NCT00371384

Brief Summary

This study will evaluate the effectiveness of two types of massage therapy for treating chronic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
399

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2006

Typical duration for phase_2

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

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.6 years

First QC Date

August 31, 2006

Last Update Submit

October 11, 2017

Conditions

Chronic Low Back Pain (Non-specific, Uncomplicated)

Keywords

massageback paineffectiveness

Outcome Measures

Primary Outcomes (2)

  • Dysfunction at 10 weeks

    10 weeks

  • Symptom bothersomeness at 10 weeks

    10 weeks

Secondary Outcomes (13)

  • Dysfunction at 26 and 52 weeks

    26 and 52 weeks

  • Symptom bothersomeness at 26 and 52 weeks

    26 adn 52 weeks

  • Anxiety at 10, 26 and 52 weeks

    10 16 and 52 weeks

  • Depression at 10, 26 and 52 weeks

    10 26 and 52 weeks

  • Perceived stress at 10, 26 and 52 weeks

    10 26 and 52 weeks

  • +8 more secondary outcomes

Study Arms (2)

2

EXPERIMENTAL

structural massage

Procedure: massage

1

EXPERIMENTAL

relaxation massage

Procedure: massage

Interventions

massagePROCEDURE

UP to 10 massages over 10 weeks

12

Eligibility Criteria

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

You may qualify if:

  • through 64 years of age
  • members of Group Health Cooperative health plan
  • low back pain lasting at least 3 months

You may not qualify if:

  • non-mechanical causes of back pain (e.g., sciatica, systemic/visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer, recent vertebral fracture)
  • inappropriate candidate for massage (active open skin lesions, conditions exacerbated by increased circulation, recent strokes or heart attacks, compromised immune system, systemic edema, hypersensitivity to touch or loss of sensation, recent surgery, active contagious infection)
  • characteristics complicating the interpretation of findings (e.g., involved with litigation or compensation claim, severe or progressive neurological deficit, back surgery within last 3 years, receiving other back treatment)
  • unable to speak or read English
  • had massage for any reason in prior 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Center for Health Studies

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • Cherkin DC, Sherman KJ, Kahn J, Wellman R, Cook AJ, Johnson E, Erro J, Delaney K, Deyo RA. A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial. Ann Intern Med. 2011 Jul 5;155(1):1-9. doi: 10.7326/0003-4819-155-1-201107050-00002.

    PMID: 21727288DERIVED

  • Cherkin DC, Sherman KJ, Kahn J, Erro JH, Deyo RA, Haneuse SJ, Cook AJ. Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial. Trials. 2009 Oct 20;10:96. doi: 10.1186/1745-6215-10-96.

    PMID: 19843340DERIVED

MeSH Terms

Conditions

Back Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Dan C Cherkin, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

August 1, 2006

Primary Completion

March 1, 2009

Study Completion

September 1, 2009

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)