An observational study in Musculoskeletal Disorders, Skeletal Disorder and Muscle Disorder, sponsored by DJO UK Ltd. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by DJO UK Ltd · Observational
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.
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's enrollment of 144 is above the median of 126 across 201 observational studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →DJO UK Ltd is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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
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
Time frame: from treatment start to treatment end (about 6 weeks)
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
Time frame: from treatment start to treatment end (about 6 weeks)
Range of motion (ROM) improvement
Maintenance or increasing of the ROM demonstrated by a goniometer the end of treatment compared to baseline in the NMES group
Time frame: 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
Time frame: end of study (about 12 weeks)
Safety - adverse event rate
Proportion of patient experiencing an adverse event associated with device use
Time frame: through study completion, an average of 15 weeks
Waveforms assessment
Assess the performance and safety of the different waveforms used in the TENS and NMES modalities
Time frame: 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
Time frame: through study completion, an average of 15 weeks
Misuse or off-label use identification
Identify misuse or off-label use of the Intelect® devices
Time frame: end of treatment (about 6 weeks)
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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