Abdominal Belt Use to Treat Low Back Pain

Phase 4CompletedNCT02062918

Federal University of São Paulo60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Low Back Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in pain using VAS

Time frame: Baseline, after 1,3, and 6 months

Secondary Outcomes

Change in functional capacity (Roland-Morris questionnaire)

Time frame: Baseline, after 1,3 and 6 months

Change in hours of abdominal belt use

Time frame: Baseline, after 1,3 and 6 months

Change in patient satisfaction with treatment using VAS

Time frame: Baseline, after 1,3 and 6 months

Abdominal Belt Use to Treat Low Back Pain

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes