Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of osteopathic manipulative treatment on pain intensity, disability level and psychosocial factors in patients with chronic non-specific neck pain. We hypothesed that osteopathic manipulative treatment is better than conventional physiotherapy in management of pain, disability and depression.

Detailed Description
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This study will conduct between April 2020 and July 2020 at Denizli State Hospital. Participants who were diagnosed as chronic non-specific neck pain by a specialist physician will include the study. They will treated at physical therapy clinic. Inclussion criteria will; participants diagnosed as non-specific neck pain by the physician and Non-spesific neck pain at least 3 months. Exclussion criteria were; participants who have had surgery or are indicated for surgery, participants who have had exercise therapy and / or physical therapy in the last 1 year with a history of trauma to the cervical region, participants who have had neck pain that develop due to a particular cause such as tumor, compression fracture, metastasis and infection. According to power analysis, 102 participant will include the study with 95% coincidence interval and 80% power. Participants will be divided into 2 groups. Randomization method will be closed envelope. Group 1 will receive Conventional Physiotherapy Programme (CP), Group 2 will receive Osteopathin Manipulative Treatment (OMT). Pain Intensity at rest and activity, psychological state( Beck Depression Inventory) and Disability level (Neck Disability Index) will assess at baseline and 3 weeks.

Official Title
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Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain: A Controlled Study

Conditions
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Chronic Pain

Intervention / Treatment
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* Procedure: Conventional Physiotherapy
* Procedure: Osteopathic Manupilative Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants diagnosed as non-specific neck pain by the physician. Non-spesific neck pain at least 3 months. Exclusion Criteria: participants who have had surgery or are indicated for surgery participants who have had exercise therapy and / or physical therapy in the last 1 year with a history of trauma to the cervical region participants who have had neck pains that develop due to a particular cause such as tumor, compression fracture, metastasis and infection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Physiotherapy Group<br>This group will receive 15 sessions of conventional physiotherapy programme 5 times per week. | Procedure: Conventional Physiotherapy<br>* Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in sitting and supported with a pillow under the head, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm² and duration of 5 minute. TENS was applied to the cervical region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.<br>|
| Experimental: Osteopathic Manipulative Treatment Group<br>This group will receive 9 sessions of Osteopathic Manipulative Treatment programme 3 times per week. | Procedure: Osteopathic Manupilative Treatment<br>* Osteopathic Manupilative Treatment consist of stretching the fascia to the cervical region, soft tissue mobilization to the surrounding muscles, cervical manual traction, passive joint mobilization to the 7 cervical spine, passive joint mobilization to the 1st costa, passive joint mobilization to the clavicle and passive joint mobilization to the sternum mobilization in supine and prome positions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | pain intensity at rest and activity will measure by VAS | Change from baseline pain intensity at 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability level | Disability level will measue by Neck Disability Index. Score ranges from 0-100. Higher score indicates worse outcome. | Change from baseline Neck Disability Index score at 3 weeks | 
| Depression level | Depression will measure by Beck Depression Inventory. Scores ranges from 0-63. Higher score indicates worse outcome. | Change from baseline Beck Depression Inventory score at 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic Manipulative Treatment, Chronic Non-spesific Neck Pain, Conventional Therapy