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TENS Reduces Movement-Evoked Pain in People With CLBP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04090814
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Information provided by (Responsible Party):
Lynn Leemans, Vrije Universiteit Brussel

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
Chronic Low-back Pain Device: HeatTens (HV-F311-E) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : August 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.

Primary Outcome Measures :
  1. Movement Evoked Pain [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04090814

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Vrije Universiteit Brussel
Brussel, Jette, Belgium, 1090
Sponsors and Collaborators
Vrije Universiteit Brussel
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Principal Investigator: Lynn Leemans Dra. Lynn Leemans
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Responsible Party: Lynn Leemans, Principal Investigator, Vrije Universiteit Brussel Identifier: NCT04090814    
Other Study ID Numbers: LLeemans
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available.

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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:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms