Frozen ShoulderNCT06705426
Scapular Mobilization Versus Capsular Stretch
A study testing Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises and Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises in people with Frozen Shoulder, run by Cairo University.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises and Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Scapular Mobilization Versus Posterior Capsular Stretch in Frozen Shoulder
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
Read the detailed description
Frozen shoulder is a musculoskeletal condition that is commonly encountered in physical therapy practice. It is characterized by a painful, gradual loss of both active and passive glenohumeral motion resulting from progressive fibrosis and ultimate contracture of the glenohumeral joint capsule. Frozen shoulder affects about 2% of the general population, with a higher prevalence in people between their 40s and 60s. Frozen shoulder occurs more in diabetic patient.
The traditional principles of treatment of frozen shoulder are to relieve pain, maintain range of motion, and ultimately to restore function. The physiotherapy treatment of frozen shoulder consists of different modalities such as Transcutaneous Electrical Nerve Stimulation (TENS), Interferential Therapy (IFT), Ultrasound, Short Wave Diathermy (SWD) etc., and the physical therapy exercises such as stretching, Codman exercise can be used.
Scapular-mobility exercises, or scapular-mobilization (SM) techniques is widely used in the management of musculoskeletal disorders of the shoulder. Scapular mobilization can cause pain reduction with improvement in the shoulder range of motion. Scapular mobilization can reduce the disability in patients with shoulder dysfunction.
Posterior capsular stretch is applied along with mobilization which causes significant improvement in increasing range of motion and functional disability. Capsular stretching showed a more significant reduction in pain when compared to general exercises.
Therefore, what are the possible effect of scapular mobilization versus posterior capsular stretch in treating patients with frozen shoulder?
- Conditions
- Frozen Shoulder
- Being tested
- Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises, Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercisesOther
Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises
Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercisesOther
Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises
| Study group | Role | What they receive |
|---|---|---|
| Scapular mobilization group A | Experimental | Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises Receives: 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 Receives: Other: Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder flexion range of motion to measure shoulder joint active range of motion (flexion) by bubble inclinometer
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: pre-intervention, after 2 weeks of treatment and post treatment 4 weeks
poaterior capsular tension measurement by ruler
Measured: pre-intervention, after 2 weeks of treatment and post treatment 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Ahmed Abd Elmeged, Cairo University
- Investigators
- Karima A Hassan, Principal investigator, Karima.abdelaty@pt.cu.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705426
- Sponsor's protocol ID
- P.T.REC/012/005349
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26870099Duzgun 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.
PubMed 22765488Duzgun 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.
PubMed 31475938Kurtais 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.
PubMed 15049727Klauser 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.
PubMed 22453857Laudner 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.
PubMed 18668168Leung 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.
PubMed 18509580Le 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.
PubMed 28405218Lewis 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.
PubMed 25107826McClure 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.
PubMed 17416125Paul 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.
PubMed 24664198Surenkok 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.
PubMed 20108851Zuckerman 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.
PubMed 21051244
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scapular Mobilization Versus Posterior Capsular Stretch in Frozen Shoulder
- ClinicalTrials.gov ID
- NCT06705426
- Acronym / sponsor ID
- P.T.REC/012/005349
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Frozen shoulder is a musculoskeletal condition that is commonly encountered in physical therapy practice. It is characterized by a painful, gradual loss of both active and passive glenohumeral motion resulting from progressive fibrosis and ultimate contracture of the glenohumeral joint capsule. Frozen shoulder affects about 2% of the general population, with a higher prevalence in people between their 40s and 60s. Frozen shoulder occurs more in diabetic patient.
The traditional principles of treatment of frozen shoulder are to relieve pain, maintain range of motion, and ultimately to restore function. The physiotherapy treatment of frozen shoulder consists of different modalities such as Transcutaneous Electrical Nerve Stimulation (TENS), Interferential Therapy (IFT), Ultrasound, Short Wave Diathermy (SWD) etc., and the physical therapy exercises such as stretching, Codman exercise can be used.
Scapular-mobility exercises, or scapular-mobilization (SM) techniques is widely used in the management of musculoskeletal disorders of the shoulder. Scapular mobilization can cause pain reduction with improvement in the shoulder range of motion. Scapular mobilization can reduce the disability in patients with shoulder dysfunction.
Posterior capsular stretch is applied along with mobilization which causes significant improvement in increasing range of motion and functional disability. Capsular stretching showed a more significant reduction in pain when compared to general exercises.
Therefore, what are the possible effect of scapular mobilization versus posterior capsular stretch in treating patients with frozen shoulder?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scapular mobilization group A | Experimental | Other: Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercisesScapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises |
| Posterior capsular stretch group B | Experimental | Other: Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercisesPosterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Recent joint infection or surgery.
- History of shoulder subluxation, dislocation, or ligamentous injury.
- Shoulder arthroplasty.
- Shoulder and cervical pathology.
- Recent trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercisesScapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises | Other | Scapular mobilization group A |
| Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercisesPosterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises | Other | Posterior capsular stretch group B |
Primary outcome
Shoulder flexion range of motion to measure shoulder joint active range of motion (flexion) by bubble inclinometer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: pre-intervention, after 2 weeks of treatment and post treatment 4 weeks
poaterior capsular tension measurement by ruler
Time frame: pre-intervention, after 2 weeks of treatment and post treatment 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Results publication: PubMed 26870099Ali 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.
- Results publication: PubMed 22765488Duzgun 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.
- Results publication: PubMed 31475938Duzgun 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.
- Results publication: PubMed 15049727Kurtais 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.
- Results publication: PubMed 22453857Klauser 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.
- Results publication: PubMed 18668168Laudner 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.
- Results publication: PubMed 18509580Leung 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.
- Results publication: PubMed 28405218Le 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.
- Results publication: PubMed 25107826Lewis 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.
- Results publication: PubMed 17416125McClure 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.
- Results publication: PubMed 24664198Paul 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.
- Results publication: PubMed 20108851Surenkok 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karima A Hassan principal investigator
Karima.abdelaty@pt.cu.edu.eg
Questions about this trial
What is this clinical trial studying?
A study testing Scapular mobilization with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises and Posterior capsular stretch with addition anterior, posterior ,caudal glenohumeral mobilization, infrared therapy, ultrasound therapy, pendulum exercises in people with Frozen Shoulder, run by Cairo University.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omnia A Abd Elmeged (+201064454510, monyahmedomnia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder flexion range of motion to measure shoulder joint active range of motion (flexion) by bubble inclinometer (time frame: pre-intervention, after 2 weeks of treatment and post treatment 4 weeks). The study lists 7 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 NCT06705426, which also lists 13 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 27 Dec 2024.