Tuina for Patients With Chronic Neck Pain

Study Overview
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Brief Summary
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The aim is to evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain.

Detailed Description
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Objective: To evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain. Study Design: Open single-centre randomized two-armed controlled trial. Setting: The study will be performed at a University out-patient clinic specialized in Integrative Medicine, with experience in the treatment of chronic pain. Participants: 88 outpatients with chronic neck pain, who will be randomly allocated to two groups (tuina, or no intervention (control)). Intervention: Patients receive either six tuina treatments within 3 weeks or no additional intervention. Main outcome measure: The primary outcome is the mean neck pain intensity over the last seven days on a visual analogue scale (Huskisson, 1974) (VAS, 0-100 mm, 0 = no pain, 100= worst imaginable pain) after four weeks.

Official Title
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Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List

Conditions
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Chronic Neck Pain

Intervention / Treatment
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* Other: tuina
* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female or male 18 to 60 years of age clinical diagnosis chronic neck pain, i.e. neck pain for at least 12 weeks if additional back pain is reported, neck pain has to be predominant intensity of the average neck pain over the last 7 days had to be more than 40 mm on a 100-mm visual analogue scale (VAS) ability to give oral and signed written informed consent patient's mental and physical ability to participate in the trial willingness to be randomized, to attend visits, to complete questionnaires written and oral informed consent Exclusion Criteria: neck pain caused by a malignant disease neck pain caused by trauma rheumatic disorder prior spinal column surgery neurological symptoms, e.g. radicular symptoms because of a prolapsed vertebral disc suspected osteoporosis obesity with BMI ≥30 Kg/m2 known vascular anomaly such as aneurysm regular intake of analgesics (>1x per week) because of a additional diseases intake of centrally acting analgesics current application for a benefit pregnancy severe acute and or chronic disease which does not allow participation in the therapy other limitations which do not allow participation in the therapy alcohol or substance abuse tuina treatment during the six months before study entry participation in another clinical trial during six months before the study and parallel to the study anticipated new treatments which have a positive influence on the neck pain such as physiotherapy against neck pain, acupuncture, massage during the study no sufficient German language skills

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: no intervention waiting list<br>Patients in the no intervention waiting list group will not receive a study intervention. | Other: no intervention<br>* Patients in the no intervention waiting list group will not receive a study intervention. They will continue their respective pre-study therapy during the study period.<br>|
| Experimental: tuina<br>tuina treatment | Other: tuina<br>* Patients in the tuina group will receive a tuina therapy (also known as Chinese massage). A Chinese massage lasts about 20 to 30 minutes. A series of 6 sessions with 2 treatments per week is applied.<br>* Other names: chinese massage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean neck pain intensity of the last seven days |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean neck pain intensity of the last seven days |  | 12 weeks | 
| Neck Pain and Disability Scale (NPDS) |  | 4 weeks, 12 weeks | 
| Neck Disability Index (NDI) |  | 4 weeks, 12 weeks | 
| SF-12 health related quality of life |  | 4 weeks, 12 weeks | 
| Costs | Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires. | 4 weeks, 12 weeks | 
| Body efficacy expectation | Body-Efficacy Expectation (BEE) is a scale to measure the conviction that one's body is able to deal with health-threatening factors by itself. It is a six items' scale developed in the Institute of Social Medicine, Epidemiology and Health Economics | 4 weeks, 12 weeks | 
| medication intake | number and type of medication used | 4 weeks, 12 weeks | 
| number of serious adverse events |  | 4 weeks, 12 weeks | 
| adverse reactions |  | 4 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck pain, tuina