An observational study in Frozen Shoulder, sponsored by Inonu University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Inonu University · Observational
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.
Frozen shoulder (FS) is a clinical condition characterized by progressive shoulder pain and marked restriction in joint range of motion, substantially affecting individuals' activities of daily living and overall quality of life. The lifetime prevalence of frozen shoulder in the general population has been reported to range between 2% and 5%. The condition most commonly occurs in the fifth and sixth decades of life and may lead to significant functional limitations throughout its clinical course. Additionally, involvement of the contralateral shoulder has been observed in a considerable proportion of individuals diagnosed with frozen shoulder.
The clinical course of frozen shoulder is typically described in three stages: the inflammatory stage, during which pain and inflammation predominate; the frozen stage, characterized by pronounced joint stiffness; and the thawing stage, during which gradual improvements in shoulder mobility are observed. Pain, often more severe at night, is a dominant feature in the early stage, whereas pain may decrease in later stages despite persistent movement restrictions. During the thawing stage, pain generally becomes minimal while range of motion progressively improves.
The diagnosis of frozen shoulder primarily relies on clinical evaluation and is defined by the presence of shoulder pain accompanied by significant limitations in both active and passive glenohumeral joint range of motion. Although frozen shoulder has historically been considered a self-limiting condition, contemporary evidence suggests that spontaneous and complete recovery may not occur in all individuals, and long-term functional impairments may persist in some cases.
The shoulder joint, owing to its extensive range of motion, depends heavily on the coordinated and balanced activation of surrounding musculature for stability and function. Pain, weakness, or impaired coordination within these muscle groups may disrupt shoulder biomechanics, resulting in notable functional deficits. In frozen shoulder, pain-related protective muscle activation and movement avoidance behaviors may contribute to progressive deterioration of periarticular muscle function.
Pain and restricted mobility in frozen shoulder are not limited to local mechanical factors but may also induce central nervous system mechanisms that suppress motor output. Pain-related inhibition has been associated with reductions in maximal voluntary muscle force, altered motor unit recruitment, and decreased muscle endurance. Furthermore, reduced use of the affected upper extremity and protective immobilization behaviors may exacerbate neuromuscular dysfunction.
The primary goals in frozen shoulder management are pain reduction and restoration of shoulder joint mobility. In clinical practice, analgesic interventions, physiotherapy, and manual mobilization techniques are commonly employed and have been shown to contribute to functional improvements. However, during phases in which pain is prominent and direct mechanical loading of the affected shoulder is poorly tolerated, the applicability of conventional exercise approaches may be limited. These challenges highlight the need for alternative rehabilitation strategies aimed at preserving neuromuscular function when direct exercise of the affected extremity is not feasible.
Cross-education refers to the phenomenon whereby unilateral resistance training leads to strength gains in the homologous muscles of the contralateral, untrained limb. This effect has been extensively investigated in conditions involving unilateral immobilization, orthopedic injuries, and movement restrictions, where maintaining muscle function in the non-exercised extremity is clinically desirable. Unilateral exercise interventions have been shown to enhance contralateral strength output, with evidence suggesting that these effects are predominantly mediated by neural mechanisms rather than peripheral muscular adaptations.
The mechanisms underlying cross-education are widely considered to originate from central nervous system adaptations. Unilateral resistance training has been associated with increased excitability of contralateral motor cortical regions and modifications within motor networks responsible for movement planning and execution. These neural adaptations may facilitate improved motor output in the untrained limb independent of muscle hypertrophy. Cross-education has therefore been conceptually linked to motor learning processes involving central reinforcement of efficient muscle activation patterns.
More recently, the potential contribution of visual-motor networks, including mechanisms associated with the mirror neuron system, has been proposed. Activation of shared neural substrates during both movement execution and observation may modulate motor cortical excitability, suggesting that visually mediated strategies could influence cross-education effects.
Frozen shoulder presents a unique clinical scenario characterized by pain, restricted mobility, and central inhibition mechanisms. These factors complicate efforts to maintain muscle strength and neuromuscular function during periods when direct loading of the affected shoulder is limited. Given that cross-education enables strength-related neural adaptations without imposing mechanical stress on the affected extremity, it represents a conceptually relevant approach for this population. Consequently, cross-education may offer a promising rehabilitation strategy for preserving shoulder function and supporting recovery in individuals with frozen shoulder.
383 studies on the registry are indexed under Bursitis; 111 are open to participants now.
This study's planned enrollment of 38 is below the median of 50 across 29 observational studies indexed under Bursitis.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants diagnosed with frozen shoulder will receive 20 minutes of standard physiotherapy followed by 20 minutes of cross-education intervention.
Other: Cross-Education Group
A 40-minute standard physiotherapy program will be administered to participants diagnosed with frozen shoulder
Other: Standard Physical Therapy Group
The 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.
In 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.
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.
Time frame: Baseline and post-intervention (8 weeks later )
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.
Time frame: Baseline and post-intervention (8 weeks later )
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
Time frame: Baseline and post-intervention (8 weeks later )
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
Time frame: Baseline and post-intervention (8 weeks later )
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.
Time frame: Baseline and post-intervention (8 weeks later )
Quality of Life (QoL)
To assess participants' health-related quality of life, the Short Form-12, Version 2 (SF-12v2), a 12-item abbreviated form of the SF-36 Health Survey, will be used. The SF-12v2 encompasses two main components: physical health and mental health. Scores range from 0 to 100, with higher scores indicating better quality of life.
Time frame: Baseline and post-intervention (8 weeks later )
Activities of Daily Living (ADL)
The Canadian Occupational Performance Measure (COPM) is a semi-structured interview tool used to assess participants' engagement in meaningful daily activities. Participants will be asked to identify four activities, which will then be evaluated using a 10-point Likert scale. Perceived performance will be rated from 1 (cannot do) to 10 (able to do extremely well), and satisfaction with performance will be rated from 1 (not at all satisfied) to 10 (extremely satisfied). Final performance and satisfaction scores will be determined by calculating the mean of the scores for the four selected activities.
Time frame: Baseline and post-intervention (8 weeks later )
Reaction Time Measurement
Participants will be assessed in a standardized seated position (feet fully in contact with the floor, shoulders in neutral alignment, elbows approximately 90° flexion). For reaction time measurements and related procedures, LED-based cue modules will be positioned on the table at fixed intervals, and the hand-to-cue distance will be standardized.
Time frame: Baseline and post-intervention (8 weeks later )
Plan to share: No — Participant data will be securely stored by the investigators and may be shared with authorized personnel if deemed necessary, in accordance with applicable privacy regulations.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
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