Acute Effects of Hot-Pack Therapy in Low Back Pain

ConditionsLow Back Pain Back Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorErzurum Technical University

About this trial

This single-centre, parallel-group randomized controlled trial will test whether one session of moist hot-pack therapy produces immediate improvements in pain intensity and lumbar erector spinae muscle stiffness in adults with nonspecific low back pain. Participants are randomized 1:1 to hot-pack or sham (room-temperature pack). Outcomes are assessed at baseline and immediately after the session using VAS (0-10 cm) and MyotonPro; a short follow-up (24-48 h) captures Oswestry Disability Index (ODI) and perceived change. The intervention is brief, low-risk, and commonly used in clinical practice, yet high-quality evidence on its acute effects is limited.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-65 years

Disqualifiers

Neurologic deficit, tumour, or systemic inflammatory disease

Trial design

Design model

Parallel

Treatments tested in this trial

Hot-Pack
Device
Thermal therapy delivered via a moist hot-pack applied to the lumbar area for 20 minutes. Target pack surface temp ≈60-65 °C at application; 6-8 towel layers to prevent burns; patient positioned prone or side-lying per comfort. Skin integrity checked at minutes 5 and 10; session stopped if adverse reactions occur. Single session only.
Sham Pack
Device
Placebo thermotherapy control using a room-temperature pack with identical preparation, towel barriers, positioning, and duration (20 minutes) as the active intervention. No heat is delivered. Used to preserve participant blinding.

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: Hot-Pack TherapyExperimental treatment 2 interventions

Group B: Room-Temperature Pack (Sham)Sham comparator 2 interventions

Trial outcomes

Primary outcomes

Change in Lumbar Erector Spinae Stiffness (MyotonPro, N/m) From Baseline to Immediate Post-Intervention

Myotonometric stiffness (N/m) is captured over lumbar erector spinae (L3-L4 level, \~2-3 cm lateral). Three taps per point; averaged. Endpoint is change score (Post - Baseline); negative values indicate reduced stiffness.

Time frame

Baseline and immediately post-session (~20-30 minutes)

Secondary outcomes

Change in Pain Intensity (VAS, 0-10) From Baseline to Immediate Post-Intervention

Pain intensity is measured on a 10-cm Visual Analogue Scale (0=no pain, 10=worst pain). The primary endpoint is the change score (Post - Baseline); negative values indicate improvement. Participants rate pain just before the session and immediately after the 20-minute intervention.

Time frame

Baseline (pre-session) and immediately post-session (~20-30 minutes after start

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erzurum Technical University

Lead sponsor

Amasya University

Collaborator

Ataturk University