Chronic Non-specific Low Back PainNCT06769321
Automatic Thermomechanical Massage Bed for Acute Pain Relief for Chronic Nonspecific Low Back Pain
A study testing Automatic Thermo-mechanical Massage Bed in people with Chronic Non-specific Low Back Pain, run by The City College of New York at 1 site in United States.
Trial summary
This prospective, double-blinded, sham-control, parallel-arm, randomized pilot trial will recruit n=40 participants, ages 18-65 (inclusive), with chronic low back pain (LBP) in the lower region, to be randomly assigned using 1:1 randomization method to receive a 40-minute single session of either active or sham… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- Automatic Thermo-mechanical Massage Bed
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to 27 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Between the ages of 18 and 65
- Has had chronic non-specific lower back pain persisting for 12 weeks or more
- Conversational level of English
Who cannot join
- Contraindications to mechanical manipulation of the back
- History of back surgery within the past three years
- Recent back injury
- Presence of back implants or active implanted devices
- Low back pain resulting from other specific conditions (e.g., infection, neoplasm)
- Sensitivity to heat
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- Circulatory insufficiency
- Heart disease
- Pregnant or breastfeeding
- Individuals with a history of substance use disorder
- Body weight over 298 lbs (135 kg)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Discovery and Innovation
New York, New York, 10031
About this study
Official title: Phase 2 RCT Automatic Thermomechanical Massage Bed for Acute Pain Relief for Chronic Nonspecific Low Back Pain
This prospective, double-blinded, sham-control, parallel-arm, randomized pilot trial will recruit n=40 participants, ages 18-65 (inclusive), with chronic low back pain (LBP) in the lower region, to be randomly assigned using 1:1 randomization method to receive a 40-minute single session of either active or sham Automated Thermo-mechanical Therapy (ATT). All research procedures, including informed consent, ATT session, and pre- and post-ATT assessments, will be completed in one single session.
- Conditions
- Chronic Non-specific Low Back Pain
- Being tested
- Automatic Thermo-mechanical Massage Bed
- Keywords
- Chronic Pain, Low back Pain, Automatic Thermo-mechanical Therapy
- Medical subject headings
- Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic Thermo-mechanical Massage BedDevice
The MASTER V6 (Master series, CGM MB-1701, CERAGEM Co. Ltd., Cheonan, Korea) used in this study is a commercially available automated thermo-mechanical therapy device that combines mechanical spinal stimulation with far-infrared (FIR) heat treatment.
| Study group | Role | What they receive |
|---|---|---|
| Active Automatic Thermomechanical Therapy | Experimental | This device delivers thermomechanical therapy to the lower back for 40 minutes Receives: Device: Automatic Thermo-mechanical Massage Bed |
| Sham Automatic Thermomechanical Therapy | Sham comparator | The comparator device is a sham device that has the same outer appearance as the investigational device. Throughout the entire massage session, the intensity will be set to a level below 1, in areas unrelated to where the major muscles causing lower back pain are located, minimizing the actual massage effect. The thermal component will be turned off entirely. Receives: Device: Automatic Thermo-mechanical Massage Bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 100mm Visual Analogue Scale for Pain
The VAS-P100 is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients. The 100-mm VAS-P is a straight horizontal line of fixed length of 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst). The participant marks on the line the point that they feel represents their perception of their current state. The score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks
Measured: Immediately before and immediately after intervention
Secondary outcomes (5)
Roland-Morris Disability Questionnaire
The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Total score can range from 0 (no disability) to 24 (severe disability). The RMDQ is scored by adding up the number of items the patient checks.
Measured: Immediately before intervention
McGill Pain Questionnaire
This questionnaire is used to evaluate a person experiencing significant pain, to monitor the pain over time and to determine the effectiveness of any intervention. The questionnaire evaluates three different domains: 1) What does the pain look like?; 2) How does your pain change with time?; 3) How strong is your pain?
