An interventional study of Isometric exercise and Transcutaneous electrical nerve stimulation in Diabetes Complications, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
This study aims to compare the effectiveness of Isometric Strengthening Exercises versus Transcutaneous Electrical Nerve Stimulation in the management of shoulder pain among individuals with diabetes mellitus.
Shoulder pain is a prevalent musculoskeletal issue in individuals with diabetes, linked to chronic hyperglycemia and altered collagen structure, leading to mobility restrictions and impaired quality of life. Despite its commonality, there is limited research on specific physiotherapy interventions, particularly isometric strengthening exercises and transcutaneous electrical nerve stimulation. Investigating these interventions is crucial due to the unique pain thresholds and healing issues in diabetic patients. This study aims to provide evidence on how isometric exercises and Transcutaneous Electrical Nerve Stimulation influence pain modulation and functional recovery, potentially optimizing rehabilitation strategies. The findings could support non-pharmacological treatments, reduce reliance on analgesics, and improve patient outcomes in managing shoulder pain in diabetic populations.
267 studies on the registry are indexed under Diabetes Complications; 54 are open to participants now.
This study's planned enrollment of 75 is close to the median of 72 across 171 interventional studies indexed under Diabetes Complications.
Browse Diabetes Complications studies →Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Twenty-five participants will receive the Isometric Exercise in addition to the conventional physical therapy program
Other: Isometric exercise · Other: The conventional exercise program
Twenty-five participants will receive Transcutaneous electrical nerve stimulation in addition to a conventional physical therapy program
Other: Transcutaneous electrical nerve stimulation · Other: The conventional exercise program
Twenty-five participants will receive conventional physical therapy program only
Other: The conventional exercise program
Isometric shoulder exercises include flexion, extension, abduction, internal and external rotation. The protocol involves holding each position for 10 seconds, resting for 5 seconds, and performing 10 repetitions in 3 sessions per week over 6 weeks. Each exercise begins from a standing position with the elbow bent at 90 degrees and a towel used for support against a wall or door frame, ensuring minimal movement and maintaining good posture throughout.
Transcutaneous electrical nerve stimulation Application Parameters: * Frequency: 80-100 Hertz * Pulse duration: 100-150 microseconds * Duration: 30 minutes * 3 sessions/week for 6 weeks Electrodes placed over the anterior and posterior shoulder.
1. Ultrasound Therapy: Administered at 3 MHz and 1.4 W/cm² for 5 minutes to improve shoulder tissue extensibility and blood circulation before exercises. 2. Codman's Pendular Exercises: Gentle passive mobilization of the glenohumeral joint is performed by allowing the affected arm to hang, aiming to reduce stiffness and pain. 3. Range of motion Exercises: Conducted within a pain-free range, progressively increasing intensity to encourage compliance. 4. Finger Ladder Exercise: Active-assisted technique for shoulder elevation, involving walking fingers up a wall. 5. Shoulder Joint Stretching Exercises: Targeting capsular tightness to improve flexibility and range of motion. Each exercise is performed in three sets of five repetitions, at least twice daily.
Assessment of shoulder range of motion
Shoulder range of motion (ROM) for flexion, abduction, and external rotation was measured using an electrogoniometer. Participants were positioned according to standardized measurement procedures, and each movement was assessed within the participant's pain-free range. Three consecutive measurements were obtained for each motion, and the average value was recorded in degrees (°) for statistical analysis to improve measurement reliability.
Time frame: At baseline and after 6 weeks
assessment of pain intensity
In visual analogue scale assessment, patients were asked to place a vertical mark along a horizontal line to indicate their current degree of pain at rest and during activity, where 0 indicated 'no pain' and 100 indicated 'worst pain'.
Time frame: At baseline and after 6 weeks
assessment of activity of daily living of the upper limb
The Disabilities of the Arm, Shoulder, and Hand questionnaire is an outcome measure designed to evaluate upper extremity functionality in daily activities, applicable to various musculoskeletal pathologies. Comprising 30 items, it measures disability and symptoms by assessing difficulties faced in physical, social, and work-related tasks, as well as their effects on sleep and self-perception regarding upper extremity issues. Patients respond using a five-point Likert scale, with scores from 1 (no difficulty) to 5 (unable to perform activity). The Disabilities of the Arm, Shoulder, and Hand questionnaire score ranges from 0 (no disability) to 100 (severest disability), and a score cannot be computed if more than three items are missing.
Time frame: At baseline and after 6 weeks
Started Jul 2026 (actual). Primary completion is estimated for Dec 2026, 5 months after the start.
Of 62 non-industry interventional studies with no phase under Diabetes Complications, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 5 months is below that.
Counting every sponsor, half of 69 studies reached it within 28 months; a quarter within 12 and three quarters within 41.
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