NCT06110000

Brief Summary

The aim of this study is to determine the Effects of pragmatic set of interventions versus scapular strengthening exercises on scapular dyskinesia in adhesive capsulitis.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

May 8, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 25, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

Scapular DyskinesisAdhesive CapsulitisPragmatic set of interventionsstrengthening exercise

Outcome Measures

Primary Outcomes (2)

  • The Shoulder Pain and Disability Index (SPADI)

    The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. SPADI was found to have reliability coefficients of ICC ≥ 0.89 in a variety of patient populations.Internal consistency is high with Cronbach α typically exceeding 0.90. The SPADI demonstrates good construct validity, correlating well with other region-specific shoulder questionnaires.

    4th week

  • Scapulometer

    is a reliable tool to measure scapular medial border and inferior angle prominence. It is used to measure the distance from the root of the spine (ROS) and the inferior angle (INF) of the scapula to the thorax wall. The novel scapulometer has excellent reliability and fair validity to quantify medial border and inferior angle prominence of the scapula. Further research utilizing this instrument is recommended.

    4th week

Secondary Outcomes (1)

  • Visual analogue scale:

    4th week

Study Arms (2)

pragmatic set of interventions

EXPERIMENTAL

The pragmatic set included 6 interventions as follows. 1. Pragmatic posterior capsular stretch (PPCS) 2. Serratus anterior stretch (SAS) 3. Rotator cuff facilitation (RCF) 4. Acromioclavicular joint mobilization 5. Pectoralis minor stretch 6. Thoracic manipulation

Other: pragmatic set of interventipons

scapular strengthening exercises

PLACEBO COMPARATOR

Scapular strengthening exercises will be individualised focusing on Serratus anterior, trapezius, Levator scapulae, Rhomboids. Serratus anterior; * Dynamic hug * Scaption with external rotation * Diagonal PNF (shoulder flexion, horizontal flexion, external rotation), Trapezius - Upper trapezius: * Unilateral shoulder shrug, * Rowing, * Forward shoulder flexion, * Shoulder abduction in scapular plane above 120 degrees. Middle trapezius: * Prone shoulder horizontal abduction * Scaption, horizontal abduction with external rotation Lower trapezius: * Unilateral scapular retraction, * Prone bilateral shoulder external rotation at 90 degrees of abduction, * Prone shoulder abduction. Levator Scapulae: * Horizontal abduction with shrug, * Horizontal abduction with ER, * Prone shoulder extension. Rhomboids: * ER at 90° of abduction, * ER at 0° of abduction, * Horizontal abduction, * Shoulder extension,

Other: scapular strengthening exercise.

Interventions

The pragmatic set included 6 interventions as follows. 1. Pragmatic posterior capsular stretch (PPCS) 2. Serratus anterior stretch (SAS) 3. Rotator cuff facilitation (RCF) 4. Acromioclavicular joint mobilization. 5. Pectoralis minor stretch 6. Thoracic manipulation Five to ten sweeps per minute are administered three to four times. The applied force is combined with deep breathing. The subject is asked to report discomfort and the applied force is adjusted.

pragmatic set of interventions

• Subjects in Group B receive strengthening exercises (exercise will perform with 15 repetitions for each set- 3sets/day, 3 days /week for 6 weeks. In Scapular strengthening exercises, treatment protocol will involve the individualized for focus muscle Serratus anterior (Dynamic hug, Scaption with external rotation, Diagonal PNF (shoulder flexion horizontal flexion, external rotation),Trapezius - Upper trapezius (unilateral shoulder shrug, rowing, forward shoulder flexion, shoulder abduction in scapular plane above 120 degrees, Middle trapezius (prone shoulder horizontal abduction, scaption, horizontal abduction with external rotation), Lower trapezius (Unilateral scapular retraction, prone bilateral shoulder external rotation at 90 degrees of abduction, prone shoulder abduction), Levator Scapulae (horizontal abduction with shrug, horizontal abduction with ER, prone shoulder extension, Rhomboids (ER at 90° of abduction, ER at 0° of abduction, Horizontal abduction, Shoulder extension)

scapular strengthening exercises

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and females with age range b/w 25-45
  • People with adhesive capsulitis (having pain, stiffness, and decrease movements of - external rotation, forward flexion and abduction)
  • Scapular dyskinesia (positive lateral scapular slide with difference of 1.5cm when measurements are compared bilaterally)

