Immediate Effects of TENS on Lumbar Erector Spinae Stiffness in Low Back Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorErzurum Technical University

About this trial

Low back pain is frequently associated with increased tone and stiffness of the lumbar erector spinae muscles, which may contribute to pain and functional limitation. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, safe, and widely used modality for pain reduction, but its very short-term (immediate) effects on lumbar muscle stiffness have not been clearly demonstrated. This randomized controlled trial will compare a single 20-minute session of conventional TENS with a control/rest condition in patients with non-specific low back pain. The primary outcomes will be change in lumbar erector spinae muscle stiffness (Myoton) and change in pain intensity (VAS) from baseline to immediately after the intervention. We hypothesize that TENS will produce a greater immediate reduction in muscle stiffness and pain than control.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18-30 years

Disqualifiers

Low back pain with a specific cause (e.g. lumbar disc herniation with radiculopathy, infection, tumor, fracture, severe deformity)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous Electrical Nerve Stimulation (TENS)

    Device

    Conventional TENS; frequency 80-100 Hz, pulse width 100-150 μs, intensity adjusted to strong but comfortable sensory level without muscle contraction; total duration 20 minutes; electrodes placed bilaterally at lumbar erector spinae level.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Experimental: TENSExperimental treatment 1 intervention
Group B: Control: Rest/PositioningOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in lumbar erector spinae muscle stiffness

Muscle stiffness of the lumbar erector spinae will be measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels. The outcome is the change score (post - pre) between TENS and control groups. Lower values indicate reduced stiffness.

Time frame
Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)
2

Change in pain intensity (VAS)

Pain intensity will be assessed using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst pain). The outcome is the change score (post - pre) to compare TENS and control groups. Lower scores indicate pain reduction.

Time frame
Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)

Secondary outcomes

Other outcomes

Sponsors and contacts

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Erzurum Technical University

Lead sponsor

Amasya University

Collaborator

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