An interventional study of Standardized Physiotherapy Program in Frozen Shoulder, Adhesive Capsulitis and Adhesive Capsulitis of the Shoulder, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the effects of a physiotherapy program on pain levels, shoulder range of motion, functional status, pain catastrophizing, perceived change, sleep quality, and quality of life in postmenopausal women diagnosed with frozen shoulder, with and without Hormone Replacement Therapy (HRT). The findings are expected to contribute to personalized treatment planning for postmenopausal women with frozen shoulder and help fill the gap in current literature.
This study investigates the impact of Hormone Replacement Therapy (HRT) on treatment outcomes in postmenopausal women undergoing a standardized physiotherapy program for frozen shoulder (adhesive capsulitis).
Participants are divided into two groups based on their current HRT status: postmenopausal women receiving HRT and those not receiving HRT. Both groups participate in the same structured physiotherapy program.
Assessments are conducted at baseline and after the intervention using the following outcome measures:
Primary Outcome Measures: Upper extremity disability and functional limitations evaluated by the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire.
Secondary Outcome Measures: Shoulder Range of Motion (ROM) measured by goniometry, sleep quality assessed via the Pittsburgh Sleep Quality Index (PSQI), menopause-specific quality of life measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL), cognitive response to pain evaluated by the Pain Catastrophizing Scale (PCS), and overall treatment perception evaluated by the Global Rating of Change (GROC) scale.
By comparing these parameters, the study aims to elucidate whether systemic HRT modulates pain perception, functional recovery, and general quality of life during physical rehabilitation in postmenopausal women with frozen shoulder.
383 studies on the registry are indexed under Bursitis; 111 are open to participants now.
This study's planned enrollment of 30 is below the median of 44 across 346 interventional studies indexed under Bursitis.
Browse Bursitis studies →Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
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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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal women diagnosed with primary frozen shoulder who are receiving hormone replacement therapy and undergoing the standardized physiotherapy program.
Procedure: Standardized Physiotherapy Program
Postmenopausal women diagnosed with primary frozen shoulder who are not receiving hormone replacement therapy and undergoing the standardized physiotherapy program.
Procedure: Standardized Physiotherapy Program
A standardized and supervised shoulder physical therapy and rehabilitation program delivered face-to-face in a clinical setting by an expert physiotherapist over 6 weeks (2 sessions per week, 50-60 minutes per session), supplemented by a prescribed home exercise program. The program includes patient education, stretching exercises, active-assisted and active range of motion (ROM) exercises, glenohumeral and scapular mobilization, progressive strengthening exercises, and post-treatment cryotherapy. Exercise progression is individualized based on participants' demographic characteristics, pain levels, progressive overload principles, and subjective feedback. Following each session, participants are routinely monitored for any exercise-related adverse effects.
Also known as: Shoulder Rehabilitation Protocol, Physical Therapy and Exercise Therapy
Change from Baseline in Upper Extremity Function and Disability Scores Using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Upper extremity disability and functional limitations will be assessed using the Turkish version of the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. The questionnaire consists of 30 items evaluating symptoms and the ability to perform various activities of daily living. Each item is scored on a 5-point Likert scale, ranging from 1 (no difficulty or symptoms) to 5 (unable to perform the activity or extreme symptoms). The total DASH score is calculated using the formula \[(sum of item scores / number of completed items) - 1\] × 25, resulting in a score ranging from 0 to 100. Higher scores indicate greater upper extremity disability and functional limitations. At least 27 of the 30 items must be completed to calculate a valid DASH score.
Time frame: Baseline, Week 6, Week 12( follow-up )
Change from Baseline in Shoulder Pain Intensity Scores using Numeric Pain Rating Scale (NPRS)
Shoulder pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), where 0 represents "no pain" and 10 represents "worst imaginable pain". Participants will rate their pain levels separately at rest and during movement. Higher scores indicate greater pain severity.
Time frame: Baseline, Week 6, Week 12( follow-up )
Change from Baseline in Active and Passive Shoulder Range of Motion (ROM)
Active and passive shoulder range of motion (flexion, abduction, internal rotation, and external rotation) will be assessed in degrees using a universal goniometer according to standardized goniometric measurement protocols. Higher degree values indicate better mobility.
Time frame: Baseline, Week 6, Week 12( follow-up )
Change from Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Scores
Health-related quality of life will be evaluated using the Menopause-Specific Quality of Life Questionnaire (MENQOL). The questionnaire consists of 29 items divided into four domains: Vasomotor (3 items), Psychosocial (7 items), Physical (16 items), and Sexual (3 items). Items are scored on a 7-point Likert scale ranging from 0 (not at all bothered) to 6 (extremely bothered). Domain scores and total scores are calculated, with higher scores indicating a greater impact of menopausal symptoms and lower quality of life.
Time frame: Baseline, Week 6, Week 12( follow-up )
Change from Baseline in Pain Catastrophizing Scale (PCS) Scores
Pain-related catastrophizing thoughts and behaviors will be evaluated using the Pain Catastrophizing Scale (PCS). The 13-item self-report questionnaire assesses three dimensions: Rumination (4 items), Magnification (3 items), and Helplessness (6 items). Items are rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("all the time"). Total scores range from 0 to 52, with higher scores indicating higher levels of pain catastrophizing.
Time frame: Baseline, Week 6, Week 12( follow-up )
Overall Patient-Perceived Improvement Measured by 5-Point Global Rating of Change (GROC) Scale
Participants' overall perception of improvement or worsening in their shoulder condition will be assessed using a 5-point Global Rating of Change (GROC) scale. The scale ranges from 1 ("much worse") to 3 ("no change") to 5 ("much better"). Higher scores indicate greater perceived overall improvement in shoulder function and symptoms.
Time frame: Week 6, Week 12( follow-up )
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores
Sleep quality and disturbances over the past month will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). The 19-item self-report questionnaire generates seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, yielding a global score ranging from 0 to 21. Higher global scores indicate poorer sleep quality, with a total score greater than 5 indicating poor sleep quality.
Time frame: Baseline, Week 6, Week 12( follow-up)
Plan to share: No — Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.
Start is estimated for Jan 2027; primary completion for Nov 2027, 10 months later.
Of 217 non-industry interventional studies with no phase under Bursitis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 10 months is close to that.
Counting every sponsor, half of 217 studies reached it within 10 months; a quarter within 5 and three quarters within 17.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start Sep 2026 → Jan 2027, primary completion Jul 2027 → Nov 2027 and completion Oct 2027 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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