TENS Reduces Movement-Evoked Pain in People With CLBP

Chronic Low-back Pain Clinical Trial

Official title:

Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain in People With Chronic Low Back Pain: A Randomised Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090814
• Other study ID #: LLeemans
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: February 2021
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.