Back to resultsMassage Therapy for Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Massage
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring massage, low back pain
Eligibility Criteria
Inclusion Criteria:
- In accordance of the diagnostic criteria of low back pain;
- Age between 20 and 55 years old;
- Not taking hormone drugs or antirheumatic drugs within the latest 2 months;
- No allergy history of hormone drugs Pain medicine;
- volunteer participation and signing an informed consent in writing.
Exclusion Criteria:
- Being pregnant or during lactation;
- Having suffered from serious psychiatric, neurologic, cardiovascular, respiratory, or renal illnesses, and so forth;
- Severe neurological deficits caused by severe lumbar disc protrusion, and operation indications;
- Receiving message therapy in past 3 months for releasing low back pain.
Sites / Locations
- Acupuncture and Tuina college of Chengdu University of TCM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Massage
Ibuprofen
Arm Description
To treat low back pain with massage
Medicine control group
Outcomes
Primary Outcome Measures
Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months
to assess the recovery of back function
Secondary Outcome Measures
Japanese Orthopaedic Association Scores
to assess the improvement of back function
McGill pain questionnaire
To assess the alleviation of pain
Full Information
NCT ID
NCT01973010
First Posted
October 22, 2013
Last Updated
September 7, 2014
Sponsor
Chengdu University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01973010
Brief Title
Massage Therapy for Chronic Low Back Pain
Official Title
Phase 1 Study of Massage Therapy for Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether massage is effective in the treatment of low back pain and to optimize clinical therapeutic schedule of massage for low back pain.
Detailed Description
Chronic low back pain is a prevalent condition among adults. Large majority of the population suffer from Chronic low back pain in their lifetime. At present, there is still no standard treatment for chronic low back pain. Massage is commonly chose and widely used by sufferer as a complement to conventional treatment. However, its effectiveness is still not convinced. This trial is designed to assess the effectiveness of massage for chronic low back pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
massage, low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Massage
Arm Type
Experimental
Arm Description
To treat low back pain with massage
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Medicine control group
Intervention Type
Other
Intervention Name(s)
Massage
Other Intervention Name(s)
Tuina
Intervention Description
Massage therapy is an intervention that can be used to relax muscle and regulate displaced joints by manual manipulation.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Pain killer
Intervention Description
Ibuprofen is an common analgesics which has been widely used in regular control of various pain symptom.
Primary Outcome Measure Information:
Title
Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months
Description
to assess the recovery of back function
Time Frame
At baseline, 4th, 6th, 8th week
Secondary Outcome Measure Information:
Title
Japanese Orthopaedic Association Scores
Description
to assess the improvement of back function
Time Frame
At baseline, 4th, 6th, 8th week
Title
McGill pain questionnaire
Description
To assess the alleviation of pain
Time Frame
At baseline, 4th, 6th, 8th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In accordance of the diagnostic criteria of low back pain;
Age between 20 and 55 years old;
Not taking hormone drugs or antirheumatic drugs within the latest 2 months;
No allergy history of hormone drugs Pain medicine;
volunteer participation and signing an informed consent in writing.
Exclusion Criteria:
Being pregnant or during lactation;
Having suffered from serious psychiatric, neurologic, cardiovascular, respiratory, or renal illnesses, and so forth;
Severe neurological deficits caused by severe lumbar disc protrusion, and operation indications;
Receiving message therapy in past 3 months for releasing low back pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanrong Liang, Professor
Organizational Affiliation
Chengdu University of TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acupuncture and Tuina college of Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25352050
Citation
Yang M, Feng Y, Pei H, Deng S, Wang M, Xiao X, Zheng H, Lai Z, Chen J, Li X, He X, Liang F. Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial. Trials. 2014 Oct 29;15:418. doi: 10.1186/1745-6215-15-418.
Results Reference
derived
Learn more about this trial
Massage Therapy for Chronic Low Back Pain
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