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Completed

NCT Number: NCT05154526

Comparison of the Efficiency of Manual Therapy and Exercise in People With Mechanical Neck Pain

Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology underlying the complaints. Most of the MNP cases are due to muscular or paraspinal soft tissue problems and show improvement in the first 6 weeks with conservative treatment methods. Various manual therapy techniques and various exercises are reported to have positive effects on neck pain. However, the isolated effects of these techniques in people with MNP are not fully known. Therefore, the aim of this study is to determine the effects of two different treatment programs in which the manual therapy technique and the exercise program are applied in individuals with MNP. In addition, comparing the effect of the treatment program in which manual therapy and exercise program are applied together with the isolated effects of these techniques is another aim.

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Key information

Conditions

Neck Pain Behavior Mobility Limitation Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)

About this study

Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology underlying the complaints. MNP causes symptoms such as pain in the cervical region, increased sensitivity to pressure, decrease in active range of motion (ROM) of the cervical region, drowsiness, and dizziness. Most of the MNP cases are due to muscular or paraspinal soft tissue problems and show improvement in the first 6 weeks with conservative treatment methods. When the current treatment recommendations are examined according to the duration of neck pain accompanied by limitation of movement, an exercise program that includes thoracic region mobilization, cervical ROM exercises, and strengthening and stretching exercises for the scapulothoracic region and upper extremity muscles is recommended for acute neck pain. In addition, various manual therapy techniques can be applied to the cervical region.

In subacute neck pain, an exercise program is applied to increase the endurance of the neck and upper extremity muscles. During this period, various manual therapy methods can be applied to the thoracic and cervical region. In chronic neck pain, combined treatment applications including various exercises, mobilization and manipulation techniques, dry needling, laser and intermittent manual/mechanical traction are recommended. It is stated that the high-velocity low-amplitude technique, which is among the manual therapy techniques and used in many musculoskeletal problems, can increase the ROM, decrease the pain and improve the function.

Various manual therapy techniques and various exercises are reported to have positive effects on neck pain. However, the isolated effects of these techniques in people with MNP are not fully known. Therefore, the aim of this study is to determine the effects of two different treatment programs in which the manual therapy technique and the exercise program are applied in individuals with MNP. In addition, comparing the effect of the treatment program in which manual therapy and exercise program are applied together with the isolated effects of these techniques is another aim.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with MNP
  • Decrease in cervical region ROM
  • Ability to adapt to verbal, written and visual instructions

Exclusion criteria

  • Spine surgery history
  • Neurological neck pain in the cervical region
  • Presence of tumor in the cervical region
  • Blood coagulation disorders
  • Vertebrobasilar artery insufficiency
  • Cervical region trauma history
  • Communicative/mental problems that prevent participation in treatment
  • Inflammatory rheumatological diseases affecting the cervical region
  • Physiotherapy and rehabilitation treatments for neck pain in the last 3 months

Treatment and study plan

Manual therapy

Other

Manual Therapy: High velocity-low amplitude technique

exercise program

Other

Exercise program

Primary outcomes

  1. Neck Disability Index

    Time frame: 6 weeks

    The neck function of the patients will be evaluated with the Neck Disability Index. The disability levels of the participants due to neck pain will be evaluated with the 'Neck Disability Index' . This scale consists of 10 items including pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleep status and leisure activities. Each item was scored from 0 (no disability) to 5 (complete disability).

  2. Pain intensity

    Time frame: 6 weeks

    Pain intensity of the patients at rest, during activity and at night was assessed using the Visual Analog Scale (VAS). In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.

Secondary outcomes

  1. Range of Motion (ROM)

    Time frame: 6 weeks

    Active neck flexion-extension, right-left lateral flexion and right-left rotation ROM of the participants will be evaluated with cervical goniometer.

  2. Pain Pressure Threshold (PPT)

    Time frame: 6 weeks l

    Participants' PPTs will be evaluated with a pressure algometer (Baseline Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) that can measure pressure in kilograms and pounds, with a 1 cm diameter circular rubber tip attached to the piston of the pressure gauge

  3. 36-Item Short Form Survey (SF-36)

    Time frame: 6 weeks

    Patients' quality of life will be evaluated with SF-36. This scale is a general health questionnaire that evaluates the person's perception of quality of life in the last four weeks under 8 sub-headings and 36 items. The sub-headings it includes; physical functions, physical roles, pain, social functions, mental health, emotional roles, energy and general health perception.

  4. Patient satisfaction level

    Time frame: At the end of 6-weeks

    Patient Satisfaction will be assessed with the Global Rating of Change (GRC) scale. The scale to be used consists of 5 points (-2: I am much worse. -1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).

Sponsors and collaborators

Lead sponsor

Tuğba Akgüller

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2021
Registry last updated
May 26, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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