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

NCT07736027 | Not Yet Recruiting

• 1 other identifier: IUC-oThQlo0H
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frozen Shoulder; Adhesive Capsulitis; Adhesive Capsulitis of the Shoulder; Hormone Replacement Therapy, Post-Menopausal; Exercise; Physical Therapy

Keywords

Frozen Shoulder, Adhesive Capsulitis, Hormone Replacement Therapy, Postmenopause, Physical Therapy, Rehabilitation, Pain Catastrophizing, Range of Motion

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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.

  Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)

Secondary Outcomes (5)

• 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)

Study Arms (2)

HRT Group

EXPERIMENTAL

Postmenopausal women diagnosed with primary frozen shoulder who are receiving hormone replacement therapy and undergoing the standardized physiotherapy program.

Procedure: Standardized Physiotherapy Program

Non-HRT Group

ACTIVE COMPARATOR

Postmenopausal women diagnosed with primary frozen shoulder who are not receiving hormone replacement therapy and undergoing the standardized physiotherapy program.

Procedure: Standardized Physiotherapy Program

Interventions

Standardized Physiotherapy Program PROCEDURE

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.

Also known as: Shoulder Rehabilitation Protocol, Physical Therapy and Exercise Therapy

HRT Group; Non-HRT Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Centro Reformer Pilates Center

Istanbul, Kadikoy, 34710, Turkey (Türkiye)

Location

Related Links

• A preliminary pilot study to address design issues related to research on potential association of hormone therapy and adhesive capsulitis

MeSH Terms

Conditions

Bursitis; Motor Activity

Interventions

Physical Therapy Modalities; Exercise Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• DERYA ÇELİK, PROF.DR.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Şükran Acar, Master of Science Candidate

CONTACT

+905346071963; acarsukran58@gmail.com

Derya Çelik, Prof. Dr.

CONTACT

+905327940169; derya.celik@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Student

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)