Recruiting PHASE3 Symptomatic Lumbar Spinal Stenosis

New treatment option for Symptomatic Lumbar Spinal Stenosis

Official title Home-based Cycling for People With Lumbar Spinal Stenosis

ClinicalTrials.gov ID: NCT04075539

What this study is testing

What it's testing
The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 50 and older

You may be able to join if

  • age ≥ 50 year-old
  • radicular claudication (i.e. walking-induced low back, buttock and/or leg pain, relieved in siting and/or lumbar flexion positions) diagnosed by a...
  • MRI or CT-scan findings consistent with LSS reported on a written radiology report provided by a board-certified radiologist or a resident in...

You likely can't join if

  • inability to speak and/or read French language
  • inability or refusal to perform ergometric bicycle at home
  • patients already having an ergometric bicycle at home
  • history of lumbar spine surgery in the previous 12 months
  • cognitive disorders
  • severe neurologic or vascular disorders involving the lower limbs
See the full eligibility criteria
Who can join
  • age ≥ 50 year-old
  • radicular claudication (i.e. walking-induced low back, buttock and/or leg pain, relieved in siting and/or lumbar flexion positions) diagnosed by a physician
  • MRI or CT-scan findings consistent with LSS reported on a written radiology report provided by a board-certified radiologist or a resident in radiology
What rules you out
  • inability to speak and/or read French language
  • inability or refusal to perform ergometric bicycle at home
  • patients already having an ergometric bicycle at home
  • history of lumbar spine surgery in the previous 12 months
  • cognitive disorders
  • severe neurologic or vascular disorders involving the lower limbs
  • contraindication to a rehabilitation program assessed by medical examination
  • people under tutorship or curatorship
  • protected adults

The study team makes the final eligibility decision.

Where it's taking place

  • Paris, Île-de-France Region, France

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Paris, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.