AzTrials
AzTrials

Chronic PainNCT05316623

Using Peripheral Neurostimulation to Improve Work Rehabilitation

A study testing TENS in people with Chronic Pain, run by Université de Sherbrooke at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Chronic Pain
What is being tested?
TENS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteCanada
Study dates
8 Aug 2023to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • Centre de recherche sur le vieillissement (CdRV)

    Sherbrooke, Quebec, J1H 4C4

    Guillaume Leonard, Ph.D., pht.

    Recruiting

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Chronic Pain
Being tested
TENS
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TENSDevice

    Also called Transcutaneous electrical nerve stimulation, Peripheral neurostimulation

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

Study groups in NCT05316623
Study groupRoleWhat they receive
Control groupSham comparatorSimulated TENS and personalized exercise program in telerehabilitation (3 sessions/week over 3 weeks) n = 12
Receives: Device: TENS
Intervention groupExperimentalReal TENS and personalized exercise program in telerehabilitation (3 sessions/week over 3 weeks) n = 12
Receives: Device: TENS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

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

    Measured: 4 months

  2. Exclusion rate

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

    Measured: 4 months

  3. Refusal rate

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

    Measured: 4 months

  4. Adherence rate

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

    Measured: 3 weeks

  5. Attrition rate

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

    Measured: 3 weeks

  6. 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

    Measured: 3 weeks

Secondary outcomes (9)
  1. Severity of pain and impact of pain on physical function

    Measured with the Brief Pain Inventory (BPI)

    Measured: 3 weeks

  2. 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

    Measured: 3 weeks

  3. 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.

    Measured: 3 weeks

  4. 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).

    Measured: Intervention period (before first and after last sessions)

  5. 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.

    Measured: 3 weeks

  6. 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).

    Measured: 3 weeks

  7. 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."

    Measured: 3 weeks

  8. 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.

    Measured: 3 weeks

  9. 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.

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start8 Aug 2023
  3. Primary completionAug 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Model description
One placebo group and one intervention group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05316623
Sponsor's protocol ID
2019-2885
Status last verified
Dec 2023
First submitted
15 Mar 2022
Last updated
21 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TENS in people with Chronic Pain, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marie-Philippe Harvey, M. Sc. (819-780-2220 ext. 45156, Marie.Philippe.Harvey@USherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in