Adhesive CapsulitisCAVD21NCT06062654

Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis

A study testing Hospital-assisted Rehabilitation and Home-based Rehabilitation in people with Adhesive Capsulitis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The present study aims to compare the efficacy of assisted rehabilitation treatment, in terms of improvement of pain and shoulder articulation, in patients with stage 2 adhesive capsulitis compared with unassisted home rehabilitation treatment. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Adhesive Capsulitis
What is being tested?: Hospital-assisted Rehabilitation and Home-based Rehabilitation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteItaly
Study dates: 1 Sep 2022to 31 Dec 2023
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients, aged between 18 and 65 years;
Stage 2 adhesive capsulitis of the shoulder, with diagnosis made by clinical, radiographic evaluation in two projections (antero-posterior, lateral) and ultrasound.

Who cannot join

Patients unable to give consent;
Pregnant women;
Patients with poly-drug allergies (anesthetics, corticosteroids); 3.
Patients with other conditions with similar clinical picture (calcific tendinopathy, glenohumeral arthrosis, rotator cuff injury, etc...).

Trial locations and contacts

1 site in 1 country.

Italy1 site

Istituto Ortopedico Rizzoli
Bologna, 40136

Other trials in Italy

About this study

Official title: Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis: a Randomized Interventional Study Aimed at Evaluating the Efficacy of Hospital-assisted Rehabilitation Treatment Compared to Home-based Rehabilitation Treatment

Conditions: Adhesive Capsulitis
Being tested: Hospital-assisted Rehabilitation, Home-based Rehabilitation
Keywords: Shoulder, Adhesive Capsulitis, Ultrasound
Medical subject headings: Bursitis

What participants receive

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

Hospital-assisted RehabilitationOther
Patients are assisted by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition and abduction.
Home-based RehabilitationOther
Patients were educated by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition, and abduction, which they perform at home independently.

Study groups in NCT06062654
Study group	Role	What they receive
Hospital-assisted Rehabilitation Treatment	Experimental	Patients in the experimental group will undergo 10 sessions (about 2 each week) of rehabilitation treatment at the outpatient clinics of the U.O. Physical Medicine and Rehabilitation Unit of the Rizzoli Orthopedic Institute. The rehabilitation protocol consists of a series of commuting exercises and passive/active mobilization exercises of the glenohumeral joint. Receives: Other: Hospital-assisted Rehabilitation; Other: Home-based Rehabilitation
Home-based Rehabilitation Treatment	Active comparator	Patients in the experimental group will have 10 sessions (about 2 each week) of rehabilitation treatment with exercises to be performed self-assisted at home. The rehabilitation protocol consists of a series of commuting exercises and passive/active mobilization exercises of the glenohumeral joint Receives: Other: Hospital-assisted Rehabilitation; Other: Home-based Rehabilitation

What is being measured

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

Shoulder Pain and Disability Index (SPADI)
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
Measured: Baseline (0 months)
Shoulder Pain and Disability Index (SPADI)
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
Measured: 2 months
Shoulder Pain and Disability Index (SPADI)
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
Measured: 4 months
Shoulder Pain and Disability Index (SPADI)
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
Measured: 6 months

Secondary outcomes (12)

Disability of the Arm, Shoulder and Hand (DASH)
It consists of a questionnaire self-completed of more than 30 questions, with values from 0 to 100 (0 shoulder activity granted, no disability, 100 shoulder activity not granted, complete disability) prepared to measure function and symptoms in patients with any musculoskeletal impairment of the upper extremity. The questions refer to the ability to perform certain actions in the last week and the symptoms that arose while performing these actions.
Measured: Baseline (0 months)
Disability of the Arm, Shoulder and Hand (DASH)
It consists of a questionnaire self-completed of more than 30 questions, with values from 0 to 100 (0 shoulder activity granted, no disability, 100 shoulder activity not granted, complete disability) prepared to measure function and symptoms in patients with any musculoskeletal impairment of the upper extremity. The questions refer to the ability to perform certain actions in the last week and the symptoms that arose while performing these actions.
Measured: 2 months
Disability of the Arm, Shoulder and Hand (DASH)
It consists of a questionnaire self-completed of more than 30 questions, with values from 0 to 100 (0 shoulder activity granted, no disability, 100 shoulder activity not granted, complete disability) prepared to measure function and symptoms in patients with any musculoskeletal impairment of the upper extremity. The questions refer to the ability to perform certain actions in the last week and the symptoms that arose while performing these actions.
Measured: 4 months
Disability of the Arm, Shoulder and Hand (DASH)
It consists of a questionnaire self-completed of more than 30 questions, with values from 0 to 100 (0 shoulder activity granted, no disability, 100 shoulder activity not granted, complete disability) prepared to measure function and symptoms in patients with any musculoskeletal impairment of the upper extremity. The questions refer to the ability to perform certain actions in the last week and the symptoms that arose while performing these actions.
Measured: 6 months
Visual Analogue Scale (VAS)
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Measured: Baseline (0 months)
Visual Analogue Scale (VAS)
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Measured: 2 months
Visual Analogue Scale (VAS)
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Measured: 4 months
Visual Analogue Scale (VAS)
One-dimensional scale, with values from 0 to 10 (0 no pain, 10 high pain) assessing pain intensity.
Measured: 6 months
American Shoulder and Elbow Scale (ASES)
It consists of a questionnaire, with values from 0 to 100 (0 non-painful shoulder joint, granted, 100 non-granted shoulder joint, complete disability), on limitations in activities of daily living, one part patient self-assessment and one by the specialist.
Measured: Baseline (0 months)
American Shoulder and Elbow Scale (ASES)
It consists of a questionnaire, with values from 0 to 100 (0 non-painful shoulder joint, granted, 100 non-granted shoulder joint, complete disability), on limitations in activities of daily living, one part patient self-assessment and one by the specialist.
Measured: 2 months
American Shoulder and Elbow Scale (ASES)
It consists of a questionnaire, with values from 0 to 100 (0 non-painful shoulder joint, granted, 100 non-granted shoulder joint, complete disability), on limitations in activities of daily living, one part patient self-assessment and one by the specialist.
Measured: 4 months
American Shoulder and Elbow Scale (ASES)
It consists of a questionnaire, with values from 0 to 100 (0 non-painful shoulder joint, granted, 100 non-granted shoulder joint, complete disability), on limitations in activities of daily living, one part patient self-assessment and one by the specialist.
Measured: 6 months

Timeline

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

1 Sep 202231 Dec 2023

First posted2 Oct 2023
Study start1 Sep 2022
Primary completion28 Apr 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
More trials run by Istituto Ortopedico RizzoliThe 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: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06062654
Sponsor's protocol ID: CAVD21
Acronym: CAVD21
Status last verified: Feb 2024
First submitted: 31 Aug 2023
Last updated: 2 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Tasto JP, Elias DW. Adhesive capsulitis. Sports Med Arthrosc Rev. 2007 Dec;15(4):216-21. doi: 10.1097/JSA.0b013e3181595c22.
PubMed 18004221
Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.
PubMed 10738419
Boyle-Walker KL, Gabard DL, Bietsch E, Masek-VanArsdale DM, Robinson BL. A profile of patients with adhesive capsulitis. J Hand Ther. 1997 Jul-Sep;10(3):222-8. doi: 10.1016/s0894-1130(97)80025-7.
PubMed 9268913
Balci N, Balci MK, Tuzuner S. Shoulder adhesive capsulitis and shoulder range of motion in type II diabetes mellitus: association with diabetic complications. J Diabetes Complications. 1999 May-Jun;13(3):135-40. doi: 10.1016/s1056-8727(99)00037-9.
PubMed 10509873
Wohlgethan JR. Frozen shoulder in hyperthyroidism. Arthritis Rheum. 1987 Aug;30(8):936-9. doi: 10.1002/art.1780300815.
PubMed 3498494
Griesser MJ, Harris JD, Campbell JE, Jones GL. Adhesive capsulitis of the shoulder: a systematic review of the effectiveness of intra-articular corticosteroid injections. J Bone Joint Surg Am. 2011 Sep 21;93(18):1727-33. doi: 10.2106/JBJS.J.01275. No abstract available.
PubMed 21938377
BLOCKEY NJ, WRIGHT JK, KELLGREN JH. Oral cortisone therapy in periarthritis of the shoulder; a controlled trial. Br Med J. 1954 Jun 26;1(4877):1455-7. doi: 10.1136/bmj.1.4877.1455. No abstract available.
PubMed 13160496
De Carli A, Vadala A, Perugia D, Frate L, Iorio C, Fabbri M, Ferretti A. Shoulder adhesive capsulitis: manipulation and arthroscopic arthrolysis or intra-articular steroid injections? Int Orthop. 2012 Jan;36(1):101-6. doi: 10.1007/s00264-011-1330-7. Epub 2011 Aug 11.
PubMed 21833684
Eustace JA, Brophy DP, Gibney RP, Bresnihan B, FitzGerald O. Comparison of the accuracy of steroid placement with clinical outcome in patients with shoulder symptoms. Ann Rheum Dis. 1997 Jan;56(1):59-63. doi: 10.1136/ard.56.1.59.
PubMed 9059143
Tobola A, Cook C, Cassas KJ, Hawkins RJ, Wienke JR, Tolan S, Kissenberth MJ. Accuracy of glenohumeral joint injections: comparing approach and experience of provider. J Shoulder Elbow Surg. 2011 Oct;20(7):1147-54. doi: 10.1016/j.jse.2010.12.021. Epub 2011 Apr 13.
PubMed 21493103
Daley EL, Bajaj S, Bisson LJ, Cole BJ. Improving injection accuracy of the elbow, knee, and shoulder: does injection site and imaging make a difference? A systematic review. Am J Sports Med. 2011 Mar;39(3):656-62. doi: 10.1177/0363546510390610. Epub 2011 Jan 21.
PubMed 21257847
Patel DN, Nayyar S, Hasan S, Khatib O, Sidash S, Jazrawi LM. Comparison of ultrasound-guided versus blind glenohumeral injections: a cadaveric study. J Shoulder Elbow Surg. 2012 Dec;21(12):1664-8. doi: 10.1016/j.jse.2011.11.026. Epub 2012 Mar 23.
PubMed 22445159
Bryant M, Gough A, Selfe J, Richards J, Burgess E. The effectiveness of ultrasound guided hydrodistension and physiotherapy in the treatment of frozen shoulder/adhesive capsulitis in primary care: a single centre service evaluation. Shoulder Elbow. 2017 Oct;9(4):292-298. doi: 10.1177/1758573217701063. Epub 2017 May 17.
PubMed 28932287
Ladermann A, Piotton S, Abrassart S, Mazzolari A, Ibrahim M, Stirling P. Hydrodilatation with corticosteroids is the most effective conservative management for frozen shoulder. Knee Surg Sports Traumatol Arthrosc. 2021 Aug;29(8):2553-2563. doi: 10.1007/s00167-020-06390-x. Epub 2021 Jan 9.
PubMed 33420809
Song A, Higgins LD, Newman J, Jain NB. Glenohumeral corticosteroid injections in adhesive capsulitis: a systematic search and review. PM R. 2014 Dec;6(12):1143-56. doi: 10.1016/j.pmrj.2014.06.015. Epub 2014 Jul 1.
PubMed 24998406

