- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04878848
Proprioceptive Neuromuscular Facilitation Techniques in Patients With Adhesive Capsulitis
Effectiveness of Proprioceptive Neuromuscular Facilitation Techniques in Patients With Adhesive Capsulitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adhesive capsulitis is a shoulder pathology characterized by contracture of the glenohumeral joint capsule and progressive pain with loss of range of motion. The disease picture is generally examined in 3 phases as painful phase, freezing phase and thaw phase. It is generally characterized by pain, decreased range of motion, function, activity limitations, night pain and sleep disturbances. Sleep disturbances associated with function, activity limitations and night pain negatively affect the patients' quality of life. In the literature, the success rate of conservative treatment is shown as 90%.
Conservative treatment consists of nonsteroidal anti-inflammatory drugs, corticosteroids, and therapeutic exercises. The purpose of therapeutic exercises in general; to reduce pain, increase range of motion, decrease activity limitations, increase scapulohumeral rhythm by correcting impaired shoulder joint biomechanics and improve function. Proprioceptive neuromuscular facilitation (PNF) is an exercise concept that uses proprioceptors to increase responses of the neuromuscular mechanism, range of motion and muscle activation. PNF techniques are applied to improve muscle strength, endurance, mobility, stability, coordination and neuromuscular control and can be easily adapted to daily life activities.
In the literature, it is aimed to increase the glenohumeral joint movements and regulate the scapulothoracic rhythm in the rehabilitation of adhesive capsulitis. However, the number of studies in the literature comparing upper extremity and scapular PNF patterns with classical exercises targeting the glenohumeral and scapulothoracic joints is limited. For this reason, the aim of the study is to focus on the structures involved in shoulder movements in adhesive capsulitis rehabilitation as a whole, and to examine the effects of the use of upper extremity and scapula PNF techniques on pain, function, range of motion, proprioception, quality of life, sleep and patient satisfaction compared to traditional exercises in patients with a diagnosis of adhesive capsulitis.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meltem Melda Taşkın, Student
- Phone Number: +905377664882
- Email: mtmeltem27@gmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34500
- Recruiting
- Istanbul University Cerrahpasa
-
Contact:
- Meltem Melda Taşkın
- Phone Number: +905377664882
- Email: mtmeltem27@gmail.com
-
Contact:
- Email: mtmeltem27@gmail.com
-
Principal Investigator:
- Meltem Melda Taşkın
-
Sub-Investigator:
- Yonca Zenginler Yazgan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being diagnosed with unilateral adhesive capsulitis (stage II-III)
- Being between at the ages of 35-65
- Complaints ongoing for at least 3 months
Exclusion Criteria:
- Rheumatological diseases such as rheumatoid arthritis, ankylosing spondylitis
- Being diagnosed with glenohumeral joint osteoarthritis, rotator cuff injury, radiculopathy
- Neurological diseases such as cerebrovascular accident, multiple sclerosis, Parkinson's disease, thoracic outlet syndrome
- Dislocation, subluxation, fracture, infection, tumor
- History of shoulder surgery
- People who cannot cooperate with physiotherapist and exercises.
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: Proprioceptive Neuromuscular Facilitation Group
Participants in the proprioceptive neuromuscular facilitation group will be given a treatment protocol consisting of rhythmic initiation, repeated stretch and hold-relax PNF techniques for upper extremity "flexion-abduction-external rotation" pattern and the scapular patterns of anterior elevation, posterior depression, anterior depression, posterior elevation for a total of 4 weeks, 3 days a week for 45 minutes.
Assessments will be applied in the baseline and at the end of 4 weeks.
|
Within the scope of proprioceptive neuromuscular facilitation exercises, rhythmic initiation, repeated stretch and hold-relax techniques in the upper extremity flexion-abduction-external rotation pattern and scapular patterns of anterior elevation, posterior depression, anterior depression and posterior elevation will be applied to the participants.
In addition to these exercises, functional activities in the flexion-abduction-external rotation pattern such as hair combing, turning over from side lying, wearing a jacket, reaching on the shelf will be performed.
|
|
Experimental: Conventional Rehabilitation Group
Participants in the conventional rehabilitation group will be given a treatment protocol consisting of stretching, strengthening exercises and joint mobilization techniques for a total of 4 weeks, 3 days a week for 45 minutes.
