Tuina for Patients With Chronic Neck Pain

Not Applicable

Completed

• Conditions: Chronic Neck Pain
• Interventions: Other: no intervention; Other: tuina

• Registration Number: NCT01923493
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-15
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-06
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no intervention waiting list	no intervention	Patients in the no intervention waiting list group will not receive a study intervention.
tuina	tuina	tuina treatment

Primary Outcome Measures

Name	Time	Method
mean neck pain intensity of the last seven days	4 weeks

Secondary Outcome Measures

Name	Time	Method
mean neck pain intensity of the last seven days	12 weeks
SF-12 health related quality of life	4 weeks, 12 weeks
Neck Pain and Disability Scale (NPDS)	4 weeks, 12 weeks
Costs	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	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
number of serious adverse events	4 weeks, 12 weeks
Neck Disability Index (NDI)	4 weeks, 12 weeks
medication intake	4 weeks, 12 weeks	number and type of medication used
adverse reactions	4 weeks, 12 weeks

Trial Locations

Locations (1)

Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany