Abdominal Belt Use to Treat Low Back Pain

Federal University of São Paulo

Status and phase: Completed; Phase 4

Conditions: Chronic Low Back Pain

Treatments: Device: Abdominal belt

Study type: Interventional

Funder types: Other

Identifiers

NCT02062918

CEP?UNIFESP-1726/10

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Control group

No Intervention group

Description:

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

Experimental group

Experimental group

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.

Treatment:

Device: Abdominal belt