Frozen ShoulderAdhesive CapsulitisAdhesive Capsulitis of the ShoulderHormone Replacement Therapy, Post-MenopausalExercisePhysical Therapy
Investigational drug(s) / intervention(s)
Standardized Physiotherapy Program
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 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.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
40 Years
Max age
60 Years
Healthy volunteers
No
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).
Primary outcome measure(s)
Change from Baseline in Shoulder Function and Disability Scores using Shoulder Pain and Disability Index (SPADI) — 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) — 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.
Trial sites (1)
Facility
City
Region
Status
Centro Reformer Pilates Center
Istanbul
Kadikoy
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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