Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202505867650652 Date of Approval: 19/05/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of neuromuscular electrical stimulation on pain relief, sensory recovery, and quality of life in patients with ulnar neuropathy.
Official scientific title Efficacy of neuromuscular electrical stimulation on pain relief, sensory recovery, and quality of life in patients with ulnar neuropathy.
Brief summary describing the background and objectives of the trial Ulnar neuropathy at the elbow (UNE) is the second most common upper extremity entrapment neuropathy. At the elbow, the ulnar nerve lacks protective cover in the ulnar groove. This causes its susceptibility to external compression. Repetitive elbow flexion and extension, arthritic changes, and valgus deformities at the elbow increase its vulnerability to injury. The symptoms may include a reduced or complete loss of sensation on the palmar and dorsal sides of the little finger and the medial part of the ring finger, motor findings could be weakness of the interosseous muscles, hand intrinsics, weakness of the handgrip and weakness of adductor pollicis. The electrical stimulation (ES) is a safe and effective treatment option. Recent studies reported that ES is efficacious in promoting axonal regeneration and functional rehabilitation in peripheral nerve injury (PNI) patients. The purpose of the current study is to evaluate the effect of graded electrical stimulation using Neuromuscular electrical stimulation combined with selected physical therapy on sensation, pain and quality of life in patients with ulnar nerve neuropathy due to neuropraxia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 25/05/2025
Actual trial start date
Anticipated date of last follow up 28/10/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neuromuscular Electrical Stimulation Group A Three times per week for 40 minutes 8 Weeks -Experimental group (A) group will receive NMES for 10 minutes in addition of the selected physical therapy (ulnar nerve neuromobilization 10 minutes, stretching exercises of hand muscles 10 min and strengthening exercises of hand muscles 10 minutes. NMES: -Frequency will be 20HZ, Pulse Duration is approximately 200 ms, Ramp time is 2 seconds. -Intensity begins with low setting increasing gradually until a slight tingling sensation is felt in hypothenar area without discomfort. -On / off cycle 10 seconds on and 10 seconds off to promote sensory adaptation without overstimulation. -Electrode placement active electrode placed on hypothenar muscles over ulnar side of hand; indifferent electrode placed on mid-forearm to stimulate the affected ulnar nerve region. 20
Control Group Selected Physical Therapy Group B Three times per week for 40 minutes 8 weeks -Control group (B) group will receive the selected physical therapy: ulnar nerve neuromobilization 15 minutes, stretching exercises of hand muscles 10 minutes, and strengthening exercises of hand muscles 15 minutes. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Forty patients with mild and moderate ulnar nerve entrapment at elbow level due to neuropraxia. -Patients aged from 30 to 50 years. -Patients from both genders. -Patients suffering from significant sensory deficits in the ring and little fingers and hand intrinsic muscles weakness. -Patients are capable of providing informed consent. . Patients with Previous surgery on the ulnar nerve. • Patients with Diabetes. • Pregnant women. • Patients with known cardiac conditions (pacemaker) that may contraindicate electrical stimulation. • Patients with Allergies to electrode materials. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/02/2025 Ethical committee office Faculty of Physical Therapy at Cairo Uni.
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El-Zayat St. Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sensory and motor nerve recovery by nerve conduction study he both Sensory nerve action potential (SNAP) and Compound motor actional potential (CMAP) for ulnar nerve Pre and after intervention by 8 weeks
Secondary Outcome Sensory recovery by Two Point Discrimination Test using a clean paperclip which is unraveled to create two separate points. Pre and after intervention by 8 weeks
Secondary Outcome Normal sensory detection thresholds for the entire body by Semmes-Weinstein Monofilaments Pre and after intervention by 8 weeks
Secondary Outcome Functional nerve recovery by the Michigan Hand Outcomes Questionnaire which is multidimensional and includes both pain and aesthetic questions. Pre and after intervention by 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinics at faculty of physical therapy at Cairo Uni. 7 Ahmed El-Zayat St., Dokki Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Physical Therapy at Cairo Uni. 7 Ahmed El-Zayat St., Dokki Giza 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy at Cairo Uni. 7 Ahmed El-Zayat St., Dokki Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Madona Melad Boshra Tadrus dona.melad2@gmail.com 00201288746784 7 Ahmed El-Zauat St., Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt Physical Therapist at the Egyptian Ministry of Health
Role Name Email Phone Street address
Scientific Enquiries Hoda Mohamed Zakaria Dr_hodazakaria@yahoo.com 00201013107750 7 Ahmed El-Zayat St., Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt Professor Physical Therapy for neurology and neurosurgery Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Ebtesam Mohamed Fahmy em_fahmy@kasralainy.edu.eg 00201002007077 7 Handosa St., Dokki
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Professor of Neurology department at faculty of medicine at Al Kasr Al Ainy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Shereen Ibrahim Taha Shereen_taha@pt.bsu.edu.eg 00201016167521 Salah Salem St.
City Postal code Country Position/Affiliation
Beni Suef 62521 Egypt Assistant Professor Physical Therapy for neuromuscular disorders and its surgery Faculty of Physical Therapy Beni Suef university Cairo University
Role Name Email Phone Street address
Scientific Enquiries Moustafa mahmoud Elkholy mostafaelkholy@med.bsu.edu.eg 00201100103296 Salah Salem St.
City Postal code Country Position/Affiliation
Beni Suef 62521 Egypt Assistant professor Neurophysiology department Faculty of medicine Beni Suef University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of Individual Participant Data (IPD) collected during the trial, after deidentification will be shared for research purposes only. Informed Consent Form Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Only Researchers in the project can see the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information