathic techniques such as General Osteopathic Treatment (GOT) or visceral therapy may act both locally and systemically, influencing muscle tone. In turn, physical modalities such as magnetic field therapy are often used in acute conditions because of their analgesic and anti-inflammatory effects. The orthopedic collar, lumbar brace, and positioning postures are intended to limit movement and unload a given section of the spine [10-22].

Main objective of the study

The main objective of the study is to determine which of the applied physiotherapeutic and osteopathic techniques (GOT / general osteopathic treatment technique, visceral therapy), physical medicine modality (magnetic field therapy), and medical devices (cervical collar, lumbar brace, positioning posture) will be the most effective in alleviating acute pain episodes of the cervical spine, lumbar spine, and temporomandibular joints as an indirect effect, with particular emphasis on pain reduction and improvement of functioning.

Specific objective of the study

To perform a comparative analysis of the effectiveness of various physiotherapeutic and osteopathic interventions during acute pain of the cervical and lumbar spine and their indirect influence on the temporomandibular joints.

Description of the study group

The study will include 300-400 patients aged 20 to 40 years, both women and men, who experience an acute pain episode of the cervical or lumbar spine and in the temporomandibular joints. Participants will be divided into 6 main therapeutic groups differing in the therapeutic method. Each of the 6 groups will undergo therapy 3 times per week for 30 minutes over 5 weeks. Measurements will be performed before the start of therapy and after its completion in the 5th week of therapy. The study will be conducted from 02.01.2026 to 02.01.2031.

Description of therapeutic groups:

  • Group 1 - Osteopathic therapy (GOT): persons assigned to this group will undergo tension balancing techniques, myofascial release, and work with the nervous system.
  • Group 2 - Visceral therapy: persons assigned to this group will undergo manual therapy of the abdominal and pelvic organs: respiratory diaphragm, pelvic diaphragm, small intestine, large intestine, peritoneum.
  • Group 3 - Physical therapy (magnetic field therapy): persons assigned to this group will receive low-frequency magnetic field therapy, applied locally to the site of pain.
  • Group 4 - In this group, a semi-rigid orthopedic collar Ortel C2 Plus Thuasne (for the cervical section) or a lumbosacral orthosis LB3000 Orliman will be used.
  • Group 5 - In this group, participants will assume a positioning posture.
  • Group 6 - Control group (healthy individuals): a group of persons without pain symptoms, not subjected to therapy, participating only in the initial and final assessment. Its purpose is to determine the natural range of variability of functional and postural parameters.

In all groups from 1 to 6, a division into female and male groups was introduced.

Inclusion criteria

Persons meeting all of the following conditions will be eligible for participation in the study:

  • Age 20-40 years - adults, professionally or socially active.
  • Acute pain episode of the cervical or lumbar spine - symptom duration does not exceed 6 weeks, without previous chronic or recurrent complaints in this area.
  • Ability to move and communicate independently - without cognitive or motor impairments that could prevent performance of the tests or therapeutic cooperation.
  • Consent to participate in the study - informed consent signed after receiving full information about the purpose, course, and methods of the study.
  • Ability to participate in the entire therapeutic and measurement cycle - no time-related or health-related obstacles preventing completion of the study.
  • Pain in the area of the temporomandibular joints, aggravated during jaw movements or chewing.
  • Presence of clicking, popping, or grinding in the temporomandibular joint during jaw movement.
  • Pain in the area of the temporomandibular joints, aggravated during jaw movements or chewing.

Exclusion criteria

Persons meeting at least one of the following criteria will be excluded from participation in the study:

  • Chronic pain - pain complaints lasting more than 6 weeks or occurring cyclically in the last year (more than 3 episodes).
  • Advanced degenerative, neurological, or post-traumatic changes. Radicular symptoms - sensory disturbances and muscle weakness of the upper and lower limbs.
  • Neoplasms, rheumatic, infectious, or metabolic diseases of the spine.
  • Postoperative condition within a period shorter than 6 months - insufficient tissue healing, risk of secondary damage.
  • Mental or neurological disorders hindering cooperation or reliable completion of questionnaires (e.g., severe depression, dementia, cognitive disorders).
  • Current pharmacological treatment affecting the neuromuscular system - e.g., antiepileptic drugs, opioids, high doses of corticosteroids.
  • Participation in other clinical studies or use of other therapy (physiotherapy, osteopathy, physical medicine) within the last 4 weeks.
  • Women during menstruation.
  • Fever.
  • The participant may discontinue participation in the study at any stage due to: withdrawal from participation in the study, failure to comply with protocol recommendations, consulting another specialist because of worsening condition.
  • Pregnancy.

