Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
28 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
56
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Şükran Acar, Master of Science Candidate
- Número de telefone: +905346071963
- E-mail: acarsukran58@gmail.com
Estude backup de contato
- Nome: Derya Çelik, Prof. Dr.
- Número de telefone: +905327940169
- E-mail: derya.celik@iuc.edu.tr
Locais de estudo
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Kadikoy
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Istanbul, Kadikoy, Turquia (Türkiye), 34710
- Centro Reformer Pilates Center
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Contato:
- Şükran Acar, MSc Candidate
- Número de telefone: +905346071963
- E-mail: acarsukran58@gmail.com
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Contato:
- Derya Çelik, Prof.Dr.
- Número de telefone: +905327940169
- E-mail: derya.celik@iuc.edu.tr
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Investigador principal:
- Şükran Acar, MSc Candidate
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Subinvestigador:
- Derya Çelik, PROF.DR.
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Subinvestigador:
- Çiğdem Yayla Abide, PROF.DR.
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Shoulder Function and Disability Scores using Shoulder Pain and Disability Index (SPADI)
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Active and Passive Shoulder Range of Motion (ROM)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: DERYA ÇELİK, PROF.DR., Istanbul University - Cerrahpasa
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de julho de 2027
Conclusão do estudo (Estimado)
1 de outubro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
25 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de julho de 2026
Primeira postagem (Real)
30 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IUC-oThQlo0H
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .