Massage Therapy for Chronic Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Chengdu University of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01973010
First received: October 22, 2013
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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 Intervention
Low Back Pain
Other: Massage
Drug: Ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Massage Therapy for Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months [ Time Frame: At baseline, 4th, 6th, 8th week ] [ Designated as safety issue: Yes ]
    to assess the recovery of back function


Secondary Outcome Measures:
  • Japanese Orthopaedic Association Scores [ Time Frame: At baseline, 4th, 6th, 8th week ] [ Designated as safety issue: Yes ]
    to assess the improvement of back function

  • McGill pain questionnaire [ Time Frame: At baseline, 4th, 6th, 8th week ] [ Designated as safety issue: Yes ]
    To assess the alleviation of pain


Estimated Enrollment: 150
Study Start Date: June 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973010

Contacts
Contact: Jie Yang, Ph.D +86-138-8229-6714 jennyyangjie@126.com

Locations
China, Sichuan
Acupuncture and Tuina college of Chengdu University of TCM Recruiting
Chengdu, Sichuan, China, 610075
Contact: Ming-xiao Yang, M.S.    +86-15882005946    dale.mx.young@gmail.com   
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
Principal Investigator: Fanrong Liang, Professor Chengdu University of TCM
  More Information

No publications provided

Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01973010     History of Changes
Other Study ID Numbers: 2011SZ0302.1
Study First Received: October 22, 2013
Last Updated: October 25, 2013
Health Authority: China: Science and Technology department of Sichuan Province

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

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

ClinicalTrials.gov processed this record on August 21, 2014