NCT05370833

Brief Summary

Chronic pain is one of the main factors influencing workers' retention at work. Considering that the prevalence of suffering from chronic pain increases with age, older workers are most likely to be absent from work because of their pain. Transcranial direct current stimulation (tDCS) is a treatment option to reduce chronic pain. This study aims to document the effect of tDCS on pain and work retention in older workers and to compare the traditional tDCS protocol (5 sessions) with an enhanced protocol (11 sessions).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started May 2022

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

April 11, 2022

Last Update Submit

July 10, 2023

Conditions

Chronic PainAging

Keywords

transcranial direct current stimulationphysical therapywork retention

Outcome Measures

Primary Outcomes (31)

  • Pain intensity

    0-10 Numerical rating scale

    Before tDCS

  • Pain intensity

    0-10 Numerical rating scale

    1 week

  • Pain intensity

    0-10 Numerical rating scale

    4 weeks

  • Pain intensity

    0-10 Numerical rating scale

    4 weeks after the last tDCS session

  • Disability

    Pain Disability Index

    Before tDCS

  • Disability

    Pain Disability Index

    1 week

  • Disability

    Pain Disability Index

    4 weeks

  • Disability

    Pain Disability Index

    4 weeks after the last tDCS session

  • Work role functioning

    Work Role Functioning Questionnaire

    Before tDCS

  • Work role functioning

    Work Role Functioning Questionnaire

    1 week

  • Work role functioning

    Work Role Functioning Questionnaire

    4 weeks

  • Work role functioning

    Work Role Functioning Questionnaire

    4 weeks after the last tDCS session

  • Physical Functioning

    Brief Pain Inventory

    Before tDCS

  • Physical Functioning

    Brief Pain Inventory

    1 week

  • Physical Functioning

    Brief Pain Inventory

    4 weeks

  • Physical Functioning

    Brief Pain Inventory

    4 weeks after the last tDCS session

  • Anxiety

    Beck anxiety inventory

    Before tDCS

  • Anxiety

    Beck anxiety inventory

    1 week

  • Anxiety

    Beck anxiety inventory

    4 weeks

  • Anxiety

    Beck anxiety inventory

    4 weeks after the last tDCS session

  • Depression

    Beck depression inventory

    Before tDCS

  • Depression

    Beck depression inventory

    1 week

  • Depression

    Beck depression inventory

    4 weeks

  • Depression

    Beck depression inventory

    4 weeks after the last tDCS session

  • Impression of change

    Patient Global impression of change

    1 week

  • Impression of change

    Patient Global impression of change

    4 weeks

  • Impression of change

    Patient Global impression of change

    4 weeks after the last tDCS session

  • Central sensitization

    central sensitization inventory

    Before tDCS

  • Central sensitization

    central sensitization inventory

    1 week

  • Central sensitization

    central sensitization inventory

    4 weeks

  • Central sensitization

    central sensitization inventory

    4 weeks after the last tDCS session

Secondary Outcomes (3)

  • Recruitment

    through study completion, about 2 years

  • Security

    through study completion, about 2 years

  • Intervention

    through study completion, about 2 years

Study Arms (2)

Standard protocol

EXPERIMENTAL

5 tDCS sessions in 1 week

Device: transcranial direct current stimulation

Enhanced protocol

EXPERIMENTAL

11 tDCS sessions devised in 4 weeks

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulationDEVICE

Anodal, 2mA, tDCS session applied on M1 for 20 minutes.

Enhanced protocolStandard protocol

Eligibility Criteria

Age56 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be more than 55 years old
  • To have chronic pain
  • To have employment relationship
  • To have pain that interferes with work tasks

You may not qualify if:

  • \- tDCS contraindications (epilepsy, metallic implant in the head, pacemaker, cochlear implant)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique régionale de la gestion de la douleur - CISSSAT

Rouyn-Noranda, Quebec, Canada

RECRUITING

Centre de Recherche sur le Vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Guillaume Leonard, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Leonard, PhD

CONTACT

819-780-2220guillaume.leonard2@usherbrooke.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2022

First Posted

May 12, 2022

Study Start

May 15, 2022

Primary Completion

April 30, 2024

Study Completion

May 30, 2024

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Upon request to the corresponding author

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Upon request

Locations

CA(2)