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OpenTrials
Completed

NCT Number: NCT02062918

Abdominal Belt Use to Treat Low Back Pain

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

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Key information

Conditions

Chronic Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universidade Federal de Sao Paulo

São Paulo, 04023-090, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

abdominal belt

Device

Primary outcomes

  1. Change in pain using VAS

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

Secondary outcomes

  1. Change in functional capacity (Roland-Morris questionnaire)

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

  2. Change in hours of abdominal belt use

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

  3. Change in patient satisfaction with treatment using VAS

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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment

Important dates

Study start
2010
Primary completion
2010
Study completion
2013
First posted
Feb 14, 2014
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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