Isometric Strengthening Exercises Versus Tens in Diabetic Population

NCT07747454 | Recruiting

• 1 other identifier: Tairq_Msc
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Complications

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and after 6 weeks

Secondary Outcomes (2)

• assessment of pain intensity

  At baseline and after 6 weeks

• assessment of activity of daily living of the upper limb

  At baseline and after 6 weeks

Study Arms (3)

Isometric Exercise group

EXPERIMENTAL

Twenty-five participants will receive the Isometric Exercise in addition to the conventional physical therapy program

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

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

Other: The conventional exercise program

Interventions

Isometric exercise OTHER

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.

Isometric Exercise group

Transcutaneous electrical nerve stimulation OTHER

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.

Transcutaneous electrical nerve stimulation group

The conventional exercise program OTHER

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.

Isometric Exercise group; Transcutaneous electrical nerve stimulation group; conventional physical therapy group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Out-Patient Clinic, Faculty of Physical Therapy, Kafrelsheikh University

Kafr ash Shaykh, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Complications

Interventions

Exercise; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Tairq Eisi Hedaiban Alharbi, physical therapist

CONTACT

00966555309550; t18t1@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Locations

EG (1)