Frozen ShoulderNCT07736027
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
A study testing Standardized Physiotherapy Program in people with Frozen Shoulder and Adhesive Capsulitis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Frozen Shoulder, Adhesive Capsulitis, Adhesive Capsulitis of the Shoulder
- What is being tested?
- Standardized Physiotherapy Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postmenopausal female patients aged 40 to 60 years.
- Shoulder pain at rest and during activities of daily living lasting for more than 3 months.
- Clinical diagnosis of Stage I or Stage II frozen shoulder (adhesive capsulitis).
- Passive range of motion (ROM) loss of greater than 25% compared to the unaffected shoulder in at least two movement planes (flexion, abduction, internal rotation, or external rotation).
- Reduced range of motion of less than 50% compared to the unaffected side in at least one movement direction (flexion, abduction, internal rotation, or external rotation).
- Increased restriction of external and internal rotation during glenohumeral abduction from 45 to 90 degrees.
Who cannot join
- Passive external rotation range of motion of less than 30 degrees (<30°).
- Presence of glenohumeral arthritis confirmed by radiography.
- History or presence of inflammatory joint disease.
- History of malignancy or active cancer diagnosis.
- Previous treatment for the current shoulder condition (e.g., physiotherapy and rehabilitation, intra-articular injections, or surgical intervention).
- Baseline shoulder pain score of less than 3 (<3) on the Numeric Pain Rating Scale (NPRS).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Centro Reformer Pilates Center
Istanbul, Kadikoy, 34710
Şükran Acar, MSc Candidate, +905346071963, acarsukran58@gmail.com
Derya Çelik, Prof.Dr., +905327940169, derya.celik@iuc.edu.tr
About this study
Official title: The Effects of Hormone Replacement Therapy on Clinical and Functional Outcomes in Postmenopausal Women With Frozen Shoulder
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.
Read the detailed description
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: Pain intensity evaluated by the Numeric Pain Rating Scale (NPRS) and shoulder pain and disability evaluated by the Shoulder Pain and Disability Index (SPADI).
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.
- Conditions
- Frozen Shoulder, Adhesive Capsulitis, Adhesive Capsulitis of the Shoulder, Hormone Replacement Therapy, Post-Menopausal, Exercise, Physical Therapy
- Being tested
- Standardized Physiotherapy Program
- Keywords
- Frozen Shoulder, Adhesive Capsulitis, Hormone Replacement Therapy, Postmenopause, Physical Therapy, Rehabilitation, Pain Catastrophizing, Range of Motion
- Medical subject headings
- Bursitis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Physiotherapy ProgramProcedure or surgery
Also called Shoulder Rehabilitation Protocol, Physical Therapy and Exercise Therapy
A standardized and supervised shoulder physical therapy and rehabilitation program delivered face-to-face in a clinical setting by an expert physiotherapist over 12 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.
| Study group | Role | What they receive |
|---|---|---|
| HRT Group | Experimental | Postmenopausal women diagnosed with primary frozen shoulder who are receiving hormone replacement therapy and undergoing the standardized physiotherapy program. Receives: Procedure: Standardized Physiotherapy Program |
| Non-HRT Group | Active comparator | Postmenopausal women diagnosed with primary frozen shoulder who are not receiving hormone replacement therapy and undergoing the standardized physiotherapy program. Receives: Procedure: Standardized Physiotherapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Shoulder Function and Disability Scores using Shoulder Pain and Disability Index (SPADI)
Shoulder pain and disability will be assessed using the Turkish version of the Shoulder Pain and Disability Index (SPADI). The index consists of 13 items divided into two subscales: pain (5 items) and disability (8 items). Each item is scored on a 0-10 numerical rating scale. For the pain subscale, 0 indicates "no pain" and 10 indicates "worst imaginable pain". For the disability subscale, 0 indicates "no difficulty" and 10 indicates "so difficult that help is required". Subscale scores and total SPADI scores are calculated, ranging from 0 to 100, where higher scores indicate greater pain severity and functional disability.
Measured: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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.
Measured: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
Secondary outcomes (5)
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.
Measured: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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.
Measured: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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.
Measured: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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.
Measured: Week 6, Week 12, and 3-month follow-up (Week 24)
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.
Measured: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sükran Acar, Istanbul University - Cerrahpasa
- Investigators
- DERYA ÇELİK, PROF.DR., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736027
- Sponsor's protocol ID
- IUC-oThQlo0H
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.