NCT01973010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 low-back-pain

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_2 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

October 22, 2013

Last Update Submit

September 7, 2014

Conditions

Keywords

massagelow back pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Japanese Orthopaedic Association Scores

    At baseline, 4th, 6th, 8th week

  • McGill pain questionnaire

    At baseline, 4th, 6th, 8th week

Study Arms (2)

Massage

EXPERIMENTAL

To treat low back pain with massage

Other: Massage

Ibuprofen

ACTIVE COMPARATOR

Medicine control group

Drug: Ibuprofen

Interventions

MassageOTHER

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

Also known as: Tuina
Massage

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

Also known as: Pain killer
Ibuprofen

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acupuncture and Tuina college of Chengdu University of TCM

Chengdu, Sichuan, 610075, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Low Back Pain

Interventions

MassageIbuprofen

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Fanrong Liang, Professor

    Chengdu University of TCM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 31, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations