Musculoskeletal ConditionsNCT06717789
Compex SP8.0 - Symptomatic Treatment of Musculoskeletal Pain
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device in people with Musculoskeletal Conditions and Musculoskeletal Pain, run by DJO UK Ltd at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musculoskeletal Conditions, Musculoskeletal Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Subject does not meet any of the exclusion criteria
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Salford University Sports Injury Clinic
Salford, Manchester, M6 6PU
Worsley Physiotherapy and Sports Injuries Clinic
Worsley, Manchester, M28 2JL
About this study
Official title: Post-Market Prospective Clinical Follow Up Study on the Symptomatic Treatment of Musculoskeletal Pain Through Sensory Nerve Stimulation Using the Compex SP8.0 Device
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.
Read the detailed description
Subjects will be treated with the Compex device according to the intended use of the device and as per routine clinical practice. Clinical data will be collected in healthcare settings as part of the routine clinical practice and according to the study protocol. Additional data points will be recorded pre and post use of the advised treatment with the compex device using an electronic patient diary.
Adult subjects who require symptomatic treatment of musculoskeletal pain (nociceptive pain or neuropathic/nociplastic pain), with a Numeric Pain Rating Scale (NPRS) score of 4 or more at baseline will undergo Electrical Nerve Stimulation with the Compex SP8.0 device at home for up to 4 weeks.
The investigator will train subjects on how to use the device at home and a guide will be provided to each subject to help them when using the device at home.
For all subjects the first treatment session will be performed by the investigator at the clinic.
The assessment of pain level will be completed by the investigator during onsite visits: before treatment (Baseline Visit), after 2 weeks of treatment and at the 4 weeks/End of study visit. Additionally, subjects will be asked to record their level of pain before and immediately after each treatment session on an electronic diary.
The assessment of the pain level experienced by the subjects will be performed using the Numeric Pain Rating Scale (NPRS). Subjects will be asked to rate the level of pain using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
The tests used to assess symptoms, compliance with treatment and satisfaction/usability of the device are:
- Numeric Pain Rating Scale (NPRS) on a 0 to 10 scale
- Usability/Satisfaction Questionnaire on a 4-point Likert scale
- Electronic Compliance diary
Participants will be stratified based on their type of pain (nociceptive vs. neuropathic/nociplastic) and then assigned within strata to one of the treatment groups: TENS HIGH FREQUENCY (50-150Hz) or TENS LOW FREQUENCY (5Hz) The diagnosis of the type of pain experienced by individual subjects will be performed by the investigator based on symptoms and physical examination in routine practice.
Subjects suffering from chronic musculoskeletal pain will be allocated to the low frequency TENS group, those with acute neurogenic pain will be allocated to the high frequency TENS group.
The following programs of pain management will be used according to the subjects assigned group:
PROGRAMMING BASIC FREQUENCY TOTAL TIME PAIN MANAGEMENT TENS 50-150Hz 20 min EPICONDYLITIS/TENDINITIS 50-150Hz 20 min MUSCLE/NECK/BACK PAIN 5Hz 20 min
The treatment with the Compex SP8.0 devices can be performed in addition to subjects prescribed rehabilitation exercises and during their functional activities.
The recommendation would be to have 2 treatment sessions per day for a total of 4 weeks or until full recovery (Pain scored 0 on the NPRS). The minimum number of accepted treatments is at least 6 treatments per week. A lower number of sessions per week (less than 6 per week) will prompt the subjects to be considered in the intention to treat population but not in the per protocol data set.
Subjects will be instructed to use the mi-function for each treatment session to optimize the treatment settings.
Subjects will be asked to record each treatment session performed and pain scores experienced before and after treatment, on the subject's diary, in order to assess daily compliance to the scheduled treatment plan and to evaluate the instant and short-term effect of the treatment.
The subjects will be evaluated at the study site for 4 scheduled onsite visits and 2 phone contacts as detailed in the study flowchart.
Follow-up phone calls with the subjects will be performed on a regular basis. During the 4 weeks of treatment, 1 phone call per week will be performed with exception of the weeks when an onsite visit is scheduled. These regular contacts serve to remind the subject to follow the treatment plan and to complete the compliance diary. Additionally, during each phone call check-in, subjects will be asked to report if any issues/adverse events have occurred since the last visit or phone contact. The regular phone contact with subjects should help in keeping the adherence to the protocol and have a higher compliance to the treatment.
- Conditions
- Musculoskeletal Conditions, Musculoskeletal Pain
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device
- 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
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 deviceDevice
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 deviceDevice
Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device, using the following pain management program,
- Low Intensity TENS (5 Hz)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to full recovery or end of treatment at week 4
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Adverse events/malfunctions/complications reported during the study. Subjects and Investigators will be prompted to record such issues on the AE evaluation form. The incidence of the observed events will be tabulated by category (as in No. of observed events / No. of patients in the safety population).
Measured: From enrollment to full recovery or end of treatment at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Apr 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- DJO UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Pigott, Principal investigator, Salford University Sports Injury Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717789
- Sponsor's protocol ID
- ENOVIS-S-INP-0006
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Prospective Clinical Follow Up Study on the Symptomatic Treatment of Musculoskeletal Pain Through Sensory Nerve Stimulation Using the Compex SP8.0 Device
- ClinicalTrials.gov ID
- NCT06717789
- Acronym / sponsor ID
- ENOVIS-S-INP-0006
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- DJO UK LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be treated with the Compex device according to the intended use of the device and as per routine clinical practice. Clinical data will be collected in healthcare settings as part of the routine clinical practice and according to the study protocol. Additional data points will be recorded pre and post use of the advised treatment with the compex device using an electronic patient diary.
Adult subjects who require symptomatic treatment of musculoskeletal pain (nociceptive pain or neuropathic/nociplastic pain), with a Numeric Pain Rating Scale (NPRS) score of 4 or more at baseline will undergo Electrical Nerve Stimulation with the Compex SP8.0 device at home for up to 4 weeks.
The investigator will train subjects on how to use the device at home and a guide will be provided to each subject to help them when using the device at home.
For all subjects the first treatment session will be performed by the investigator at the clinic.
The assessment of pain level will be completed by the investigator during onsite visits: before treatment (Baseline Visit), after 2 weeks of treatment and at the 4 weeks/End of study visit. Additionally, subjects will be asked to record their level of pain before and immediately after each treatment session on an electronic diary.
The assessment of the pain level experienced by the subjects will be performed using the Numeric Pain Rating Scale (NPRS). Subjects will be asked to rate the level of pain using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
The tests used to assess symptoms, compliance with treatment and satisfaction/usability of the device are:
- Numeric Pain Rating Scale (NPRS) on a 0 to 10 scale
- Usability/Satisfaction Questionnaire on a 4-point Likert scale
- Electronic Compliance diary
Participants will be stratified based on their type of pain (nociceptive vs. neuropathic/nociplastic) and then assigned within strata to one of the treatment groups: TENS HIGH FREQUENCY (50-150Hz) or TENS LOW FREQUENCY (5Hz) The diagnosis of the type of pain experienced by individual subjects will be performed by the investigator based on symptoms and physical examination in routine practice.
Subjects suffering from chronic musculoskeletal pain will be allocated to the low frequency TENS group, those with acute neurogenic pain will be allocated to the high frequency TENS group.
The following programs of pain management will be used according to the subjects assigned group:
PROGRAMMING BASIC FREQUENCY TOTAL TIME PAIN MANAGEMENT TENS 50-150Hz 20 min EPICONDYLITIS/TENDINITIS 50-150Hz 20 min MUSCLE/NECK/BACK PAIN 5Hz 20 min
The treatment with the Compex SP8.0 devices can be performed in addition to subjects prescribed rehabilitation exercises and during their functional activities.
The recommendation would be to have 2 treatment sessions per day for a total of 4 weeks or until full recovery (Pain scored 0 on the NPRS). The minimum number of accepted treatments is at least 6 treatments per week. A lower number of sessions per week (less than 6 per week) will prompt the subjects to be considered in the intention to treat population but not in the per protocol data set.
Subjects will be instructed to use the mi-function for each treatment session to optimize the treatment settings.
Subjects will be asked to record each treatment session performed and pain scores experienced before and after treatment, on the subject's diary, in order to assess daily compliance to the scheduled treatment plan and to evaluate the instant and short-term effect of the treatment.
The subjects will be evaluated at the study site for 4 scheduled onsite visits and 2 phone contacts as detailed in the study flowchart.
Follow-up phone calls with the subjects will be performed on a regular basis. During the 4 weeks of treatment, 1 phone call per week will be performed with exception of the weeks when an onsite visit is scheduled. These regular contacts serve to remind the subject to follow the treatment plan and to complete the compliance diary. Additionally, during each phone call check-in, subjects will be asked to report if any issues/adverse events have occurred since the last visit or phone contact. The regular phone contact with subjects should help in keeping the adherence to the protocol and have a higher compliance to the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device
| Arm | Type | Receives |
|---|---|---|
| High Frequency TENS | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 deviceBased 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. |
| Low frequency TENS | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 deviceBased 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 deviceTranscutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device, using the following pain management program, • High Intensity TENS (50-150 Hz) | Device | High Frequency TENS |
| Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 deviceTranscutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device, using the following pain management program, • Low Intensity TENS (5 Hz) | Device | Low frequency TENS |
Primary outcome
Change in pain level
Time frame: From enrollment to full recovery or end of treatment at week 4
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.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From enrollment to full recovery or end of treatment at week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Pigott principal investigator
Salford University Sports Injury Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device in people with Musculoskeletal Conditions and Musculoskeletal Pain, run by DJO UK Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain level (time frame: From enrollment to full recovery or end of treatment at week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.