Compex SP8.0 - Symptomatic Treatment of Musculoskeletal Pain

NCT06717789 | Not Yet Recruiting

• 1 other identifier: ENOVIS-S-INP-0006
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

This post-market clinical study of the SP8.0 Compex device aims to comprehensively assess the safety and performance of the device when used in accordance with the approved Instructions for Use. The results of this study will also support the clinical evaluation of the next-generation wireless product currently under development. The Compex Consumer devices contain different programs, such as conditioning, fitness, recovery, massage, rehabilitation, and pain management. This study will utilize the Compex SP 8.0 pain management programs, with the aim of assessing the effectiveness of the treatment provided by the device in managing pain through different physiological mechanisms.

Conditions

Musculoskeletal Conditions; Musculoskeletal Pain

Keywords

Electrostimulation; Transcutaneous Electrical Nerve Stimulation (TENS); Stimulation of sensory nerves; Compex SP8.0; Gate control principle; Endorphinic TENS; Low Frequency TENS; High Frequency TENS

Outcome Measures

Primary Outcomes (1)

• Change in pain level

  Improvement in pain demonstrated by the score on the Numerical Pain Rating Scale (NPRS) at the beginning and the end of the treatment period when using the pain management treatment programs of the device. The Numerical Pain Rating scale (NRS)is a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". The overall success of the study as well as the evaluation of the primary endpoint will be based on the proportion of subjects who experience a ≥ 2-point decrease in pain scores at the end of the treatment period as compared to baseline.

  From enrollment to full recovery or end of treatment at week 4

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  From enrollment to full recovery or end of treatment at week 4

Other Outcomes (2)

• Device Usability and subject's satisfaction

  From enrollment to full recovery or end of treatment at week 4

• Short term effects of the treatment on pain level

  From enrollment to full recovery or end of treatment at week 4

Study Arms (2)

High Frequency TENS

EXPERIMENTAL

Based on the diagnosis and the type of pain , subjects will be assigned to the High Frequency TENS (gate control principle at 50-150 Hz) treatmet group, which includes the following preset programs: * Pain management TENS * Epicondylitis * Tendinitis.

Device: Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device

Low frequency TENS

EXPERIMENTAL

Based on the diagnosis and the type of pain , subjects will be assigned to the Low Frequency TENS (endorphinic TENS at 5 Hz) treatmet group, which includes the following preset programs: * Muscle pain * Neck pain * Back pain

Device: Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device, using the following pain management program, • High Intensity TENS (50-150 Hz)

High Frequency TENS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects currently experiencing musculoskeletal pain with a Numeric Pain Rating Scale (NPRS) score of 4 or more at baseline.
• Subjects are considered suitable to self-administer stimulation of motor nerves or stimulation of sensory nerves at home, based on the Investigator's judgement.
• Subjects are suitable to receive treatment using the Compex SP8.0 device Pain management programs (pre-set parameters) for up to 4 weeks, based on the Investigator's judgement.
• Subject, both male and female, ≥ 18 years of age at the time of consent
• Subject has reviewed the IEC-approved consent form, has properly consented per the protocol and has documented their consent to participate in the study by signing the Ethics-approved consent form.

You may not qualify if:

• Pregnancy
• Presence of Implanted electronic devices (e.g., pacemakers, defibrillators)
• Skin conditions that contraindicate TENS use (e.g., rashes, wounds in electrode placement areas).
• Known allergy to electrode materials.
• Current participation in another clinical study that could interfere with this study's outcomes.
• Subjects who are not able to read and understand the Instructions for Use, warnings, cautions and dangers
• Subjects who are not able to read and understand indications and contraindications of the device
• Subjects who are not able to sense auditory and visual signals
• Subjects who are being treated with any other electrotherapy device for pain relief.
• Subjects who are being treated with acupuncture
• Participation in another clinical study within 30 days prior to screening

Sponsors & Collaborators

• DJO UK Ltd: lead

Study Sites (2)

Salford University Sports Injury Clinic

Salford, Manchester, M6 6PU, United Kingdom

Location

Worsley Physiotherapy and Sports Injuries Clinic

Worsley, Manchester, M28 2JL, United Kingdom

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Timothy Pigott

  Salford University Sports Injury Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Sebeo

CONTACT

+49 15146128712; prci@enovis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 5, 2024
• Study Start: February 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)