Tuina for Patients With Chronic Neck Pain (tuina)
|ClinicalTrials.gov Identifier: NCT01923493|
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : February 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Neck Pain||Other: tuina Other: no intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: no intervention waiting list
Patients in the no intervention waiting list group will not receive a study intervention.
Other: no intervention
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.
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.
Other Name: chinese massage
- mean neck pain intensity of the last seven days [ Time Frame: 4 weeks ]
- mean neck pain intensity of the last seven days [ Time Frame: 12 weeks ]
- Neck Pain and Disability Scale (NPDS) [ Time Frame: 4 weeks, 12 weeks ]
- Neck Disability Index (NDI) [ Time Frame: 4 weeks, 12 weeks ]
- SF-12 health related quality of life [ Time Frame: 4 weeks, 12 weeks ]
- Costs [ Time Frame: 4 weeks, 12 weeks ]Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
- Body efficacy expectation [ Time Frame: 4 weeks, 12 weeks ]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
- medication intake [ Time Frame: 4 weeks, 12 weeks ]number and type of medication used
- number of serious adverse events [ Time Frame: 4 weeks, 12 weeks ]
- adverse reactions [ Time Frame: 4 weeks, 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923493
|Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin|
|Berlin, Germany, 10117|
|Principal Investigator:||Claudia M Witt, MD||Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin|