Back Pain
Conditions
Brief summary
The study will evaluate the clinical efficacy and performance of the BTL-043 and BTL-899 devices for alleviating back pain. It is a prospective, multi-center, open-label, single-arm study. Subjects will be required to complete four (4) treatment visits and two (2) follow-up visits. At the baseline visit, the Oswestry Disability Index (ODI), Visual Analogue Scale for pain (VAS), the Quebec Back Pain Disability Index (QBPDS), palpation of the treatment area, Fingertip-to-Floor-Flexion (FTFF) test, and Lateral FTFF test will be performed. Additionally, two-dimensional (2D) photographs of the subject's posture from the left and right profile will be taken, their Fitzpatrick skin type assessed, and the subject's weight and height will be recorded. The treatment administration phase will consist of four (4) treatment visits, delivered 5-10 days apart. During each treatment visit, subjects will receive treatments with both study devices, BTL-043 and BTL-899, consecutively, one immediately after the other. Therapy time will be set to 30 minutes for each treatment with each study device. After the last treatment, the subjects will complete the ODI, QBPDS, the Therapy Comfort Questionnaire (TCQ), and the Subject Satisfaction Questionnaire & Quality of Life Questionnaire (SSQ & QoL), along with the VAS, undergo palpation of the treatment area, FTFF, Lateral FTFF, weight and height measurements, and 2D photographing. During the 1-month and 3-month follow-up visits, the subjects will complete the SSQ & QoL, the ODI, QBPDS, VAS, undergo palpation of the treatment area, FTFF, Lateral FTFF, weight and height measurements, and 2D photographing. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all follow-up visits.
Interventions
DEVICETreatment with BTL-043
All of the study subjects will receive the treatment with BTL-043, with the treatment applied before BTL-899. Therapy time will be set to 30 minutes. BTL-043 uses the TriHIL technology, which combines 1064 nm near-infrared laser energy at a maximum power of 30 W delivered through a hands-free applicator.
DEVICEBTL-899
All of the study subjects will receive four treatments with BTL-899. The treatment administration phase will consist of four (4) treatment visits, delivered 5-10 days apart. Subjects will undergo the BTL-899 treatment, immediately after BTL-043 treatment. Therapy time will be set to 30 minutes.
Sponsors
BTL Industries Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 22 years and older * Voluntarily signed an informed consent form * Subject is willing to comply with study instructions and to return to the clinic for the required visits * Willingness to adhere to and continue pre-enrollment pain management plan * Subjects willing and able to maintain their regular (pre-procedure) diet, exercise, and therapy regimen without causing significant changes during study participation * Subject willing and able to abstain from partaking in any new treatments other than this study procedure to treat back pain * Women of child-bearing potential\* are required to use birth control measures during the whole duration of the study \*Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
Exclusion criteria
* Major systemic diseases - e.g. uncontrolled Diabetes mellitus, systemic lupus erythematosus * Ongoing pregnancy, postpartum and nursing period * Photosensitivity, medications affecting sensitivity to light * Tattoos or other highly-pigmented regions in the treated area * Corticosteroids or injections of the treated area within the last 3 months, long-term corticosteroids use * Anticoagulant therapy, bleeding disorders * Hemorrhagic conditions in the treated area * Application within 4 to 6 months after radiotherapy * Known or suspected malignancy, history of cancer or any type of malignancy * Febrile conditions, serious illness, chronic infection * Epilepsy and tendency to seizures * Sensory loss in the treatment area * Deep vein thrombosis * Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators) * Metal implants, bone fixation hardware, external metallic objects or electrical devices in the vicinity of the treated area * Drug pumps * Pulmonary insufficiency * Renal insufficiency * Cardiovascular diseases * Disturbance of temperature or pain perception * Septic conditions and empyema * Acute inflammations * Systemic or local infection such as osteomyelitis and tuberculosis * Contagious skin disease * Elevated body temperature * Graves' disease * Women using birth control in the form of a metal-containing intrauterine device (IUD) * Swollen or neoplastic tissues, space occupying lesions or skin eruptions in the treated area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Visual Analogue Scale (VAS) Score at 3 Months | Baseline and 3 months | The Visual Analogue Scale (VAS) is a self-reported measure used to assess the intensity of back pain experienced by the participants in the treatment area. Participants rate their perceived pain level on a numerical scale ranging from 0 to 10. On this scale, 0 is equivalent to "no pain" and 10 indicates the "worst possible pain". The baseline score is compared to the score collected at the 3-month follow-up visit. A negative change from baseline (a decrease in the VAS score) indicates a reduction in pain intensity and an improvement in the participant's condition over time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Oswestry Disability Index (ODI) Score at 3 Months | Baseline and 3 months] | The ODI is a self-reported, patient-administered questionnaire used to evaluate how low back pain affects everyday activities. It consists of ten (10) items in total. The final score (sum of all items) is then calculated as a percentage of maximum possible points (50). The higher the percentage, the greater the disability. |
| Change from Baseline in the Quebec Back Pain Disability Scale (QBPDS) Score at 3 Months | Baseline and 3 months] | The QBPDS is a self-administered questionnaire consisting of 20 items designed to assess the level of functional disability in individuals with back pain. Each item is scored on a scale from 0 to 5, with higher total scores indicating greater disability. The questionnaire will be administered at the baseline, after the last therapy visit, and at both follow up visits. |
| Change from Baseline in Fingertip-to-Floor-Flexion (FTFF) at 3 Months | 3 months post treatment | The FTFF is a composite test measuring multiple motions and muscles that will be used to evaluate improvement of subject's movement flexibility. The subject will be asked to bend forward, and the distance between the tip of the middle finger and the floor will be measured with a tape measure. |
| Change from Baseline in Lateral Fingertip-to-Floor-Flexion at 3 Months | Baseline and 3 months | The Lateral FTFF is a test measuring lateral flexion that will be used to evaluate improvement of subject's movement flexibility. First the subject will be standing erect, and then the subject will be asked to bend laterally flexing the spine. The distance between the middle finger to the floor will be measured with a tape. The change in distance from erect standing to lateral flexion will be considered the range of lateral flexion. |
| Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire | 3 months post treatment | Subject satisfaction with the treatment outcomes and its impact on quality of life is assessed using a 16-item self-reported questionnaire. Each item is rated on a 5-point Likert scale, where 1 indicates "strongly disagree" and 5 indicates "strongly agree". Higher scores represent greater treatment satisfaction and improvement in the subject's quality of life. |
| Therapy Comfort Assessed by the Therapy Comfort Questionnaire | Immediately after the final treatment | Therapy comfort is assessed using a self-reported questionnaire. Participants indicate their overall comfort on a 5-point Likert scale (where 1 is "strongly disagree" and 5 is "strongly agree" with the statement "I found the treatment comfortable"). Additionally, any pain experienced during treatment is rated on a Numerical Analogue Scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Lower pain scores and higher agreement scores indicate greater therapy comfort. |
| Change from Baseline in the position measurements of the left and right profile based on the 2D photographs at 3 months | Baseline and 3 months | Full-body 2D photographs will be taken from the left and right profiles to evaluate improvement in the subject's posture. Subjects will be asked to stand barefoot, feet shoulder-width apart, positioned adjacent to a wall. |
Countries
United States
Outcome results
None listed