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NCT Number: NCT07747454

Isometric Strengthening Exercises Versus Tens 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.

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Key information

Conditions

Diabetes Complications Diabetes Mellitus Endocrine System Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kafr ash Shaykh, Egypt

Location status: Recruiting

Location contact

Tairq Eisi Hedaiban Alharbi, physical therapist

CONTACT

[email protected]

00966555309550

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

The conventional exercise program

Other
  • 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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'.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tairq Eisi Hedaiban Alharbi, physical therapist

CONTACT

[email protected]

00966555309550

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Isometric Strengthening Exercises Versus Tens in Management of Shoulder Pain in Diabetic Population

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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