- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07736027
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Şükran Acar, Master of Science Candidate
- Telefonnummer: +905346071963
- E-post: acarsukran58@gmail.com
Studera Kontakt Backup
- Namn: Derya Çelik, Prof. Dr.
- Telefonnummer: +905327940169
- E-post: derya.celik@iuc.edu.tr
Studieorter
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Kadikoy
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Istanbul, Kadikoy, Turkiet (Türkiye), 34710
- Centro Reformer Pilates Center
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Kontakt:
- Şükran Acar, MSc Candidate
- Telefonnummer: +905346071963
- E-post: acarsukran58@gmail.com
-
Kontakt:
- Derya Çelik, Prof.Dr.
- Telefonnummer: +905327940169
- E-post: derya.celik@iuc.edu.tr
-
Huvudutredare:
- Şükran Acar, MSc Candidate
-
Underutredare:
- Derya Çelik, PROF.DR.
-
Underutredare:
- Çiğdem Yayla Abide, PROF.DR.
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: HRT Group
Postmenopausal women diagnosed with primary frozen shoulder who are receiving hormone replacement therapy and undergoing the 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.
Andra namn:
|
|
Aktiv komparator: Non-HRT Group
Postmenopausal women diagnosed with primary frozen shoulder who are not receiving hormone replacement therapy and undergoing the 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in Upper Extremity Function and Disability Scores Using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Tidsram: 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. |
Baseline, Week 6, Week 12( follow-up )
|
|
Change from Baseline in Shoulder Pain Intensity Scores using Numeric Pain Rating Scale (NPRS)
Tidsram: 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. |
Baseline, Week 6, Week 12( follow-up )
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in Active and Passive Shoulder Range of Motion (ROM)
Tidsram: Baseline, Week 6, Week 12( follow-up )
|
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. |
Baseline, Week 6, Week 12( follow-up )
|
|
Change from Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Scores
Tidsram: Baseline, Week 6, Week 12( follow-up )
|
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. |
Baseline, Week 6, Week 12( follow-up )
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Change from Baseline in Pain Catastrophizing Scale (PCS) Scores
Tidsram: Baseline, Week 6, Week 12( follow-up )
|
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. |
Baseline, Week 6, Week 12( follow-up )
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Overall Patient-Perceived Improvement Measured by 5-Point Global Rating of Change (GROC) Scale
Tidsram: Week 6, Week 12( follow-up )
|
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. |
Week 6, Week 12( follow-up )
|
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Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores
Tidsram: Baseline, Week 6, Week 12( follow-up)
|
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. |
Baseline, Week 6, Week 12( follow-up)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: DERYA ÇELİK, PROF.DR., Istanbul University - Cerrahpasa
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IUC-oThQlo0H
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.
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