Tuina for Patients With Chronic Neck Pain

Chronic Neck Pain Clinical Trial

— tuina  

Official title:

Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923493
• Other study ID #: Tuina-13
• Status: Completed
• Phase: N/A
• First received: August 13, 2013
• Last updated: February 6, 2015
• Start date: August 2013
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

Other:
• tuina
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.
• 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.

Locations

Country	Name	City	State
Germany	Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean neck pain intensity of the last seven days		4 weeks	No
Secondary	mean neck pain intensity of the last seven days		12 weeks	No
Secondary	Neck Pain and Disability Scale (NPDS)		4 weeks, 12 weeks	No
Secondary	Neck Disability Index (NDI)		4 weeks, 12 weeks	No
Secondary	SF-12 health related quality of life		4 weeks, 12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	medication intake	number and type of medication used	4 weeks, 12 weeks	No
Secondary	number of serious adverse events		4 weeks, 12 weeks	Yes
Secondary	adverse reactions		4 weeks, 12 weeks	Yes