Assessments will be applied in the baseline and at the end of 4 weeks.
|
Active assisted / active range of motion exercises and Wand exercises will be applied to the participants in the conventional rehabilitation group for flexion, abduction and external rotation movements.
Exercises will be applied as 5 repetitions in the first 2 weeks and 10 repetitions in the last 2 weeks.
Strengthening exercises will be performed with an elastic band and free weights.
Strengthening exercises will be started as 2 sets of 5 repetitions and at the end of the second week, it will be applied as 2 sets of 10 repetitions.
In addition to these exercises, glenohumeral distraction, glenohumeral posterior and caudal glide will be applied for joint mobilization and it will show progression at the end of the second week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disabilities of the Arm, Shoulder, and Hand Questionnaire
Time Frame: Baseline and end of weeks 4.
|
The Disabilities of the Arm, Shoulder and Hand Questionnaire was developed to measure physical disability and symptoms of the upper extremities in people with upper extremity disorders (hand, wrist, elbow, and shoulder).
It is a 30-item scale that addresses difficulty in performing various physical activities that require upper extremity function (physical function, 21 items); symptoms of pain, activity-related pain, tingling, weakness, and stiffness (pain symptoms, 5 items); or impact of disability and symptoms on social activities, work, sleep, and psychological well-being (emotional and social function, 4 items).
The score ranges from 0 to 100, where 0 = no disability and 100 = most severe disability.
In this study, the change that occurred during the 4-week period from the beginning will be examined.
|
Baseline and end of weeks 4.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Shoulder Proprioception with Cybex Humac Norm II Isokinetic Dynamometer
Time Frame: Baseline and end of weeks 4.
|
Evaluation of shoulder proprioception will be made with Cybex isokinetic device.
Measurements will be performed in 30, 60, 90º flexion and abduction and 15, 30º external rotation.
For each measurement, the device will be operated 3 times in continuous passive movement (CPM) mode with an angular velocity of 60˚ / second.
The patient will be asked to focus on the movement and remember the angle.
The difference between the target angle and the angle reached by the patient will be recorded.
In this study, the change that occurred during the 4-week period from the beginning will be examined.
|
Baseline and end of weeks 4.
|
|
Visual Analog Scale
Time Frame: Baseline and end of weeks 4.
|
The Visual Analog Scale is a self-reported scale consisting of a horizontal or vertical line, usually 10 centimetres long (100 mm) anchored at the extremes by two verbal descriptors referring to the pain status.
The Visual Analogue Scale is a scale in which the severity of pain is marked on a vertical or horizontal line of 0-10 cm in length.
During the evaluation, in the measurement of pain intensity, "0: no pain" and "10: unbearable pain" will be explained to the patient.
Patients will be asked to mark the level of pain they feel at rest, during activity and at night.
In this study, the change that occurred during the 4-week period from the beginning will be examined.
|
Baseline and end of weeks 4.
|
|
Shoulder Pain and Disability Index
Time Frame: Baseline and end of weeks 4.
|
Shoulder, Pain and Disability Index were used to evaluate the functional status of the patients.
SPADI is a scale that evaluates the pain and difficulty experienced by patients during various activities.
It has 2 different subscales, pain and disability.
In the pain subscale, pain status is questioned during 5 different daily life activities.
In the disability subscale, the difficulty experienced in 8 different activities is measured.
The patient was asked to score the level of pain and difficulty between 0-10 and the values were recorded.
(0: no pain, 10: worst imaginable pain - 0: no difficulty, 10: extremely difficult, need help) In this study, the change that occurred during the 4-week period from the beginning will be examined.
|
Baseline and end of weeks 4.
|
|
Shoulder Disability Scale
Time Frame: Baseline and end of weeks 4.
|
Shoulder Disability Scale will be used to assess the disability status associated with pain in the shoulder.
The scale includes 16 questions about daily life activities that increase symptoms.
Answers to the questions are given as "yes", "no" or "not applicable" depending on whether the activity has been painful in the last 24 hours.
The score is calculated by dividing the number of yeses by the sum of the number of yes and the number of no.
The obtained score is multiplied by 100 and converted into a percentage value.
