Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tuina for Patients With Chronic Neck Pain (tuina)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01923493
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE August 13, 2013
First Posted Date  ICMJE August 15, 2013
Last Update Posted Date February 9, 2015
Study Start Date  ICMJE August 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2013)
mean neck pain intensity of the last seven days [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2013)
  • mean neck pain intensity of the last seven days [ Time Frame: 12 weeks ]
  • Neck Pain and Disability Scale (NPDS) [ Time Frame: 4 weeks, 12 weeks ]
  • Neck Disability Index (NDI) [ Time Frame: 4 weeks, 12 weeks ]
  • SF-12 health related quality of life [ Time Frame: 4 weeks, 12 weeks ]
  • 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.
  • 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
  • medication intake [ Time Frame: 4 weeks, 12 weeks ]
    number and type of medication used
  • number of serious adverse events [ Time Frame: 4 weeks, 12 weeks ]
  • adverse reactions [ Time Frame: 4 weeks, 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tuina for Patients With Chronic Neck Pain
Official Title  ICMJE Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Neck Pain
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: no intervention waiting list
    Patients in the no intervention waiting list group will not receive a study intervention.
    Intervention: Other: no intervention
  • Experimental: tuina
    tuina treatment
    Intervention: Other: tuina
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2015)
92
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2013)
88
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01923493
Other Study ID Numbers  ICMJE Tuina-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claudia M. Witt, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claudia M Witt, MD Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
PRS Account Charite University, Berlin, Germany
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP