Using TENS to Relieve Pain and Potentiate the Rehabilitation of Pain Patients

May 17, 2016 updated by: Guillaume Léonard, Université de Sherbrooke

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active TENS
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.
Device: Active transcutaneous electrical nerve stimulation (TENS)
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.
Placebo Comparator: Simulated TENS
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.
Device: Simulated transcutaneous electrical nerve stimulation (TENS)
A modification of the TENS connexion parameters will prevent the current from reaching the electrods (once a first sensation will be perceived).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Exercise tolerance
Time Frame: 8- to 12- week rehabilitation period (T2)
This functional outcome will be collected directly from the medical record (score obtained to the 6-minute walk test [6MWT]).
8- to 12- week rehabilitation period (T2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)
This outcome will be measured by the Beck Depression Inventory
Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)
Physical function
Time Frame: Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)
This outcome will be measured by the Brief Pain Inventory.
Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)
Qualitative aspects of pain
Time Frame: Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)
This outcome will be measured by the McGill-Melzack pain questionnaire
Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)
Balance
Time Frame: up to 8- to 12- week rehabilitation period (T2)
This functional outcome will be collected directly from the medical record (score obtained to the Berg Balance Scale [BBS])
up to 8- to 12- week rehabilitation period (T2)
Mobility and balance
Time Frame: up to 8- to 12- week rehabilitation period (T2)
This functional outcome will be collected directly from the medical record (score obtained to the Time up and go [TUG])
up to 8- to 12- week rehabilitation period (T2)
Functional ability
Time Frame: up to 8- to 12- week rehabilitation period (T2)
This functional outcome will be collected directly from the medical record (score obtained to the Functional autonomy measurement system [SMAF])
up to 8- to 12- week rehabilitation period (T2)

Collaborators and Investigators

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Sponsor

Sponsor

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Université de Sherbrooke

Collaborators

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Fondation Vitae

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

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September 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

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May 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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May 14, 2015

First Posted (Estimate)

First Posted

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May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

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  • 2016-535

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