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Scapular DyskinesisNCT06110000

Pragmatic Set of Interventions Versus Scapular Strengthening Exercises on Scapular Dyskinesia in Adhesive Capsulitis

A study testing pragmatic set of interventipons and scapular strengthening exercise. in people with Scapular Dyskinesis and Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 45 years
Conditions the study is for
Scapular Dyskinesis, Adhesive Capsulitis
What is being tested?
pragmatic set of interventipons and scapular strengthening exercise.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 sitePakistan
Study dates
8 May 2023to 8 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Imran Amjad, Phd contact

03324390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Amina welfare and Trust

    Lahore, Punjab Province, 54000

    Saba Rafique, MSOMPT, 03034045433, saba.rafique@riphah.edu.pk

    Amna Shahzade, MSOMPT

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Pragmatic Set of Interventions Versus Scapular Strengthening Exercises on Scapular Dyskinesia in Adhesive Capsulitis

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.

Read the detailed description

Scapular dyskinesia (SD) is a term that describes a physical impairment in which the scapula's position and motion are altered.Symptoms of SD can be one or a combination of the anterior shoulder pain, Postero-superior scapular pain, superior shoulder pain, proximal lateral arm pain. scapular dyskinesia is commonly found in adhesive capsulitis patients. To determine the scapular dyskinesia with shoulder pain two tests that apply manual assistance to the scapula are lateral scapular slide test and wall push up test.

Pragmatic set of interventions are an important element in rehabilitation, and has improved the treatment of many musculoskeletal and neurological conditions. Scapular strengthening exercises, which aims to improve abnormal scapular movements that commonly occur in people with adhesive capsulitis.

The purpose of this study is to explore the effect of scapular focused exercises on the rehabilitation of adhesive capsulitis, patient with scapular dyskinesia. The importance of scapular rehabilitation in the treatment of scapular dyskinesia and to examine the comparative effect of pragmatic set of intervention with scapular strengthening protocol on scapular dyskinesia.

My study on the effect of a pragmatic set of intervention versus scapular strengthening exercises on scapular dyskinesia in adhesive capsulitis is important because it addresses a gap in the current literature. While both interventions have been shown to improve scapular dyskinesia in patients with adhesive capsulitis, there is a lack of studies comparing the two methods. My study will help determine which intervention is more effective in treating scapular dyskinesia, which will be valuable information for healthcare providers working with patients with adhesive capsulitis

Being tested
pragmatic set of interventipons, scapular strengthening exercise.
Keywords
Scapular Dyskinesis, Adhesive Capsulitis, Pragmatic set of interventions, strengthening exercise
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pragmatic set of interventiponsOther

    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.
  • scapular strengthening exercise.Other

    • 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)
Study groups in NCT06110000
Study groupRoleWhat they receive
pragmatic set of interventionsExperimentalThe 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
Receives: Other: pragmatic set of interventipons
scapular strengthening exercisesPlacebo comparatorScapular 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,
Receives: Other: scapular strengthening exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4th week

  2. 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.

    Measured: 4th week

Secondary outcomes (1)
  1. Visual analogue scale:

    This VAS will be used in this study to measure Pain. Patients were instructed to assess the severity of shoulder pain experienced last week on a 0-10 cm horizontal line (0 = painless and 10 = worst pain imaginable). The VAS has been shown to have excellent test-retest reliability (ICC = 0.97) and high validity (r with a 5-point verbal descriptive scale = 0.71-0.78) to evaluate pain perception.

    Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2023
  2. Study start8 May 2023
  3. Primary completion8 Dec 2023 (estimated)
  4. Study completion8 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06110000
Sponsor's protocol ID
REC/RCR & AHS/23/0150
Status last verified
Oct 2023
First submitted
25 Oct 2023
Last updated
31 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20110457
  • 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.

    PubMed 35774629
  • 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.

    PubMed 36678176
  • 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.

    PubMed 36796714
  • 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.

    PubMed 36796859
  • 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.

    PubMed 37330779
  • 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.

    PubMed 30926184

Questions about this trial

What is this clinical trial studying?

A study testing pragmatic set of interventipons and scapular strengthening exercise. in people with Scapular Dyskinesis and Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Shoulder Pain and Disability Index (SPADI) (time frame: 4th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06110000, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.

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