Methods used in the study

For the purposes of the study, an original questionnaire was developed, completed by each patient at the beginning of participation in the study. Its purpose was to obtain basic information:

  • demographic data: age, sex, occupation, level of physical activity,
  • characteristics of complaints: location, duration, radiation, neurological deficits, circumstances of occurrence, dependence of pain occurrence on time of day and night,
  • previous injuries, surgeries (within the abdominal cavity, spine, pelvis),
  • information specific to women: pregnancy (current and past), menstrual cycle (regularity, phase of the cycle),
  • assessment of previous forms of treatment, if any,
  • expectations regarding therapy and level of motivation,
  • subjective assessment of the impact of pain on everyday functioning (sleep, work, social life),

Diagnostic tools and procedures

A. General Osteopathic Treatment technique (General osteopathic treatment)

General osteopathic treatment (GOT) begins with preparation of the patient. The patient is positioned supine, with the limbs extended and placed freely. The therapist asks the patient to relax the body and breathe calmly. Initially, a brief palpation is performed to assess muscular tension in the neck, shoulder girdle, and pelvic regions, which constitutes the starting point for further manual work.

The first stage of therapy is work with the shoulder girdle and upper limbs. The therapist holds the patient's limbs and performs rhythmic mobilizations of the shoulder, elbow, and wrist joints. The movements are smooth, of moderate amplitude, and their repetitiveness induces a state of relaxation in the patient. In the further part, alternating movements are introduced, resembling the gait pattern. As a result, the shoulder girdle is unloaded, the neck muscles are relaxed, and there is an indirect effect on the area of the temporomandibular joints.

Another important element of the procedure is mobilization of the cervical spine. The therapist places the hands under the patient's occiput, gently supporting the head. Then gentle oscillatory movements are performed in several planes: flexion and extension, rotations, and lateral flexions. These movements are very subtle, of small amplitude, and never evoke pain. They may be supplemented by gentle cervical tractions synchronized with the patient's exhalation phase. This type of action allows reduction of neck muscle tension, unloading of the intervertebral joints, improvement of local circulation, and limitation of excessive sympathetic nervous system activity.

Next, the therapist proceeds to work with the lower limbs and pelvis. The hip joints are mobilized alternately, performing light tractions and oscillatory movements. Subtle rotational movements within the pelvis are also introduced, allowing restoration of balance in the lumbar region. This part of the session supports relaxation of the paraspinal muscles, reduces pain complaints in the lower back, and activates venous and lymphatic circulation.

The final part of therapy consists of global integration. The therapist guides the patient's limbs in alternating upper and lower movements in a rhythm resembling natural gait. The movements are synchronized with breathing, which deepens the relaxing effect and allows harmonization of tensions throughout the body. Thanks to this, the patient experiences a sense of deep relaxation, and the musculoskeletal-fascial system returns to balance.

The conclusion of therapy consists in gradually reducing the intensity and range of the performed movements until they are completely quieted. The patient remains still for a moment so that the body can adapt to the obtained changes. Then the therapist asks the patient to slowly move to a sitting position and informs them that the effect of the treatment may intensify in the following hours after the end of the session.

B. Visceral therapy

Therapy begins with preparation of the patient, lasting about 3-5 minutes. The patient lies in a supine position, with the legs slightly bent at the knees, which allows relaxation of the abdominal muscles. The therapist conducts a short initial interview, collecting information about current complaints and checking for possible contraindications. Then a palpatory assessment of the tissues in the abdomen, thorax, and pelvis is performed in order to locate areas of increased tension and dysfunction.

The first part of the session, lasting about 10 minutes, includes work on the visceral system related to the cervical spine. The therapist mobilizes the upper thoracic outlet, applying gentle release techniques in the region of the cervicothoracic junction and clavicles, which improves venous-lymphatic drainage. The next step is work with the esophagus and stomach - light traction and mobilization techniques in the area of the cardia and fundus reduce tensions that may project onto the cervical spine. This is supplemented by normalization of tension in the region of the cervical diaphragm through subtle techniques in the region of the suprahyoid muscles and cervical fascia.