High score is associated with increased disability.
In this study, the change that occurred during the 4-week period from the beginning will be examined.
|
Baseline and end of weeks 4.
|
|
Range of Motion Assesment
Time Frame: Baseline and end of weeks 4.
|
The shoulder flexion, extension, abduction, external and internal rotation openings of the patients will be measured passively and actively with the universal goniometer.
Measurements will be made 3 times and the average of each measurement will be recorded.
In this study, the change that occurred during the 4-week period from the beginning will be examined.
|
Baseline and end of weeks 4.
|
|
Lateral Scapular Slide Test
Time Frame: Baseline and end of weeks 4.
|
The lateral scapular slide test is a method used for the assessment of dominant and non-dominant side scapular dyskinesia based on the measurement of the distance between the inferior end of the scapula and the spinous process of the vertebra in the same alignment.
The difference between the two sides is measured with a tape measure when the arms are at the side of the body and in the resting position, when the hands are at the waist and when the arm is in 90º abduction.
Scapular dyskinesia will be considered positive for cases where the distance between the two sides is 1.5 cm or more.
In this study, the change that occurred during the 4-week period from the beginning will be examined.
|
Baseline and end of weeks 4.
|
|
Pittsburgh Sleep Quality Index
Time Frame: Baseline and end of weeks 4.
|
Pittsburgh Sleep Quality Index is a self-report scale that determines sleep quality, type and severity of sleep disorder in the last 1 month.
Self-report questions include different factors related to sleep quality and these factors are grouped into 7 components.
These components are; It provides information on subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills and daytime sleep dysfunction.
The total PUKI score takes a value between 0-21.
Sleep quality of those with a total score of 5 or less is considered as "healthy", between 6-10 as "bad sleep", and those with a score above 10 as "sleep disorder".
In this study, the change that occurred during the 4-week period from the beginning will be examined.
|
Baseline and end of weeks 4.
|
|
World Health Organization Quality of Life Evaluation Questionnaire Short Form Turkish Version
Time Frame: Baseline and end of weeks 4.
|
The health-related quality of life scale was developed by the World Health Organization and aims to evaluate the overall quality of life.
The scale consists of 27 questions that measure physical, mental, social and environmental well-being.
Since each field expresses the quality of life in its field independently of each other, domain scores are calculated between 4-20.
The higher the score means the higher the quality of life.
In this study, the change that occurred during the 4-week period from the beginning will be examined.
|
Baseline and end of weeks 4.
|
|
Global Rating of Change
Time Frame: End of weeks 4.
|
It is a widely used scale to evaluate satisfaction in clinical trials, especially in global musculoskeletal problems.
It aims to evaluate the effect of treatment and recovery on the patient.
The difference between pre-treatment and post-treatment is evaluated on a 5-point numerical scale (-2: much worse, -1: I am worse, 0: I am the same, 1: I am better, 2: I am much better) In this study, we will evaluate patient satisfaction at the end of 4 weeks.
|
End of weeks 4.
|
Collaborators and Investigators
Investigators
- Study Director: Yonca Zenginler Yazgan, Assistant Professor, Istanbul University - Cerrahpasa (IUC)
Publications and helpful links
General Publications
- Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
- Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
- Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.
- Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.
- Shimura K, Kasai T. Effects of proprioceptive neuromuscular facilitation on the initiation of voluntary movement and motor evoked potentials in upper limb muscles. Hum Mov Sci. 2002 Apr;21(1):101-13. doi: 10.1016/s0167-9457(01)00057-4.
- Levine WN, Kashyap CP, Bak SF, Ahmad CS, Blaine TA, Bigliani LU. Nonoperative management of idiopathic adhesive capsulitis. J Shoulder Elbow Surg. 2007 Sep-Oct;16(5):569-73. doi: 10.1016/j.jse.2006.12.007. Epub 2007 May 24.
- Hayes K, Walton JR, Szomor ZR, Murrell GA. Reliability of five methods for assessing shoulder range of motion. Aust J Physiother. 2001;47(4):289-94. doi: 10.1016/s0004-9514(14)60274-9.
- 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.
