Effectiveness of Motorised Lumbar Support for Non-specific Low Back Pain

NCT07366827 | Recruiting

• 1 other identifier: 2025-3312
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain (LBP) represents a common musculoskeletal conditions worlwide, causing substantial disability and economic burden. While traditional semi-rigid lumbar supports are commonly prescribed to alleviate LBP symptoms, their effectiveness remains limited by their static mechanical properties and lack of adaptability to movement patterns. Motorized lumbar support offer a novel approach by allowing the application of controlled decompressive forces while maintaining functional mobility. This experimental study aims to compare the effectiveness between a motorized lumbar support and a standard semi-rigid support in adults with non-specific LBP. Seventy adults with non-specific low back pain (LBP) will be recruited. Primary outcomes (pain intensity and physical functioning \[daily average\]) will be collected daily, while secondary outcomes (average pain intensity over the last week, pain-related disability, etc.) will be assessed at baseline, 3 and 9 weeks after randomization.

Conditions

Non-specific Low Back Pain

Keywords

non-specific low back pain; motorized lumbar support; standard lumbar support

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  The numeric scale from 0 to 10 (0: no pain; 10: worst imaginable pain) will be used to rate average pain intensity experienced during the day.

  Once a day for three weeks.

• Physical functioning

  The numeric scale from 0 to 10 (0: no difficulty functioning; 10: inability to function) will be used to rate the ability to carry out daily activities.

  Once a day for three weeks.

Secondary Outcomes (8)

• Pain-related disability

  Baseline, week 3 and 9.

• Pain intensity

  Baseline, week 3 and 9.

• Pain catastrophizing

  Baseline, week 3 and 9.

• Fear of movement

  Baseline, week 3 and 9.

• Pain self-efficacy

  Baseline, week 3 and 9.

Other Outcomes (1)

• Perceived effect of the lumbar support

  Once a day for three weeks.

Study Arms (2)

Motorized lumbar support

EXPERIMENTAL

The motorized lumbar support is battery-powered orthosis providing adjustable traction between thoracic and pelvic components, and apply controlled decompressive forces while maintaining mobility.

Other: Motorized lumbar support

Standard lumbar support

ACTIVE COMPARATOR

This is a semi-rigid lumbar support featuring six steel stays, elastic side panels, and a neoprene wrap that allows for individualized adjustment.

Other: Standard lumbar support

Interventions

Motorized lumbar support OTHER

Participants will be advised to wear motorized lumbar support for a minimum of 4 hours and a maximum of 8 consecutive hours per day throughout the three-week study period. To reach the target of 4 hours, participants will gradually increase their daily wear time : 2 hours on the first day, 3 hours on the second day and 4 hours on the third day.

Motorized lumbar support

Standard lumbar support OTHER

Participants will be advised to wear motorized lumbar support for a minimum of 4 hours and a maximum of 8 consecutive hours per day throughout the three-week study period. To reach the target of 4 hours, participants will gradually increase their daily wear time : 2 hours on the first day, 3 hours on the second day and 4 hours on the third day.

Standard lumbar support

Eligibility Criteria

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

You may qualify if:

• Adults between 18 and 65 years old with non-specific low back pain.
• Average pain level of ≥3 out of 10 during the previous week.
• Pain-related disability ≥10% at ODI.
• Pain relief must be present during manual traction, measured by a moderate improvement (+3) on a global rating of change scale (anchors: -7 to +7).

You may not qualify if:

• Specific cause of low back pain (e.g., fracture, cancer, spinal stenosis, severe spondylolisthesis)
• Presence of neuropathic pain (leg or back of 4 at the DN4).
• Pregnancy.
• Body mass index \> 32.
• Waist size between 74 and 115 cm.
• Respiratory and circulatory conditions.
• Osteoporosis.
• Paraplegia and hemiplegia.
• Abdominal wounds at the site of the orthosis.
• Rib or pelvic fractures less than 3 months.
• Presence of electronic medical device.

Sponsors & Collaborators

• Laval University: lead
• Corset Saint-Francis: collaborator
• MedTeq: collaborator

Study Sites (1)

Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)

Québec, Quebec, G1M 2S8, Canada

RECRUITING

Study Officials

• Hugo Massé-Alarie, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Massé-Alarie, PhD

CONTACT

+1 (418) 529 9141; hugo.masse-alarie@fmed.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The statistician will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 26, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become accessible after the publication and will remain accessible for a period of 5 years after initial release.
• Access Criteria: Access to IPD will be granted to qualified researchers whose proposals are methodologically sound and ethically approved. Researchers must obtain approval from their Institutional Review Board (IRB), Research Ethics Board (REB), or equivalent ethics committee, and must sign a Data Use Agreement (DUA) before receiving any data. Requests for access should be submitted to: hugo.masse-alarie@fmed.ulaval.ca.

Locations

CA (1)