The next part, lasting 15 minutes, includes work on the visceral system related to the lumbar spine. It begins with mobilization of the respiratory diaphragm, the relaxation and improvement of dome mobility of which reduce overload transferred to the lumbar region. The next stage is work with the liver and gallbladder - mobilization techniques improve the glide and elasticity of the hepatic ligaments, whose fascial connections may influence lumbar spine stability. The therapist continues work within the intestines, especially the hepatic and splenic flexures of the colon, releasing mesenteric tensions and supporting peristalsis. This is complemented by work with the urinary bladder, consisting of balancing the pelvic ligaments and fasciae, which helps normalize tensions affecting the lower spine.

An additional important stage of this session is work with the peritoneum. The therapist applies gentle myofascial release techniques in the area of the parietal and visceral peritoneum, focusing on reducing glide restrictions between the organs and the walls of the abdominal cavity. The aim is to improve organ mobility, reduce tensions transmitted through the ligamentous-fascial system, and support balance between the abdominal cavity and the lumbar and cervical spine.

The final part of the procedure, lasting 5 minutes, is integration and conclusion of therapy. The therapist performs global balancing techniques, allowing equalization of tensions throughout the abdominal cavity and harmonization of the function of the diaphragms and visceral system. The patient slowly moves to a sitting position, and the therapist gives recommendations concerning further management - draws attention to the benefits of diaphragmatic breathing, reminds the patient of the need to maintain proper body posture, and encourages observation of the body's reactions in the following hours after therapy.

C. Magnetic field therapy

In the therapy of acute pain syndromes of the cervical spine, low-frequency magnetic field therapy is effectively applied, acting as an analgesic, anti-inflammatory, and anti-edematous modality. The procedure is performed using parameters ensuring safe and effective biological action: exposure time is 30 minutes, magnetic field intensity is set at 4 mT, and pulse frequency is 15 Hz. The magnetic field is used in pulsatile mode, which is particularly beneficial in acute conditions because it promotes pain reduction and reduction of muscle tension, as well as improvement of microcirculation within the neck tissues.

In the therapy of acute pain complaints of the lumbar spine, low-frequency magnetic field therapy with an intensity of 4 mT, a frequency of 15 Hz, and a duration of 30 minutes is used in pulsatile mode. Such a method of magnetic field application leads to pain reduction and decreased tension of the paraspinal muscles, improved blood supply, and stimulation of metabolic processes in tissues. The action of the magnetic field also supports reduction of inflammation, making it possible to restore normal spinal mobility more quickly and improve the patient's comfort of functioning.

D. Positioning postures (30 min)

In the therapy of acute pain complaints, it is extremely important to find such a position for the patient in which the complaints are significantly reduced or disappear completely. This position must be comfortable, natural, and free of tension and forced settings. The task of the therapist is to search for positions that provide the patient with the greatest relief and then leave the patient in this position for about thirty minutes. In the event of recurrence of pain or the appearance of discomfort, the therapist may gently correct the body position.

Cervical spine The patient is positioned supine, and the head rests comfortably on a pillow or in the therapist's hands. Then slow, slight movements are introduced - slight rotation, flexion, extension, or lateral flexions - until the patient reports the greatest relief. Most often, the optimal setting turns out to be slight cervical flexion combined with rotation to the side opposite the painful one. Once the comfortable position is found, it is maintained for 30 minutes, and, if necessary, small corrections are made. The effect of therapy is reduction of cervical spine pain, relaxation of the neck muscles, unloading of the cervical joints, and improvement of blood supply.

Lumbar spine The patient lies supine, and the therapist searches for a position bringing relief through various settings of the lower limbs - hip and knee flexion, support of the lower legs on a roller or chair, as well as slight pelvic rotations. Different variants are tested until the patient reports the least pain or its complete absence. Most often, the greatest relief is provided by the so-called "chair position," i.e., hip and knee flexion at 90 degrees, sometimes with slight pelvic rotation. After the optimal setting is found, the patient remains in it for 30 minutes without active movement. The effect is unloading of the intervertebral and articular structures, relaxation of the paraspinal muscles, and a clear reduction in pain complaints.

