Using TENS to Relieve Pain and Potentiate the Rehabilitation of Pain Patients
Primary Purpose
Chronic Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active transcutaneous electrical nerve stimulation (TENS)
Simulated transcutaneous electrical nerve stimulation (TENS)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring TENS, chronic pain, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- will receive physiotherapy rehabilitation at the Day Hospital of the Pavillon d'Youville of the CSSS-IUGS,
- be at least 65 years of age,
- suffering from chronic pain (pain lasting for more than 6 months),
- presenting with pain during the rehabilitation session at the Day hospital
Exclusion Criteria:
- Having a cardiac simulator (TENS contraindications).
- Having with cognitive alterations (score of < 24/30 at the Folstein test)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active TENS
Simulated TENS
Arm Description
Receiving active transcutaneous electrical nerve stimulation (TENS) treatments during the rehabilitation sessions (only the first half of the rehabilitation period, i.e. 4 to 6 weeks.
Receiving simulated transcutaneous electrical nerve stimulation (TENS) treatments during the rehabilitation sessions (only the first half of the rehabilitation period, i.e. 4 to 6 weeks.
Outcomes
Primary Outcome Measures
Exercise tolerance
This functional outcome will be collected directly from the medical record (score obtained to the 6-minute walk test [6MWT]).
Secondary Outcome Measures
Mood
This outcome will be measured by the Beck Depression Inventory
Physical function
This outcome will be measured by the Brief Pain Inventory.
Qualitative aspects of pain
This outcome will be measured by the McGill-Melzack pain questionnaire
Balance
This functional outcome will be collected directly from the medical record (score obtained to the Berg Balance Scale [BBS])
Mobility and balance
This functional outcome will be collected directly from the medical record (score obtained to the Time up and go [TUG])
Functional ability
This functional outcome will be collected directly from the medical record (score obtained to the Functional autonomy measurement system [SMAF])
Full Information
NCT ID
NCT02445677
First Posted
May 8, 2015
Last Updated
May 17, 2016
Sponsor
Université de Sherbrooke
Collaborators
Fondation Vitae
1. Study Identification
Unique Protocol Identification Number
NCT02445677
Brief Title
Using TENS to Relieve Pain and Potentiate the Rehabilitation of Pain Patients
Official Title
Using Transcutaneous Electrical Nerve Stimulation (TENS) to Relieve Pain and Potentiate the Rehabilitation of Pain Patients: a Double Blind, Randomized Study Among Patients at the CSSS-IUGS Day Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The study has now a correlational design: no participant recruitment is needed.
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Fondation Vitae
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Introduction: Chronic pain affects more than half of elderly individuals. Past studies have shown that pain can interfere with motor learning and rehabilitation. It was suggested that relieving pain before physical therapy sessions might be an interesting strategy to potentiate the rehabilitation of older patients suffering from pain.
Objective: This study aims to determine if the analgesic effect induced by TENS can be used to maximize the rehabilitation of elderly patients suffering from chronic pain. More specifically, the objectives are to: 1) compare functional outcomes of patients from the Day Hospital receiving rehabilitation with either active TENS treatments or simulated TENS treatments, and 2) determine if there is an association between the analgesic effect of TENS and the clinical evolution of patients following their rehabilitation.
Methods: In this RCT, patients will be assigned randomly to either the: 1) experimental group receiving active TENS treatments or 2) the control group receiving simulated TENS treatments. Thirty-six patients will be recruited according to the following criteria: 1) will receive physiotherapy rehabilitation at the Day Hospital of the CSSS-IUGS, 2) be at least 65 years of age, 3) suffering from chronic pain (pain lasting for more than 6 months), 4) presenting pain during the rehabilitation at the Day hospital. For security reasons, patients with a cardiac simulator will be excluded from the present study (TENS contraindications). Patients with cognitive alterations (score of < 24/30 at the Folstein test) will also be excluded. Sociodemographic information will be retrieved from medical records by the research assistant at baseline (T1). Moreover, various questionnaires will be administered at T1, after half of the rehabilitation period (i.e. 4 to 6 weeks) (T2), and after the 8- to 12- week rehabilitation period (T3) to measure the qualitative aspects of pain, mood, and physical function. Functional outcomes will as well be collected directly from the medical record at each assessment times (T1, T2 and T3).The measures include exercise tolerance, balance, mobility and balance, and functional ability.
Anticipated results: We believe that: 1) use of active TENS during the rehabilitation sessions will potentiate rehabilitation of patients suffering from chronic pain at the CSSS-IUGS Day Hospital, and 2) there is a relationship between the analgesic effect induced by TENS and the clinical evolution of patients.
Detailed Description
Introduction Chronic pain affects more than half of elderly individuals. Past studies have shown that pain can interfere with motor learning and rehabilitation. This phenomenon, potentially attributable to the deleterious effect that nociceptive inputs have on the motor system, suggests that relieving pain before physical therapy sessions might be an interesting strategy to potentiate the rehabilitation of older patients suffering from pain.
Objective The objective of this study is to determine if the analgesic effect induced by transcutaneous electrical nerve stimulation (TENS) can be used to maximize the rehabilitation of elderly patients suffering from chronic pain. More specifically, this study aims to: 1) compare functional outcomes of patients from the Day Hospital receiving rehabilitation with active TENS treatments with patients receiving rehabilitation with simulated TENS treatments, and 2) determine if there is an association between the analgesic effect of TENS and the clinical evolution of patients following their rehabilitation.
