Tuina for Patients With Chronic Neck Pain (tuina)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01923493
First received: August 13, 2013
Last updated: December 17, 2013
Last verified: August 2013
  Purpose

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 Intervention
Chronic Neck Pain
Other: tuina
Other: no intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • mean neck pain intensity of the last seven days [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean neck pain intensity of the last seven days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Neck Pain and Disability Scale (NPDS) [ Time Frame: 4 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Neck Disability Index (NDI) [ Time Frame: 4 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • SF-12 health related quality of life [ Time Frame: 4 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Costs [ Time Frame: 4 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.

  • Body efficacy expectation [ Time Frame: 4 weeks, 12 weeks ] [ Designated as safety issue: No ]
    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

  • medication intake [ Time Frame: 4 weeks, 12 weeks ] [ Designated as safety issue: No ]
    number and type of medication used

  • number of serious adverse events [ Time Frame: 4 weeks, 12 weeks ] [ Designated as safety issue: Yes ]
  • adverse reactions [ Time Frame: 4 weeks, 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923493

Contacts
Contact: Claudia M Witt, MD +4930450529132 claudia.witt@charite.de

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

No publications provided

Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01923493     History of Changes
Other Study ID Numbers: Tuina-13
Study First Received: August 13, 2013
Last Updated: December 17, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
neck pain
tuina

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014