E. Use of a cervical collar

Before beginning the procedure, the physiotherapist prepares an orthopedic collar of appropriate size, adjusted to the height and circumference of the patient's neck. Then the therapist explains to the patient the purpose and course of the procedure and asks the patient to assume a sitting or supine position, with the head set in a neutral position, without tilting or rotation.

Application of the collar begins with gentle lifting of the patient's chin and stabilization of the head in a neutral position. The collar is placed from the front in such a way that its contoured submandibular part supports the mandible, and the lower edge rests evenly on the sternum and clavicles. It is important that the collar surrounds the entire neck without exerting excessive pressure. The posterior part of the collar is placed behind the patient's neck, ensuring even distribution of pressure. Then the Velcro fasteners or adjustment straps are fastened, checking whether the collar stabilizes the neck, does not cause dyspnea or discomfort, and does not significantly limit swallowing. After completing the application, the physiotherapist makes sure that the patient feels comfortable and gives instructions regarding further management.

The collar should be worn for three hours. During this time, the patient avoids sudden head movements, but may perform light activities of daily living if allowed by the therapist's or physician's recommendations. The patient is obliged to monitor their well-being - they should pay attention to whether pressure pain, dizziness, or difficulty breathing appear.

After three hours, the patient independently unfastens the Velcro or straps at the back of the collar and carefully removes it while keeping the head in a neutral position. Then the collar is placed in a clean place. If worrying symptoms such as discomfort, pain, or dizziness occur after its removal, the patient should inform the physiotherapist or attending physician.

F. Use of a stabilizing brace for the lumbar spine

The physiotherapist selects a lumbar brace of appropriate size, adjusted to the patient's body shape and trunk circumference. Before starting the procedure, the therapist explains the purpose and significance of using the brace, and discusses the subsequent stages of the procedure. The patient is asked to assume a standing or sitting position with the trunk upright and the spine in a neutral position. Application of the brace begins with proper placement of the belt on the lower back so that it covers the lumbar region and fits closely to the body. The physiotherapist guides the lateral parts of the stabilizer to the front and fastens them over the abdomen, controlling even tension. If necessary, additional elastic straps are tightened to obtain proper stabilization, taking care not to restrict the patient's free breathing or cause a feeling of pressure. Next, the therapist checks the positioning of the belt, its symmetry relative to the spine, and the comfort of the user.

After applying the brace, the physiotherapist instructs the patient on the principles of its use. The brace should be worn for three hours, during which the patient performs daily activities according to the therapist's recommendations. Excessive loads, sudden twisting movements, and lifting heavy objects should be avoided. The patient should monitor their well-being, paying attention to whether pressure, abdominal pain, dyspnea, or skin irritation appear at the site of belt contact. After three hours, the patient independently removes the brace at home. To do this, the patient unfastens the Velcro or straps, gradually loosening the elastic bands, and then gently removes the brace while remaining in a standing or sitting position with the trunk upright. After removing the brace, it should be placed in a clean, dry place and the condition of the skin at the site where it was worn should be checked.

G. Postural assessment - stabilometric platform by Koordynacja used for assessment of ground reaction forces

Preparation of the participant The participant was dressed in sportswear allowing freedom of movement. The examination was conducted barefoot - the patient stood barefoot on the surface of the stabilometric platform. The upper limbs remained freely alongside the trunk, and the gaze was directed forward at a designated point located about 2-3 meters away at eye level. Thanks to such preparation, conditions enabling objective assessment of postural reactions were obtained.

Course of the examination The procedure included two parts - assessment of stability with eyes open and with eyes closed. Each trial lasted thirty seconds. In the first stage, the patient stood in a bipedal position, assuming an upright posture, with the feet parallel and hip-width apart. In this position, two tests were performed: with eyes open and with eyes closed.

In the next stage, a single-leg standing trial was carried out. The participant stood successively on the right and left lower limb, while the free limb was flexed at the hip and knee joints, without touching the ground. Also in this case, the test was performed both with eyes open and closed.

