Transcranial Direct Current Stimulation in Clinical Setting to Reduce Pain in Older Workers

Sponsor
Université de Sherbrooke (Other)
Overall Status
Recruiting
CT.gov ID
NCT05370833
Collaborator
CISSS Abitibi-Témiscamingue (Other)
24
2
2
23.5
12
0.5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: transcranial direct current stimulation
N/A

Detailed Description

Chronic pain affects many spheres of the lives of affected individuals and those around them. In Canada, the prevalence of chronic pain is estimated at 15% of adults aged 18 and over. Among seniors, the prevalence of this health problem can reach up to 50% and affect one in two seniors. Chronic pain is one of the leading causes of work disability. In this context, pain reduction remains one of the most effective methods to enable the worker to stay at work. Considering the aging Quebec population, labor needs and the average retirement age which is increasingly postponed, it becomes crucial to take an interest in aging workers and their continued employment.

Transcranial direct current stimulation (tDCS) is a non-invasive neurostimulation method that has shown promise in reducing chronic pain. Recently, several research teams have shown that tDCS has beneficial effects on pain, physical function and social participation in seniors. Despite all these recent advances, very few studies have focused on optimizing tDCS treatment modalities and no studies have focused on the impact of tDCS on return to work or retention. The vast majority of studies using tDCS to reduce pain give one tDCS session per day for 5 consecutive days. 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Observation et Analyse Des Effets de la Stimulation transcrânienne à Courant Continu en Milieu Clinique Pour Soulager la Douleur Chronique Chez Les Travailleurs Vieillissants
Actual Study Start Date :
May 15, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Standard protocol

5 tDCS sessions in 1 week

Device: transcranial direct current stimulation
Anodal, 2mA, tDCS session applied on M1 for 20 minutes.

Experimental: Enhanced protocol

11 tDCS sessions devised in 4 weeks

Device: transcranial direct current stimulation
Anodal, 2mA, tDCS session applied on M1 for 20 minutes.

Outcome Measures

Primary Outcome Measures

  1. Pain intensity [Before tDCS]

    0-10 Numerical rating scale

  2. Pain intensity [1 week]

    0-10 Numerical rating scale

  3. Pain intensity [4 weeks]

    0-10 Numerical rating scale

  4. Pain intensity [4 weeks after the last tDCS session]

    0-10 Numerical rating scale

  5. Disability [Before tDCS]

    Pain Disability Index

  6. Disability [1 week]

    Pain Disability Index

  7. Disability [4 weeks]

    Pain Disability Index

  8. Disability [4 weeks after the last tDCS session]

    Pain Disability Index

  9. Work role functioning [Before tDCS]

    Work Role Functioning Questionnaire

  10. Work role functioning [1 week]

    Work Role Functioning Questionnaire

  11. Work role functioning [4 weeks]

    Work Role Functioning Questionnaire

  12. Work role functioning [4 weeks after the last tDCS session]

    Work Role Functioning Questionnaire

  13. Physical Functioning [Before tDCS]

    Brief Pain Inventory

  14. Physical Functioning [1 week]

    Brief Pain Inventory

  15. Physical Functioning [4 weeks]

    Brief Pain Inventory

  16. Physical Functioning [4 weeks after the last tDCS session]

    Brief Pain Inventory

  17. Anxiety [Before tDCS]

    Beck anxiety inventory

  18. Anxiety [1 week]

    Beck anxiety inventory

  19. Anxiety [4 weeks]

    Beck anxiety inventory

  20. Anxiety [4 weeks after the last tDCS session]

    Beck anxiety inventory

  21. Depression [Before tDCS]

    Beck depression inventory

  22. Depression [1 week]

    Beck depression inventory

  23. Depression [4 weeks]

    Beck depression inventory

  24. Depression [4 weeks after the last tDCS session]

    Beck depression inventory

  25. Impression of change [1 week]

    Patient Global impression of change

  26. Impression of change [4 weeks]

    Patient Global impression of change

  27. Impression of change [4 weeks after the last tDCS session]

    Patient Global impression of change

  28. Central sensitization [Before tDCS]

    central sensitization inventory

  29. Central sensitization [1 week]

    central sensitization inventory

  30. Central sensitization [4 weeks]

    central sensitization inventory

  31. Central sensitization [4 weeks after the last tDCS session]

    central sensitization inventory

Secondary Outcome Measures

  1. Recruitment [through study completion, about 2 years]

    Feasibility of the study

  2. Security [through study completion, about 2 years]

    Feasibility of the study

  3. Intervention [through study completion, about 2 years]

    Feasibility of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
56 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • To be more than 55 years old

  • To have chronic pain

  • To have employment relationship

  • To have pain that interferes with work tasks

Exclusion Criteria:
  • tDCS contraindications (epilepsy, metallic implant in the head, pacemaker, cochlear implant)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique régionale de la gestion de la douleur - CISSSAT Rouyn-Noranda Quebec Canada
2 Centre de Recherche sur le Vieillissement Sherbrooke Quebec Canada J1H 4C4

Sponsors and Collaborators

  • Université de Sherbrooke
  • CISSS Abitibi-Témiscamingue

Investigators

  • Principal Investigator: Guillaume Leonard, PhD, Université de Sherbrooke

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guillaume Léonard, Professor, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT05370833
Other Study ID Numbers:
  • MP-31-2022-4640
First Posted:
May 12, 2022
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guillaume Léonard, Professor, Université de Sherbrooke
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2022