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
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2027to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Effect of Hormone Replacement Therapy Use on the Effectiveness of Physiotherapy in Postmenopausal Women Diagnosed 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: 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.
- 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 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.
| 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 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.
Measured: 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.
Measured: Baseline, Week 6, Week 12( follow-up )
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( 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6, Week 12( follow-up)
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 Jan 2027 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 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.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- 30 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
- Nov 2026
- First submitted
- 25 Jul 2026
- Last updated
- 5 Nov 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hormone Replacement Therapy Use on the Effectiveness of Physiotherapy in Postmenopausal Women Diagnosed With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT07736027
- Acronym / sponsor ID
- IUC-oThQlo0H
- Conditions
- Frozen Shoulder, Adhesive Capsulitis, Adhesive Capsulitis of the Shoulder, Hormone Replacement Therapy, Post-Menopausal, Exercise, Physical Therapy
- Keywords
- Frozen Shoulder, Adhesive Capsulitis, Hormone Replacement Therapy, Postmenopause, Physical Therapy, Rehabilitation, Pain Catastrophizing, Range of Motion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRT Group | Experimental | Procedure: Standardized Physiotherapy ProgramPostmenopausal women diagnosed with primary frozen shoulder who are receiving hormone replacement therapy and undergoing the standardized physiotherapy program. |
| Non-HRT Group | Active comparator | Procedure: Standardized Physiotherapy ProgramPostmenopausal women diagnosed with primary frozen shoulder who are not receiving hormone replacement therapy and undergoing the standardized physiotherapy program. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Physiotherapy ProgramAlso: Shoulder Rehabilitation Protocol, Physical Therapy and Exercise TherapyA 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. | Procedure or surgery | HRT Group, Non-HRT Group |
Primary outcome
Change from Baseline in Upper Extremity Function and Disability Scores Using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time frame: Baseline, Week 6, Week 12( follow-up )
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.
Change from Baseline in Shoulder Pain Intensity Scores using Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, Week 6, Week 12( follow-up )
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.
5 secondary outcomes
Change from Baseline in Active and Passive Shoulder Range of Motion (ROM)
Time frame: Baseline, Week 6, Week 12( follow-up )
Change from Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Scores
Time frame: Baseline, Week 6, Week 12( follow-up )
Change from Baseline in Pain Catastrophizing Scale (PCS) Scores
Time frame: Baseline, Week 6, Week 12( follow-up )
Overall Patient-Perceived Improvement Measured by 5-Point Global Rating of Change (GROC) Scale
Time frame: Week 6, Week 12( follow-up )
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores
Time frame: Baseline, Week 6, Week 12( follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- A preliminary pilot study to address design issues related to research on potential association of hormone therapy and adhesive capsulitisLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DERYA ÇELİK, PROF.DR. study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Şükran Acar, Master of Science Candidate (+905346071963, acarsukran58@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Upper Extremity Function and Disability Scores Using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire (time frame: Baseline, Week 6, Week 12( follow-up )). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.