Low Back PainHOTPACK-LBPNCT07242183
Acute Effects of Hot-Pack Therapy in Low Back Pain
A study testing Hot-Pack in people with Low Back Pain and Back Pain, run by Erzurum Technical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Back Pain
- What is being tested?
- Hot-Pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sena ADANIR, MsC:PT contact
About this study
Official title: Acute Effects of Hot-pack Therapy on Lumbar Erector Spinae Muscle Stiffness and Pain in Adults With Low Back Pain: A Randomised Controlled 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.
Read the detailed description
Rationale. Hot-pack (thermotherapy) is frequently prescribed to reduce pain and muscle tension in low back pain, but controlled evidence quantifying immediate changes in muscle mechanical properties and pain remains scarce. Demonstrating short-term benefits with objective measures (MyotonPro) and validated scales (VAS, ODI) could inform pragmatic care pathways for nonspecific low back pain.
Objectives and Hypotheses. Primary objective: determine whether a single hot-pack session reduces erector spinae stiffness (MyotonPro) and pain (VAS) versus sham. Secondary objective: explore short-term effects on functional disability (ODI) and perceived improvement. We hypothesize greater immediate reductions in stiffness and pain, and better short-term function, with hot-pack versus sham.
Design and Setting. Prospective, two-arm, parallel RCT at Atatürk University Faculty of Medicine (Physical Medicine \& Rehabilitation / Orthopedics). Target sample: 30 adults (pilot). Allocation is 1:1 using computer-generated randomization; outcome assessors and participants are blinded.
Participants. Adults 18-65 y with nonspecific/mechanical low back pain and baseline VAS ≥ 3/10. Key exclusions include pregnancy, pacemaker/implanted devices, recent lumbar surgery or heat/cold therapy (<6 weeks), dermatologic lesions, neurologic deficit, tumour, or systemic inflammatory disease. Written informed consent is obtained before any procedure.
Interventions.
Hot-pack (Active): Moist hot-pack at 60-65 °C applied over the lumbar region for 20 minutes with a 6-8 towel barrier. Skin is checked at minutes 5 and 10.
Sham (Comparator): Identical setup using a room-temperature pack (no heat).
Outcome Measures and Timing.
Primary: Change in pain intensity (VAS, 0-10 cm) from pre- to immediate post-intervention.
Key Secondary: Change in erector spinae stiffness (MyotonPro) from pre- to immediate post-intervention; ODI at 24-48 h; patient-reported perceived change.
Procedures. After screening and consent, baseline demographics and outcomes are recorded. MyotonPro measurements are taken over the lumbar erector spinae at L3-L4, 2-3 cm lateral, with three repeats per point and averaged. Post-session, VAS and MyotonPro are repeated; ODI and a brief perceived-change item are collected 24-48 h later. All assessments are performed by trained physiotherapists following device protocols and the Declaration of Helsinki.
Randomization, Masking, and Data Handling. Randomization is computer-assisted (1:1). Participants and assessors are blinded to group assignment via a sham procedure mirroring the active setup. Data are recorded with coded IDs and analysed with mixed-model repeated-measures ANOVA (group × time), reporting effect sizes and 95% CIs.
- Conditions
- Low Back Pain, Back Pain
- Being tested
- Hot-Pack, Sham Pack
- Keywords
- Hot-pack, Muscle Stiffness, Erector Spinae, Myotonometry
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot-PackDevice
Also called Thermotherapy; Heat therapy
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 PackDevice
Also called Placebo thermotherapy; Room-temperature pack
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Hot-Pack; Device: Sham Pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately post-session (~20-30 minutes)
Secondary outcomes (1)
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.
Measured: Baseline (pre-session) and immediately post-session (~20-30 minutes after start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start10 Nov 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- Amasya University, Ataturk University
- Responsible party
- Principal investigator, esedullah akaras, Erzurum Technical University
- Investigators
- Gökhan YAĞIZ, Dr., Study chair, Amasya UniversityJulian OWEN, Dr., Study director, Bangor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242183
- Sponsor's protocol ID
- ETU-PMR-HOTPACK-2025-RCT-v3
- Acronym
- HOTPACK-LBP
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data. Only aggregate findings will be reported in publications and at ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Hot-pack Therapy on Lumbar Erector Spinae Muscle Stiffness and Pain in Adults With Low Back Pain: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07242183
- Acronym / sponsor ID
- HOTPACK-LBP / ETU-PMR-HOTPACK-2025-RCT-v3
- Conditions
- Low Back Pain, Back Pain
- Keywords
- Hot-pack, Muscle Stiffness, Erector Spinae, Myotonometry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Collaborators
- Amasya University, Ataturk University
- Study start
- 10 Nov 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale. Hot-pack (thermotherapy) is frequently prescribed to reduce pain and muscle tension in low back pain, but controlled evidence quantifying immediate changes in muscle mechanical properties and pain remains scarce. Demonstrating short-term benefits with objective measures (MyotonPro) and validated scales (VAS, ODI) could inform pragmatic care pathways for nonspecific low back pain.
