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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Withdrawn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
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring TENS, chronic pain, rehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 with pain during the rehabilitation session at the Day hospital

Exclusion Criteria:

  1. Having a cardiac simulator (TENS contraindications).
  2. 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

    First Posted
    May 8, 2015
    Last Updated
    May 17, 2016
    Sponsor
    Université de Sherbrooke
    Collaborators
    Fondation Vitae
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    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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