Acute Effects of Hot-Pack Therapy in Low Back Pain

NCT07242183 | Not Yet Recruiting

• 1 other identifier: ETU-PMR-HOTPACK-2025-RCT-v3
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Low Back Pain; Back Pain

Keywords

Hot-pack; Muscle Stiffness; Erector Spinae; Myotonometry

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

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

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

Study Arms (2)

Hot-Pack Therapy

EXPERIMENTAL

Single-session moist hot-pack applied to the lumbar region. Pack surface temperature ≈60-65 °C; 6-8 towel layers as barrier; total duration 20 minutes. Skin checks at minutes 5 and 10. Outcomes: pain (VAS) and erector spinae stiffness (MyotonPro) immediately post-session; ODI at 24-48 h

Device: Hot-Pack; Device: Sham Pack

Room-Temperature Pack (Sham)

SHAM COMPARATOR

Single-session room-temperature pack applied to the lumbar region using the same setup as the active arm (identical towels/barrier, positioning, and timing) but without heat. Total duration 20 minutes. Outcomes measured on the same schedule. Maintains participant and assessor blinding.

Device: Hot-Pack; Device: Sham Pack

Interventions

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.

Also known as: Thermotherapy; Heat therapy

Hot-Pack Therapy; Room-Temperature Pack (Sham)

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.

Also known as: Placebo thermotherapy; Room-temperature pack

Hot-Pack Therapy; Room-Temperature Pack (Sham)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years
• Nonspecific/mechanical low back pain (clinical diagnosis)
• Baseline pain ≥3/10 on a 0-10 Visual Analogue Scale (VAS)
• Able to understand procedures and provide written informed consent
• Able to attend baseline, immediate post-session, and 24-48 h follow-up assessments

You may not qualify if:

• Neurologic deficit, tumour, or systemic inflammatory disease
• Prior lumbar spine surgery
• Heat or cold therapy to the lumbar region within the past 6 weeks
• Dermatologic lesions, open wounds, or skin conditions over the lumbar area
• Contraindications to heat (e.g., impaired sensation/neuropathy over the area, severe circulatory disorders)
• Pregnancy
• Implanted electronic devices (e.g., pacemaker)
• Inability to comply with the study schedule or procedures

Sponsors & Collaborators

• Erzurum Technical University: lead
• Amasya University: collaborator
• Ataturk University: collaborator

MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Hyperthermia, Induced; Diathermy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Gökhan YAĞIZ, Dr.

  Amasya University

  STUDY CHAIR

• Julian OWEN, Dr.

  Bangor University

  STUDY DIRECTOR

Central Study Contacts

Esedullah AKARAS, Dr.

CONTACT

+904445388; esedullah.akaras@erzurum.edu.tr

Sena ADANIR, MsC:PT

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants receive either a heated moist pack or an identical setup with a room-temperature pack; identical towel barriers and procedures maintain participant blinding. The treating therapist cannot be blinded due to the nature of heat delivery. Outcome assessors are blinded to allocation; data are recorded with coded IDs to preserve blinding during analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Two-arm, single-session randomized controlled trial comparing moist hot-pack versus sham (room-temperature pack) in adults with nonspecific low back pain. Participants are randomized 1:1; treating therapist is not blinded, while participants and outcomes assessors are blinded. Outcomes: pain (VAS) and lumbar erector spinae stiffness (MyotonPro) immediately post-session; ODI at 24-48 h.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 10, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share