Tuina for Patients With Chronic Neck Pain (tuina)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Other: no intervention; Other: tuina

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Experimental: tuina; tuina treatment	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.; Other Names: chinese massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean neck pain intensity of the last seven days	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Claudia M Witt, MD, Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (Estimate): August 15, 2013

Study Record Updates

• Last Update Posted (Estimate): February 9, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: neck pain; tuina
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: Tuina-13