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

Primary Purpose

Adhesive Capsulitis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home Exercise Protocol
Physical Therapy Protocol
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring physical therapy, home exercise, adhesive capsulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    home exercise

    physical therapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in Shoulder Pain and Disability Index(SPADI)
    shoulder pain and disability index to evaluate shoulder pain and function

    Secondary Outcome Measures

    Change in Range of Motion (ROM)
    evaluate range of motion
    Change in Sane Normal and Pain Visual Analogue Score (SANE)
    Subjective shoulder score to determine shoulder pain/function
    Change in Mental Health Index- 5 (MHI-5)
    Mental Health Index- 5 to determine patient mental health status
    Change in Short Form- 36 (SF-36)
    Short Form Survey- 36 to determine general overall health for patient
    Change in Visual Analog Scale Pain (VAS-Pain)
    Visual analog scale- pain to assess shoulder pain

    Full Information

    First Posted
    January 7, 2017
    Last Updated
    June 25, 2023
    Sponsor
    Boston Medical Center
    Collaborators
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03049787
    Brief Title
    Formal Physical Therapy (PT) vs. Home PT for Adhesive Capsulitis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was never started as the PI was working on another clinical trial.
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    July 30, 2022 (Actual)
    Study Completion Date
    July 30, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boston Medical Center
    Collaborators
    Brigham and Women's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adhesive Capsulitis
    Keywords
    physical therapy, home exercise, adhesive capsulitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    home exercise
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    physical therapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Home Exercise Protocol
    Intervention Description
    Home exercise therapy protocol given to patient to be completed at home.
    Intervention Type
    Other
    Intervention Name(s)
    Physical Therapy Protocol
    Intervention Description
    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 Measure Information:
    Title
    Change in Shoulder Pain and Disability Index(SPADI)
    Description
    shoulder pain and disability index to evaluate shoulder pain and function
    Time Frame
    6 months compared to baseline score
    Secondary Outcome Measure Information:
    Title
    Change in Range of Motion (ROM)
    Description
    evaluate range of motion
    Time Frame
    6 months compared to baseline score
    Title
    Change in Sane Normal and Pain Visual Analogue Score (SANE)
    Description
    Subjective shoulder score to determine shoulder pain/function
    Time Frame
    6 months compared to baseline score
    Title
    Change in Mental Health Index- 5 (MHI-5)
    Description
    Mental Health Index- 5 to determine patient mental health status
    Time Frame
    6 months compared to baseline score
    Title
    Change in Short Form- 36 (SF-36)
    Description
    Short Form Survey- 36 to determine general overall health for patient
    Time Frame
    6 months compared to baseline score
    Title
    Change in Visual Analog Scale Pain (VAS-Pain)
    Description
    Visual analog scale- pain to assess shoulder pain
    Time Frame
    6 months compared to baseline score

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical Diagnosis of Adhesive Capsulitis (limited range of motion) Given glenohumeral and subacromial injection as part of standard care. Capacity to conduct home exercise program or physical therapy (based upon physician judgment, proximity to physical therapy office and as decided by patient) English speaking 18 years of age or greater Exclusion Criteria: Prior glenohumeral or subacromial corticosteroid injection within 6 months Prior ipsilateral shoulder surgery Current prescription (narcotic) pain medication use Pain disorder (ex. Fibromyalgia, Reflex Sympathetic Dystrophy) Cervical radiculopathy Full-thickness rotator cuff tear Calcific Tendinopathy (past or present) Advanced Stage osteoarthritis as seen on radiograph Past/present ipsilateral shoulder fracture 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xinning Li, MD
    Organizational Affiliation
    Boston Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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