Compex SP8.0 - Symptomatic Treatment of Musculoskeletal Pain

Sponsor
DJO UK Ltd
Study ID
NCT06717789
Status
Not Yet Recruiting

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Conditions

  • Musculoskeletal Conditions
  • Musculoskeletal Pain

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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)
  • 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, • Low Intensity TENS (5 Hz)

Study Details

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.

Key Dates

First listed
Dec 5, 2024
Start date
Feb 28, 2025
Status verified
Nov 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
74 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High Frequency TENS
    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.
  • Experimental: Low frequency TENS
    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

Primary Outcome Measure

Change in pain level [ Time Frame: From enrollment to full recovery or end of treatment at week 4 ]

Central Contacts

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