Massage Therapy for Chronic Low Back Pain

September 7, 2014 updated by: Chengdu University of Traditional Chinese Medicine

Phase 1 Study of Massage Therapy for Chronic Low Back Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610075
        • Acupuncture and Tuina college of Chengdu University of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Massage
To treat low back pain with massage
Other: Massage
Massage therapy is an intervention that can be used to relax muscle and regulate displaced joints by manual manipulation.
Other Names:
  • Tuina
ACTIVE_COMPARATOR: Ibuprofen
Medicine control group
Drug: Ibuprofen
Ibuprofen is an common analgesics which has been widely used in regular control of various pain symptom.
Other Names:
  • Pain killer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months
Time Frame: At baseline, 4th, 6th, 8th week
to assess the recovery of back function
At baseline, 4th, 6th, 8th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Japanese Orthopaedic Association Scores
Time Frame: At baseline, 4th, 6th, 8th week
to assess the improvement of back function
At baseline, 4th, 6th, 8th week
McGill pain questionnaire
Time Frame: At baseline, 4th, 6th, 8th week
To assess the alleviation of pain
At baseline, 4th, 6th, 8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (ESTIMATE)

October 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 7, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011SZ0302.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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