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| Name | Class |
|---|---|
| Donawa Lifescience Consulting SRL | UNKNOWN |
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DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use. This study will record post market clinical data on the use of a number of MDR-CE marked devices that are part of the Chattanooga Intelect® device family to ensure the continued acceptability of the benefit-risk ratio, and to identify possible systematic misuse or off-label use of the devices (Intelect® Mobile 2 Combo, Intelect® Mobile 2 Ultrasound, Intelect® Mobile 2 Electrotherapy (Stim), Intelect® Transport 2 Combo and Intelect® Transport 2 Ultrasound).
This clinical investigation is a post-market, real word, international, multi center, prospective, observational study to confirm the safety and performance of the Chattanooga Intelect® when used in accordance with their approved intended use, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS/US group | Patient affected by acute or chronic musculoskeletal pain or affected by post-operative pain that will be treated with TENS alone, US alone or TENS + US according to the current standard clinical practice at site. Data from patients in this group will be used to determine the primary study objective, some of the exploratory objectives and the safety objectives. | ||
| NMES group | Patients affected by skeletal muscle deficit disorders who benefit form muscle re-education and/or maintaining/increasing the range of motion will be treated with NMES alone or NMES + US according to the current standard clinical practice at site. Data from patients in this group will be used to determine the secondary study objective, some of the exploratory objectives and the safety objectives |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain reduction | Pain reduction measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) at end of treatment compared to pre-treatment (baseline) VAS in the TENS/US group | from treatment start to treatment end (about 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle reeducation | Improvement in muscle re-education demonstrated by score on a digital dynamometer at the end of treatment compared to baseline in the NMES group | from treatment start to treatment end (about 6 weeks) |
| Range of motion (ROM) improvement |
| Measure | Description | Time Frame |
|---|---|---|
| Waveforms assessment | Assess the performance and safety of the different waveforms used in the TENS and NMES modalities | through study completion, an average of 15 weeks |
| Electrodes assessment | Assess the performance and safety of various types of electrodes used with the Intelect® devices for TENS or NEMS modalities |
Inclusion Criteria:
Exclusion Criteria:
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Patients with musculoskeletal and skeletal muscle deficit disorders planned to be treated with any of the Intelect® devices who spontaneously went to any of the selected sites for receiving a treatment. For the purpose of determining the type of performance data to be collected, patients will be assigned to two groups: TENS/US group or NMES group based on the treatment they receive during their first session.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Arcangeli | Contact | 3498772528 | 0039 | elena.arcangeli@enovis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attal Cabinet | Completed | Serris | France | |||
| Casertafisio |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Maintenance or increasing of the ROM demonstrated by a goniometer the end of treatment compared to baseline in the NMES group |
| from treatment start to treatment end (about 6 weeks) |
| Clinical status improvement | Improvement in patient clinical status using the Global Clinical Assessment of improvement questionnaire at the end of the treatment in the NMES group | end of study (about 12 weeks) |
| Safety - adverse event rate | Proportion of patient experiencing an adverse event associated with device use | through study completion, an average of 15 weeks |
| through study completion, an average of 15 weeks |
| Misuse or off-label use identification | Identify misuse or off-label use of the Intelect® devices | end of treatment (about 6 weeks) |
| Recruiting |
| Caserta |
| 81100 |
| Italy |
|
| Rachis Center | Recruiting | Roma | 00199 | Italy |
|
| Dr Chad Woods Physiotherapy | Recruiting | Peebles | EH45 | United Kingdom |
|
| D013568 | Pathological Conditions, Signs and Symptoms |