H. Fukuda test

Assesses vestibular function through analysis of body drift while marching in place with closed eyes. First phase of the test: the patient stands with closed eyes, in silence, mouth closed, without the need to clench or press the bite between the upper and lower teeth. Then the patient stretches the arms forward and marches in place at a fairly fast pace (40 steps), lifting the knees high. Slight rotation during marching is physiological. Attention should be paid if, during marching with closed eyes and stretched upper limbs, the patient rotates to one side by more than 30 degrees. If the rotation exceeds 30 degrees, the second part of the examination is performed. On the side of dysfunction (the direction in which the patient rotates), a cotton roll is placed between the tooth surfaces, and then the patient repeats the test. If the rotation improves, the Fukuda test is positive, which suggests, for example, tension dysfunction of the temporomandibular joint. If the rotation does not improve, the Fukuda test is negative, and the temporomandibular joint dysfunction is not primary in nature.

I. Assessment of muscle tone using Myoton PRO of selected muscles, in standing position:

  • masseter muscles,
  • temporalis muscles,
  • lateral pterygoid muscles,
  • medial pterygoid muscles,
  • digastric muscles,
  • suboccipital muscles,
  • sternocleidomastoid muscles,
  • trapezius muscle, descending part,
  • suprahyoid muscles,
  • infrahyoid muscles,
  • erector spinae muscle in the cervical and lumbar regions,
  • splenius capitis and splenius cervicis muscles,
  • latissimus dorsi muscles,
  • rectus abdominis muscle,
  • external oblique abdominal muscles,
  • gluteus maximus muscles,
  • gluteus medius muscles,

J. Assessment of jaw-maxilla clenching force

The level of tension between the maxilla and mandible bones corresponds to the anatomical position of the tentorium cerebelli and the tongue. The authors designed a dedicated measuring device used to assess the clenching force between the maxilla and mandible bones. The construction consists of two parallel beams, between which strain gauges were placed, recording their deformation under the influence of pressure force. The signal from the strain gauges was then transmitted to a force meter, which displayed the result in units of mass (kilograms). The obtained result was entered into an Excel sheet. Duration of measurement: 30 s with eyes open and 30 s with eyes closed. The test was performed in a standing position. The therapist held the measuring device during the examination.

K. Assessment of diaphragm muscle tension force - pushing force

Measurement of diaphragm muscle tension is intended to correspond to pushing force. Due to the lack of possibility of checking the pushing force for the entire abdominal press, it was assumed that only the tension of the diaphragm muscle would be measured. To verify the measurement, a device consisting of a belt to which a force gauge was attached was used. The belt was fastened to the participant at the level of the lower ribs, corresponding to the diaphragm level. The force gauge registered the force value, presenting the result in units of mass (kilograms). The read results were then entered into an Excel sheet for further analysis. Duration of measurement: 30 s with eyes open and 30 s with eyes closed. The test was performed in a standing position.

L. Assessment of ground reaction forces

To assess ground reaction forces (feet), the Computerised Stability Platform CQStab2P-vUSB-1506 was used. For statistical analysis, anterior-posterior and medial-lateral sway were taken into account. The obtained results were entered into an Excel file. Duration of measurement: 30 s with eyes open and 30 s with eyes closed. The test was performed in a standing position.

Ł. Quality of life questionnaire - WHOQOL-BREF

Developed by WHO, it was used to assess the impact of therapy on quality of life. The questionnaire analyzes four main domains: physical quality of life - energy, sleep, daily activity; psychological quality of life - mood, sense of meaning, concentration; social relationships - social support, personal relationships; environment - safety, access to healthcare, comfort. Assessment was carried out before and after the therapeutic cycle, enabling analysis of the impact not only on pain, but also on general functioning.

M. Oswestry Disability Index questionnaire

A standardized tool for assessing disability caused by low back pain. It consists of 10 sections, questions, each assessing a different aspect of everyday functioning. The patient assesses limitations resulting from pain in such areas as pain intensity, lifting objects, walking, sitting, standing, sleep, sexual life, social life, and traveling, e.g., driving a car.

N. Neck Disability Index

A standardized tool consisting of 10 sections that assess the impact of neck pain on everyday life. Each section contains 6 scored responses from 0 to 5. Questionnaire sections: neck pain, personal care, lifting, reading, headaches, concentration, work, driving, sleep, leisure.

