NCT06705426

Brief Summary

The goal of this study is to compare the effect of scapular mobilization versus posterior capsular stretch on pain, function, range of motion, and posterior capsular tension in patient with frozen shoulder

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

November 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 27, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 22, 2024

Last Update Submit

December 25, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Shoulder flexion range of motion to measure shoulder joint active range of motion (flexion) by bubble inclinometer

    pre-intervention, after 2 weeks of treatment and post treatment 4 weeks

  • Shoulder abduction range of motion to measure shoulder joint active range of motion (abduction) by bubble inclinometer

    pre-intervention, after 2 weeks of treatment and post treatment 4 weeks

  • Shoulder internal rotation range of motion to measure shoulder joint active range of motion (internal rotation) by bubble inclinometer

    pre-intervention, after 2 weeks of treatment and post treatment 4 weeks

  • Shoulder external rotation range of motion to measure shoulder joint active range of motion (external rotation) by bubble inclinometer

    pre-intervention, after 2 weeks of treatment and post treatment 4 weeks

  • Shoulder pain and disability index to measure the shoulder pain the maximum possible score for the pain scale is 50

    pre-intervention, after 2 weeks of treatment and post treatment 4 weeks

  • Shoulder pain and disability index to measure the disability level the maximum possible score for the disability scale is 80

    pre-intervention, after 2 weeks of treatment and post treatment 4 weeks

  • poaterior capsular tension measurement by ruler

    pre-intervention, after 2 weeks of treatment and post treatment 4 weeks

Study Arms (2)

Scapular mobilization group A

EXPERIMENTAL

Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises

Other: Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises

Posterior capsular stretch group B

EXPERIMENTAL

Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises

Other: Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises

Interventions

Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises

Scapular mobilization group A

Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises

Posterior capsular stretch group B

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged from 40-65 years old.
  • Diabetic and non-diabetic patients' diagnosis of stage 3 frozen shoulder (frozen phase) by an orthopedist.
  • The presence of pain and limited movement in the shoulder for at least 2 months.
  • Passive joint movements are limited when compared with the normal side.
  • Unilateral involvement.

You may not qualify if:

  • Recent joint infection or surgery.
  • History of shoulder subluxation, dislocation, or ligamentous injury.
  • Shoulder arthroplasty.
  • Shoulder and cervical pathology.
  • Recent trauma.
  • Neurological disorders with muscle weakness in the shoulder joint.
  • Infection, pregnancy, carcinoma patients, severe cardiac or psychiatric conditions.
  • Previous shoulder surgeries to the affected shoulder.
  • Previous manipulations under anesthesia of the affected shoulder.
  • Radiological evidence for glenohumeral joint arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Ali SA, Khan M. Comparison for efficacy of general exercises with and without mobilization therapy for the management of adhesive capsulitis of shoulder - An interventional study. Pak J Med Sci. 2015 Nov-Dec;31(6):1372-6. doi: 10.12669/pjms.316.7909.

    PMID: 26870099BACKGROUND
  • Duzgun I, Baltaci G, Atay OA. Manual therapy is an effective treatment for frozen shoulder in diabetics: an observational study. Eklem Hastalik Cerrahisi. 2012;23(2):94-9.

    PMID: 22765488BACKGROUND
  • Duzgun I, Turgut E, Eraslan L, Elbasan B, Oskay D, Atay OA. Which method for frozen shoulder mobilization: manual posterior capsule stretching or scapular mobilization? J Musculoskelet Neuronal Interact. 2019 Sep 1;19(3):311-316.

    PMID: 31475938BACKGROUND
  • Kurtais Gursel Y, Ulus Y, Bilgic A, Dincer G, van der Heijden GJ. Adding ultrasound in the management of soft tissue disorders of the shoulder: a randomized placebo-controlled trial. Phys Ther. 2004 Apr;84(4):336-43.

    PMID: 15049727BACKGROUND
  • Klauser AS, Tagliafico A, Allen GM, Boutry N, Campbell R, Court-Payen M, Grainger A, Guerini H, McNally E, O'Connor PJ, Ostlere S, Petroons P, Reijnierse M, Sconfienza LM, Silvestri E, Wilson DJ, Martinoli C. Clinical indications for musculoskeletal ultrasound: a Delphi-based consensus paper of the European Society of Musculoskeletal Radiology. Eur Radiol. 2012 May;22(5):1140-8. doi: 10.1007/s00330-011-2356-3. Epub 2012 Mar 28.

    PMID: 22453857BACKGROUND
  • Laudner KG, Sipes RC, Wilson JT. The acute effects of sleeper stretches on shoulder range of motion. J Athl Train. 2008 Jul-Aug;43(4):359-63. doi: 10.4085/1062-6050-43.4.359.

    PMID: 18668168BACKGROUND
  • Leung MS, Cheing GL. Effects of deep and superficial heating in the management of frozen shoulder. J Rehabil Med. 2008 Feb;40(2):145-50. doi: 10.2340/16501977-0146.

    PMID: 18509580BACKGROUND
  • Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7.

    PMID: 28405218BACKGROUND
  • Lewis J. Frozen shoulder contracture syndrome - Aetiology, diagnosis and management. Man Ther. 2015 Feb;20(1):2-9. doi: 10.1016/j.math.2014.07.006. Epub 2014 Jul 18.

    PMID: 25107826BACKGROUND
  • McClure P, Balaicuis J, Heiland D, Broersma ME, Thorndike CK, Wood A. A randomized controlled comparison of stretching procedures for posterior shoulder tightness. J Orthop Sports Phys Ther. 2007 Mar;37(3):108-14. doi: 10.2519/jospt.2007.2337.

    PMID: 17416125BACKGROUND
  • Paul A, Rajkumar JS, Peter S, Lambert L. Effectiveness of sustained stretching of the inferior capsule in the management of a frozen shoulder. Clin Orthop Relat Res. 2014 Jul;472(7):2262-8. doi: 10.1007/s11999-014-3581-2. Epub 2014 Mar 25.

    PMID: 24664198BACKGROUND
  • Surenkok O, Aytar A, Baltaci G. Acute effects of scapular mobilization in shoulder dysfunction: a double-blind randomized placebo-controlled trial. J Sport Rehabil. 2009 Nov;18(4):493-501. doi: 10.1123/jsr.18.4.493.

    PMID: 20108851BACKGROUND
  • Zuckerman JD, Rokito A. Frozen shoulder: a consensus definition. J Shoulder Elbow Surg. 2011 Mar;20(2):322-5. doi: 10.1016/j.jse.2010.07.008. Epub 2010 Nov 4.

    PMID: 21051244BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Officials

  • Karima A Hassan

    Karima.abdelaty@pt.cu.edu.eg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investiator

Study Record Dates

First Submitted

November 22, 2024

First Posted

November 26, 2024

Study Start

January 1, 2025

Primary Completion

April 1, 2025

Study Completion

July 1, 2025

Last Updated

December 27, 2024

Record last verified: 2024-11