Tuina for Patients With Chronic Neck Pain (tuina)

• ClinicalTrials.gov Identifier: NCT01923493
• Recruitment Status: Completed
• First Posted: August 15, 2013
• Last Update Posted: February 9, 2015
• Sponsor: Charite University, Berlin, Germany
• Information provided by (Responsible Party): Claudia M. Witt, Charite University, Berlin, Germany

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Neck Pain	Other: tuina; Other: no intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

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 Name: chinese massage

Outcome Measures

Primary Outcome Measures :

1. mean neck pain intensity of the last seven days [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

1. mean neck pain intensity of the last seven days [ Time Frame: 12 weeks ]
2. Neck Pain and Disability Scale (NPDS) [ Time Frame: 4 weeks, 12 weeks ]
3. Neck Disability Index (NDI) [ Time Frame: 4 weeks, 12 weeks ]
4. SF-12 health related quality of life [ Time Frame: 4 weeks, 12 weeks ]
5. 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.
6. 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
7. medication intake [ Time Frame: 4 weeks, 12 weeks ]
   number and type of medication used
8. number of serious adverse events [ Time Frame: 4 weeks, 12 weeks ]
9. adverse reactions [ Time Frame: 4 weeks, 12 weeks ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Germany

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

Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

• Principal Investigator: Claudia M Witt, MD; Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin

More Information

• Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT01923493
• Other Study ID Numbers: Tuina-13
• First Posted: August 15, 2013
• Last Update Posted: February 9, 2015
• Last Verified: February 2015

Keywords provided by Claudia M. Witt, Charite University, Berlin, Germany:

neck pain; tuina

Additional relevant MeSH terms:

Neck Pain; Pain; Neurologic Manifestations