Back to resultsTENS Reduces Movement-Evoked Pain in People With CLBP
Primary Purpose
Chronic Low-back Pain
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HeatTens (HV-F311-E)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain
Eligibility Criteria
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
Sites / Locations
- Vrije Universiteit Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Movement-Evoked Pain during TENS treatment
Movement-Evoked Pain
Arm Description
Participants performed several physical tasks while using the HeatTens device (HV-F311-E). During these tasks, participants needed to rate their pain.
Participants performed several physical tasks during with their pain was assessed.
Outcomes
Primary Outcome Measures
Movement Evoked Pain
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04090814
First Posted
September 5, 2019
Last Updated
February 2, 2021
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT04090814
Brief Title
TENS Reduces Movement-Evoked Pain in People With CLBP
Official Title
Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain in People With Chronic Low Back Pain: A Randomised Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Movement-Evoked Pain during TENS treatment
Arm Type
Experimental
Arm Description
Participants performed several physical tasks while using the HeatTens device (HV-F311-E). During these tasks, participants needed to rate their pain.
Arm Title
Movement-Evoked Pain
Arm Type
No Intervention
Arm Description
Participants performed several physical tasks during with their pain was assessed.
Intervention Type
Device
Intervention Name(s)
HeatTens (HV-F311-E)
Intervention Description
(1) 2~108 Hertz (modulation program inside); (2) 100 microseconds (pulse duration)
Primary Outcome Measure Information:
Title
Movement Evoked Pain
Description
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).
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Leemans
Organizational Affiliation
Dra. Lynn Leemans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vrije Universiteit Brussel
City
Brussel
State/Province
Jette
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available.
Citations:
PubMed Identifier
21402445
Citation
Srikandarajah S, Gilron I. Systematic review of movement-evoked pain versus pain at rest in postsurgical clinical trials and meta-analyses: a fundamental distinction requiring standardized measurement. Pain. 2011 Aug;152(8):1734-1739. doi: 10.1016/j.pain.2011.02.008. Epub 2011 Mar 12.
Results Reference
background
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TENS Reduces Movement-Evoked Pain in People With CLBP
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