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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370833
• Other study ID #: MP-31-2022-4640
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: July 2023
• Source: Université de Sherbrooke
• Contact: Guillaume Leonard, PhD
• Phone: 819-780-2220
• Email: guillaume.leonard2[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 56 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
Canada	Clinique régionale de la gestion de la douleur - CISSSAT	Rouyn-Noranda	Quebec
Canada	Centre de Recherche sur le Vieillissement	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	CISSS Abitibi-Témiscamingue

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	0-10 Numerical rating scale	Before tDCS
Primary	Pain intensity	0-10 Numerical rating scale	1 week
Primary	Pain intensity	0-10 Numerical rating scale	4 weeks
Primary	Pain intensity	0-10 Numerical rating scale	4 weeks after the last tDCS session
Primary	Disability	Pain Disability Index	Before tDCS
Primary	Disability	Pain Disability Index	1 week
Primary	Disability	Pain Disability Index	4 weeks
Primary	Disability	Pain Disability Index	4 weeks after the last tDCS session
Primary	Work role functioning	Work Role Functioning Questionnaire	Before tDCS
Primary	Work role functioning	Work Role Functioning Questionnaire	1 week
Primary	Work role functioning	Work Role Functioning Questionnaire	4 weeks
Primary	Work role functioning	Work Role Functioning Questionnaire	4 weeks after the last tDCS session
Primary	Physical Functioning	Brief Pain Inventory	Before tDCS
Primary	Physical Functioning	Brief Pain Inventory	1 week
Primary	Physical Functioning	Brief Pain Inventory	4 weeks
Primary	Physical Functioning	Brief Pain Inventory	4 weeks after the last tDCS session
Primary	Anxiety	Beck anxiety inventory	Before tDCS
Primary	Anxiety	Beck anxiety inventory	1 week
Primary	Anxiety	Beck anxiety inventory	4 weeks
Primary	Anxiety	Beck anxiety inventory	4 weeks after the last tDCS session
Primary	Depression	Beck depression inventory	Before tDCS
Primary	Depression	Beck depression inventory	1 week
Primary	Depression	Beck depression inventory	4 weeks
Primary	Depression	Beck depression inventory	4 weeks after the last tDCS session
Primary	Impression of change	Patient Global impression of change	1 week
Primary	Impression of change	Patient Global impression of change	4 weeks
Primary	Impression of change	Patient Global impression of change	4 weeks after the last tDCS session
Primary	Central sensitization	central sensitization inventory	Before tDCS
Primary	Central sensitization	central sensitization inventory	1 week
Primary	Central sensitization	central sensitization inventory	4 weeks
Primary	Central sensitization	central sensitization inventory	4 weeks after the last tDCS session
Secondary	Recruitment	Feasibility of the study	through study completion, about 2 years
Secondary	Security	Feasibility of the study	through study completion, about 2 years
Secondary	Intervention	Feasibility of the study	through study completion, about 2 years