NCT01124201

Brief Summary

The purpose of this study was to compare the efficacy of three exercise programs in patients with chronic low back pain: Segmental stabilization, superficial strengthening and stretching. Groups were contrasted regarding pain, functional disability and TrA muscle activation capacity. The three groups of exercise improved pain and functional disabilities, and the Segmental stabilization group was better in the ability to recruit TrA muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

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

February 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
Last Updated

May 14, 2010

Status Verified

March 1, 2007

Enrollment Period

1.1 years

First QC Date

May 13, 2010

Last Update Submit

May 13, 2010

Conditions

Keywords

low back painclinical trialstabilizationmuscle stretching exercisesexercise therapy

Outcome Measures

Primary Outcomes (3)

  • Pain (visual analogical scale and McGill pain questionnaire)

    Six weeks

  • Functional disability (Oswestry disability questionnaire)

    Six weeks

  • TrA muscle activation capacity (Pressure Biofeedback Unit = PBU)

    Six weeks

Study Arms (3)

Stabilization group

EXPERIMENTAL

In the Segmental Stabilization group exercises focused on the transversus abdominis and lumbar multifidus muscles.

Other: Stabilization , strengthening and stretching

Strengthening group

EXPERIMENTAL

In the Superficial Strengthening group, exercises focused on the rectus abdominis, abdominus obliquus internus, abdominus obliquus externus and erector spinae muscles.

Other: Stabilization , strengthening and stretching

Stretching group

EXPERIMENTAL

Stretching group: erector spinae, posterior connective tissues and ischiotibials muscles

Other: Stabilization , strengthening and stretching

Interventions

Interventions were conducted over 6 weeks, twice per week, lasting 30 minutes each. Sessions were supervised by the investigator, and participants were instructed to report any adverse event. Groups were instructed not to participate in any other physical program during the study. Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles). Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment.

Also known as: Pressure Biofeedback Unit
Stabilization groupStrengthening groupStretching group

Eligibility Criteria

Age23 Years - 53 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • low back pain for more than 3 months
  • patients willing to participate and could participate in an exercise program safely and without cognitive impairments that would limit their participation.

You may not qualify if:

  • past history of back surgery
  • rheumatologic disorders
  • spine infections
  • spine exercise training in the 3 months before study onset.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

Related Publications (6)

  • Barr KP, Griggs M, Cadby T. Lumbar stabilization: a review of core concepts and current literature, part 2. Am J Phys Med Rehabil. 2007 Jan;86(1):72-80. doi: 10.1097/01.phm.0000250566.44629.a0.

    PMID: 17304690BACKGROUND
  • MacDonald DA, Moseley GL, Hodges PW. The lumbar multifidus: does the evidence support clinical beliefs? Man Ther. 2006 Nov;11(4):254-63. doi: 10.1016/j.math.2006.02.004. Epub 2006 May 23.

    PMID: 16716640BACKGROUND
  • Ferreira PH, Ferreira ML, Maher CG, Refshauge K, Herbert RD, Hodges PW. Changes in recruitment of transversus abdominis correlate with disability in people with chronic low back pain. Br J Sports Med. 2010 Dec;44(16):1166-72. doi: 10.1136/bjsm.2009.061515. Epub 2009 May 26.

    PMID: 19474006BACKGROUND
  • Liddle SD, Baxter GD, Gracey JH. Exercise and chronic low back pain: what works? Pain. 2004 Jan;107(1-2):176-90. doi: 10.1016/j.pain.2003.10.017.

    PMID: 14715404BACKGROUND
  • Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.

    PMID: 15867409BACKGROUND
  • Franca FR, Burke TN, Hanada ES, Marques AP. Segmental stabilization and muscular strengthening in chronic low back pain: a comparative study. Clinics (Sao Paulo). 2010;65(10):1013-7. doi: 10.1590/s1807-59322010001000015.

Related Links

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fabio R França, MSc

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2010

First Posted

May 14, 2010

Study Start

February 1, 2007

Primary Completion

March 1, 2008

Study Completion

June 1, 2009

Last Updated

May 14, 2010

Record last verified: 2007-03

Locations