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

NCT03049787 | Withdrawn

• 1 other identifier: H-32842
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adhesive Capsulitis

Keywords

physical therapy; home exercise; adhesive capsulitis

Outcome Measures

Primary Outcomes (1)

• Change in Shoulder Pain and Disability Index(SPADI)

  shoulder pain and disability index to evaluate shoulder pain and function

  6 months compared to baseline score

Secondary Outcomes (5)

• Change in Range of Motion (ROM)

  6 months compared to baseline score

• Change in Sane Normal and Pain Visual Analogue Score (SANE)

  6 months compared to baseline score

• Change in Mental Health Index- 5 (MHI-5)

  6 months compared to baseline score

• Change in Short Form- 36 (SF-36)

  6 months compared to baseline score

• Change in Visual Analog Scale Pain (VAS-Pain)

  6 months compared to baseline score

Study Arms (2)

home exercise

EXPERIMENTAL

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

physical therapy

ACTIVE COMPARATOR

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

Interventions

Home Exercise Protocol OTHER

Home exercise therapy protocol given to patient to be completed at home.

home exercise

Physical Therapy Protocol OTHER

Formal physical therapy protocol to be given to physical therapist working with patient to direct formal intervention along with a home therapy protocol.

physical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or greater

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Medical Center: lead
• Brigham and Women's Hospital: collaborator

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Xinning Li, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2017
• First Posted: February 10, 2017
• Study Start: June 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share