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Tuina for Patients With Chronic Neck Pain (tuina)

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tuina
no intervention
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring neck pain, tuina

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

no intervention waiting list

tuina

Arm Description

Patients in the no intervention waiting list group will not receive a study intervention.

tuina treatment

Outcomes

Primary Outcome Measures

mean neck pain intensity of the last seven days

Secondary Outcome Measures

mean neck pain intensity of the last seven days
Neck Pain and Disability Scale (NPDS)
Neck Disability Index (NDI)
SF-12 health related quality of life
Costs
Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
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
medication intake
number and type of medication used
number of serious adverse events
adverse reactions

Full Information

First Posted
August 13, 2013
Last Updated
February 6, 2015
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01923493
Brief Title
Tuina for Patients With Chronic Neck Pain
Acronym
tuina
Official Title
Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
neck pain, tuina

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no intervention waiting list
Arm Type
Active Comparator
Arm Description
Patients in the no intervention waiting list group will not receive a study intervention.
Arm Title
tuina
Arm Type
Experimental
Arm Description
tuina treatment
Intervention Type
Other
Intervention Name(s)
tuina
Other Intervention Name(s)
chinese massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
mean neck pain intensity of the last seven days
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
mean neck pain intensity of the last seven days
Time Frame
12 weeks
Title
Neck Pain and Disability Scale (NPDS)
Time Frame
4 weeks, 12 weeks
Title
Neck Disability Index (NDI)
Time Frame
4 weeks, 12 weeks
Title
SF-12 health related quality of life
Time Frame
4 weeks, 12 weeks
Title
Costs
Description
Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
Time Frame
4 weeks, 12 weeks
Title
Body efficacy expectation
Description
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
Time Frame
4 weeks, 12 weeks
Title
medication intake
Description
number and type of medication used
Time Frame
4 weeks, 12 weeks
Title
number of serious adverse events
Time Frame
4 weeks, 12 weeks
Title
adverse reactions
Time Frame
4 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia M Witt, MD
Organizational Affiliation
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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Tuina for Patients With Chronic Neck Pain

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