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Using Peripheral Neurostimulation to Improve Work Rehabilitation

Primary Purpose

Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TENS
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de recherche sur le vieillissement (CdRV)

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recruitment rate
The number of participants randomized divided by the number of participants screened.
Exclusion rate
The number of ineligible participants divided by the number of participants screened.
Refusal rate
The number of participants who refused to participate in the trial divided by the number of participants screened.
Adherence rate
The number of people who finished intervention divided by the number of participants randomized.
Attrition rate
The number of people who did not finish intervention divided by the number of participants randomized.
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

Secondary Outcome Measures

Severity of pain and impact of pain on physical function
Measured with the Brief Pain Inventory (BPI)
Pain intensity
Measured with a visual analog scale (VAS). Scale from 0 to 100, where 0 indicates no pain and 100 indicates worst pain imaginable
Psychosocial component and impact of pain on the emotional sphere
Measured with Beck's depression inventory. Contains 21 items with a 4-point likert scale. The minimum possible score is 0 and the maximum possible score is 63. The higher the score, the more important the psychosocial component is for the individual.
Qualitative component of pain
McGill Pain Questionnaire (MPQ). The MPQ is composed of 20 questions and scores range from 0 (no pain) to 78 (severe pain).
Pain catastrophizing
Measured with the Pain Catastrophizing Scale. It consists of 13 thoughts or emotions related to a painful experience. Each thought is scored on 5 points from 0 to 4. The total score is 52 points. If the score is between 20 and 29, the risk of pain chronicization is moderate. If the score is between 29 and 52, the risk is high. The higher the score, the higher the risk.
Disability in work Rehabilitation
Measured with the Work Rehabilitation Questionnaire (WORQ). The WORQ is used to better understand the extent of problems in functioning that people may have due to their health condition(s) and who are undergoing work or vocational rehabilitation. In the main section, responders rate the extent of their problem in the past week on a scale from 0 (no problem) to 10 (complete problem / not possible).
Overall treatment satisfaction
Measured with The self-report measure Patient Global Impression of Change (PGIC). PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Quality of movement
Measuring the posture of the participants during the execution of a squat (sagittal view on camera). Based on the Back Squat Assessment.
Quality of movement
Measuring the posture of the participants during the execution of a squat (sagittal view on camera). Based on the squat portion of the New Basic Functional Assessment Protocol.

Full Information

First Posted
March 15, 2022
Last Updated
March 24, 2023
Sponsor
Université de Sherbrooke
Collaborators
Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR), Réseau québécois de recherche sur le vieillissement (RQRV)
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1. Study Identification

Unique Protocol Identification Number
NCT05316623
Brief Title
Using Peripheral Neurostimulation to Improve Work Rehabilitation
Official Title
Using Peripheral Neurostimulation to Improve Work Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR), Réseau québécois de recherche sur le vieillissement (RQRV)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Problem and hypotheses: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One placebo group and one intervention group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple blind
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Simulated TENS and personalized exercise program in telerehabilitation (3 sessions/week over 3 weeks) n = 12
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Real TENS and personalized exercise program in telerehabilitation (3 sessions/week over 3 weeks) n = 12
Intervention Type
Device
Intervention Name(s)
TENS
Other Intervention Name(s)
Transcutaneous electrical nerve stimulation, Peripheral neurostimulation
Intervention Description
TENS (strong and comfortable intensity) applied during exercises in a telerehabilitation setting.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
The number of participants randomized divided by the number of participants screened.
Time Frame
4 months
Title
Exclusion rate
Description
The number of ineligible participants divided by the number of participants screened.
Time Frame
4 months
Title
Refusal rate
Description
The number of participants who refused to participate in the trial divided by the number of participants screened.
Time Frame
4 months
Title
Adherence rate
Description
The number of people who finished intervention divided by the number of participants randomized.
Time Frame
3 weeks
Title
Attrition rate
Description
The number of people who did not finish intervention divided by the number of participants randomized.
Time Frame
3 weeks
Title
Kinesiophobia
Description
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
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Severity of pain and impact of pain on physical function
Description
Measured with the Brief Pain Inventory (BPI)
Time Frame
3 weeks
Title
Pain intensity
Description
Measured with a visual analog scale (VAS). Scale from 0 to 100, where 0 indicates no pain and 100 indicates worst pain imaginable
Time Frame
3 weeks
Title
Psychosocial component and impact of pain on the emotional sphere
Description
Measured with Beck's depression inventory. Contains 21 items with a 4-point likert scale. The minimum possible score is 0 and the maximum possible score is 63. The higher the score, the more important the psychosocial component is for the individual.
Time Frame
3 weeks
Title
Qualitative component of pain
Description
McGill Pain Questionnaire (MPQ). The MPQ is composed of 20 questions and scores range from 0 (no pain) to 78 (severe pain).
Time Frame
Intervention period (before first and after last sessions)
Title
Pain catastrophizing
Description
Measured with the Pain Catastrophizing Scale. It consists of 13 thoughts or emotions related to a painful experience. Each thought is scored on 5 points from 0 to 4. The total score is 52 points. If the score is between 20 and 29, the risk of pain chronicization is moderate. If the score is between 29 and 52, the risk is high. The higher the score, the higher the risk.
Time Frame
3 weeks
Title
Disability in work Rehabilitation
Description
Measured with the Work Rehabilitation Questionnaire (WORQ). The WORQ is used to better understand the extent of problems in functioning that people may have due to their health condition(s) and who are undergoing work or vocational rehabilitation. In the main section, responders rate the extent of their problem in the past week on a scale from 0 (no problem) to 10 (complete problem / not possible).
Time Frame
3 weeks
Title
Overall treatment satisfaction
Description
Measured with The self-report measure Patient Global Impression of Change (PGIC). PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Time Frame
3 weeks
Title
Quality of movement
Description
Measuring the posture of the participants during the execution of a squat (sagittal view on camera). Based on the Back Squat Assessment.
Time Frame
3 weeks
Title
Quality of movement
Description
Measuring the posture of the participants during the execution of a squat (sagittal view on camera). Based on the squat portion of the New Basic Functional Assessment Protocol.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Philippe Harvey, M. Sc.
Phone
819-780-2220
Ext
45156
Email
Marie.Philippe.Harvey@USherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Léonard, PhD
Phone
819-821-8000
Ext
72933
Email
Guillaume.Leonard2@Usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Léonard, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche sur le vieillissement (CdRV)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Using Peripheral Neurostimulation to Improve Work Rehabilitation

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