Hormone Replacement Therapy as an Adjunct Treatment for Adhesive Capsulitis of the Shoulder (Frozen Shoulder) in Peri- and Postmenopausal Women
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- American Shoulder and Elbow Surgeons (ASES) Shoulder Function Scores
研究概览
简要总结
The purpose of this study is to determine the effects of hormone replacement therapy (HRT) in addition to standard treatment on frozen shoulder symptoms in women with age-related changes to their menstrual cycle. Frozen shoulder refers to the condition a doctor diagnosed the participant with regarding shoulder pain, stiffness, and progressive loss of range of motion. Age-related menstrual cycle changes, known as perimenopause and/or menopause, refers to a change or stoppage of monthly menstrual cycles. Other symptoms participants may be experiencing include vaginal dryness, hot flashes, or night sweats. Hormone replacement therapy (HRT) refers to medicine with female hormones in it. For this study, HRT will be in the form of a patch that goes on the skin and a daily oral pill. Participants will be randomly assigned to receive either HRT plus standard care, or only standard care. Follow-up tests will be completed at 6 months of treatment to assess participant progress.
详细描述
Adhesive capsulitis of the shoulder (ACS), also known as frozen shoulder, affects up to 5% of the population with most cases occurring in peri- and postmenopausal women. This condition is debilitating, negatively impacting quality of life, yet current treatments are insufficient. There are mechanistic studies and biological plausibility to suggest the onset of this condition is associated with hormonal involvement, specifically estrogen. Given hormone replacement therapy (HRT) is widely prescribed to women experiencing menopause-related symptoms, investigators propose using HRT as an adjunct treatment for ACS. The primary objective of this study is to evaluate patient-reported outcomes using the American Shoulder and Elbow Surgeons (ASES) score following treatment with HRT + standard care versus standard care alone. The secondary objective is to determine changes in range of motion (ROM) and functional workspace using both routine clinical metrics and a novel clinical marker-less movement analysis system. Investigators hypothesize that HRT can improve pain scores and ROM limitations in peri- and postmenopausal women who present with ACS. Investigators will recruit 60 women who are peri- or postmenopausal and employ a longitudinal randomized controlled trial to determine the effects of HRT + standard treatment on ACS symptom severity. All participants will receive standard care of physical therapy and a glenohumeral joint steroid injection; the experimental group will also receive HRT. Measures will be repeated after six months of treatments. Within- and between-group changes in pain scores, ROM, and functional workspace will be evaluated using repeated measures ANOVAs with Tukey's multiple comparisons test as indicated by treatment groups. An alpha level of 0.05 will be used to determine statistical significance for all measures. This pilot project will provide critical preliminary data to support future extramural funding applications to government agencies, foundations, and industry partners.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of adhesive capsulitis of the shoulder
排除标准
- •History of hormone sensitive cancer
- •Bilateral adhesive capsulitis of the shoulder
- •Currently using hormonal treatments including contraceptives
研究组 & 干预措施
Hormone Replacement Therapy plus standard care
Participants will be prescribed HRT for 6 months (estrogen patch and oral progestin) in addition to receiving a steroid injection at the shoulder and referral to physical therapy.
干预措施: Hormone Replacement Therapy (HRT) (Drug)
Hormone Replacement Therapy plus standard care
Participants will be prescribed HRT for 6 months (estrogen patch and oral progestin) in addition to receiving a steroid injection at the shoulder and referral to physical therapy.
干预措施: Corticosteroid and 1%lidocain (Drug)
Hormone Replacement Therapy plus standard care
Participants will be prescribed HRT for 6 months (estrogen patch and oral progestin) in addition to receiving a steroid injection at the shoulder and referral to physical therapy.
干预措施: physical therapy (Behavioral)
Standard Care
Participants will receive standard care for frozen shoulder including a steroid injection at the shoulder and referral to physical therapy
干预措施: Corticosteroid and 1%lidocain (Drug)
Standard Care
Participants will receive standard care for frozen shoulder including a steroid injection at the shoulder and referral to physical therapy
干预措施: physical therapy (Behavioral)
结局指标
主要结局
American Shoulder and Elbow Surgeons (ASES) Shoulder Function Scores
时间窗: 6 months
Pain in affected shoulder measured on the American Shoulder and Elbow Surgeons (ASES) shoulder function scale. Scores range from 0 to 100 with 0 indicating the lowest level of shoulder function and 100 indicating the highest level of shoulder function.
Shoulder range of motion via goniometry measures.
时间窗: 6 months
Investigators will assess the degree of flexion, extension, adduction, and abduction in the shoulder to determine range of motion.
次要结局
未报告次要终点