O. Insomnia Severity Index

A standardized questionnaire consisting of 7 questions, which the patient assesses on a scale from 0 to 4. They concern the subjective experience of sleep problems during the last two weeks. Questions in the ISI: difficulty falling asleep, difficulty maintaining sleep, waking too early, satisfaction with the current sleep pattern, impact of sleep problems on everyday functioning, noticeability of sleep problems by others, stress, anxiety due to sleep problems.

Ó. RDC/TMD questionnaire

A standardized questionnaire consisting of 2 parts. In the first part, the therapist conducts an interview concerning pain symptoms, movement limitations, joint sounds, and also performs palpation examination and measurements of jaw range of motion. In the second part, the patient independently assesses the impact of pain on psychosocial functioning, stress level, and quality of life.

Detailed study plan - 5-week course (3 sessions per week)

Patients were divided into 5 groups, in which they will undergo therapeutic procedures for 5 weeks. Each of the groups (1-7) will undergo procedures using different physiotherapeutic methods in the case of acute pain episodes of the lumbar spine, cervical spine, and temporomandibular joints.

I. Initial stage: participant qualification and baseline assessment (Week 0)

At the end and at the beginning of the study, patients are invited to a qualification meeting. During this meeting, the following are performed:

  • Interview - based on an original questionnaire verifying health history, nature of symptoms, risk factors (including surgeries undergone, menstrual cycle, pregnancy), lifestyle, activity level, and patient expectations.
  • Assessment using standardized questionnaires
  • WHOQOL-BREF questionnaire - determination of quality of life in four domains: physical, psychological, social, and environmental.
  • Oswestry Disability Index questionnaire - ODI
  • Neck Disability Index
  • Insomnia Severity Index
  • Performance of jaw mobility measurements and pain assessment of selected muscular structures according to the RDC/TMD questionnaire

Functional and postural assessment:

  • Balance analysis on a stabilometric platform - assessment of ground reaction forces.
  • Examination of muscle tone of the above-mentioned muscles using Myoton Pro.
  • Assessment of jaw-maxilla clenching force.
  • Assessment of diaphragm muscle tension force - pushing force.
  • Qualification and allocation to therapeutic groups - participants are classified into one of the five study groups (four intervention groups and one control group).

II. Therapeutic stage: intervention lasting 5 weeks

The interventional study lasts a total of 5 weeks. Depending on allocation, patients will participate in 15 therapeutic sessions. Intervals between procedures are 48-72 hours.

Each therapeutic session lasts 30 minutes and is conducted by an experienced physiotherapist in outpatient conditions at the Physiotherapy and Osteopathy Clinic at Sosnkowskiego 48 Street in Gorzów Wlkp.

III. Completion of the study: repeated assessment (Week 5 - after completion of therapy)

After completion of therapy sessions in each group, a comprehensive repeated patient assessment is performed according to the same parameters as at the beginning:

  • Fukuda test,
  • Repeated completion of questionnaires: WHOQOL-BREF, Oswestry Disability Index, Neck Disability Index, Insomnia Severity Index, RDC/TMD questionnaire,
  • Analysis of posture and balance contr

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20-40 years - adults who are professionally or socially active.
  • An acute pain episode of the cervical or lumbar spine - symptom duration not exceeding 6 weeks, with no previous chronic or recurrent episodes of pain in this area.
  • Ability to move independently and communicate - without cognitive or motor impairments that could prevent test performance or therapeutic cooperation.
  • Consent to participate in the study - informed consent signed after receiving full information about the aim, course, and methods of the study.
  • Ability to participate in the entire therapeutic and measurement cycle - no time-related or health-related obstacles preventing completion of the study.
  • Pain in the temporomandibular joint area, intensified during jaw movements or chewing.
  • Presence of clicking, popping, or grinding in the temporomandibular joint during jaw movement.
  • Pain in the temporomandibular joint area, intensified during jaw movements or chewing

