Vibrational tool for non-migraine headache management
| ISRCTN | ISRCTN37415803 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37415803 |
| Secondary identifying numbers | INN 2023-14 |
- Submission date
- 15/03/2025
- Registration date
- 26/03/2025
- Last edited
- 25/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
This study examines the feasibility of preventative and acute treatment of chronic cluster headaches using vibration as a potential intervention to warrant a large-scale clinical trial.
Who can participate?
Patients aged 18–50 years suffering from tension or cluster-type headaches
What does the study involve?
Participants were randomly allocated to one of two groups. The experimental group received vibratory treatment at set frequencies and the control received sham treatment. All individuals were evaluated before and immediately after the intervention and 30 and 60 days after the conclusion of treatment.
What are the possible benefits and risks of participating?
The study will determine if the use of vibration and resonance-type devices significantly reduces pain over time, pointing to their effectiveness as a maintenance or preventative type of therapy and to determine if a larger scale, multi-site randomized control trial is warranted. There are no perceived risks in participating in the study.
Where is the study run from?
The Institute for Neurology and Neurosurgery of Havana (INN) (Cuba) outpatient clinics
When is the study starting and how long is it expected to run for?
February 2023 to February 2024
Who is funding the study?
Rezzimax LLC (USA)
Who is the main contact?
Prof. Dr. Gerry Leisman, g.leisman@edu.haifa.ac.il
Contact information
Prof Gerry Leisman
Public, Scientific
Public, Scientific
Movement & Cognition Laboratory
Faculty of Social Welfare and Health Sciences
University of Haifa
199 Abba Khoushy Avenue
Eshkol Tower, rm. 910
Haifa
3498838
Israel
 ORCID ID |
0000-0002-9975-7331 |
|---|---|
| Phone | +972 (0)52 420 5643 |
| g.leisman@alumni.manchester.ac.uk |
Dr Yanin Machado-Ferrer
Principal Investigator
Principal Investigator
Instituto de Neurología y Neurocirugía
Neurofisiología Cliníca
Calle 29 No. 139 esquina D, Vedado
Plaza de la Revolución
Havana
10400
Cuba
| Phone | +53 (0)52817774 |
|---|---|
| dra.yaninmachado@gmail.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Resonance massage tool effects in non-migraine headache management |
| Study acronym | None |
| Study hypothesis | This study of standard-of-care versus traditional treatment endeavors to examine the potential of preventative and acute treatment of chronic cluster headaches using a vagal nerve stimulation device. |
| Ethics approval(s) |
Approved 23/02/2023, Institute for Neurology and Neurosurgery of Havana (Calle 29 No. 139 esquina D, Vedado, Plaza de la Revolución, La Habana, 10400, Cuba; +53 (0)7 834 5578; braind@infomed.sld.cu), ref: 2023-14 |
| Condition | Non-migraine headache (cluster and tension) |
| Intervention | Randomization and blinding: Randomization for participant allocation to two groups was provided. The groups were: Experimental (ENS) and Control A (CS) receiving sham intervention. Randomization was performed via a randomized block design with varying block sizes of two, four, and six participants. In each block, one-half of the participants were randomly assigned to Group CS and another half to Group ENS. Using computer-generated sequence methods, randomization was achieved while maintaining participant and investigator confidentiality about both the generated allocation sequence and the randomization approach. Since each computer-generated randomization sequence was distinct, replication was impossible. Randomization was applied to “Group ENS” or to “Group CS”. Only the designated individual at the study site knew which assignment corresponded to which experimental treatment or control group with this information not to be revealed until study unblinding occurred, after all data had been entered into the database and the database sealed before statistical analyses. The initial study was conducted using the Rezzimax® Tuner Pro II (Rezzimax, Richmond, UT, USA) device with a tuning fork attachment. It is a battery-operated resonant massage tool containing a Precision Microdrive Model No. 320-102 vibration motor with a rated operating voltage of 3 V and rated vibrational speed of 790 rpm (+/−1600) and a normative amplitude of 17 G. The device has a range between 20 and 120 Hz with 10 preset levels. It also has four proprietary algorithms or patterns to assist in decreasing pain. For this study, the patterns were not utilized. Participants selected a comfortable level between 1 and 10 for each technique. Each of the participants received the following instructions. Each participant placed their tongue between their teeth. They then were instructed to hum with the resonance of the Rezzimax® Tuner Pro II, illustrated in Fig. 1. The procedure is described more fully at the following link (https://www.youtube.com/watch?v=iyFZ79aw4Lk). The tuner and the tong were used and a variable level of between 5 and 10. Tongs were placed on both sides of the neck with the tuner device resting against the spine. The tuner was held in place by the back of the neck keeping it in place. The participant was requested to rotate their head from side to side maintaining pressure against the tuner. The device was kept in place for two minutes with a pillow behind the neck pressing against the tuner. An intensity level of 6 or lower was applied and the tongs were applied over the central portion of each eyebrow. After two minutes the tongs were then placed on the top of the nose towards the forehead. The tuner was then kept in place for an additional two minutes. The intensity was increased up to level 10 or lower if uncomfortable to the individual. Afterwards, the tongs were placed under the jaw with the tuner held in place with both hands by the participant. After this stage, the tongs were covered in plastic and placed inside the mouth between the cheeks and teeth. The tuner was then turned from side to side for one minute and then the participant was required to open and close the moth with the tuner in place for an additional one minute. Statistical analysis: This study examined a sample of 60 individuals (30 in Group ENS and 30 in CS), who were recruited at the Institute for Neurology and Neurosurgery, headache, and chronic pain programs, as well as poster advertisements in hospital clinics. Descriptive statistics and frequency distributions were used to evaluate the baseline sample characteristics. Results were considered statistically significant with a value of <0.05. In cases where a significant group-by-time interaction was found, simple effects testing with a Bonferroni correction was performed. The blinding’s integrity was evaluated using a chi-square test. Biostatisticians provided advice during the analyses, which were carried out using SPSS software (v. 25; SPSS, Inc., IBM, Chicago, IL, USA). Requests for individual participant deidentified data are available at doi: 10.13140/RG.2.2.18953.45920. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Rezzimax® Tuner Pro II device |
| Primary outcome measure | 1. Pain is measured using: 1.1. The Headache Impact Test-6 (HIT-6) 1.2. Rivermead PPCS Questionnaire (RPSQ) 1.3. Montreal Cognitive Assessment (MoCA) 1.4. Participant Health Questionnaire-9 (PHQ-9) 2. Anxiety is measured using: 2.1. Generalised Anxiety Disorder Scale-7 (GAD-7) and/or 2.2. Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Measured at baseline and after 60 and 90 days |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 23/02/2023 |
| Overall study end date | 11/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Participant inclusion criteria | 1. 18–50 years of age 2. Diagnosis of persistent headache criteria for at least three times/week for three months to a maximum of 5 years prior to the study (the history of chronic headache is defined as ±15 days/month for >3 months) 3. Medication, including non-steroidal anti-inflammatories, acetaminophen, ibuprofen or aspirin excluded the participant from the experimental group 4. Participants suffer from either tension-type headache (presented as dull with constant pain on both sides of the head). 5. Additional symptoms include sensitivity to light and sound, pressure-like sensation behind the eyes, and soreness in the face, head, neck, and shoulders, with episodes lasting for more than 30 minutes or cluster headaches (cluster headaches are defined as severe and recurrent headaches, including other symptoms such as wet eyes, swollen eyelids, a clogged or runny nose, sensitivity to light and sound, restlessness or agitation, along with scorching or piercing pain behind or around one eye) 8. Headaches range anywhere from 15 minutes to 3 hours and occur unexpectedly and without notice. The attacks need to happen regularly, usually a few hours after the commencement of sleep. |
| Participant exclusion criteria | 1. Transcranial Magnetic Stimulation therapy (TMS) 2. Contraindications (e.g., pacemaker, metallic implant) 3. Migraine (International Classification of Headache Disorders-3 [ICHD-3]) 4. Other medical conditions (such as a history of seizures in the past or present, structural brain disease or disorders, psychotic disorders (e.g., schizophrenia, bipolar disorder), liver or kidney disease, cancer, uncontrolled hypertension, diabetes, or pregnancy) 5. History of any neurological disease or disorder 6. History of allergies, sinusitis, psychiatric disorder including PTSD, anxiety, depression, or fever 7. More than four cups of coffee per day, any form of medication, withdrawal from cigarettes, smoking, drugs or menstrual headache 8. Use of recreational drugs 9. Use of chronically employed drugs (e.g. non-steroidal anti-inflammatory drugs) 10. Headaches other than cluster or tension-type headaches including migraine (defined clinically as individuals who at the outset of a headache manifested symptoms that included partial loss of vision, numbness, tingling, and muscle weakness; sensitivity to light, sound and smell; nausea and/or vomiting; auras present before the headache appears, with or without the presence of zigzag lines, flashing lights or spots; or trouble speaking or finding words (dysnomia) 11. Hypnic headaches 12. Waking in the night from a headache 13. Medication-overuse headache 14. Sinus headache (occurring with sinusitis) accompanied by a throbbing, dull pain radiating over the forehead, cheeks and eyes; face pain or pressure; nasal discharge and plugged nose 15. Caffeine-related headaches with a high caffeine intake of greater than 400 mg, or around 4 cups of coffee per day 16. Head Injury or post-Head Injury headaches, menstrual headache and hangover headache |
| Recruitment start date | 25/02/2023 |
| Recruitment end date | 01/05/2023 |
Locations
Countries of recruitment
- Cuba
Study participating centre
Institiute for Neurology and Neurosurgery of Havana
Calle 29 No. 139 esquina D, Vedado, Plaza de la Revolución
Havana
10400
Cuba
Havana
10400
Cuba
Sponsor information
Rezzimax Corp.
Industry
Industry
Sharik Peck CEO
Rezzimax LLC.
405 S 200 W
Richmond, Utah
84333
United States of America
| Phone | +1 (0)435 258 5601 |
|---|---|
| sharik@rezzimax.com | |
| Website | https://www.rezzimax.com |
Funders
Funder type
Industry
Rezzimax LLC
No information available
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (https://www.researchgate.net/publication/381690956_Resonance_Effects_in_Non-Migraine_Headache_Management). The data is currently available and will remain in that data repository. Patient consent for aggregating the blinded anonymized data was obtained from each participant as is available on request for up to 5 years from the date of conclusion of the study according to the rules of the IRB of the Institute for Neurology and Neurosurgery of Havana. |
Editorial Notes
17/03/2025: Study's existence confirmed by the Institute for Neurology and Neurosurgery of Havana.
