Abdominal Belt Use to Treat Low Back Pain

Study Overview
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Brief Summary
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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

Official Title
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Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: Abdominal belt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Patients in the control group did not use an abdominal belt. | |
| Experimental: Experimental group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal belt, Chronic low back pain, Pain, Functional capacity