Exclusion criteria

  • Chronic pain - pain complaints lasting longer than 6 weeks or occurring cyclically during the last year (more than 3 episodes).
  • Advanced degenerative, neurological, or post-traumatic changes. Radicular symptoms - sensory disturbances and reduced muscle strength in the upper and lower limbs.
  • Neoplasms, rheumatic, infectious, or metabolic diseases of the spine.
  • Postoperative status within a period shorter than 6 months - insufficient tissue healing and risk of secondary damage.
  • Mental or neurological disorders that hinder cooperation or the reliable completion of questionnaires (e.g. severe depression, dementia, cognitive disorders).
  • Current pharmacological treatment affecting the neuromuscular system - e.g. antiepileptic drugs, opioids, high doses of corticosteroids.
  • Participation in other clinical studies or use of other therapy (physiotherapy, osteopathy, physical medicine) within the last 4 weeks.
  • Women during menstruation.
  • Fever.
  • The study participant may discontinue participation in the study at any stage due to: withdrawal from the study, failure to comply with the protocol recommendations, or consultation with another specialist due to worsening of the condition.
  • Pregnancy.

Treatment and study plan

General Osteopathic Treatment

Other

The GOT intervention is performed in the supine position, with the patient relaxed and breathing calmly. After a brief palpatory assessment of tissue tension in the neck, shoulder girdle, and pelvis, the therapist begins rhythmic mobilization of the upper limbs as well as the shoulder, elbow, and wrist joints. This is followed by alternating movements resembling a gait pattern, which help unload the shoulder girdle and reduce tension in the cervical spine, as well as indirectly in the temporomandibular joint region. The next stage involves gentle mobilization of the cervical spine, including flexion, extension, rotation, lateral flexion, and light traction synchronized with exhalation. In the following part, the therapist mobilizes the pelvis, hips, and lower limbs through traction, oscillatory movements, and subtle rotations. The final phase includes global integration of tensions through alternating limb movements coordinated with breathing.

Visceral therapy

Other

The visceral therapy intervention begins with 3-5 minutes of patient preparation in the supine position with the lower limbs slightly flexed, which promotes relaxation of the abdominal wall. After a brief interview and palpatory assessment of the abdomen, thorax, and pelvis, the therapist identifies areas of increased tension and tissue restriction. In the first, 10-minute part of the therapy, structures functionally related to the cervical spine are treated, including the upper thoracic outlet, cervicothoracic junction, clavicular region, esophagus, stomach, and cervical fascial structures. The next, 15-minute phase includes work with the respiratory diaphragm, liver, gallbladder, colonic flexures, urinary bladder, and pelvic fascial structures. In addition, the therapist performs techniques on the parietal and visceral peritoneum. The final stage includes global balancing techniques as well as breathing and postural recommendations.

Magnetic field therapy

Other

The magnetic field therapy intervention is applied in patients with acute cervical or lumbar spine pain as a supportive physical modality with analgesic, anti-inflammatory, and anti-edematous effects. Each session lasts 30 minutes and is performed using standardized parameters: low-frequency pulsed magnetic field, intensity of 4 mT, frequency of 15 Hz, and pulsatile mode. In patients with cervical pain, the therapy is administered locally to the painful region to reduce pain, muscle tension, and tissue swelling, while improving local microcirculation. In lumbar pain, the magnetic field is applied to the lower back region to decrease pain and paraspinal muscle tension, enhance blood supply, and stimulate tissue metabolism. The intervention is intended to support reduction of acute inflammatory symptoms, improve tissue recovery, and facilitate restoration of spinal mobility and functional comfort.

Positioning postures

Other

The positioning posture intervention is used in acute cervical and lumbar pain to identify and maintain a body position that provides the greatest symptom relief. The patient is placed in a comfortable, non-forced posture, and the therapist carefully adjusts body alignment until pain is clearly reduced or completely relieved. Once the most comfortable position is found, it is maintained for 30 minutes, with minor corrections if discomfort reappears. In cervical spine pain, the patient lies supine with the head supported on a pillow or in the therapist's hands, while gentle flexion, extension, rotation, or lateral flexion is tested to find the most relieving neck position. In lumbar pain, the patient also remains supine, and the therapist adjusts hip and knee flexion, leg support, or slight pelvic rotation, most often achieving relief in the chair position. The intervention aims to reduce pain, relax muscles, and unload spinal structures.

