Adhesive Capsulitis Clinical Trial
Official title:
The Effect of Proprioceptive Neuromuscular Facilitation and Shoulder Stabilization Exercises on Pain, Quality of Life and Functionality in Adhesive Capsulitis Treatment
Verified date | February 2024 |
Source | Uskudar University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Adhesive capsulitis (AC), also known as frozen shoulder, is an insidious, painful condition of the shoulder lasting more than 3 months. This inflammatory condition causing fibrosis of the glenohumeral joint capsule is accompanied by gradual progressive stiffness and marked limitation of range of motion (typically external rotation). Patients experiencing this condition often suffer from poor quality of life due to the limitation of both the active and passive range of shoulder mobility. The prevalence of frozen shoulder is between 2-5% and is more common in women. Along with the increase in comorbidities and changes in lifestyle, the incidence of FS is increasing. However, the natural history and pathogenesis of adhesive capsulitis have not been widely studied and are still unknown. Adhesive capsulitis presents clinically as shoulder pain with progressive restricted movement, both active and passive, with normal radiographic scans of the glenohumeral joint. Classically, it progresses prognostically with 3 overlapping stages: pain (stage 1, lasting 2-9 months), stiffness (stage 2, lasting 4-12 months), and healing (stage 3, lasting 5-24 months). However, this is an estimated time frame and many patients may still experience symptoms after 6 years. Treatment modalities include conservative (ie, steroid injection, physiotherapy) and operative (ie, distension arthrography, manipulation under anesthesia, and arthroscopic release). Various physical therapy treatments commonly used in the treatment of adhesive capsulitis include ice pack, hot pack, transcutaneous electrical nerve stimulation and active and passive ROM exercises, joint mobilization techniques, proprioceptive neuromuscular facilitation (PNF), supervised home exercise programs, and Kinesio taping.
Status | Completed |
Enrollment | 32 |
Est. completion date | January 30, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients aged 20- 65 years diagnosed with unilateral Stage II adhesive capsulitis by magnetic resonance imaging - Shoulder pain persisting for at least 3 months - VAS pain score equal to or greater than 5/10 - Patients who agreed to participate in the study Exclusion Criteria: - - Receiving physical therapy or manual therapy on the same shoulder within 1 year - Having mental and cognitive problems, - Patients who have undergone surgical procedure/injection/manipulation to the shoulder joint for any reason - Neurological disorders that affect shoulder function during daily activities - Pain or discomfort in the cervical spine, elbow, wrist, or hand - Other pathological conditions concerning the shoulder (rotator cuff tear, tendinitis, etc.) |
Country | Name | City | State |
---|---|---|---|
Turkey | Uskudar University Health Science | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Uskudar University |
Turkey,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) Evaluation | The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to draw a line on this line to indicate where his condition is appropriate. | Change from baseline to week 3 | |
Secondary | Manual Muscle Testing | During the testing of muscle strength without using any device ("manual muscle testing"), the evaluation system (Medical Research Council (MRC)) scale, which is widely used all over the world, is used. It is the evaluation of motion in the context of gravity. | Change from baseline to week 3 | |
Secondary | Joint Range of Motion | A Goniometer is the most common tool for measuring range of motion of the joints of the body. It uses a stationary arm, fulcrum, and movement arm to measure joint angles from the axis of the joint. Making a ROM measurement by using a goniometer requires training for reliable results. See the goniometry collection of pages for instructions on how to correctly (reliably and accurately) place the goniometer when measuring range of motion. | Change from baseline to week 3 | |
Secondary | DASH (Arm, Shoulder and Hand Problems Questionnaire) | The DASH questionnaire consists of 3 parts. The first part consists of 30 questions. 21 questions evaluate the degree of difficulty of the patient in daily activities, 5 questions evaluate the symptomatic features of pain, and 4 questions evaluate social function, self-confidence and sleep. | Change from baseline to week 3 | |
Secondary | Short Form 12 (SF-12) | SF-12, a measure of Health-Related Quality of Life, can be used in age, disease and treatment groups. It is a shortened version of the SF-36 and contains 12 questions, each with two to five answer options. The patient is told to choose the option that best suits him/her. The SF-12 covers eight dimensions: general health, physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. A physical and mental health score, each ranging from 0 to 100, can be calculated using scoring algorithms. Scores are calibrated to a mean score of 50, or the norm, with lower scores representing worse and higher scores representing better Health-Related Quality of Life. | Change from baseline to week 3 |
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