Abdominal Belt Use to Treat Low Back Pain

February 13, 2014 updated by: Jamil Natour, Federal University of São Paulo

Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment

Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic mechanical-postural low back pain.

Methods: A randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion. The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient satisfaction (Likert scale); and number of anti-inflammatory pills ingested. Intention-to-treat analysis was also used.

Hypothesis - abdominal belt will improve pain in chronic low back pain patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-090
        • Universidade Federal de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients from both genders,
  • between 18 and 65 years of age,
  • who sought medical care for a complaint of lumbar pain,
  • diagnosed with Chronic low back pain, with VAS for pain between 4 and 8 cm (0-10),
  • who agreed to participate in the study and signed terms of informed consent.

Exclusion Criteria:

  • diagnosis or under diagnostic investigation of low back pain from secondary causes (spondyloarthopathy, infection, neoplasm, complete sciatica),
  • fibromyalgia,
  • previous spinal surgery,
  • litigation (patients on leave from work or in work leave processes due to low back pain);
  • having changed physical activity in previous three months;
  • body mass index (BMI) higher than 30;
  • acupuncture treatment or physiotherapy in the previous three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients in the control group did not use an abdominal belt.
Experimental: Experimental group
Patients were instructed in how to use the abdominal belt for activities of physical effort that exacerbated lumbar pain as well as during moments of pain, and not to use it during rest. They should record the number of hours of belt use per day on spreadsheets distributed for this purpose.
Device: Abdominal belt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pain using VAS
Time Frame: Baseline, after 1,3, and 6 months
Baseline, after 1,3, and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in functional capacity (Roland-Morris questionnaire)
Time Frame: Baseline, after 1,3 and 6 months
Baseline, after 1,3 and 6 months
Change in hours of abdominal belt use
Time Frame: Baseline, after 1,3 and 6 months
Baseline, after 1,3 and 6 months
Change in patient satisfaction with treatment using VAS
Time Frame: Baseline, after 1,3 and 6 months
Baseline, after 1,3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 13, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP?UNIFESP-1726/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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