NCT04878848

Brief Summary

Adhesive capsulitis is a condition that causes limitation of function and movement in the shoulder joint and affects many activities of daily life. The clinical indicators of adhesive capsulitis; shoulder pain and progressive global stiffness of the glenohumeral joint, night pains and accompanying sleep disturbances, joint capsule contracture, decrease in synovial fluid, abnormal changes in scapular position, functional limitation and consequently decreased quality of life. When we look at the literature, it is seen that traditional rehabilitation practices aim to improve range of motion and reduce pain caused by capsular contracture. In this context, classical therapeutic exercises consisting of stretching and strengthening, joint mobilization methods, proprioceptive neuromuscular facilitation methods are applied. However, there are limited number of studies investigating the effects of PNF techniques on pain, function and activity limitation. Therefore, within the scope of the research, it is planned to apply a traditional rehabilitation program prepared in accordance with the guidelines for one group, and PNF approaches for the upper extremity and scapula in the other group. Thus, it is aimed 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 adhesive capsulitis rehabilitation. Exercises will be applied 3 days a week for 4 weeks. Each training session will last 45 minutes. Pain, function, range of motion, proprioception, quality of life and sleep quality evaluations will be performed at the beginning of the study and at the end of 4 weeks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 5, 2021

Last Update Submit

May 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder, and Hand Questionnaire

    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 Outcomes (9)

  • Evaluation of Shoulder Proprioception with Cybex Humac Norm II Isokinetic Dynamometer

    Baseline and end of weeks 4.

  • Visual Analog Scale

    Baseline and end of weeks 4.

  • Shoulder Pain and Disability Index

    Baseline and end of weeks 4.

  • Shoulder Disability Scale

    Baseline and end of weeks 4.

  • Range of Motion Assesment

    Baseline and end of weeks 4.

  • +4 more secondary outcomes

Study Arms (2)

Proprioceptive Neuromuscular Facilitation Group

EXPERIMENTAL

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.

Other: Proprioceptive Neuromuscular Facilitation Exercises

Conventional Rehabilitation Group

EXPERIMENTAL

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.

Other: Conventional Rehabilitation Group

Interventions

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.

Proprioceptive Neuromuscular Facilitation Group

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.

Conventional Rehabilitation Group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with unilateral adhesive capsulitis (stage II-III)
  • Being between at the ages of 35-65
  • Complaints ongoing for at least 3 months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, 34500, Turkey (Türkiye)

RECRUITING

Related Publications (14)

  • 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.

    PMID: 26229109BACKGROUND
  • 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.

    PMID: 25842028BACKGROUND
  • 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.

    PMID: 27069405BACKGROUND
  • 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.

    PMID: 27190456BACKGROUND
  • 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.

    PMID: 11983436BACKGROUND
  • 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.

    PMID: 30347591BACKGROUND
  • 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.

    PMID: 17531513BACKGROUND
  • 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.

    PMID: 11382253BACKGROUND
  • 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.

    PMID: 11722295BACKGROUND
  • 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.

    PMID: 31760624BACKGROUND
  • 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.

    PMID: 28641738BACKGROUND
  • 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.

    PMID: 9626712BACKGROUND
  • 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.

    PMID: 20046623BACKGROUND
  • 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.

    PMID: 11188601BACKGROUND

MeSH Terms

Conditions

BursitisShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yonca Zenginler Yazgan, Assistant Professor

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

Meltem Melda Taşkın, Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Evaluations will be made by a single investigator and participants will be blinded to what treatment is being administered.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Within the scope of the research, it is planned to apply a traditional rehabilitation program consisting of stretching and strengthening exercises prepared in accordance with the guidelines for one group, and PNF approaches for the upper extremity and scapula in the other group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 10, 2021

Study Start

February 3, 2021

Primary Completion

August 3, 2021

Study Completion

November 10, 2021

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

Demographic informations such as age, gender, height, weight, occupation Results of range of motion, pain severity, function, proprioception, sleep quality, quality of life assessments will be shared with other researches.

Locations