Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder

Официальное название

The Effects of Hormone Replacement Therapy on Clinical and Functional Outcomes in Postmenopausal Women With Frozen Shoulder

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 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 cryothera

Первичные конечные точки

• Change from Baseline in Shoulder Function and Disability Scores using Shoulder Pain and Disability Index (SPADI) [Срок оценки: 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) [Срок оценки: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)]

Вторичные конечные точки (5)

• Change from Baseline in Active and Passive Shoulder Range of Motion (ROM) [Срок оценки: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)]
• Change from Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Scores [Срок оценки: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)]
• Change from Baseline in Pain Catastrophizing Scale (PCS) Scores [Срок оценки: 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 [Срок оценки: Week 6, Week 12, and 3-month follow-up (Week 24)]
• Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores [Срок оценки: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Centro Reformer Pilates Center — Istanbul

Идентификаторы

NCT: NCT07736027 · IUC-oThQlo0H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