Isometric Strengthening Exercises Versus Tens in Diabetic Population
ConditionDiabetes Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorKafrelsheikh University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Previous shoulder surgery or fracture.
Cervical radiculopathy or neurological disorders.
Rheumatoid arthritis or severe osteoarthritis.
Cardiac pacemaker.
Trial design
Design model
Parallel
Treatments tested in this trial
Isometric exercise
Other interventionIsometric 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 interventionTranscutaneous 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 intervention1. 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.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Isometric Exercise groupExperimental treatment 2 interventions
Group B: Transcutaneous electrical nerve stimulation groupExperimental treatment 2 interventions
Group C: conventional physical therapy groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
At baseline and after 6 weeksSecondary outcomes
1
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 weeks2
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 weeksSponsors and contacts
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Source ClinicalTrials.gov