Trial record 2 of 66 for:    Open Studies | "Neck Pain"

Tuina for Patients With Chronic Neck Pain (tuina)

This study is currently recruiting participants.
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
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 April 17, 2014