Recruiting

Motorized Support & Semi-Rigid Support

Sponsor:

Laval University

Code:

NCT07366827

Conditions

Non-specific Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Motorized lumbar support

Standard lumbar support

Study Details

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

Study ID

NCT07366827

Start date

Feb 16, 2026

Status verified date

Apr, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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).

Exclusion Criteria:

  • 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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Motorized lumbar support

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

active comparator: Standard lumbar support

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

Interventions

Motorized lumbar support

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

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.

Primary outcome measure

  • Pain intensity [ Time Frame: Once a day for three weeks. ]
  • Physical functioning [ Time Frame: Once a day for three weeks. ]

Central Contacts and Locations

Central contacts

Hugo Massé-Alarie, PhD

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

Locations

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

Recruiting

Québec, Quebec, Canada, G1M 2S8

Contacts

Orlane Ballot, PhD

418-529-9141orlane.ballot.1@ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2026-04-24.