Diabetes ComplicationsNCT07747454
Isometric Strengthening Exercises Versus Tens in Diabetic Population
A study testing Isometric exercise, Transcutaneous electrical nerve stimulation and The conventional exercise program in people with Diabetes Complications, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- Isometric exercise, Transcutaneous electrical nerve stimulation and The conventional exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Jan 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Out-Patient Clinic, Faculty of Physical Therapy, Kafrelsheikh University
Kafr ash Shaykh
Tairq Eisi Hedaiban Alharbi, physical therapist, 00966555309550, t18t1@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Complications
- Being tested
- Isometric exercise, Transcutaneous electrical nerve stimulation, The conventional exercise program
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exerciseOther
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 stimulationOther
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.
The conventional exercise programOther
- Ultrasound Therapy: Administered at 3 MHz and 1.4 W/cm² for 5 minutes to improve shoulder tissue extensibility and blood circulation before exercises.
- 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.
- Range of motion Exercises: Conducted within a pain-free range, progressively increasing intensity to encourage compliance.
- Finger Ladder Exercise: Active-assisted technique for shoulder elevation, involving walking fingers up a wall.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Isometric Exercise group | Experimental | Twenty-five participants will receive the Isometric Exercise in addition to the conventional physical therapy program Receives: Other: Isometric exercise; Other: The conventional exercise program |
| Transcutaneous electrical nerve stimulation group | Experimental | Twenty-five participants will receive Transcutaneous electrical nerve stimulation in addition to a conventional physical therapy program Receives: Other: Transcutaneous electrical nerve stimulation; Other: The conventional exercise program |
| conventional physical therapy group | Active comparator | Twenty-five participants will receive conventional physical therapy program only Receives: Other: The conventional exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 6 weeks
Secondary outcomes (2)
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'.
Measured: 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.
Measured: At baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Jul 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tariq Eisi Alharbi, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747454
- Sponsor's protocol ID
- Tairq_Msc
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isometric Strengthening Exercises Versus Tens in Management of Shoulder Pain in Diabetic Population
- ClinicalTrials.gov ID
- NCT07747454
- Acronym / sponsor ID
- Tairq_Msc
- Conditions
- Diabetes Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 Aug 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isometric Exercise group | Experimental | Other: Isometric exercise, Other: The conventional exercise programTwenty-five participants will receive the Isometric Exercise in addition to the conventional physical therapy program |
| Transcutaneous electrical nerve stimulation group | Experimental | Other: Transcutaneous electrical nerve stimulation, Other: The conventional exercise programTwenty-five participants will receive Transcutaneous electrical nerve stimulation in addition to a conventional physical therapy program |
| conventional physical therapy group | Active comparator | Other: The conventional exercise programTwenty-five participants will receive conventional physical therapy program only |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Isometric exerciseIsometric 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. | Other | Isometric Exercise group |
| Transcutaneous electrical nerve stimulationTranscutaneous 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. | Other | Transcutaneous electrical nerve stimulation group |
| The conventional exercise program1. 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. | Other | Isometric Exercise group, Transcutaneous electrical nerve stimulation group, conventional physical therapy group |
Primary outcome
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.
2 secondary outcomes
assessment of pain intensity
Time frame: At baseline and after 6 weeks
assessment of activity of daily living of the upper limb
Time frame: At baseline and after 6 weeks
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 5 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercise, Transcutaneous electrical nerve stimulation and The conventional exercise program in people with Diabetes Complications, run by Kafrelsheikh University at 1 site in Egypt.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 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 1 site in Egypt. 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?
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 Tairq Eisi Hedaiban Alharbi, physical therapist (00966555309550, t18t1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of shoulder range of motion (time frame: At baseline and after 6 weeks). 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 5 Aug 2026.