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
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All Adhesive Capsulitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis: a Randomized Interventional Study Aimed at Evaluating the Efficacy of Hospital-assisted Rehabilitation Treatment Compared to Home-based Rehabilitation Treatment
ClinicalTrials.gov ID: NCT06062654
Acronym / sponsor ID: CAVD21 / CAVD21
Conditions: Adhesive Capsulitis
Keywords: Shoulder, Adhesive Capsulitis, Ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Istituto Ortopedico RizzoliUniversity, hospital or other
Study start: 1 Sep 2022 (actual)
Primary completion: 28 Apr 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 2 Oct 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Hospital-assisted Rehabilitation Treatment	Experimental	Other: Hospital-assisted Rehabilitation, Other: Home-based RehabilitationPatients in the experimental group will undergo 10 sessions (about 2 each week) of rehabilitation treatment at the outpatient clinics of the U.O. Physical Medicine and Rehabilitation Unit of the Rizzoli Orthopedic Institute. The rehabilitation protocol consists of a series of commuting exercises and passive/active mobilization exercises of the glenohumeral joint.
Home-based Rehabilitation Treatment	Active comparator	Other: Hospital-assisted Rehabilitation, Other: Home-based RehabilitationPatients in the experimental group will have 10 sessions (about 2 each week) of rehabilitation treatment with exercises to be performed self-assisted at home. The rehabilitation protocol consists of a series of commuting exercises and passive/active mobilization exercises of the glenohumeral joint

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female patients, aged between 18 and 65 years;
Stage 2 adhesive capsulitis of the shoulder, with diagnosis made by clinical, radiographic evaluation in two projections (antero-posterior, lateral) and ultrasound.

Key exclusion criteria (4 listed)

Patients unable to give consent;
Pregnant women;
Patients with poly-drug allergies (anesthetics, corticosteroids); 3.
Patients with other conditions with similar clinical picture (calcific tendinopathy, glenohumeral arthrosis, rotator cuff injury, etc...).

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
Hospital-assisted RehabilitationPatients are assisted by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition and abduction.	Other	Home-based Rehabilitation Treatment, Hospital-assisted Rehabilitation Treatment
Home-based RehabilitationPatients were educated by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition, and abduction, which they perform at home independently.	Other	Home-based Rehabilitation Treatment, Hospital-assisted Rehabilitation Treatment

Primary outcome

Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline (0 months)
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
Shoulder Pain and Disability Index (SPADI)
Time frame: 2 months
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
Shoulder Pain and Disability Index (SPADI)
Time frame: 4 months
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
Shoulder Pain and Disability Index (SPADI)
Time frame: 6 months
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.

