Clinical trial NCT06469502: Comparison of the Effectiveness of Stretching and Strengthening Exercises in Patients With Frozen Shoulder
Official title: Comparison of the Effectiveness of Stretching and Strengthening Exercises on Pain, Functional Status, Range of Motion and Psychosocial Factors in Patients With Frozen Shoulder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frozen Shoulder
Keywords: frozen shoulder
exercise
stretching
strengthening
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.

Detailed description: Frozen shoulder is a common disorder characterized by spontaneous shoulder pain, progressive inflammation and fibrosis of the joint capsule and loss of both active and passive glenohumeral range of motion.Exercise reduces pain, increases range of motion and function in patients with frozen shoulder. When investigators examine the literature, stretching and strengthening exercises are frequently encountered in the content of multimodal exercise programs applied clinically and at home in frozen shoulder. However, they have not been compared in isolation. Stretching is known to increase flexibility, while strengthening is often used to increase strength capacity and hypertrophy.Both exercise methods produce mechanical tension, known as a factor that stimulates anabolic metabolism and increases protein synthesis.Therefore, the aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.According to the power analysis result, 56 patients will be randomized into two groups (Group 1 =28, Group 2=28). The treatment will last for a total of 6 weeks and the follow-up period will be 6 weeks. Group 1 will be included in the program consisting of stretching exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of stretching exercises (3 times a week) under the supervision of a physiotherapist. Group 2 will be included in the program consisting of strengthening exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of strengthening exercises (3 times per week) under the supervision of a physiotherapist. The primary outcomes are the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH) and the Numeric Pain Rating Scale (NPRS), while the secondary outcomes are the American Shoulder and Elbow Surgeons Standardized Shoulder Evaluation (ASES), Shoulder range of motion, Brief Pain Inventory-Short Form (BFI-SF) and Pain Catastrophizing Scale (PCS).

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 40-65
* Clinical and radiologic diagnosis of unilateral primary frozen shoulder
* Being in frozen shoulder stages 2 and 3
* Having an ROM of less than 50% in one or more directions of shoulder flexion, abduction, external rotation compared to the unaffected shoulder
* Giving informed consent and volunteering
* To have the ability to understand evaluation scales

Exclusion Criteria:

* Neurological, cardiovascular, cerebrovascular disease
* Those with severe mental illness or impaired consciousness
* Upper extremity fractures and tumors
* Rheumatic disease
* Pathologies of cervical origin
* Untreated shoulder trauma
* Severe osteoporosis
* Previous treatment for the current complaint (physiotherapy and rehabilitation, intra-articular injection, surgery)

Primary outcomes:
measure: Quick DASH
timeFrame: baseline, after 6 weeks and 6 weeks follow up
measure: NPRS
timeFrame: baseline, after 6 weeks and 6 weeks follow up
Secondary outcomes:
measure: ASES
timeFrame: baseline, after 6 weeks and 6 weeks follow up
measure: Shoulder Range of Motion (ROM)
timeFrame: baseline, after 6 weeks and 6 weeks follow up
measure: BPI-SF
timeFrame: baseline, after 6 weeks and 6 weeks follow up
measure: PCS
timeFrame: baseline, after 6 weeks and 6 weeks follow up
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
References: