Tuina for Patients With Chronic Neck Pain (tuina)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|