12 secondary outcomes

Disability of the Arm, Shoulder and Hand (DASH)
Time frame: Baseline (0 months)
Disability of the Arm, Shoulder and Hand (DASH)
Time frame: 2 months
Disability of the Arm, Shoulder and Hand (DASH)
Time frame: 4 months
Disability of the Arm, Shoulder and Hand (DASH)
Time frame: 6 months
Visual Analogue Scale (VAS)
Time frame: Baseline (0 months)
Visual Analogue Scale (VAS)
Time frame: 2 months
Visual Analogue Scale (VAS)
Time frame: 4 months
Visual Analogue Scale (VAS)
Time frame: 6 months
American Shoulder and Elbow Scale (ASES)
Time frame: Baseline (0 months)
American Shoulder and Elbow Scale (ASES)
Time frame: 2 months
American Shoulder and Elbow Scale (ASES)
Time frame: 4 months
American Shoulder and Elbow Scale (ASES)
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
Background: PubMed 18004221Tasto JP, Elias DW. Adhesive capsulitis. Sports Med Arthrosc Rev. 2007 Dec;15(4):216-21. doi: 10.1097/JSA.0b013e3181595c22.
Background: PubMed 10738419Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.
Background: PubMed 9268913Boyle-Walker KL, Gabard DL, Bietsch E, Masek-VanArsdale DM, Robinson BL. A profile of patients with adhesive capsulitis. J Hand Ther. 1997 Jul-Sep;10(3):222-8. doi: 10.1016/s0894-1130(97)80025-7.
Background: PubMed 10509873Balci N, Balci MK, Tuzuner S. Shoulder adhesive capsulitis and shoulder range of motion in type II diabetes mellitus: association with diabetic complications. J Diabetes Complications. 1999 May-Jun;13(3):135-40. doi: 10.1016/s1056-8727(99)00037-9.
Background: PubMed 3498494Wohlgethan JR. Frozen shoulder in hyperthyroidism. Arthritis Rheum. 1987 Aug;30(8):936-9. doi: 10.1002/art.1780300815.
Background: PubMed 21938377Griesser MJ, Harris JD, Campbell JE, Jones GL. Adhesive capsulitis of the shoulder: a systematic review of the effectiveness of intra-articular corticosteroid injections. J Bone Joint Surg Am. 2011 Sep 21;93(18):1727-33. doi: 10.2106/JBJS.J.01275. No abstract available.
Background: PubMed 13160496BLOCKEY NJ, WRIGHT JK, KELLGREN JH. Oral cortisone therapy in periarthritis of the shoulder; a controlled trial. Br Med J. 1954 Jun 26;1(4877):1455-7. doi: 10.1136/bmj.1.4877.1455. No abstract available.
Background: PubMed 21833684De Carli A, Vadala A, Perugia D, Frate L, Iorio C, Fabbri M, Ferretti A. Shoulder adhesive capsulitis: manipulation and arthroscopic arthrolysis or intra-articular steroid injections? Int Orthop. 2012 Jan;36(1):101-6. doi: 10.1007/s00264-011-1330-7. Epub 2011 Aug 11.
Background: PubMed 9059143Eustace JA, Brophy DP, Gibney RP, Bresnihan B, FitzGerald O. Comparison of the accuracy of steroid placement with clinical outcome in patients with shoulder symptoms. Ann Rheum Dis. 1997 Jan;56(1):59-63. doi: 10.1136/ard.56.1.59.
Background: PubMed 21493103Tobola A, Cook C, Cassas KJ, Hawkins RJ, Wienke JR, Tolan S, Kissenberth MJ. Accuracy of glenohumeral joint injections: comparing approach and experience of provider. J Shoulder Elbow Surg. 2011 Oct;20(7):1147-54. doi: 10.1016/j.jse.2010.12.021. Epub 2011 Apr 13.
Background: PubMed 21257847Daley EL, Bajaj S, Bisson LJ, Cole BJ. Improving injection accuracy of the elbow, knee, and shoulder: does injection site and imaging make a difference? A systematic review. Am J Sports Med. 2011 Mar;39(3):656-62. doi: 10.1177/0363546510390610. Epub 2011 Jan 21.
Background: PubMed 22445159Patel DN, Nayyar S, Hasan S, Khatib O, Sidash S, Jazrawi LM. Comparison of ultrasound-guided versus blind glenohumeral injections: a cadaveric study. J Shoulder Elbow Surg. 2012 Dec;21(12):1664-8. doi: 10.1016/j.jse.2011.11.026. Epub 2012 Mar 23.

Related trials for Adhesive Capsulitis

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Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hospital-assisted Rehabilitation and Home-based Rehabilitation in people with Adhesive Capsulitis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 2 Feb 2024. 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 Italy. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder Pain and Disability Index (SPADI) (time frame: Baseline (0 months)). The study lists 4 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 NCT06062654, which also lists 26 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 2 Feb 2024.