About this trial
This randomized controlled, single-blind, quasi-experimental study primarily aims to investigate the effects of unilateral resistance exercise applied without directly loading the affected shoulder on muscle strength and upper extremity function in individuals with frozen shoulder. Additionally, the study seeks to examine the effects on joint range of motion, quality of life, and activities of daily living. The study will be conducted among individuals diagnosed with frozen shoulder at the Physiotherapy and Rehabilitation Outpatient Clinic of Malatya Battalgazi State Hospital. The data collection process is planned to be completed between February 2026 and December 2026.
Participants will be selected from the relevant population using a non-probability convenience sampling method. Individuals meeting the inclusion criteria will be enrolled after providing written informed consent. The study will be carried out in accordance with the principles of the Declaration of Helsinki. Participants will be randomly assigned to either the control or intervention group.
The study will include individuals aged 18-65 years with a diagnosis of unilateral primary or secondary frozen shoulder, presenting with more than 50% restriction in at least one of the following shoulder movements compared to the unaffected side: external rotation, abduction, or flexion, and with more than 30% limitation in joint range of motion in at least two movement planes.
Individuals with concomitant shoulder trauma (e.g., rotator cuff injury), bilateral shoulder involvement, acromioclavicular joint osteoarthritis, prior treatment for frozen shoulder, psychiatric disorders that may affect compliance with medical or physical therapy interventions, concomitant neurological conditions, or a Mini-Mental State Examination (MMSE) score below 24 will be excluded from the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Having a diagnosis of unilateral primary or secondary frozen shoulder.
Range of motion in external rotation, abduction, or flexion reduced by less than 50% in at least one of these directions compared to the unaffected shoulder.
Loss of joint range of motion exceeding 30% in at least two movement planes compared to the unaffected shoulder.
Aged between 18 and 65 years.
Disqualifiers
Presence of a concomitant shoulder injury (e.g., rotator cuff tear).
Osteoarthritis in both shoulders or in the acromioclavicular joint.
Previous treatment for frozen shoulder.
Psychiatric disorders that may interfere with adherence to medical or physical therapy.
Trial population
The study will include patients aged 18-65 years with a diagnosis of unilateral primary or secondary frozen shoulder. Participants will be randomly assigned to either the control or intervention group.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Standard Physical Therapy Group
Other interventionThe program will be applied to both groups twice weekly for eight weeks, with the experimental group additionally receiving cross-education. The control group will undergo a 40-minute standard physical therapy protocol per session, progressively structured to reduce pain and improve shoulder range of motion. During weeks 0-3, passive and active-assisted range of motion exercises, scapular mobilization, stretching, and joint mobilizations with distraction will be performed within pain limits. Between weeks 3-5, active-assisted and active exercises, stretching, joint mobilizations, and scapulothoracic strengthening will continue. During weeks 6-8, active range of motion and strengthening exercises targeting the rotator cuff and scapulothoracic muscles will be implemented within pain limits.
Cross-Education Group
Other interventionIn the experimental group, each session will last 40 minutes, comprising 20 minutes of standard physical therapy and 20 minutes of cross-education. The standard physical therapy content will be identical to that of the control group. The cross-education program will aim to increase the internal rotation, external rotation, flexion, and abduction strength of the unaffected shoulder during immobilization. Resistance exercises will be performed at 70-80% of the one-repetition maximum (1RM) of the unaffected extremity, with loads progressively adjusted according to individual tolerance. Strengthening exercises targeting the internal rotators, external rotators, flexors, and abductors will be performed using dumbbells and therabands. Each contraction will last 3 seconds, with repetitions performed at 10-second intervals.
Treatment groups
Trial outcomes
Primary outcomes
Shoulder Pain and Functional Disability
Participants' shoulder pain and functional disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The SPADI is a 13-item self-reported questionnaire designed to evaluate pain and functional impairment associated with shoulder dysfunction. Each item is rated on a numeric scale ranging from 0 ('no pain/no difficulty') to 10 ('worst imaginable pain/extreme difficulty requiring assistance'). The total SPADI score ranges from 0 to 100, with higher scores indicating greater pain and functional disability. The SPADI has been demonstrated to be a valid and reliable outcome measure for the assessment of individuals with frozen shoulder.
Secondary outcomes
Numeric Pain Rating Scale (NPRS)
Pain at rest, during activity, and at night will be assessed. Activity-related pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale ranging from 0 to 10, where 0 indicates 'no pain' and 10 represents 'the worst pain imaginable.
Muscle Strength
The isometric muscle strength of the shoulder flexor, extensor, abductor, adductor, and internal and external rotator muscle groups will be assessed using a handheld dynamometer. During the measurements, participants will be tested in a seated position on a standard chair. Participants will be instructed to generate a maximal voluntary isometric contraction against the dynamometer for approximately 3 seconds. Three trials will be performed for each muscle group, with a 1-minute rest interval between trials. The highest value obtained from the three trials will be recorded as the isometric muscle strength
Joint Range of Motion Assessment
Shoulder joint range of motion will be assessed using goniometric measurements. Shoulder flexion will be evaluated in the supine position, with the scapula stabilized laterally, while participants are instructed to actively and passively elevate the arm. Shoulder abduction will be assessed in the same position by instructing participants to actively and passively raise the arm laterally. Shoulder internal and external rotation range of motion will be measured with the shoulder stabilized and the elbow positioned at 90° of flexion, while participants are instructed to rotate the forearm inward and outward, respectively, under both active and passive conditions. Active total elevation will be measured in the seated position using a goniometer. Active shoulder internal rotation will be evaluated by measuring the distance between the tip of the thumb and the spinous process of the T5 vertebra while the hand is positioned behind the back
Upper Extremity Function
Subjective assessment of upper extremity function and symptoms will be performed using the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH), which consists of 11 items. The QuickDASH score ranges from 0 to 100, with higher scores indicating greater functional disability.
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