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Formal Physical Therapy (PT) vs. Home PT for Adhesive Capsulitis

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ClinicalTrials.gov Identifier: NCT03049787
Recruitment Status : Enrolling by invitation
First Posted : February 10, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Xinning Li, Boston Medical Center

Brief Summary:
This study aims to evaluate physical therapy (standard of care) and home exercise vs. home exercise alone for the treatment of adhesive capsulitis.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Other: Home Exercise Protocol Other: Physical Therapy Protocol Not Applicable

Detailed Description:
Patients with adhesive capsulitis receive a glenohumeral and subacromial injection routinely for treatment. In addition, the patients are routinely prescribed physical therapy with a home exercise component. The purpose of this study is to evaluate whether home exercise alone is an alternative option to physical therapy. Patients will be approached about the study after they have agreed to receive a glenohumeral and subacromial injection per standard of care for their clinical treatment. The hypothesis being tested is whether home exercise is alone is as beneficial for pain relief, restoration of range of motion, and improvement in shoulder disability from adhesive capsulitis as physical therapy. Additionally sex differences, diabetes mellitus, endocrine, and mental health histories will be noted.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Traditional Physical Therapy Versus Home Exercise in Conjunction With Glenohumeral and Subacromial Corticosteroid Injection for the Treatment of Shoulder Adhesive Capsulitis
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: home exercise
For the home exercise protocol alone arm, subjects will be given an experimental home exercise program and study team will demonstrate the exercises in the clinic and will direct the subjects to perform the exercises 1-2 times daily until symptom resolution.
Other: Home Exercise Protocol
Home exercise therapy protocol given to patient to be completed at home.

Active Comparator: physical therapy
Patients will be prescribed routine physical therapy protocol where they will see a physical therapist twice a week and will be instructed by the physical therapist to perform physical therapy exercises at home daily until symptom resolution, as is the routine practice.
Other: Physical Therapy Protocol
Formal physical therapy protocol to be given to physical therapist working with patient to direct formal intervention along with a home therapy protocol.




Primary Outcome Measures :
  1. Change in Shoulder Pain and Disability Index(SPADI) [ Time Frame: 6 months compared to baseline score ]
    shoulder pain and disability index to evaluate shoulder pain and function


Secondary Outcome Measures :
  1. Change in Range of Motion (ROM) [ Time Frame: 6 months compared to baseline score ]
    evaluate range of motion

  2. Change in Sane Normal and Pain Visual Analogue Score (SANE) [ Time Frame: 6 months compared to baseline score ]
    Subjective shoulder score to determine shoulder pain/function

  3. Change in Mental Health Index- 5 (MHI-5) [ Time Frame: 6 months compared to baseline score ]
    Mental Health Index- 5 to determine patient mental health status

  4. Change in Short Form- 36 (SF-36) [ Time Frame: 6 months compared to baseline score ]
    Short Form Survey- 36 to determine general overall health for patient

  5. Change in Visual Analog Scale Pain (VAS-Pain) [ Time Frame: 6 months compared to baseline score ]
    Visual analog scale- pain to assess shoulder pain



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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:

  1. Clinical Diagnosis of Adhesive Capsulitis (limited range of motion)
  2. Given glenohumeral and subacromial injection as part of standard care.
  3. Capacity to conduct home exercise program or physical therapy (based upon physician judgment, proximity to physical therapy office and as decided by patient)
  4. English speaking
  5. 18 years of age or greater

Exclusion Criteria:

  1. Prior glenohumeral or subacromial corticosteroid injection within 6 months
  2. Prior ipsilateral shoulder surgery
  3. Current prescription (narcotic) pain medication use
  4. Pain disorder (ex. Fibromyalgia, Reflex Sympathetic Dystrophy)
  5. Cervical radiculopathy
  6. Full-thickness rotator cuff tear
  7. Calcific Tendinopathy (past or present)
  8. Advanced Stage osteoarthritis as seen on radiograph
  9. Past/present ipsilateral shoulder fracture
  10. Women that may be pregnant or nursing (self report)

Past/present physical therapy treatment will be documented, but will not be considered an exclusion factor. The reasoning behind this is that the physical therapy likely was not properly targeting the adhesive capsulitis for the patient to arrive in an orthopaedic clinic and is likely at a similar starting point to most other patients regardless of previous physical therapy. All patients currently enrolled in physical therapy will be assigned to either our physical therapy or home exercise program.


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): NCT03049787


Sponsors and Collaborators
Boston Medical Center
Brigham and Women's Hospital
Investigators
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Principal Investigator: Xinning Li, MD Boston Medical Center

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Responsible Party: Xinning Li, Assistant Professor, Department of Orthopaedic Surgery, Boston Medical Center
ClinicalTrials.gov Identifier: NCT03049787     History of Changes
Other Study ID Numbers: H-32842
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xinning Li, Boston Medical Center:
physical therapy
home exercise
adhesive capsulitis
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases