The Effects of Hormone Replacement Therapy on Clinical and Functional Outcomes in Postmenopausal Women With Frozen Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change from Baseline in Shoulder Function and Disability Scores using Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change from Baseline in Shoulder Function and Disability Scores using Shoulder Pain and Disability Index (SPADI)
时间窗: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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.
Change from Baseline in Shoulder Pain Intensity Scores using Numeric Pain Rating Scale (NPRS)
时间窗: Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
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.
次要结局
- Change from Baseline in Active and Passive Shoulder Range of Motion (ROM)(Baseline, Week 6, Week 12, and 3-month follow-up (Week 24))
- Change from Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Scores(Baseline, Week 6, Week 12, and 3-month follow-up (Week 24))
- Change from Baseline in Pain Catastrophizing Scale (PCS) Scores(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(Week 6, Week 12, and 3-month follow-up (Week 24))
- Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores(Baseline, Week 6, Week 12, and 3-month follow-up (Week 24))
研究者
Sükran Acar
MSc Student
Istanbul University - Cerrahpasa