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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05797311
Other study ID # UskudarUniversity
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date January 30, 2024

Study information

Verified date February 2024
Source Uskudar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

There are studies on the application of PNF techniques in proprioceptive neuromuscular facilitation (PNF), sports injuries, orthopedics, cardiorespiratory and neurological conditions developed by Knott and Kabat. Recently, the application of these techniques in orthopedic conditions has been developing. However, studies have been conducted to find out the effect of PNF therapy on Adhesive Capsulitis, but there is conflicting evidence between them. Although some studies have suggested PNF, determining which technique is better in the treatment of AC remains controversial and needs to be answered. Therefore, in our study, it was aimed to compare the effects and advantages of proprioceptive neuromuscular exercises and shoulder stabilization exercises applied in the treatment of patients with Adhesive capsulitis and to evaluate the acute effects of these exercises on shoulder movements.


Recruitment information / eligibility

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.)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Proprioceptive Neuromuscular Facilitation (PNF)
Proprioceptive Neuromuscular Facilitation (PNF) techniques are a therapeutic exercise approach developed based on functional activities in daily life. At the stage of regaining movement and function, it creates models similar to functional activities.
Shoulder Stabilization Exercises
Scapular stabilization exercise and stabilization exercise for the shoulder joints

Locations

Country Name City State
Turkey Uskudar University Health Science Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Balci NC, Yuruk ZO, Zeybek A, Gulsen M, Tekindal MA. Acute effect of scapular proprioceptive neuromuscular facilitation (PNF) techniques and classic exercises in adhesive capsulitis: a randomized controlled trial. J Phys Ther Sci. 2016 Apr;28(4):1219-27. doi: 10.1589/jpts.28.1219. Epub 2016 Apr 28. — View Citation

Barbosa F, Swamy G, Salem H, Creswell T, Espag M, Tambe A, Clark D. Chronic adhesive capsulitis (Frozen shoulder): Comparative outcomes of treatment in patients with diabetes and obesity. J Clin Orthop Trauma. 2019 Mar-Apr;10(2):265-268. doi: 10.1016/j.jcot.2018.02.015. Epub 2018 Feb 25. — View Citation

Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581. — View Citation

Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12. — View Citation

Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018. — View Citation

Kraal T, Visser C, Sierevelt I, Beimers L. How to treat a frozen shoulder? A survey among shoulder specialists in the Netherlands and Belgium. Acta Orthop Belg. 2016 Mar;82(1):78-84. — View Citation

Mezian K, Coffey R, Chang KV. Frozen Shoulder. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/ — View Citation

Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28. — View Citation

Park SI, Choi YK, Lee JH, Kim YM. Effects of shoulder stabilization exercise on pain and functional recovery of shoulder impingement syndrome patients. J Phys Ther Sci. 2013 Nov;25(11):1359-62. doi: 10.1589/jpts.25.1359. Epub 2013 Dec 11. — View Citation

Tedla JS, Sangadala DR. Proprioceptive neuromuscular facilitation techniques in adhesive capsulitis: a systematic review and meta-analysis. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):482-491. — View Citation

Outcome

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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