Use of a ceriaical collar

Other

The orthopedic collar intervention begins with selection of a collar appropriate to the patient's neck height and circumference. The physiotherapist explains the purpose of the procedure and positions the patient sitting or supine with the head in a neutral position. The collar is then applied by gently lifting the chin, supporting the mandible with the contoured anterior part, and placing the lower edge evenly on the sternum and clavicles. The posterior part is secured behind the neck with Velcro straps, ensuring effective stabilization without excessive pressure, dyspnea, discomfort, or swallowing difficulties. After fitting, the therapist checks patient comfort and provides instructions for use. The collar is worn for 3 hours, during which the patient avoids sudden head movements but may perform light daily activities if recommended. The patient is instructed to monitor for adverse symptoms such as pressure pain, dizziness, or breathing difficulty. After 3 hours, the collar is remov

Use of a stabilizing brace for the lumbar spina

Other

The lumbar brace intervention involves selection of a brace matched to the patient's body shape and trunk circumference. The physiotherapist explains the purpose of the support and positions the patient standing or sitting with the trunk upright and the lumbar spine in a neutral position. The brace is applied over the lower back so that it covers the lumbar region closely and symmetrically. The lateral parts are fastened over the abdomen with even tension, and additional elastic straps may be adjusted to increase stabilization without causing discomfort or restricting breathing. After application, the therapist checks fit, symmetry, and patient comfort. The brace is worn for 3 hours during light daily activities performed according to therapeutic recommendations. The patient is advised to avoid heavy lifting, excessive loads, and sudden twisting movements, and to monitor for pressure, abdominal pain, dyspnea, or skin irritation.

Primary outcomes

  1. Assessment of muscle tone using Myoton PRO of selected muscles, in standing position.

    Time frame: 2 months

    Muscle tone assessment is performed using the Myoton PRO device in a standardized standing position. Before measurement, the patient is instructed to stand upright in a relaxed posture, with the feet placed comfortably apart and the upper limbs resting freely alongside the body. The examiner identifies and marks the selected measurement points bilaterally, then applies the probe perpendicularly to the skin surface over each muscle. The device delivers a brief mechanical impulse and records objective biomechanical parameters of muscle tone and stiffness. The examination includes the following muscles: masseter, temporalis, lateral and medial pterygoids, digastric, suboccipital, sternocleidomastoid, descending part of trapezius, suprahyoid, infrahyoid, erector spinae in the cervical and lumbar regions, splenius capitis, splenius cervicis, latissimus dorsi, rectus abdominis, external oblique, gluteus maximus, and gluteus medius. Measurements are performed under the same conditions before

  2. Assessment of jaw-maxilla clenching force

    Time frame: 2 months

    The level of tension between the maxilla and mandible bones corresponds to the anatomical position of the tentorium cerebelli and the tongue. The authors designed a dedicated measuring device used to assess the clenching force between the maxilla and mandible bones. The construction consists of two parallel beams, between which strain gauges were placed, recording their deformation under the influence of pressure force. The signal from the strain gauges was then transmitted to a force meter, which displayed the result in units of mass (kilograms). The obtained result was entered into an Excel sheet. Duration of measurement: 30 s with eyes open and 30 s with eyes closed. The test was performed in a standing position. The therapist held the measuring device during the examination.

  3. Assessment of diaphragm muscle tension force-pushing force

    Time frame: 2 months

    Measurement of diaphragm muscle tension is intended to correspond to pushing force. Due to the lack of possibility of checking the pushing force for the entire abdominal press, it was assumed that only the tension of the diaphragm muscle would be measured. To verify the measurement, a device consisting of a belt to which a force gauge was attached was used. The belt was fastened to the participant at the level of the lower ribs, corresponding to the diaphragm level. The force gauge registered the force value, presenting the result in units of mass (kilograms). The read results were then entered into an Excel sheet for further analysis. Duration of measurement: 30 s with eyes open and 30 s with eyes closed. The test was performed in a standing position.

  4. Assessment of ground reaction forces

    Time frame: 2 months

    To assess ground reaction forces (feet), the Computerised Stability Platform CQStab2P-vUSB-1506 was used. For statistical analysis, anterior-posterior and medial-lateral sway were taken into account. The obtained results were entered into an Excel file. Duration of measurement: 30 s with eyes open and 30 s with eyes closed. The test was performed in a standing position.

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2031
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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