TENS Reduces Movement-Evoked Pain in People With CLBP

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Low-back Pain

Intervention / Treatment
-----------------
* Device: HeatTens (HV-F311-E)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Movement-Evoked Pain during TENS treatment<br>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)<br>* (1) 2 108 Hertz (modulation program inside); (2) 100 microseconds (pulse duration)<br>|
| No Intervention: Movement-Evoked Pain<br>Participants performed several physical tasks during with their pain was assessed. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |