TENS Reduces Movement-Evoked Pain in People With CLBP

Not Applicable

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Device: HeatTens (HV-F311-E)

• Registration Number: NCT04090814
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Study Start: 2019-10-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Movement-Evoked Pain during TENS treatment	HeatTens (HV-F311-E)	Participants performed several physical tasks while using the HeatTens device (HV-F311-E). During these tasks, participants needed to rate their pain.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Vrije Universiteit Brussel; 🇧🇪 Brussel, Jette, Belgium