- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07747454
Isometric Strengthening Exercises Versus Tens in Diabetic Population
July 30, 2026 updated by: Tariq Eisi Alharbi, Kafrelsheikh University
Isometric Strengthening Exercises Versus Tens in Management of Shoulder Pain in Diabetic Population
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tairq Eisi Hedaiban Alharbi, physical therapist
- Phone Number: 00966555309550
- Email: t18t1@hotmail.com
Study Locations
-
-
-
Kafr ash Shaykh, Egypt
- Recruiting
- Out-Patient Clinic, Faculty of Physical Therapy, Kafrelsheikh University
-
Contact:
- Tairq Eisi Hedaiban Alharbi, physical therapist
- Phone Number: 00966555309550
- Email: t18t1@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 40-65 years, diagnosed as type 2 diabetes mellitus for at least 5 years
- Clinical diagnosis of unilateral frozen shoulder in the painful or stiff stage.
- Limitation of passive and active range of motion in external rotation, abduction, and flexion.
- Shoulder pain for at least 3 months.
Exclusion Criteria:
- Previous shoulder surgery or fracture.
- Cervical radiculopathy or neurological disorders.
- Rheumatoid arthritis or severe osteoarthritis.
- Cardiac pacemaker.
- Received corticosteroid injection within the last 3 months.
- diabetes mellitus type 1
- Participants with Vitamin B12 or D deficiency
- Osteoarthritis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Isometric Exercise group
Twenty-five participants will receive the Isometric Exercise in addition to the conventional physical therapy 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.
|
|
Experimental: Transcutaneous electrical nerve stimulation group
Twenty-five participants will receive Transcutaneous electrical nerve stimulation in addition to a conventional physical therapy program
|
Transcutaneous electrical nerve stimulation Application Parameters:
|
|
Active Comparator: conventional physical therapy group
Twenty-five participants will receive conventional physical therapy program only
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of shoulder range of motion
Time Frame: At baseline and after 6 weeks
|
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.
|
At baseline and after 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of pain intensity
Time Frame: At baseline and after 6 weeks
|
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'.
|
At baseline and after 6 weeks
|
|
assessment of activity of daily living of the upper limb
Time Frame: At baseline and after 6 weeks
|
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.
|
At baseline and after 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
July 30, 2026
First Submitted That Met QC Criteria
July 30, 2026
First Posted (Actual)
August 5, 2026
Study Record Updates
Last Update Posted (Actual)
August 5, 2026
Last Update Submitted That Met QC Criteria
July 30, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Complications
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Anesthesia and Analgesia
- Electric Stimulation Therapy
- Analgesia
- Exercise
- Transcutaneous Electric Nerve Stimulation
Other Study ID Numbers
- Tairq_Msc
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.