Methods This study is a randomized clinical trial with two parallel arms. Patients will be assigned randomly to either the: 1) experimental group receiving active TENS treatments or 2) the control group receiving simulated TENS treatments (double blind study). Thirty-six patients will be recruited according to the following criteria: 1) will receive physiotherapy rehabilitation at the Day Hospital of the Pavillon d'Youville of the CSSS-IUGS, 2) be at least 65 years of age, 3) suffering from chronic pain (pain lasting for more than 6 months), 4) presenting pain during the rehabilitation at the Day hospital. For security reasons, patients with a cardiac simulator will be excluded from the present study (TENS contraindications). Patients with cognitive alterations (score of < 24/30 at the Folstein test) will also be excluded. In order to have a better characterisation of the sample, information will be retrieved from medical records by the research assistant, including: 1) age, gender, pain localisation, medical diagnosis and medication. Moreover, various questionnaires will be administered at baseline (T1), after half of the rehabilitation period (i.e. 4 to 6 weeks) (T2), and after the 8- to 12- week rehabilitation period (T3) to measure: 1) the qualitative aspects of pain (McGill-Melzack pain questionnaire), 2) mood (Beck Depression Inventory), and 3) physical function (Brief Pain Inventory). Functional outcomes will also be collected directly from the medical record at baseline at each assessment times (T1, T2, T3). The measures include: 1) exercise tolerance (6-minute walk test [6MWT]), 2) balance (Berg Balance Scale [BBS]), 3) mobility and balance (Time up and go [TUG]), and 4) functional ability (Functional autonomy measurement system [SMAF]).
Anticipated results We believe that: 1) use of active TENS during rehabilitation sessions will potentiate rehabilitation of patients suffering from chronic pain at the CSSS-IUGS Day Hospital, and 2) there is a relationship between the analgesic effect induced by TENS and the clinical evolution of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
TENS, chronic pain, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active TENS
Arm Type
Experimental
Arm Description
Receiving active transcutaneous electrical nerve stimulation (TENS) treatments during the rehabilitation sessions (only the first half of the rehabilitation period, i.e. 4 to 6 weeks.
Arm Title
Simulated TENS
Arm Type
Placebo Comparator
Arm Description
Receiving simulated transcutaneous electrical nerve stimulation (TENS) treatments during the rehabilitation sessions (only the first half of the rehabilitation period, i.e. 4 to 6 weeks.
Intervention Type
Device
Intervention Name(s)
Active transcutaneous electrical nerve stimulation (TENS)
Intervention Description
TENS is a technique use to relieve pain in an injured or diseased part of the body in which electrodes applied to the skin deliver intermittent stimulation to surface nerves and block the transmission of pain signals. In this research, the frequency will be set at 100 Hz, implusion duration at 60 μsec and intensity will be increase until having strong but confortable stimulations.
Intervention Type
Device
Intervention Name(s)
Simulated transcutaneous electrical nerve stimulation (TENS)
Intervention Description
A modification of the TENS connexion parameters will prevent the current from reaching the electrods (once a first sensation will be perceived).
Primary Outcome Measure Information:
Title
Exercise tolerance
Description
This functional outcome will be collected directly from the medical record (score obtained to the 6-minute walk test [6MWT]).
Time Frame
8- to 12- week rehabilitation period (T2)
Secondary Outcome Measure Information:
Title
Mood
Description
This outcome will be measured by the Beck Depression Inventory
Time Frame
Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)
Title
Physical function
Description
This outcome will be measured by the Brief Pain Inventory.
Time Frame
Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)
Title
Qualitative aspects of pain
Description
This outcome will be measured by the McGill-Melzack pain questionnaire
Time Frame
Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)
Title
Balance
Description
This functional outcome will be collected directly from the medical record (score obtained to the Berg Balance Scale [BBS])
Time Frame
up to 8- to 12- week rehabilitation period (T2)
Title
Mobility and balance
Description
This functional outcome will be collected directly from the medical record (score obtained to the Time up and go [TUG])
Time Frame
up to 8- to 12- week rehabilitation period (T2)
Title
Functional ability
Description
This functional outcome will be collected directly from the medical record (score obtained to the Functional autonomy measurement system [SMAF])
Time Frame
up to 8- to 12- week rehabilitation period (T2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
will receive physiotherapy rehabilitation at the Day Hospital of the Pavillon d'Youville of the CSSS-IUGS,
be at least 65 years of age,
suffering from chronic pain (pain lasting for more than 6 months),
presenting with pain during the rehabilitation session at the Day hospital
Exclusion Criteria:
Having a cardiac simulator (TENS contraindications).
Having with cognitive alterations (score of < 24/30 at the Folstein test)
12. IPD Sharing Statement
Citations:
PubMed Identifier
31841037
Citation
Vaillancourt S, Coulombe-Leveque A, Fradette J, Martel S, Naour W, da Silva RA, Leonard G. Combining transcutaneous electrical nerve stimulation with therapeutic exercise to reduce pain in an elderly population: a pilot study. Disabil Rehabil. 2021 Jul;43(15):2141-2148. doi: 10.1080/09638288.2019.1693639. Epub 2019 Dec 15.
Results Reference
derived
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Using TENS to Relieve Pain and Potentiate the Rehabilitation of Pain Patients
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