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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorIstanbul University - Cerrahpasa

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standardized Physiotherapy Program

    Procedure/Surgery

    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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: HRT GroupExperimental treatment 1 intervention
Group B: Non-HRT GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
2

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.

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

Secondary outcomes

1

Change from Baseline in Active and Passive Shoulder Range of Motion (ROM)

Active and passive shoulder range of motion (flexion, abduction, internal rotation, and external rotation) will be assessed in degrees using a universal goniometer according to standardized goniometric measurement protocols. Higher degree values indicate better mobility.

Time frame
Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
2

Change from Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Scores

Health-related quality of life will be evaluated using the Menopause-Specific Quality of Life Questionnaire (MENQOL). The questionnaire consists of 29 items divided into four domains: Vasomotor (3 items), Psychosocial (7 items), Physical (16 items), and Sexual (3 items). Items are scored on a 7-point Likert scale ranging from 0 (not at all bothered) to 6 (extremely bothered). Domain scores and total scores are calculated, with higher scores indicating a greater impact of menopausal symptoms and lower quality of life.

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

Change from Baseline in Pain Catastrophizing Scale (PCS) Scores

Pain-related catastrophizing thoughts and behaviors will be evaluated using the Pain Catastrophizing Scale (PCS). The 13-item self-report questionnaire assesses three dimensions: Rumination (4 items), Magnification (3 items), and Helplessness (6 items). Items are rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("all the time"). Total scores range from 0 to 52, with higher scores indicating higher levels of pain catastrophizing.

Time frame
Baseline, Week 6, Week 12, and 3-month follow-up (Week 24)
4

Overall Patient-Perceived Improvement Measured by 5-Point Global Rating of Change (GROC) Scale

Participants' overall perception of improvement or worsening in their shoulder condition will be assessed using a 5-point Global Rating of Change (GROC) scale. The scale ranges from 1 ("much worse") to 3 ("no change") to 5 ("much better"). Higher scores indicate greater perceived overall improvement in shoulder function and symptoms.

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

Other outcomes

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