Abdominal Belt Use to Treat Low Back Pain

Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02062918

Enrollment

Registered

2014-02-14

Start date

2010-01-31

Completion date

2013-02-28

Last updated

2014-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

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

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

Interventions

DEVICEAbdominal belt

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Change in pain using VAS	Baseline, after 1,3, and 6 months

Secondary

Measure	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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026