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Massage Therapy for Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT01973010
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : September 9, 2014
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Massage Drug: Ibuprofen Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Massage Therapy for Chronic Low Back Pain
Study Start Date : June 2013
Primary Completion Date : May 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

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 Name: 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 Name: Pain killer

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Japanese Orthopaedic Association Scores [ Time Frame: At baseline, 4th, 6th, 8th week ]
    to assess the improvement of back function

  2. McGill pain questionnaire [ Time Frame: At baseline, 4th, 6th, 8th week ]
    To assess the alleviation of pain

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973010

China, Sichuan
Acupuncture and Tuina college of Chengdu University of TCM
Chengdu, Sichuan, China, 610075
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Principal Investigator: Fanrong Liang, Professor Chengdu University of TCM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01973010     History of Changes
Other Study ID Numbers: 2011SZ0302.1
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Chengdu University of Traditional Chinese Medicine:
low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action