TENS Reduces Movement-Evoked Pain in People With CLBP

NCT04090814 | Completed

• 1 other identifier: LLeemans
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Movement-Evoked Pain during TENS treatment

EXPERIMENTAL

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)

Movement-Evoked Pain

NO INTERVENTION

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

Interventions

HeatTens (HV-F311-E) DEVICE

(1) 2\~108 Hertz (modulation program inside); (2) 100 microseconds (pulse duration)

Movement-Evoked Pain during TENS treatment

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, Jette, 1090, Belgium

Location

Related 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.

  PMID: 21402445 BACKGROUND

Study Officials

• Lynn Leemans

  Dra. Lynn Leemans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 16, 2019
• Study Start: October 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)