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

N/ANot Yet RecruitingNCT07736027

Istanbul University - Cerrahpasa56 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

Standardized Physiotherapy ProgramPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Change from Baseline in Shoulder Function and Disability Scores using Shoulder Pain and Disability Index (SPADI)

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.