Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
28 de julio de 2026 actualizado por: Sükran Acar, Istanbul University - Cerrahpasa
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
56
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Şükran Acar, Master of Science Candidate
- Número de teléfono: +905346071963
- Correo electrónico: acarsukran58@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Derya Çelik, Prof. Dr.
- Número de teléfono: +905327940169
- Correo electrónico: derya.celik@iuc.edu.tr
Ubicaciones de estudio
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Kadikoy
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Istanbul, Kadikoy, Turquía (Türkiye), 34710
- Centro Reformer Pilates Center
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Contacto:
- Şükran Acar, MSc Candidate
- Número de teléfono: +905346071963
- Correo electrónico: acarsukran58@gmail.com
-
Contacto:
- Derya Çelik, Prof.Dr.
- Número de teléfono: +905327940169
- Correo electrónico: derya.celik@iuc.edu.tr
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Investigador principal:
- Şükran Acar, MSc Candidate
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Sub-Investigador:
- Derya Çelik, PROF.DR.
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Sub-Investigador:
- Çiğdem Yayla Abide, PROF.DR.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: HRT Group
Postmenopausal women diagnosed with primary frozen shoulder who are receiving hormone replacement therapy and undergoing the standardized physiotherapy program.
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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.
Otros nombres:
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Comparador activo: Non-HRT Group
Postmenopausal women diagnosed with primary frozen shoulder who are not receiving hormone replacement therapy and undergoing the standardized physiotherapy program.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Shoulder Function and Disability Scores using Shoulder Pain and Disability Index (SPADI)
Periodo de tiempo: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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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.
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Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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Change from Baseline in Shoulder Pain Intensity Scores using Numeric Pain Rating Scale (NPRS)
Periodo de tiempo: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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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.
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Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Active and Passive Shoulder Range of Motion (ROM)
Periodo de tiempo: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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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.
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Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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Change from Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Scores
Periodo de tiempo: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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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.
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Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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Change from Baseline in Pain Catastrophizing Scale (PCS) Scores
Periodo de tiempo: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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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.
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Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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Overall Patient-Perceived Improvement Measured by 5-Point Global Rating of Change (GROC) Scale
Periodo de tiempo: Week 6, Week 12, and 3-month follow-up (Week 24)
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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.
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Week 6, Week 12, and 3-month follow-up (Week 24)
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Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores
Periodo de tiempo: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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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.
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Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: DERYA ÇELİK, PROF.DR., Istanbul University - Cerrahpasa
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de julio de 2027
Finalización del estudio (Estimado)
1 de octubre de 2027
Fechas de registro del estudio
Enviado por primera vez
25 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de julio de 2026
Publicado por primera vez (Actual)
30 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IUC-oThQlo0H
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .