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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
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.
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.
Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
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
Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
Time frame: 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
Time frame: 4 weeks, 12 weeks
medication intake
number and type of medication used
Time frame: 4 weeks, 12 weeks
number of serious adverse events
Time frame: 4 weeks, 12 weeks
adverse reactions
Time frame: 4 weeks, 12 weeks
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