Objectives and Hypotheses. Primary objective: determine whether a single hot-pack session reduces erector spinae stiffness (MyotonPro) and pain (VAS) versus sham. Secondary objective: explore short-term effects on functional disability (ODI) and perceived improvement. We hypothesize greater immediate reductions in stiffness and pain, and better short-term function, with hot-pack versus sham.
Design and Setting. Prospective, two-arm, parallel RCT at Atatürk University Faculty of Medicine (Physical Medicine \& Rehabilitation / Orthopedics). Target sample: 30 adults (pilot). Allocation is 1:1 using computer-generated randomization; outcome assessors and participants are blinded.
Participants. Adults 18-65 y with nonspecific/mechanical low back pain and baseline VAS ≥ 3/10. Key exclusions include pregnancy, pacemaker/implanted devices, recent lumbar surgery or heat/cold therapy (<6 weeks), dermatologic lesions, neurologic deficit, tumour, or systemic inflammatory disease. Written informed consent is obtained before any procedure.
Interventions.
Hot-pack (Active): Moist hot-pack at 60-65 °C applied over the lumbar region for 20 minutes with a 6-8 towel barrier. Skin is checked at minutes 5 and 10.
Sham (Comparator): Identical setup using a room-temperature pack (no heat).
Outcome Measures and Timing.
Primary: Change in pain intensity (VAS, 0-10 cm) from pre- to immediate post-intervention.
Key Secondary: Change in erector spinae stiffness (MyotonPro) from pre- to immediate post-intervention; ODI at 24-48 h; patient-reported perceived change.
Procedures. After screening and consent, baseline demographics and outcomes are recorded. MyotonPro measurements are taken over the lumbar erector spinae at L3-L4, 2-3 cm lateral, with three repeats per point and averaged. Post-session, VAS and MyotonPro are repeated; ODI and a brief perceived-change item are collected 24-48 h later. All assessments are performed by trained physiotherapists following device protocols and the Declaration of Helsinki.
Randomization, Masking, and Data Handling. Randomization is computer-assisted (1:1). Participants and assessors are blinded to group assignment via a sham procedure mirroring the active setup. Data are recorded with coded IDs and analysed with mixed-model repeated-measures ANOVA (group × time), reporting effect sizes and 95% CIs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hot-Pack Therapy | Experimental | Device: Hot-Pack, Device: Sham PackSingle-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 |
| Room-Temperature Pack (Sham) | Sham comparator | Device: Hot-Pack, Device: Sham PackSingle-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot-PackAlso: Thermotherapy; Heat therapyThermal 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. | Device | Hot-Pack Therapy, Room-Temperature Pack (Sham) |
| Sham PackAlso: Placebo thermotherapy; Room-temperature packPlacebo 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. | Device | Hot-Pack Therapy, Room-Temperature Pack (Sham) |
Primary outcome
Change in Lumbar Erector Spinae Stiffness (MyotonPro, N/m) From Baseline to Immediate Post-Intervention
Time frame: Baseline and immediately post-session (~20-30 minutes)
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.
1 secondary outcome
Change in Pain Intensity (VAS, 0-10) From Baseline to Immediate Post-Intervention
Time frame: Baseline (pre-session) and immediately post-session (~20-30 minutes after start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No. No plan to share individual participant data. Only aggregate findings will be reported in publications and at ClinicalTrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sena ADANIR, MsC:PT contact
Gökhan YAĞIZ, Dr. study chair
Amasya University
Julian OWEN, Dr. study director
Bangor University
Questions about this trial
What is this clinical trial studying?
A study testing Hot-Pack in people with Low Back Pain and Back Pain, run by Erzurum Technical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esedullah AKARAS, Dr. (+904445388 ext. 2772, esedullah.akaras@erzurum.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lumbar Erector Spinae Stiffness (MyotonPro, N/m) From Baseline to Immediate Post-Intervention (time frame: Baseline and immediately post-session (~20-30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.