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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no intervention waiting list | Active Comparator | Patients in the no intervention waiting list group will not receive a study intervention. |
|
| tuina | Experimental | tuina treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tuina | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| mean neck pain intensity of the last seven days | 4 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia M Witt, MD | Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin | Berlin | State of Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| no intervention | Other | 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. |
|
| 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 |