Measured: Immediately before intervention and immediately after intervention
State-Trait Anxiety Inventory
This questionnaire is widely used to measure the state and trait components of anxiety
Measured: Immediately before and immediately after intervention
5-point Verbal Rating Scale for Pain Relief
Verbal rating scales about pain relief on a 5-point rating scale: none= 0, slight= 1, moderate= 2, good= 3, complete relief= 4. (Administered only at the post-ATMB intervention)28
Measured: Immediately after intervention
Modified-Modified Schöber Test
This is a physical examination used to measure the ability of a patient to flex the lower back. The patient is standing, and the examiner marks both posterior superior iliac spine (PSIS) and then draws a horizontal line at the center of both marks. A second line is marked 15 cm above the first line. The patient is then instructed to flex forward without bending the knees as if attempting to touch his/her toes, examiner re-measures the distance between the top and bottom line
Measured: Immediately before and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start5 Jun 2024
- Primary completion27 Jul 2024
- Study completion27 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-specific 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
- This a double-blind sham-controlled randomized trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The City College of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marom Bikson, The City College of New York
- Investigators
- Marom Bikson, PhD, Principal investigator, The City College of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769321
- Sponsor's protocol ID
- 2024-0288-CCNY
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Donnery K, Pilloni G, FallahRad M, Lee K, Han B, Park S, Kim J, Charvet L, Bikson M. Automated thermo-mechanical therapy for immediate relief in chronic non-specific lower back pain: a randomized controlled trial. Front Neuroergon. 2026 Jan 9;6:1674928. doi: 10.3389/fnrgo.2025.1674928. eCollection 2025.
PubMed 41585325
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 RCT Automatic Thermomechanical Massage Bed for Acute Pain Relief for Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT06769321
- Acronym / sponsor ID
- 2024-0288-CCNY
- Conditions
- Chronic Non-specific Low Back Pain
- Keywords
- Chronic Pain, Low back Pain, Automatic Thermo-mechanical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The City College of New YorkUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 27 Jul 2024 (actual)
- Study completion
- 27 Jul 2024 (actual)
- First posted
- 10 Jan 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 prospective, double-blinded, sham-control, parallel-arm, randomized pilot trial will recruit n=40 participants, ages 18-65 (inclusive), with chronic low back pain (LBP) in the lower region, to be randomly assigned using 1:1 randomization method to receive a 40-minute single session of either active or sham Automated Thermo-mechanical Therapy (ATT). All research procedures, including informed consent, ATT session, and pre- and post-ATT assessments, will be completed in one single session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This a double-blind sham-controlled randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Active Automatic Thermomechanical Therapy | Experimental | Device: Automatic Thermo-mechanical Massage BedThis device delivers thermomechanical therapy to the lower back for 40 minutes |
| Sham Automatic Thermomechanical Therapy | Sham comparator | Device: Automatic Thermo-mechanical Massage BedThe comparator device is a sham device that has the same outer appearance as the investigational device. Throughout the entire massage session, the intensity will be set to a level below 1, in areas unrelated to where the major muscles causing lower back pain are located, minimizing the actual massage effect. The thermal component will be turned off entirely. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 65
- Has had chronic non-specific lower back pain persisting for 12 weeks or more
- Conversational level of English
Key exclusion criteria (11 listed)
- Contraindications to mechanical manipulation of the back
- History of back surgery within the past three years
- Recent back injury
- Presence of back implants or active implanted devices
- Low back pain resulting from other specific conditions (e.g., infection, neoplasm)
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 |
|---|---|---|
| Automatic Thermo-mechanical Massage BedThe MASTER V6 (Master series, CGM MB-1701, CERAGEM Co. Ltd., Cheonan, Korea) used in this study is a commercially available automated thermo-mechanical therapy device that combines mechanical spinal stimulation with far-infrared (FIR) heat treatment. | Device | Active Automatic Thermomechanical Therapy, Sham Automatic Thermomechanical Therapy |
Primary outcome
The 100mm Visual Analogue Scale for Pain
Time frame: Immediately before and immediately after intervention
The VAS-P100 is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients. The 100-mm VAS-P is a straight horizontal line of fixed length of 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst). The participant marks on the line the point that they feel represents their perception of their current state. The score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks
5 secondary outcomes
Roland-Morris Disability Questionnaire
Time frame: Immediately before intervention
McGill Pain Questionnaire
Time frame: Immediately before intervention and immediately after intervention
State-Trait Anxiety Inventory
Time frame: Immediately before and immediately after intervention
5-point Verbal Rating Scale for Pain Relief
Time frame: Immediately after intervention
Modified-Modified Schöber Test
Time frame: Immediately before and immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Derived from this study: PubMed 41585325Donnery K, Pilloni G, FallahRad M, Lee K, Han B, Park S, Kim J, Charvet L, Bikson M. Automated thermo-mechanical therapy for immediate relief in chronic non-specific lower back pain: a randomized controlled trial. Front Neuroergon. 2026 Jan 9;6:1674928. doi: 10.3389/fnrgo.2025.1674928. eCollection 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marom Bikson, PhD principal investigator
The City College of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic Thermo-mechanical Massage Bed in people with Chronic Non-specific Low Back Pain, run by The City College of New York at 1 site in United States.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 100mm Visual Analogue Scale for Pain (time frame: Immediately before and immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06769321, which also lists 1 linked publication.
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 13 Jan 2025.