Massage Therapy for Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Phase 1 Study of Massage Therapy for Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973010
• Other study ID #: 2011SZ0302.1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 22, 2013
• Last updated: September 7, 2014
• Start date: June 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology department of Sichuan Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Massage
Massage therapy is an intervention that can be used to relax muscle and regulate displaced joints by manual manipulation.

Drug:
• Ibuprofen
Ibuprofen is an common analgesics which has been widely used in regular control of various pain symptom.

Locations

Country	Name	City	State
China	Acupuncture and Tuina college of Chengdu University of TCM	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months	to assess the recovery of back function	At baseline, 4th, 6th, 8th week	Yes
Secondary	Japanese Orthopaedic Association Scores	to assess the improvement of back function	At baseline, 4th, 6th, 8th week	Yes
Secondary	McGill pain questionnaire	To assess the alleviation of pain	At baseline, 4th, 6th, 8th week	Yes