TENS Reduces Movement-Evoked Pain in People With CLBP

NCT ID: NCT04090814

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2019-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HeatTens (HV-F311-E)

Intervention Type: DEVICE

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

Movement-Evoked Pain

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HeatTens (HV-F311-E)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Lynn Leemans

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynn Leemans

Role: PRINCIPAL_INVESTIGATOR

Dra. Lynn Leemans

Locations

Vrije Universiteit Brussel

Brussels, Jette, Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 21402445 (View on PubMed)

Other Identifiers

LLeemans

Identifier Type: -

Identifier Source: org_study_id