NCT03643731

Brief Summary

A two-armed randomized controlled clinical trial with blind assessments and a follow-up period of 4 weeks is developed. The aim of this study is to investigate the effects of the combination of heat and TENS (HeatTENS device) on pain in people with chronic low back pain. A sample of 70 patients will be recruited. Following baseline measurements, subjects will be randomly allocated to the experimental or the control group. The experimental group will be asked to use the device on a daily basis, 30 minutes per day. The control group will have no device. After 4 weeks of FU, measurements will be repeated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 29, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

August 10, 2018

Last Update Submit

September 5, 2019

Conditions

Chronic Low Back PainMovement Evoked Pain

Outcome Measures

Primary Outcomes (1)

  • Movement Evoked Pain

    Pain that is experienced in response to a physical task. Participants will perform 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). Participants will provide a pain rating on a 11 points Numeric Rating Scale (NRS) with the endpoints no pain" (0) and "excruciating pain" (10)

    Change from Baseline Movement Evoked Pain after treatment and at 4 weeks

Secondary Outcomes (8)

  • 5 minute walk test (5MWT)

    Change from Baseline 5MWT after treatment and at 4 weeks

  • Pressure Pain Threshold (PPT)

    Change from Baseline Pressure Pain Threshold after treatment and at 4 weeks

  • Temporal summation (TS)

    Change from Baseline Tempral Summation after treatment and at 4 weeks

  • Conditioned pain modulation

    Change from Baseline Conditioned pain modulation after treatment and at 4 weeks

  • Fear Avoidance Beliefs Questionnaire- work

    Change from Baseline Fear Avoidance Beliefs Questionnaire after treatment and at 4 weeks

  • +3 more secondary outcomes

Study Arms (2)

HeatTens

EXPERIMENTAL

After baseline measurements and during 4 weeks of follow up Composition and dosing of the device: HeatTens (HV-F311-E) 2 - 108 Hz (modulation), 100 microsec (pulse duration) for 30 minutes.

Device: HeatTens (HV-F311-E)

Control group

NO INTERVENTION

No intervention

Interventions

HeatTens (HV-F311-E)DEVICE

Patients need to apply the device during 30 minutes.

HeatTens

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, Jette, 1090, Belgium

Location

Related Publications (1)

  • Leemans L, Elma O, Nijs J, Wideman TH, Siffain C, den Bandt H, Van Laere S, Beckwee D. Transcutaneous electrical nerve stimulation and heat to reduce pain in a chronic low back pain population: a randomized controlled clinical trial. Braz J Phys Ther. 2021 Jan-Feb;25(1):86-96. doi: 10.1016/j.bjpt.2020.04.001. Epub 2020 May 12.

    PMID: 32434666DERIVED

Study Officials

  • David Beckwée, PhD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 23, 2018

Study Start

August 29, 2018

Primary Completion

August 9, 2019

Study Completion

August 9, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations

BE(1)