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Abdominal Belt Use to Treat Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Abdominal belt
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Abdominal belt, Chronic low back pain, Pain, Functional capacity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade Federal de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

Patients in the control group did not use an abdominal belt.

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.

Outcomes

Primary Outcome Measures

Change in pain using VAS

Secondary Outcome Measures

Change in functional capacity (Roland-Morris questionnaire)
Change in hours of abdominal belt use
Change in patient satisfaction with treatment using VAS

Full Information

First Posted
February 12, 2014
Last Updated
February 13, 2014
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02062918
Brief Title
Abdominal Belt Use to Treat Low Back Pain
Official Title
Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Abdominal belt, Chronic low back pain, Pain, Functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group did not use an abdominal belt.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Abdominal belt
Primary Outcome Measure Information:
Title
Change in pain using VAS
Time Frame
Baseline, after 1,3, and 6 months
Secondary Outcome Measure Information:
Title
Change in functional capacity (Roland-Morris questionnaire)
Time Frame
Baseline, after 1,3 and 6 months
Title
Change in hours of abdominal belt use
Time Frame
Baseline, after 1,3 and 6 months
Title
Change in patient satisfaction with treatment using VAS
Time Frame
Baseline, after 1,3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-090
Country
Brazil

12. IPD Sharing Statement

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Abdominal Belt Use to Treat Low Back Pain

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