- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05797311
The Effect of PNF and Shoulder Stabilization Exercises on Pain, QoL and Functionality in Patient With AC
The Effect of Proprioceptive Neuromuscular Facilitation and Shoulder Stabilization Exercises on Pain, Quality of Life and Functionality in Adhesive Capsulitis Treatment
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Uskudar University Health Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PNF Group
After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, additional PNF exercises were performed once a day, 5 times a week by the same Physiotherapist in the cases in the PNF group. It will be applied for a total of 3 weeks (Total of 15 sessions).
|
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.
|
|
Other: Stabilization Group
After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, stabilization exercises were performed by the same Physiotherapist once a day, 5 times a week, for a total of 5 times a week. It will be applied for 3 weeks (Total of 15 sessions).
In all the exercises, the subjects maintained the position for 10 seconds, and they took a rest for 3 seconds. Ten repetitions was considered one set, and the subjects conducted three sets. A break of 3 minutes was given between each set. |
Scapular stabilization exercise and stabilization exercise for the shoulder joints
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS) Evaluation
Time Frame: Change from baseline to week 3
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Manual Muscle Testing
Time Frame: Change from baseline to week 3
|
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
|
|
DASH (Arm, Shoulder and Hand Problems Questionnaire)
Time Frame: Change from baseline to week 3
|
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
|
|
Joint Range of Motion
Time Frame: Change from baseline to week 3
|
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
|
|
Short Form 12 (SF-12)
Time Frame: Change from baseline to week 3
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: safiye gul abat, PT, Uskudar University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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/
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UskudarUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adhesive Capsulitis
-
Daniel G. RendeiroCompletedAdhesive Capsulitis of Shoulder | Frozen Shoulder | Shoulder Adhesive CapsulitisUnited States
-
University of MalayaNot yet recruitingAdhesive Capsulitis of Shoulder
-
Taipei Veterans General Hospital, TaiwanRecruitingAdhesive Capsulitis of ShoulderTaiwan
-
Cairo UniversityNot yet recruitingAdhesive Capsulitis of Shoulder
-
Health Education Research Foundation (HERF)RecruitingAdhesive Capsulitis of ShoulderPakistan
-
Taif UniversityCompletedAdhesive Capsulitis of ShoulderSaudi Arabia
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
-
Balikesir UniversityCompletedAdhesive Capsulitis of Shoulder
-
Haytham M ElhafezCairo UniversitySuspendedAdhesive Capsulitis of the ShoulderEgypt
-
Superior UniversityActive, not recruitingAdhesive Capsulitis, ShoulderPakistan
Clinical Trials on Proprioceptive Neuromuscular Facilitation (PNF)
-
University of Sao PauloUnknownAssessment of Muscle Force IrradiationBrazil
-
Medical University of LublinCompleted
-
Kahramanmaras Sutcu Imam UniversityCompletedCerebral Palsy | Upper Extremity Dysfunction | Muscle Strength | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Upper Extremity FunctionsTurkey
-
Cairo UniversityRecruiting
-
Universidade Federal de PernambucoDaniella Araújo de Oliveira; Angélica da Silva TenórioCompletedOsteoarthritis KneeBrazil
-
University of GrazVU University of AmsterdamCompleted
-
Wafaa Mahmoud AminWithdrawnMotor ActivitySaudi Arabia
-
Riphah International UniversityRecruiting
-
Riphah International UniversityCompletedKnee OsteoarthritisPakistan
-
Benha UniversityCompletedOsgood-Schlatter DiseaseAlgeria