- Mulligan EP, Brunette M, Shirley Z, Khazzam M. Sleep quality and nocturnal pain in patients with shoulder disorders. J Shoulder Elbow Surg. 2015 Sep;24(9):1452-7. doi: 10.1016/j.jse.2015.02.013. Epub 2015 Apr 1.
- Celik D, Kaya Mutlu E. Does adding mobilization to stretching improve outcomes for people with frozen shoulder? A randomized controlled clinical trial. Clin Rehabil. 2016 Aug;30(8):786-94. doi: 10.1177/0269215515597294. Epub 2015 Jul 30.
- Fernandes MR. Correlation between functional disability and quality of life in patients with adhesive capsulitis. Acta Ortop Bras. 2015 Mar-Apr;23(2):81-4. doi: 10.1590/1413-78522015230200791.
- Toprak M, Erden M. Sleep quality, pain, anxiety, depression and quality of life in patients with frozen shoulder1. J Back Musculoskelet Rehabil. 2019;32(2):287-291. doi: 10.3233/BMR-171010.
- Kibler WB, Sciascia A. Evaluation and Management of Scapular Dyskinesis in Overhead Athletes. Curr Rev Musculoskelet Med. 2019 Dec;12(4):515-526. doi: 10.1007/s12178-019-09591-1.
- Ager AL, Roy JS, Roos M, Belley AF, Cools A, Hebert LJ. Shoulder proprioception: How is it measured and is it reliable? A systematic review. J Hand Ther. 2017 Apr-Jun;30(2):221-231. doi: 10.1016/j.jht.2017.05.003.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Shoulder Pain
-
Nida Koçer NazlıgülCompletedShoulder Impingement Syndrome | Chronic Shoulder Pain | Rotator Cuff-Related Shoulder Pain | Suprascapular Nerve-Related Shoulder PainTurkey (Türkiye)
-
Istanbul University - CerrahpasaRecruitingSubacromial Pain Syndrome | Patient Education | Shoulder Pain Syndrome | Rotator Cuff Related Shoulder PainTurkey (Türkiye)
-
Istanbul UniversityRecruitingSubacromial Pain Syndrome | Shoulder Bursitis | Shoulder Tendinopathy | Rotator Cuff Tears of the Shoulder | Rotator Cuff Related Shoulder PainTurkey (Türkiye)
-
University Ramon LlullCompletedHealthy | Shoulder Impingement Syndrome | Shoulder Injury | Shoulder Flexibility | Shoulder Pain Chronic | Shoulder Joint LimitationSpain
-
Helping Hand Institute of Rehabilitation SciencesRecruitingShoulder Injuries | Shoulder Capsulitis | Shoulder Arthritis | Shoulder Impingement | Shoulder Bursitis | Shoulder Pain ChronicPakistan
-
Royal National Orthopaedic Hospital NHS TrustSyncVR MedicalNot yet recruitingShoulder Pain | Chronic Shoulder Pain | Musculoskeletal Shoulder PainUnited Kingdom
-
Deraya UniversityNot yet recruitingAdhesive Capsulitis of Shoulder | Frozen Shoulder | Shoulder Pain and StiffnessEgypt
-
Universidad de ZaragozaAragon Institute for Health Research (IIS Aragón)CompletedShoulder Pain Syndrome | Nonspecific Shoulder PainSpain
-
Şeyhmus KAPLANCompletedSubacromial Impingement | Pain, Shoulder
-
Istanbul UniversityRecruitingSubacromial Pain Syndrome | Shoulder Pain Syndrome | Rotator Cuff Related Shoulder PainTurkey (Türkiye)
Clinical Trials on Proprioceptive Neuromuscular Facilitation Exercises
-
Delta University for Science and TechnologyCompleted
-
Riphah International UniversityRecruiting
-
Riphah International UniversityRecruiting
-
Cairo UniversityCompletedChronic Obstructive Pulmonary Disease ModerateEgypt
-
Riphah International UniversityRecruitingAnterior Innominate Iliosacral DysfunctionPakistan
-
Riphah International UniversityRecruiting
-
Uskudar UniversityCompletedAdhesive CapsulitisTurkey
-
Nigde Omer Halisdemir UniversityCompletedSports Physical TherapyTurkey
-
Cairo UniversityCompleted
-
Universidad Católica de ÁvilaCompletedProprioceptive Neuromuscular FacilitationSpain