Investigation of the Effectiveness of Exercise and Anti-Fibrotic Approaches in Frozen Shoulder

ConditionAdhesive Capsulitis of Shoulder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorIstanbul University

About this trial

The purpose of this clinical study is to investigate the efficacy of losartan as an antifibrotic approach in addition to a physiotherapy program in patients diagnosed with frozen shoulder. The effects of losartan use on pain intensity, shoulder joint range of motion, functional status, and pain catastrophizing level will be evaluated and compared with the outcomes of patients participating in a physiotherapy program alone.

The key questions this study aims to answer are:

* Is there a difference in shoulder functionality between frozen shoulder patients using losartan in addition to a physiotherapy program and those participating in a physiotherapy program alone? * Is there a difference in pain intensity, shoulder joint range of motion, and pain catastrophizing level between frozen shoulder patients using losartan in addition to a physiotherapy program and those participating in a physiotherapy program alone? A total of 33 patients will be enrolled in the study. Participants will be randomly assigned to one of two groups: the physiotherapy group (PT) and the physiotherapy + losartan group (PT+L). Both groups will receive the same physiotherapy program comprising range of motion exercises, stretching exercises, strengthening exercises, and mobilization techniques. Patients in the PT+L group will additionally receive 12.5 mg of oral losartan once daily for four weeks. Clinical assessments will be conducted at baseline, at week 4, and at week 8.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older diagnosed with frozen shoulder (adhesive capsulitis)

Having less than 50% of range of motion (ROM) in at least one of the following shoulder movements compared to the unaffected side: external rotation, abduction, flexion, or internal rotation

Having more than 25% loss of ROM in at least two movement planes compared to the unaffected shoulder

Patients in stage II or III of frozen shoulder

Disqualifiers

Women who are pregnant, breastfeeding, or planning pregnancy during the study

Patients in stage I of frozen shoulder

Patients diagnosed with inflammatory or other types of arthritis due to autoimmune diseases affecting the shoulder

Patients with rotator cuff pathology and/or glenohumeral arthritis

Trial design

Design model

Parallel

Treatments tested in this trial

Patient Education
Other intervention
During the first session, participants will receive information about the stages and prognosis of frozen shoulder and recommended sleeping positions for patients who have difficulty sleeping at night due to pain.
Shoulder Exercise Therapy
Other intervention
Participants in both groups will be enrolled in a structured exercise program consisting of exercises recommended in the literature. This program includes range of motion, stretching, and strengthening exercises. The exercises will be performed under the supervision of a physiotherapist, twice a week for four weeks, totaling eight sessions.
Losartan
Drug
Participants will receive 12.5 mg of oral losartan once daily for four weeks.
Joint Mobilization Techniques
Other intervention
Glenohumeral joint distraction and anterior, posterior, and inferior glides will be applied. Each technique will be performed for 2 minutes, with 3 repetitions. The intensity of the mobilization techniques will be adjusted according to each patient's pain and tolerance levels.
Cold Application
Other intervention
A cold pack will be applied for 15 minutes after each exercise session.

Treatment groups

33 Participants

are divided into 2 treatment groups

Group A: Physiotherapy Group (FT)Active comparator 4 interventions

Group B: Physiotherapy + Losartan Group (FT+L)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)

The Q-DASH is a questionnaire used to assess upper extremity function and symptoms. It consists of 11 items, each scored from 1 to 5. The total score ranges from 0 to 100, with higher scores indicating greater functional limitation.

Time frame