Adhesive CapsulitisNCT03049787
Formal Physical Therapy (PT) vs. Home PT for Adhesive Capsulitis
A study testing Home Exercise Protocol and Physical Therapy Protocol in people with Adhesive Capsulitis, run by Boston Medical Center.
Trial summary
This study aims to evaluate physical therapy (standard of care) and home exercise vs. home exercise alone for the treatment of adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Home Exercise Protocol and Physical Therapy Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
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
This study aims to evaluate physical therapy (standard of care) and home exercise vs. home exercise alone for the treatment of adhesive capsulitis.
Read the 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.
- Conditions
- Adhesive Capsulitis
- Being tested
- Home Exercise Protocol, Physical Therapy Protocol
- Keywords
- physical therapy, home exercise, adhesive capsulitis
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise ProtocolOther
Home exercise therapy protocol given to patient to be completed at home.
Physical Therapy ProtocolOther
Formal physical therapy protocol to be given to physical therapist working with patient to direct formal intervention along with a home therapy protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical Therapy Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain and Disability Index(SPADI)
shoulder pain and disability index to evaluate shoulder pain and function
Measured: 6 months compared to baseline score
Secondary outcomes (5)
Change in Range of Motion (ROM)
evaluate range of motion
Measured: 6 months compared to baseline score
Change in Sane Normal and Pain Visual Analogue Score (SANE)
Subjective shoulder score to determine shoulder pain/function
Measured: 6 months compared to baseline score
Change in Mental Health Index- 5 (MHI-5)
Mental Health Index- 5 to determine patient mental health status
Measured: 6 months compared to baseline score
Change in Short Form- 36 (SF-36)
Short Form Survey- 36 to determine general overall health for patient
Measured: 6 months compared to baseline score
Change in Visual Analog Scale Pain (VAS-Pain)
Visual analog scale- pain to assess shoulder pain
Measured: 6 months compared to baseline score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study startJun 2022 (estimated)
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Why it stopped: The study was never started as the PI was working on another clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Xinning Li, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049787
- Sponsor's protocol ID
- H-32842
- Status last verified
- Jun 2023
- First submitted
- 7 Jan 2017
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03049787
- Acronym / sponsor ID
- H-32842
- Conditions
- Adhesive Capsulitis
- Keywords
- physical therapy, home exercise, adhesive capsulitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never started as the PI was working on another clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Jun 2022 (estimated)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home exercise | Experimental | Other: Home Exercise ProtocolFor 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. |
| physical therapy | Active comparator | Other: Physical Therapy ProtocolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Exercise ProtocolHome exercise therapy protocol given to patient to be completed at home. | Other | home exercise |
| Physical Therapy ProtocolFormal physical therapy protocol to be given to physical therapist working with patient to direct formal intervention along with a home therapy protocol. | Other | physical therapy |
Primary outcome
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
5 secondary outcomes
Change in Range of Motion (ROM)
Time frame: 6 months compared to baseline score
Change in Sane Normal and Pain Visual Analogue Score (SANE)
Time frame: 6 months compared to baseline score
Change in Mental Health Index- 5 (MHI-5)
Time frame: 6 months compared to baseline score
Change in Short Form- 36 (SF-36)
Time frame: 6 months compared to baseline score
Change in Visual Analog Scale Pain (VAS-Pain)
Time frame: 6 months compared to baseline score
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinning Li, MD principal investigator
Boston Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Protocol and Physical Therapy Protocol in people with Adhesive Capsulitis, run by Boston Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Pain and Disability Index(SPADI) (time frame: 6 months compared to baseline score). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.