Rehab Program for Spinal Stenosis

Overseen By Mariève Houle, PhD(c)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université du Québec à Trois-Rivières

Disqualifiers: Congenital LSS, Osteoarthritis, Neurological disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

66 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC. The intervention group will receive standardized education and specific exercises while the control group will only receive standardized education. The program in both groups will last for 6 weeks with 4 evaluation timepoints (baseline, week 2, week 4 and post-intervention assessment). The primary outcomes will be walking capacity measured with the Self-Paced Walking Test and the secondary outcomes will be back and leg pain intensity, LSS-related disability, self-efficacy, level of physical activity, anxiety and depression, physical activity level, gait pattern characteristics, balance, and global perceived change.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Specific Rehabilitation Program for spinal stenosis?

Research shows that a 6-week specific rehabilitation program combining education and exercises can improve walking capacity in patients with lumbar spinal stenosis, which is a common cause of disability. This suggests that targeted rehabilitation programs may help improve mobility and quality of life for those with this condition. ^{1 2 3 4 5}

Is the rehab program for spinal stenosis safe for humans?

Research on spinal stenosis treatments, including surgery, shows a low risk of complications, with a 3.5 per 1000 operations fatality rate within 30 days. Non-surgical treatments, like lifestyle interventions and balance exercises, have been studied for safety and feasibility, suggesting they are generally safe for humans. ^{6 7 8 9 10}

How is the Specific Rehabilitation Program treatment different from other treatments for spinal stenosis?

The Specific Rehabilitation Program is unique because it combines education and exercises specifically designed to improve walking capacity in patients with spinal stenosis, focusing on self-management and accessibility, which are not commonly available in other conservative treatments. ^{3 4 5 11 12}

Eligibility Criteria

This trial is for people over 50 with lumbar spinal stenosis (LSS) causing nerve compression, who can speak French and commit to three sessions a week. They should be able to walk 20 meters but not continuously for 30 minutes. Excluded are those with congenital LSS, significant hip/knee arthritis, neurological diseases like Parkinson's, uncontrolled diabetes, heart failure, vascular claudication or recent back surgery.

Inclusion Criteria

I can speak and understand French.

I can attend 3 sessions a week.

Being able to provide informed written consent.

Exclusion Criteria

My diabetes is not under control.

I have heart failure.

I experience leg pain from walking due to poor blood flow.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week specific rehabilitation program combining education and exercises

6 weeks

4 visits (baseline, week 2, week 4, post-intervention assessment)

Follow-up

Participants are monitored for changes in anxiety, depression, physical activity, and other secondary outcomes

6 weeks

2 visits (week 6, week 12)

Treatment Details

Interventions

• Specific Rehabilitation Program

Trial Overview The study tests if a specific 6-week program of education plus exercises improves walking in LSS patients compared to education alone. Participants will be checked at the start, after weeks two and four, and post-intervention on their walking ability, pain levels, disability due to LSS, self-efficacy and mental health.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Intervention group will received education and a specific rehabilitation program (exercises).

Group II: Control Group Experimental Treatment 1 Intervention

Control group will received education alone.

Who Is Running the Clinical Trial?

Université du Québec à Trois-Rivières

Lead Sponsor

Trials

48

Recruited

4,500+

Findings from Research

A physical therapy approach for lumbar spinal stenosis focuses on manual therapy to improve spinal motion and neural mobility, combined with an active exercise program that includes flexion exercises.

Successful treatment outcomes depend on a comprehensive and personalized strategy tailored to each patient's specific needs and conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy for lumbar spinal stenosis: a comprehensive physical therapy approach. Rademeyer, I.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

A nonsurgical treatment approach for patients with lumbar spinal stenosis. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Postoperative rehabilitation does not improve functional outcome in lumbar spinal stenosis: a prospective study with 2-year postoperative follow-up. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Nonsurgical Treatment Versus Self-directed Care to Improve Walking Ability in Lumbar Spinal Stenosis: A Randomized Trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with lumbar spinal stenosis with neurogenic claudication: a randomized controlled clinical trial protocol. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The boot camp program for lumbar spinal stenosis: a protocol for a randomized controlled trial. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Spinal stenosis surgery in Sweden 1987-1999. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The spinal stenosis pedometer and nutrition lifestyle intervention (SSPANLI): development and pilot. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The effect of single and dual-task balance exercises on balance performance in older adult patients with degenerative lumbar spinal stenosis: A randomized controlled trial. [2023]

10. England pubmed.ncbi.nlm.nih.gov

The spinal stenosis pedometer and nutrition lifestyle intervention (SSPANLI) randomized controlled trial protocol. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Manual therapy for lumbar spinal stenosis: a comprehensive physical therapy approach. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Physical therapy to treat spinal stenosis]. [2015]