Exercise Intervention for Neuropathic Pain After Spinal Cord Injury

Overseen By Andrew Taylor, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Cardioactive medications

Disqualifiers: Pregnancy, Diabetes, Heart disease, Cancer, others

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

Compensation: Varies

Number of Visits: 3

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special type of exercise can reduce pain and improve brain function in people with spinal cord injuries. The exercise uses functional electrical stimulation (FES) to activate paralyzed leg muscles, potentially providing a better workout for the heart, lungs, and possibly the brain. Participants will either engage in FES rowing exercises or remain on a waitlist for 12 weeks, while researchers measure changes in pain and brain activity. This trial suits individuals with a spinal cord injury at or below the C5 level, who have been injured for 3 to 24 months, and can respond to FES stimulation. As an unphased trial, it offers a unique opportunity to explore innovative treatments and contribute to groundbreaking research.

What prior data suggests that this exercise intervention is safe for individuals with spinal cord injury?

Research has shown that Functional Electrical Stimulation (FES) rowing is generally safe for people with spinal cord injuries. In previous studies, participants engaged in FES rowing for 30 minutes without major problems, indicating that the treatment is well-tolerated. Another study, which aimed to improve heart health, found that FES rowing did not cause significant side effects. Participants completed several sessions and improved their fitness without major safety concerns. While these results are encouraging, discussing any potential risks with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Functional Electrical Stimulation (FES) rowing exercise for neuropathic pain after spinal cord injury because it offers a novel approach that combines exercise with electrical stimulation to potentially improve outcomes. Unlike standard treatments like medications and physical therapy, FES rowing specifically targets muscle activation and cardiovascular fitness, which may lead to enhanced pain relief and functional recovery. This method also promotes engagement and motivation through a structured, goal-oriented exercise regimen, which could offer benefits beyond typical passive treatments.

What evidence suggests that this exercise intervention is effective for neuropathic pain after spinal cord injury?

Research has shown that functional electrical stimulation (FES) during rowing can improve heart and lung health in people with spinal cord injuries. FES activates paralyzed leg muscles, enabling more comprehensive exercise. Studies have found that FES rowing enhances heart and lung function, which is crucial for maintaining health. Although some research has not identified significant improvements in nerve function, FES rowing remains safe and may help reduce swelling and pain. This trial will compare participants engaging in FES rowing with those on a waitlist who will not participate in FES rowing. This exercise might also improve mood and quality of life by providing a more intense workout than using only the arms. ^{1 2 3 4 6}

Who Is on the Research Team?

Nils C Linnman, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injuries at or below C5, classified as A, B, or C by the American Spinal Injury Association. They should be within 3-24 months post-injury. Excluded are those pregnant, breastfeeding, unable to undergo MRI/PET scans, with major medical/neurological/psychiatric illnesses, diabetes, kidney/liver issues, tobacco/drug use history, certain physical exam abnormalities (like heart murmurs), unresponsive to FES stimulation.

Inclusion Criteria

My spinal cord injury is at or below C5 and is classified as severe to moderate, occurring within the last 3-24 months.

You have a spinal cord injury at or below the C5 level and have a certain level of impairment based on a specific grading system, within 3-24 months after the injury.

Exclusion Criteria

You have used drugs for fun in the past.

I have a history of epilepsy.

I have serious heart rhythm problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Strength Training

Participants undergo strength training with electrodes placed over motor points of the quadriceps and hamstrings to achieve full knee flexion-extension

2-6 weeks

Regular visits for training sessions

FES-RT Treatment

Participants engage in FES-rowing training sessions 3 times per week, aiming for an exercise intensity of 70-85% maintained for a continuous 30-40 min

12 weeks

3 visits per week (in-person)

Wait-list Control

Participants undergo treatment as usual without FES-rowing

12 weeks

Follow-up

Participants are monitored for changes in pain interference, hippocampal volume, and glial activation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Functional Electrical Stimulation rowing exercise

Trial Overview The trial tests if a 12-week Functional Electrical Stimulation rowing exercise (FES-RT) can reduce neuropathic pain and brain inflammation in people with recent spinal cord injury compared to a wait-list group. It measures changes in pain interference and brain structure/function using advanced imaging techniques like PET and MRI.

How Is the Trial Designed?

Group I: FES rowing Experimental Treatment 1 Intervention

Exercise training sessions will be performed 3 times per week for 12 weeks. The initial training sessions will include 6 sets of FES-rowing for 5 min at 60% of VO2 peak with a work-to-rest ratio of 2:1. Participants unable to row continuously for 5 min will row for 2-4 min with 30-second breaks incorporated until they achieve sets totaling 30 min. The goal is for each volunteer to achieve an exercise intensity of 70-85% maintained for a continuous 30-40 min performed 3 times each week.

Group II: Wait list Active Control 1 Intervention

During the 12-week treatment as usual program, subjects will not participate in FES-rowing.

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12350409/

Efficacy of functional electrical stimulation alone and as an ... Twelve studies investigated the effect of functional electrical stimulation (FES) on respiratory function in individuals with spinal cord injury ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32094516/

Effects of hybrid-functional electrical stimulation (FES) rowing ... No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI ...

3. nature.com nature.com/articles/sc2014159

FES-rowing in tetraplegia: a preliminary report | Spinal Cord A training intervention study using functional electrical stimulation-rowing (FES-R) in a group of eight individuals with tetraplegia.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999302000321

Functional electric stimulation–assisted rowing We asked 3 questions: (1) Is FES rowing effective in improving cardiovascular fitness of people with spinal cord damage?; (2) Is FES rowing a safe training ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02602639

Functional Electrical Stimulation With Rowing as Exercise ... Therefore, the main purpose of this pilot research project is to implement and test a form of a spinal cord injury-specific exercise, known as FES rowing (FES: ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12161830/

Functional electric stimulation-assisted rowing Results: Subjects completed between 22 to 36 sessions. After 3 months of training, rowing distance increased by 25% (P<.02), peak oxygen consumption by 11.2% (P ...