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

The Effectiveness of Traditional Physical Therapy Versus Home Exercise in Conjunction With Glenohumeral and Subacromial Corticosteroid Injection for the Treatment of Shoulder Adhesive Capsulitis

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03049787
Enrollment
0
Registered
2017-02-10
Start date
2022-06-30
Completion date
2022-07-30
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis

Keywords

physical therapy, home exercise, adhesive capsulitis

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.

Interventions

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

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

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Shoulder Pain and Disability Index(SPADI)6 months compared to baseline scoreshoulder pain and disability index to evaluate shoulder pain and function

Secondary

MeasureTime frameDescription
Change in Short Form- 36 (SF-36)6 months compared to baseline scoreShort Form Survey- 36 to determine general overall health for patient
Change in Visual Analog Scale Pain (VAS-Pain)6 months compared to baseline scoreVisual analog scale- pain to assess shoulder pain
Change in Range of Motion (ROM)6 months compared to baseline scoreevaluate range of motion
Change in Sane Normal and Pain Visual Analogue Score (SANE)6 months compared to baseline scoreSubjective shoulder score to determine shoulder pain/function
Change in Mental Health Index- 5 (MHI-5)6 months compared to baseline scoreMental Health Index- 5 to determine patient mental health status

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026