Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this trial

The primary goal of this clinical trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT), considering recruitment, compliance with study protocols, and adverse events. The secondary goal is to evaluate the effectiveness of a video-based educational explanation of transcutaneous electrical nerve stimulation (TENS) in eliciting placebo-induced hypoalgesia and improving clinical outcomes in patients with acute low back pain.

The main question it aims to answer is: Does the addition of a video-based educational explanation of TENS to standard physical therapy rehabilitation, consisting of TENS and exercises, increase the pressure pain threshold, reduce pain intensity, and improve functional mobility, patient satisfaction, and quality of life in patients with acute low back pain?

Participants will be divided into two groups for comparison: the control group will receive standard physical therapy rehabilitation consisting of TENS and exercises, while the experimental group will receive the same program in addition to the video-based educational explanation of TENS.

Eligibility criteria

Qualifiers

acute low back pain without radicular pain to lower limbs

minimal pain level of 4 on the 0-10 VAS

18-65 years of age

TENS naïve or have not used TENS in the past 5 years.

Disqualifiers

Radicular pain to lower limbs

Serious spinal disorders, such as fractures, tumors, or inflammatory arthritis disease

Nerve root disorders confirmed by neurological tests

Neurological diseases

Trial design

Treatments tested in this trial

  • TENS
  • TENS educational explanation video
  • Exercise

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators