Peripheral Nerve InjuriesNCT07532499
EMG-Triggered Electrical Stimulation After Median/Ulnar Nerve Repairs
A study testing EMG-triggered electrical stimulation and Conventional physiotherapy group in people with Peripheral Nerve Injuries and Median Nerve Injury, run by Pamukkale University.
Trial summary
Immobilization following median and/or ulnar nerve repairs results in strength loss in the wrist and finger extensor muscles. Given the critical importance of wrist extension for functional grip, this condition significantly restricts hand functions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Nerve Injuries, Median Nerve Injury, Ulnar Nerve Injury
- What is being tested?
- EMG-triggered electrical stimulation and Conventional physiotherapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intact communication skills
- No prior history of neurological, orthopedic, rheumatologic, or metabolic diseases affecting the involved extremity
Who cannot join
- Presence of concomitant central nervous system involvement
- Pregnancy
- Patients with cardiac pacemakers
- Patients with cardiac arrhythmias
- Patients with epilepsy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of EMG-Triggered Electrical Stimulation of Extensor Muscles on Functional Status Following Median and/or Ulnar Nerve Repairs: A Single-Blind, Randomized Controlled Study
Immobilization following median and/or ulnar nerve repairs results in strength loss in the wrist and finger extensor muscles. Given the critical importance of wrist extension for functional grip, this condition significantly restricts hand functions. Therefore, this study aims to investigate the effects of EMG-triggered electrical stimulation applied to the wrist and finger extensors, in addition to conventional physiotherapy, on functional outcomes in patients undergoing median and/or ulnar nerve repair, with the objective of restoring extensor muscle weakness induced by immobilization.
- Being tested
- EMG-triggered electrical stimulation, Conventional physiotherapy group
- Keywords
- peripheral nerve injuries, EMG-triggered electrical stimulation, physiotherapy, functional recovery
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG-triggered electrical stimulationOther
This group will receive EMG-triggered electrical stimulation therapy in addition to conventional physiotherapy in the 5th week.The EMG-triggered electrical stimulation protocol will be conducted over 12 sessions (3 days/week for 4 weeks). Surface electrodes will be placed parallel to the fibers of the wrist and finger extensors-specifically the EDC, ECRL/B, and ECU-using anatomical landmarks and palpation. Following a baseline calibration (5s contraction/10s rest) to establish a microvolt threshold, the device will require active cognitive participation from the patient to initiate stimulation. Once the threshold is exceeded, stimulation will be delivered at 60 Hz with a 300 µS pulse width and 0.5s ramp times. The procedure involves 10 repetitions per muscle, utilizing a 10s contraction and 30s rest cycle to enhance functional recovery.
Conventional physiotherapy groupOther
The conventional physiotherapy program will comprise splinting, edema control, range of motion exercises, and resistance training.
| Study group | Role | What they receive |
|---|---|---|
| EMG-triggered electrical stimulation group | Experimental | Not described Receives: Other: EMG-triggered electrical stimulation |
| Conventional physiotherapy group | Active comparator | Not described Receives: Other: Conventional physiotherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual muscle test
Measured: At 12 and 24 weeks after surgery.
Secondary outcomes (2)
Gross and fine grip strength measurements by hand dynamometry and pinch gauge (kg)
Measured: At 12 and 24 weeks after surgery.
Assessment of hand function via Michigan Hand Outcomes Questionnaire
The score for each domain and the total score range from min 0 to max 100. For all domains except pain, a higher score denotes better hand performance or satisfaction. For the pain domain, a higher score indicates more pain.
Measured: At 12 and 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nerve InjuriesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UMUT ERASLAN, Pamukkale University
- Investigators
- Umut Eraslan, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532499
- Sponsor's protocol ID
- E-60116787-020-849492
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baldwin ER, Klakowicz PM, Collins DF. Wide-pulse-width, high-frequency neuromuscular stimulation: implications for functional electrical stimulation. J Appl Physiol (1985). 2006 Jul;101(1):228-40. doi: 10.1152/japplphysiol.00871.2005. Epub 2006 Apr 20.
PubMed 16627680Shin HK, Cho SH, Jeon HS, Lee YH, Song JC, Jang SH, Lee CH, Kwon YH. Cortical effect and functional recovery by the electromyography-triggered neuromuscular stimulation in chronic stroke patients. Neurosci Lett. 2008 Sep 19;442(3):174-9. doi: 10.1016/j.neulet.2008.07.026. Epub 2008 Jul 15.
PubMed 18644424
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of EMG-Triggered Electrical Stimulation of Extensor Muscles on Functional Status Following Median and/or Ulnar Nerve Repairs: A Single-Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07532499
- Acronym / sponsor ID
- E-60116787-020-849492
- Keywords
- peripheral nerve injuries, EMG-triggered electrical stimulation, physiotherapy, functional recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 16 Apr 2026 (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.
Immobilization following median and/or ulnar nerve repairs results in strength loss in the wrist and finger extensor muscles. Given the critical importance of wrist extension for functional grip, this condition significantly restricts hand functions. Therefore, this study aims to investigate the effects of EMG-triggered electrical stimulation applied to the wrist and finger extensors, in addition to conventional physiotherapy, on functional outcomes in patients undergoing median and/or ulnar nerve repair, with the objective of restoring extensor muscle weakness induced by immobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMG-triggered electrical stimulation group | Experimental | Other: EMG-triggered electrical stimulation |
| Conventional physiotherapy group | Active comparator | Other: Conventional physiotherapy group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intact communication skills
- No prior history of neurological, orthopedic, rheumatologic, or metabolic diseases affecting the involved extremity
Key exclusion criteria (5 listed)
- Presence of concomitant central nervous system involvement
- Pregnancy
- Patients with cardiac pacemakers
- Patients with cardiac arrhythmias
- Patients with epilepsy
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 |
|---|---|---|
| EMG-triggered electrical stimulationThis group will receive EMG-triggered electrical stimulation therapy in addition to conventional physiotherapy in the 5th week.The EMG-triggered electrical stimulation protocol will be conducted over 12 sessions (3 days/week for 4 weeks). Surface electrodes will be placed parallel to the fibers of the wrist and finger extensors-specifically the EDC, ECRL/B, and ECU-using anatomical landmarks and palpation. Following a baseline calibration (5s contraction/10s rest) to establish a microvolt threshold, the device will require active cognitive participation from the patient to initiate stimulation. Once the threshold is exceeded, stimulation will be delivered at 60 Hz with a 300 µS pulse width and 0.5s ramp times. The procedure involves 10 repetitions per muscle, utilizing a 10s contraction and 30s rest cycle to enhance functional recovery. | Other | EMG-triggered electrical stimulation group |
| Conventional physiotherapy groupThe conventional physiotherapy program will comprise splinting, edema control, range of motion exercises, and resistance training. | Other | Conventional physiotherapy group |
Primary outcome
Manual muscle test
Time frame: At 12 and 24 weeks after surgery.
2 secondary outcomes
Gross and fine grip strength measurements by hand dynamometry and pinch gauge (kg)
Time frame: At 12 and 24 weeks after surgery.
Assessment of hand function via Michigan Hand Outcomes Questionnaire
Time frame: At 12 and 24 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 16627680Baldwin ER, Klakowicz PM, Collins DF. Wide-pulse-width, high-frequency neuromuscular stimulation: implications for functional electrical stimulation. J Appl Physiol (1985). 2006 Jul;101(1):228-40. doi: 10.1152/japplphysiol.00871.2005. Epub 2006 Apr 20.
- Background: PubMed 18644424Shin HK, Cho SH, Jeon HS, Lee YH, Song JC, Jang SH, Lee CH, Kwon YH. Cortical effect and functional recovery by the electromyography-triggered neuromuscular stimulation in chronic stroke patients. Neurosci Lett. 2008 Sep 19;442(3):174-9. doi: 10.1016/j.neulet.2008.07.026. Epub 2008 Jul 15.
- Individual participant dataSharing planned: Undecided
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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.
Umut Eraslan principal investigator
Pamukkale University
Questions about this trial
What is this clinical trial studying?
A study testing EMG-triggered electrical stimulation and Conventional physiotherapy group in people with Peripheral Nerve Injuries and Median Nerve Injury, run by Pamukkale University.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umut Eraslan (+905444126520, ueraslan@pau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual muscle test (time frame: At 12 and 24 weeks after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07532499, which also lists 2 linked publications.
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 16 Apr 2026.