Muscle Disorder, Musculoskeletal Disorders, Skeletal Disorder
Conditions
Keywords
TENS, NMES, Ultrasound, Pain, ROM
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
DJO UK Ltd
Donawa Lifescience Consulting S.r.l.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Patients with musculoskeletal and skeletal muscle deficit disorders assigned to be treated with any of the Intelect® devices according to the current clinical practice at the selected sites and based on the opinion of the Investigator. 2. Patient male or female with age ≥18 years old. 3. Patient able to provide written informed consent. For France only: To be affiliated to the social security system or to be beneficiary of such system
Exclusion criteria
1. Patients participating in another clinical study or who have completed a clinical study less than 30 days prior to enrollment. 2. Patients who for any reason e.g. significant co-morbidities or other reasons, are considered by the Investigator unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction | from treatment start to treatment end (about 6 weeks) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle reeducation | from treatment start to treatment end (about 6 weeks) | Improvement in muscle re-education demonstrated by score on a digital dynamometer at the end of treatment compared to baseline in the NMES group |
| Range of motion (ROM) improvement | from treatment start to treatment end (about 6 weeks) | Maintenance or increasing of the ROM demonstrated by a goniometer the end of treatment compared to baseline in the NMES group |
| Clinical status improvement | end of study (about 12 weeks) | Improvement in patient clinical status using the Global Clinical Assessment of improvement questionnaire at the end of the treatment in the NMES group |
| Safety - adverse event rate | through study completion, an average of 15 weeks | Proportion of patient experiencing an adverse event associated with device use |
Countries
France, Italy, United Kingdom
Outcome results
None listed