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Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment

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ClinicalTrials.gov Identifier: NCT02283996
Recruitment Status : Recruiting
First Posted : November 5, 2014
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Scott D Martin, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a significant difference in outcome between the two study arms. One group will undergo regular physical therapy with corticosteroid injections (Arm 1) and the other will have steroid injections during the inflammatory phase only and then be regularly observed (Arm 2). We also hypothesize there will be a significant financial burden associated with the PT arm that is not justified with the possibility of increased symptom reports in that arm.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Frozen Shoulder Shoulder Frozen Other: Physical Therapy Drug: Depot Methylprednisolone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
Actual Study Start Date : November 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Physical Therapy with Steroid Injection
Patients will undergo regular physical therapy as defined by the standard of care at Massachusetts General Hospital for Adhesive Capsulitis (Frozen Shoulder). If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.
Other: Physical Therapy

The following link contains the protocol for physical therapy that will be used in the study. There are no other ancillary devices or drugs used in this study aside from the depot methylprednisolone listed under interventions.

Brigham and Women's/Massachusetts General Standard of Care Guidelines for Physical Therapy in Treatment of Adhesive Capsulitis:

http://www.brighamandwomens.org/Patients_Visitors/pcs/rehabilitationservices/Physical%20Therapy%20Standards%20of%20Care%20and%20Protocols/Shoulder%20-%20Adhesive%20capsulitis.pdf


Drug: Depot Methylprednisolone
40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine
Other Name: Depo Medrol

Experimental: Watchful Waiting with Steroid Injection
Patients will undergo no therapeutic intervention outside of steroid injection. If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.
Drug: Depot Methylprednisolone
40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine
Other Name: Depo Medrol




Primary Outcome Measures :
  1. Functional outcome based on the American Shoulder and Elbow Surgeons Standardized Questionnaire [ Time Frame: November 2014 to November 2017 ]
    At 1 year post-enrollment, patients will repeat the American Shoulder and Elbow Surgeons Standardized questionnaire. The scores range from 0-100 with categorized subsets.


Secondary Outcome Measures :
  1. Functional outcome based on the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet [ Time Frame: November 2014 to November 2017 ]
    At 1 year post-enrollment, patients will repeat the Disabilities of the Arm, Shoulder, and Hand (DASH) score sheet. The scores range from 0-100 with categorized subsets.

  2. Functional outcome based on the Constant shoulder score sheet [ Time Frame: November 2014 to November 2017 ]
    At 1 year post-enrollment, patients will repeat the Constant shoulder score sheet. The scores range from 0-100 with categorized subsets.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient must be 18 years or older
  • Must meet the following definition for adhesive capsulitis as defined by the American Academy of Orthopedic Surgeons: Self-limiting condition resulting from any inflammatory process about the shoulder in which capsular scar tissue is produced, resulting in pain and limited range of motion; also called frozen shoulder
  • Must be amenable to randomization into either cohort

Exclusion Criteria:

  • Non-English speaking patients
  • Pregnant women (women of childbearing potential will be advised to undergo regular pregnancy testing)
  • Patients who had previously undergone operative therapy for the condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283996


Contacts
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Contact: Scott D Martin, MD 617-732-5329 sdmartin@partners.org
Contact: Mark R Nazal, MPH 617-643-0886 mnazal@mgh.harvard.edu

Locations
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United States, Massachusetts
MGH, Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mark R Nazal, MPH    617-643-0886    mnazal@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Scott D Martin, MD Massachusetts General Hospital

Publications:

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Responsible Party: Scott D Martin, Associate Professor of Orthopedic Surgery, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02283996     History of Changes
Other Study ID Numbers: 2014P001688
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Keywords provided by Scott D Martin, Massachusetts General Hospital:
Adhesive Capsulitis
Frozen Shoulder
Shoulder Frozen
Physical Therapy
Corticosteroid Injections
Hydrodilation, Hydro-dilation
Watchful Waiting
Prospective
Glenohumeral Ligament
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Lidocaine
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents