Abdominal Belt Use to Treat Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062918
• Other study ID #: CEP?UNIFESP-1726/10
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2014
• Last updated: February 13, 2014
• Start date: January 2010
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Abdominal belt

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain using VAS		Baseline, after 1,3, and 6 months	No
Secondary	Change in functional capacity (Roland-Morris questionnaire)		Baseline, after 1,3 and 6 months	No
Secondary	Change in hours of abdominal belt use		Baseline, after 1,3 and 6 months	No
Secondary	Change in patient satisfaction with treatment using VAS		Baseline, after 1,3 and 6 months	No