Muscle DisorderNCT06677086
HIFEM for Musculoskeletal System Improvement
A study testing Treatment with BTL-899 in people with Muscle Disorder and Musculoskeletal Diseases, run by BTL Industries Ltd. at 3 sites in United States.
Trial summary
The goal of this clinical trial is to investigate the effect of the BTL-899 device on improving the Musculoskeletal System in healthy adult volunteers. The main question it aims to answer is: Whether the BTL-899 device is able to change musculoskeletal system perception before and after treatment, based on the Subject… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Disorder, Musculoskeletal Diseases
- What is being tested?
- Treatment with BTL-899
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 May 2024to 22 Jan 2025
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 22 years and older
- Voluntarily signed an informed consent form
- BMI ≤ 35 kg/m2
- Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime and the study procedure for improvement of the musculoskeletal system
- Subjects willing and able to maintain their regular (pre-procedure) diet, exercise and therapy regimen without affecting significant change in either direction during study participation
Who cannot join
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
- Application over muscles in acute phase of injury
Show all 17Show fewer
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Hemorrhagic conditions, blood coagulation disorders or anticoagulation therapy.
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Pregnancy, postpartum period, nursing, and menstruation
- A metal-containing intrauterine device (IUD)
- Graves' disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New York Orthopedic Hand Surgery
Brooklyn, New York, 11215
Trokhan Orthopaedics LLC
Closter, New Jersey, 07624
Southeast Texas Orthopedic Group
Houston, Texas, 77024
About this study
Official title: Effect of HIFEM Application on Musculoskeletal System: Evaluation of Musculoskeletal System Improvement
The goal of this clinical trial is to investigate the effect of the BTL-899 device on improving the Musculoskeletal System in healthy adult volunteers. The main question it aims to answer is:
Whether the BTL-899 device is able to change musculoskeletal system perception before and after treatment, based on the Subject Satisfaction questionnaire.
Participants will complete four treatments, and two follow-up visits.
Read the detailed description
This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in the musculoskeletal system, specifically of the upper and lower extremities. The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the study device.
At the baseline visit, the subject's weight will be recorded and subjects will fill in the Western Ontario and McMaster Universities questionnaire.
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the designated area. Each therapy session will last 30 minutes.
At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Therapy Comfort, Subject Satisfaction Questionnaire and Western Ontario and McMaster Universities questionnaire to fill in.
Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all of the follow-up visits.
During the post-procedure visits (at 1-month and 3-month follow-up visits), the subject's satisfaction, Western Ontario and McMaster Universities questionnaire, and weight will be recorded. In addition, subjects will receive a Lifestyle Change Questionnaire to fill in.
- Conditions
- Muscle Disorder, Musculoskeletal Diseases
- Being tested
- Treatment with BTL-899
- Keywords
- muscle, musculoskeletal system, extremities
- Medical subject headings
- Muscular Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BTL-899Device
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 device will be applied over the designated area. Each treatment session will last 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BTL-899 | Experimental | Four (4) BTL-899 treatments will be applied to the impaired musculoskeletal area, either on the upper or lower extremity. Receives: Device: Treatment with BTL-899 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal System Perception
The evaluation of changes in musculoskeletal system perception before and after treatment will be based on the 5-point Likert Scale Subject Satisfaction questionnaire. Responses to questions about the treated musculoskeletal area will range from "strongly agree" (1 point) to "strongly disagree" (5 points). A higher score for each statement indicate better outcomes. The Subject Satisfaction Questionnaire will be administered after the final treatment, as well as at the 1-month and 3-month follow-up visits.
Measured: 15 months
Secondary outcomes (3)
Incidence of Treatment-related Adverse Events
To evaluate the safety of the device and determine side effects and adverse events (AE) associated with the BTL-899 treatment of the musculoskeletal system through monitoring of adverse reactions and side effects.
