Abdominal Belt Use to Treat Low Back Pain

NCT02062918 | Completed Phase 4

• 1 other identifier: CEP?UNIFESP-1726/10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Low Back Pain

Keywords

Abdominal belt; Chronic low back pain; Pain; Functional capacity

Outcome Measures

Primary Outcomes (1)

• Change in pain using VAS

  Baseline, after 1,3, and 6 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Control group

NO INTERVENTION

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

Experimental group

EXPERIMENTAL

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

Interventions

Abdominal belt DEVICE

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023-090, Brazil

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rheumatology Division

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 14, 2014
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: February 1, 2013
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

BR (1)