Using Peripheral Neurostimulation to Improve Work Rehabilitation
NCT ID: NCT05316623
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
24 participants
INTERVENTIONAL
2023-08-08
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In 2019, the proportion of Canadians aged 55 and over who were employed was 35.9%, the highest rate recorded to date since 1976. Despite their willingness to remain employed, seniors are more prone to work disability and early retirement. Older workers with disabilities are particularly vulnerable to job retention. In Quebec, the average length of absence following a work-related injury is 134 days for workers aged 55 and over, while it is less than 50 days for those aged 15 to 24. This difference can be explained in part by the presence of persistent pain that disproportionately affects older individuals and can significantly impede rehabilitation to work. The indirect costs associated with unemployment and absenteeism of people living with chronic pain were estimated to be $22.5 billion in Canada in 2019. A recent review conducted and published by our team found that strategies to reduce pain are one of the most important elements to consider in enabling workers to remain in the workplace after an episode of musculoskeletal disorder.
Exercise plays a central role in chronic pain management and work rehabilitation. However, pain can be a major barrier to physical activity. Therefore, finding ways to reduce pain during and after exercise is essential to facilitate rehabilitation. Peripheral neurostimulation (TENS) - an electrotherapeutic modality that uses an electrical current to depolarize peripheral nerve fibers with electrodes applied directly to the skin - is effective in temporarily relieving pain. It represents an interesting avenue for increasing exercise tolerance associated with exercise in the pain subject. To date, 3 studies have investigated the use of TENS during exercise, all showing positive results. None, however, have yet investigated this strategy (TENS + exercise) in aging workers living with persistent pain.
We postulate that telerehabilitation treatments (therapeutic exercises) provided concurrently with actual TENS will be more effective in reducing the biopsychological impacts of pain than the same rehabilitation treatments paired with placebo TENS. Thus, our hypothesis is that the experimental treatment will cause participants to enter a "virtuous circle": the TENS will allow for a punctual reduction of pain and kinesiophobia, which will encourage the realization/resumption of activity and lead to sustained benefits (e.g., physical function, pain, mood).
Objectives:
The primary objective of this pilot study is to explore the feasibility and acceptability of using real TENS, compared to placebo TENS, as a complementary treatment to a telerehabilitation exercise program, in workers who are off work.
The secondary objective is to compare the effect of the two types of intervention (real TENS + exercises vs. placebo TENS + exercises) on clinical outcomes (e.g. pain intensity, functioning in vocational rehabilitation, etc.).
Methods and analysis:
Design:
This project consists of a randomized controlled trial following a quadruple blind design.
Participants:
The target population is aging workers who are off work due to a musculoskeletal injury.
Sampling and recruitment procedures:
Participants will be recruited at the ISO-SANTÉ and Physio-Atlas clinics in Sherbrooke, which specialize in work rehabilitation (volunteer, non-probability sampling). The recruitment of individuals will be done through posters and with the help of clinicians who will be invited to talk to patients about the project.
Conduct of the study:
The purpose of this study is to recruit 24 participants who will take part in an exercise program spread over 3 weeks, with 3 sessions per week. The duration of each session is 30 minutes. The exercise program will be determined by the research team, in collaboration with clinic health professionals, and the exercises will be delivered via the TeraPlus telerehabilitation platform. The TENS (real or simulated) will be worn by participants throughout their telerehabilitation exercises, under the supervision of the student researcher.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
Simulated TENS and personalized exercise program in telerehabilitation (3 sessions/week over 3 weeks) n = 12
TENS
TENS (strong and comfortable intensity) applied during exercises in a telerehabilitation setting.
Intervention group
Real TENS and personalized exercise program in telerehabilitation (3 sessions/week over 3 weeks) n = 12
TENS
TENS (strong and comfortable intensity) applied during exercises in a telerehabilitation setting.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TENS
TENS (strong and comfortable intensity) applied during exercises in a telerehabilitation setting.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Being off work completely due to a musculoskeletal injury
* Starting a physical rehabilitation program
* Being in employment
* Experiencing pain of mild intensity (score of 1-3 points on a numerical scale of 0-10 points) to moderate intensity (score of 4-6 points) during movements/exercises
* Being comfortable enough with technology to participate in video conferences, respond to emails or text messages
* Having stable medication and lifestyle habits
* Speaking French
Exclusion Criteria
* Wearing a cardiac defibrillator or pacemaker
* Being diagnosed with cancer
* Having already experimented with TENS
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR)
UNKNOWN
Réseau québécois de recherche sur le vieillissement (RQRV)
UNKNOWN
Université de Sherbrooke
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Guillaume Léonard
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guillaume Léonard, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre de recherche sur le vieillissement (CdRV)
Sherbrooke, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Guillaume Leonard, Ph.D., pht.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-2885
Identifier Type: -
Identifier Source: org_study_id