Measured: 15 months
Comfort Assessed by Therapy Comfort Questionnaire
Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree") and the 10-point Numeric Pain Rating Scale (0 = no pain, 10 = worst possible pain"). A higher score for the statement "I found the treatment comfortable", and lower score on the Numeric Pain Rating Scale indicate higher therapy comfort. The Therapy Comfort questionnaire will be given to subjects after the last treatment.
Measured: 15 months
Physical Function Assessed by the Western Ontario and McMaster Universities questionnaire.
Changes in physical function post-treatment will be assessed using the Western Ontario and McMaster Universities (WOMAC) questionnaire. This 24-item questionnaire measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Improvement is considered a decrease in the obtained score. The questionnaire will be administered at the baseline visit, after the final treatment, and during both follow-up visits at 1 month and 3 months post-treatment.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start8 May 2024
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677086
- Sponsor's protocol ID
- BTL-899_CTUS900
- Status last verified
- Dec 2024
- First submitted
- 5 Nov 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of HIFEM Application on Musculoskeletal System: Evaluation of Musculoskeletal System Improvement
- ClinicalTrials.gov ID
- NCT06677086
- Acronym / sponsor ID
- BTL-899_CTUS900
- Conditions
- Muscle Disorder, Musculoskeletal Diseases
- Keywords
- muscle, musculoskeletal system, extremities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2024 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 6 Nov 2024 (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.
The goal of this clinical trial is to investigate the effect of the BTL-899 device on improving the Musculoskeletal System in healthy adult volunteers. The main question it aims to answer is:
Whether the BTL-899 device is able to change musculoskeletal system perception before and after treatment, based on the Subject Satisfaction questionnaire.
Participants will complete four treatments, and two follow-up visits.
Detailed description
This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in the musculoskeletal system, specifically of the upper and lower extremities. The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the study device.
At the baseline visit, the subject's weight will be recorded and subjects will fill in the Western Ontario and McMaster Universities questionnaire.
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the designated area. Each therapy session will last 30 minutes.
At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Therapy Comfort, Subject Satisfaction Questionnaire and Western Ontario and McMaster Universities questionnaire to fill in.
Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all of the follow-up visits.
During the post-procedure visits (at 1-month and 3-month follow-up visits), the subject's satisfaction, Western Ontario and McMaster Universities questionnaire, and weight will be recorded. In addition, subjects will receive a Lifestyle Change Questionnaire to fill in.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with BTL-899 | Experimental | Device: Treatment with BTL-899Four (4) BTL-899 treatments will be applied to the impaired musculoskeletal area, either on the upper or lower extremity. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 22 years and older
- Voluntarily signed an informed consent form
- BMI ≤ 35 kg/m2
- Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime and the study procedure for improvement of the musculoskeletal system
Key exclusion criteria (17 listed)
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
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 |
|---|---|---|
| Treatment with BTL-899The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 device will be applied over the designated area. Each treatment session will last 30 minutes. | Device | Treatment with BTL-899 |
Primary outcome
Musculoskeletal System Perception
Time frame: 15 months
The evaluation of changes in musculoskeletal system perception before and after treatment will be based on the 5-point Likert Scale Subject Satisfaction questionnaire. Responses to questions about the treated musculoskeletal area will range from "strongly agree" (1 point) to "strongly disagree" (5 points). A higher score for each statement indicate better outcomes. The Subject Satisfaction Questionnaire will be administered after the final treatment, as well as at the 1-month and 3-month follow-up visits.
3 secondary outcomes
Incidence of Treatment-related Adverse Events
Time frame: 15 months
Comfort Assessed by Therapy Comfort Questionnaire
Time frame: 15 months
Physical Function Assessed by the Western Ontario and McMaster Universities questionnaire.
Time frame: 15 months
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 8 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with BTL-899 in people with Muscle Disorder and Musculoskeletal Diseases, run by BTL Industries Ltd. at 3 sites 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 6 inclusion and 17 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 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Musculoskeletal System Perception (time frame: 15 months). 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 8 Jun 2025.