Recruiting

Peripheral Neurostimulation

Sponsor:

Université de Sherbrooke

Code:

NCT05316623

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

TENS

Study Details

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

Study ID

NCT05316623

Start date

Aug 8, 2023

Status verified date

Dec, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

sham comparator: Control group

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

experimental: Intervention group

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

Interventions

TENS

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

Primary outcome measure

  • Recruitment rate [ Time Frame: 4 months ]
  • Exclusion rate [ Time Frame: 4 months ]
  • Refusal rate [ Time Frame: 4 months ]
  • Adherence rate [ Time Frame: 3 weeks ]
  • Attrition rate [ Time Frame: 3 weeks ]
  • Kinesiophobia [ Time Frame: 3 weeks ]

Central Contacts and Locations

Central contacts

Locations

Centre de recherche sur le vieillissement (CdRV)

Recruiting

Sherbrooke, Quebec, Canada, J1H 4C4

More Information

Sponsor

Université de Sherbrooke

Last update posted

Dec 21, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2023-12-21.