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

NCT02445677 | Withdrawn

• 1 other identifier: 2016-535
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Keywords

TENS; chronic pain; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance

  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 Outcomes (6)

• Mood

  Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)

• Physical function

  Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)

• Qualitative aspects of pain

  Twice: at baseline (T1) and 8- to 12- week rehabilitation period (T2)

• Balance

  up to 8- to 12- week rehabilitation period (T2)

• Mobility and balance

  up to 8- to 12- week rehabilitation period (T2)

Study Arms (2)

Active TENS

EXPERIMENTAL

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)

Simulated TENS

PLACEBO COMPARATOR

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)

Interventions

Active transcutaneous electrical nerve stimulation (TENS) DEVICE

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.

Active TENS

Simulated transcutaneous electrical nerve stimulation (TENS) DEVICE

A modification of the TENS connexion parameters will prevent the current from reaching the electrods (once a first sensation will be perceived).

Simulated TENS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Having a cardiac simulator (TENS contraindications).
• Having with cognitive alterations (score of \< 24/30 at the Folstein test)

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Fondation Vitae: collaborator

Related Publications (1)

• 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.

  PMID: 31841037 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 15, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05