TENS Reduces Movement-Evoked Pain in People With CLBP

Sponsor
Vrije Universiteit Brussel (Other)
Overall Status
Completed
CT.gov ID
NCT04090814
Collaborator
(none)
25
1
2
1
24.5

Study Details

Study Description

Brief Summary

In this cross-over study 25 patients with chronic low back pain (CLBP) were tested for pain relief in 2 conditions: while using the Transcutaneous Electrical Nerve Stimulation (TENS) application and without using it. Primary outcome: Movement-Evoked Pain (MEP). This was measured using the Back Performance Scale (BPS) and a 5-minute walk test (5MWT). Participants performed 5 functional tasks and were asked to rate their pain before, during, and after each movement on a numeric rating score scale. The same principle will be used for the 5MWT: for each walking-minute, 3 pain measurements will be assessed.

Condition or Disease Intervention/Treatment Phase
  • Device: HeatTens (HV-F311-E)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain in People With Chronic Low Back Pain: A Randomised Crossover Study
Actual Study Start Date :
Oct 1, 2019
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Movement-Evoked Pain during TENS treatment

Participants performed several physical tasks while using the HeatTens device (HV-F311-E). During these tasks, participants needed to rate their pain.

Device: HeatTens (HV-F311-E)
(1) 2~108 Hertz (modulation program inside); (2) 100 microseconds (pulse duration)

No Intervention: Movement-Evoked Pain

Participants performed several physical tasks during with their pain was assessed.

Outcome Measures

Primary Outcome Measures

  1. Movement Evoked Pain [Change in pain score between (1) Movement Evoked Pain measures assessed without TENS application and (2) Movement-Evoked Pain measured assessed while using TENS application. Between both measures, a wash out period of 30 minutes was introduced.]

    Pain that is experienced in response to 2 physical tasks: the Back Performance Scale and the 5 minutes walk test. Participants performed 5 physical tasks (= 1) grasping toes with fingertips in a sitting position; 2) forward bending from standing; 3) picking up paper from standing; 4) long-sitting from supine and 5) lifting a 5kg box from floor to table) and walked for 5 minutes. Participants provided a pain rating on a 11 points Numeric Rating Scale (NRS) with the endpoints no pain" (0) and "excruciating pain" (10). Pain will be assessed during the physical tasks (=at the same moment).

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • chronic nonspecific LBP for at least 3 months' duration: non-specific LBP implies that patients are not allowed to have any evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy).
Exclusion Criteria:
  • spinal surgery in the past 6 months

  • severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, etc.),

  • pregnant or given birth in the preceding year,

  • having initiated a new LBP treatment in the 6 weeks prior to study participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vrije Universiteit Brussel Brussel Jette Belgium 1090

Sponsors and Collaborators

  • Vrije Universiteit Brussel

Investigators

  • Principal Investigator: Lynn Leemans, Dra. Lynn Leemans

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lynn Leemans, Principal Investigator, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:
NCT04090814
Other Study ID Numbers:
  • LLeemans
First Posted:
Sep 16, 2019
Last Update Posted:
Feb 3, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2021