Tatsios Petros
Glyfada, Athens, 16561, Greece
NCT Number: NCT05229393
Chronic neck pain (CNP) is reported to be one of the most common musculoskeletal pain syndromes. Studies showed that patients with chronic neck pain compensated with changes in Pain, Function, Musculoskeletal and Respiratory outcomes. The diaphragm is a primary respiratory muscle contributing to postural stability and spinal control. Many studies showed that manual therapy and exercise improve clinical and respiratory outcomes in CNP patients. Few studies highlight the importance of diaphragm manual therapy and Reeducation Breathing Exercises in musculoskeletal diseases and in CNP patients. However, the exact mechanism is still unclear. This study aims to examine the hypothesis that: "Diaphragm Manual Therapy and Breathing Reeducation Exercises combined with cervical manual therapy - improve clinical and respiratory outcomes more than cervical manual therapy intervention only or conventional physiotherapy
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Notify Me25 year–65 year
All sexes
Interventional
Not applicable
Glyfada, Athens, 16561, Greece
Chronic neck pain (CNP) may affect the physical, social, and psychological aspects of the individual, contributing to the increase in costs in society and business. Neck pain is a major cause of morbidity and disability in everyday life and at the workplace, in many different countries and populations, but its basic pathology and pathophysiology are still unclear.
CNP patients present respiratory dysfunction and pain presence is accompanied by a varying amount of decrements in several clinical outcomes affecting the neuromusculoskeletal system like disability, range of motion restriction, and decreased proprioception as well as neuromuscular control. However, the quality of life and psychology of patients with CNP are affected in parallel. The diaphragm is the most important respiratory muscle also contributing to postural stability and spinal control. Several studies have shown that diaphragm manual therapy and breathing retraining exercises can improve respiratory, as well as pain, function, and musculoskeletal outcomes in chronic low back pain. However, the effectiveness in patients with chronic neck pain has not been definitively determined in relation to other physical therapy interventions. The primary purpose of the present study is to determine further the effectiveness of Diaphragmatic Manual Therapy and Breathing Reeducation Exercises in CNP patients. The secondary purpose is to investigate the relationship between CNP, breathing dysfunction, pain, disability, and musculoskeletal clinical outcomes.
The present study is expected to recruit 90 patients with CNP. Patients with CNP will be randomly assigned to (1) Diaphragmatic Manual Therapy plus Cervical Manual Therapy plus Breathing Reeducation Exercises (2) Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy and (3) Conventional Physiotherapy. Each participant will receive a particular intervention program depending on their group allocation. All participants will receive two evaluation sessions before and after the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diaphragmatic Manual Therapy consists of techniques intended to indirectly stretch and mobilize the diaphragmatic muscle fibers. This will help to improve muscle contraction and decrease tension. The experimental maneuvers include the Doming Diaphragmatic Technique as described by Leon Chaitow, Lewit, and the Manual Diaphragmatic Release Technique as described by Leon Chaitow. Both maneuvers are performed in two sets of 10 repetitions, within a 1-minute interval.
Cervical Manual Therapy consists of vertebral mobilization techniques according to the Mulligan technique.
Breathing Reeducation Exercises consist of i) recognition of the abnormal breathing pattern, ii) relaxation techniques for all the primary and accessory respiratory muscles, iii) diaphragm breathing reeducation iv) pursed lips exercise v) reeducation of the normal breathing rate
Ultrasound sham as Diaphragmatic Manual techniques. Disconnected ultrasound will be applied in the same position as for the experimental group for 15 min as a placebo treatment.
Cervical Manual Therapy: will consist of vertebral mobilization techniques according to Mulligan -
Conventional Physiotherapy Program consists of TENS for 15min, Microwave pulsed Diathermy for 10min, soft tissue techniques for 15min
Time frame: change from baseline up to 4 weeks and up to 3 months
The NDI consists of 10 sections. Each section is scored on a 0 (no pain) to 5 (worst imaginable pain) rating scale. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.
Time frame: change from baseline up to 4 weeks and up to 3 months
Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 100 (Worst Outcome)
Time frame: change from baseline up to 4 weeks and up to 3 months
A smartphone-based application and KFORCE SENS electronic goniometer, KINVENT, France will be used to accurately measure ROM during neck movements of Flexion-Extension, Left-Right Side Flexion, and Left-Right Rotation.
Time frame: change from baseline up to 4 weeks and up to 3 months
Lateral Photography- examination of the FHP through lateral photographs can provide very reliable estimates. The reliability remained high in both the sitting and standing position.
Time frame: change from baseline up to 4 weeks and up to 3 months
Screening tool used to detect patients with hyperventilation complaints and DB patterns. Scores>20 are used as the cut-score to identify DB in patients with various conditions. NQ values in healthy individuals range from 10 to 12 ± 7 and values do tend to decrease towards these levels after breathing retraining.
Time frame: change from baseline up to 4 weeks and up to 3 months
A test that assesses breathing dysfunction. Instructions will be given to the examiners for how to perform and record the Hi-Lo: ''Examiner at the front and slightly to the side of the person have to place one hand on the sternum of the patient and the other hand on their upper abdomen. The examiner has to determine whether thoracic or abdominal motion is dominant during breathing and to what extent this is so. Also, has to check for paradoxical breathing. The extent of thoracic or abdominal breathing rate using a score between 1 and 3.
Time frame: change from baseline up to 4 weeks and up to 3 months
A test that assesses breathing dysfunction. To perform, ask the patient to count out loud after maximal inspiration. The ability to reach 50 indicates normal respiratory function.
Time frame: change from baseline up to 4 weeks and up to 3 months
Measured by Capnography. ETCO2 less than 35 mmHg, RR of 16 breaths/min or more, will be considered as signs of respiratory pattern abnormality.
Time frame: change from baseline up to 4 weeks and up to 3 months
A test that assesses DB. This test is an indicator of a person's respiratory response to biochemical, biomechanical, and psychological fac-tors, and it seems that abnormally, shortened, BHT may indicate abnormalities in the respiratory function that are closely related to DB. Participants will be instructed to assume a comfortable sitting position and breath usually and gently in and out and at the end of a normal exhalation, they will be asked to pinch their nose and hold their breath. The instruction is to hold their breath until they cannot hold their breath any longer and require breathing in again. According to Kiesel (2020) [30], a BHT <25 secs is con-sidered as a sign of DB.
Time frame: change from baseline up to 4 weeks and up to 3 months
The difference between the values obtained during deep inspiration and expiration will be determined by tape ruler (cm), high degrees represent better outcome, low degrees represent worse outcome
Time frame: change from baseline up to 4 weeks and up to 3 months
Assesses the level of anxiety and depression experienced by patients in a hospital outpatient clinic. A subscale score >8 denotes anxiety or depression.
Time frame: change from baseline up to 4 weeks and up to 3 months
Kinesiophobia is one of the most frequently employed measures for assessing pain-related fear in pain patients through a 17-item questionnaire.
Time frame: change from baseline up to 4 weeks and up to 3 months
Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment.
University of West Attica
Other
The Effectiveness of Manual Therapy to the Cervical Spine and Diaphragm,Combined With Breathing Reeducation Exercises, in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial
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