You may not qualify if:

  • History of shoulder surgery or other significant shoulder injury, neurological or musculoskeletal conditions that may affect shoulder function.
  • History of significant medical conditions (e.g., heart disease, cancer) that may affect their ability to participate in the study.
  • Pregnant or breast feeder, as the exercise program may not be safe or appropriate for them.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amina welfare and Trust

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (7)

  • 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.

    PMID: 20110457BACKGROUND
  • Mohamed AA, Alawna M. Effect of Adding Vertical Correction to Dynamic Scapular Recognition on Scapular Dyskinesis and Shoulder Disability in Patients With Adhesive Capsulitis: A Randomized Clinical Study. J Chiropr Med. 2022 Jun;21(2):124-135. doi: 10.1016/j.jcm.2022.02.002. Epub 2022 Apr 4.

    PMID: 35774629BACKGROUND
  • Zhu Y, Blundell JE, Holschuh NM, McLean R, Menon RS. Validation of a Mobile App-Based Visual Analog Scale for Appetite Measurement in the Real World: A Randomized Digital Clinical Trial. Nutrients. 2023 Jan 7;15(2):304. doi: 10.3390/nu15020304.

    PMID: 36678176BACKGROUND
  • Lluch-Girbes E, Requejo-Salinas N, Fernandez-Matias R, Revert E, Vila Mejias M, Rezende Camargo P, Jaggi A, Sciascia A, Horsley I, Pontillo M, Gibson J, Richardson E, Johansson F, Maenhout A, Oliver GD, Turgut E, Jayaraman C, Duzgun I, Borms D, Ellenbecker T, Cools A. Kinetic chain revisited: consensus expert opinion on terminology, clinical reasoning, examination, and treatment in people with shoulder pain. J Shoulder Elbow Surg. 2023 Aug;32(8):e415-e428. doi: 10.1016/j.jse.2023.01.018. Epub 2023 Feb 15.

    PMID: 36796714BACKGROUND
  • Dube MO, Desmeules F, Lewis JS, Roy JS. Does the addition of motor control or strengthening exercises to education result in better outcomes for rotator cuff-related shoulder pain? A multiarm randomised controlled trial. Br J Sports Med. 2023 Apr;57(8):457-463. doi: 10.1136/bjsports-2021-105027. Epub 2023 Feb 16.

    PMID: 36796859BACKGROUND
  • Karaagac A, Arslan SA, Keskin ED. Assessment of pain, scapulothoracic muscle strength, endurance and scapular dyskinesis in individuals with and without nonspecific chronic neck pain: A cross-sectional study. J Bodyw Mov Ther. 2023 Jul;35:261-267. doi: 10.1016/j.jbmt.2023.04.008. Epub 2023 Apr 19.

    PMID: 37330779BACKGROUND
  • Ucurum SG, Karabay D, Ozturk BB, Kaya DO. Comparison of scapular position and upper extremity muscle strength in patients with and without lateral epicondylalgia: a case-control study. J Shoulder Elbow Surg. 2019 Jun;28(6):1111-1119. doi: 10.1016/j.jse.2018.12.010. Epub 2019 Mar 26.

    PMID: 30926184BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Rabiya Noor, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Blinding,refers to a practice where study participants are prevented from knowing certain information that may somehow influence them-thereby tainting the results.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are divided into two groups. Group A assigned to pragmatic group of interventions and group B assigned with scapular strengthening exercises at the beginning of the trial and continue that throughout the length of the trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

May 8, 2023

Primary Completion

December 8, 2023

Study Completion

January 8, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations