Using Peripheral Neurostimulation to Improve Work Rehabilitation

NCT05316623 | Unknown DMC

• 1 other identifier: 2019-2885
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Physical exercise plays a central role in work rehabilitation. However, the presence of pain (particularly common in older adults and aging workers) can lead to a fear of movement (kinesiophobia) and hinder rehabilitation. Access to rehabilitation care is also a barrier for many older adults, which could be circumvented through telerehabilitation. The objective of this pilot study is to document the feasibility and explore the effect of a telerehabilitation intervention combining therapeutic exercises and real TENS (experimental group) or placebo TENS (control group) in individuals aged 55 and over who have stopped working (triple-blind randomized controlled study). To do so, various feasibility indicators (e.g., recruitment rate, adherence) and clinical measures (e.g., kinesiophobia, pain during exercise) will be documented before and after the intervention. Together, these measures will help assess the appropriateness of conducting a large-scale study aimed at potentiating work rehabilitation in older populations.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  The number of participants randomized divided by the number of participants screened.

  4 months

• Exclusion rate

  The number of ineligible participants divided by the number of participants screened.

  4 months

• Refusal rate

  The number of participants who refused to participate in the trial divided by the number of participants screened.

  4 months

• Adherence rate

  The number of people who finished intervention divided by the number of participants randomized.

  3 weeks

• Attrition rate

  The number of people who did not finish intervention divided by the number of participants randomized.

  3 weeks

• Kinesiophobia

  excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability due to painful injury or reinjury - Measured with the Tampa scale of kinesiophobia

  3 weeks

Secondary Outcomes (9)

• Severity of pain and impact of pain on physical function

  3 weeks

• Pain intensity

  3 weeks

• Psychosocial component and impact of pain on the emotional sphere

  3 weeks

• Qualitative component of pain

  Intervention period (before first and after last sessions)

• Pain catastrophizing

  3 weeks

Study Arms (2)

Control group

SHAM COMPARATOR

Simulated TENS and personalized exercise program in telerehabilitation (3 sessions/week over 3 weeks) n = 12

Device: TENS

Intervention group

EXPERIMENTAL

Real TENS and personalized exercise program in telerehabilitation (3 sessions/week over 3 weeks) n = 12

Device: TENS

Interventions

TENS DEVICE

TENS (strong and comfortable intensity) applied during exercises in a telerehabilitation setting.

Also known as: Transcutaneous electrical nerve stimulation, Peripheral neurostimulation

Control group; Intervention group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 55 years of age or older
• 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

You may not qualify if:

• Having a cognitive deficiency
• Wearing a cardiac defibrillator or pacemaker
• Being diagnosed with cancer
• Having already experimented with TENS

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR): collaborator
• Réseau québécois de recherche sur le vieillissement (RQRV): collaborator

Study Sites (1)

Centre de recherche sur le vieillissement (CdRV)

Sherbrooke, Quebec, J1H 4C4, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Guillaume Léonard, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Philippe Harvey, M. Sc.

CONTACT

819-780-2220; Marie.Philippe.Harvey@USherbrooke.ca

Guillaume Léonard, PhD

CONTACT

819-821-8000; Guillaume.Leonard2@Usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple blind
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One placebo group and one intervention group

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 7, 2022
• Study Start: August 8, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)