Adhesive CapsulitisNCT01874821
Adhesive Capsulitis and Dynamic Splinting
A study testing Dynasplint in people with Adhesive Capsulitis, run by Dynasplint Systems, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of dynamic splinting in reducing contracture following diagnosis of adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Dynasplint
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 25% reduction in maximal external rotation plus greater than 25% reduction in at least one other plane of motion (elevation or abduction), as compared to the asymptomatic shoulder, measure supine with humerus abducted to 90º
- Duration from onset less than 12 months.
- Pain that is worsened by moving the arm in that direction
Who cannot join
- Any previous shoulder surgery.
- Brachial plexus injuries
- Neurologically mediated pain and fibromatosis-like contracture
- Concomitant neurologic complaints or abnormalities
- Glenohumeral impingement or mechanical blockage
- Oncological process affecting the shoulder
- Previous total mastectomy
- Glenohumeral arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adhesive Capsulitis and Dynamic Splinting: a Randomized, Controlled Trial
The purpose of this study is to examine the efficacy of dynamic splinting in reducing contracture following diagnosis of adhesive capsulitis.
Read the detailed description
This randomized controlled trial will explore the efficacy of dynamic splinting in conjunction with the current standard of care as compared to standard of care alone.
- Conditions
- Adhesive Capsulitis
- Being tested
- Dynasplint, Standard of Care
- Keywords
- Frozen Shoulder, Adhesive Capsulitis, ROM, Dynasplint
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynasplintDevice
Also called Shoulder
Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen
Standard of CareOther
The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Dynasplint | Experimental | Along with standard manual physical therapy, patients will have a stretching device (Dynasplint) used in rehabilitation to regain ROM in stiff joints. Patients will use this device 20-30 minutes 2 times per day at home. Receives: Device: Dynasplint; Other: Standard of Care |
| Control | Other | Patient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
Why it stopped: Unrelated to trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynasplint Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874821
- Sponsor's protocol ID
- 2010.005
- Other IDs
- SHD
- Status last verified
- Aug 2013
- First submitted
- 7 Jun 2013
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Baums MH, Spahn G, Nozaki M, Steckel H, Schultz W, Klinger HM. Functional outcome and general health status in patients after arthroscopic release in adhesive capsulitis. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):638-44. doi: 10.1007/s00167-006-0203-x. Epub 2006 Oct 10.
PubMed 17031613Castellarin G, Ricci M, Vedovi E, Vecchini E, Sembenini P, Marangon A, Vangelista A. Manipulation and arthroscopy under general anesthesia and early rehabilitative treatment for frozen shoulders. Arch Phys Med Rehabil. 2004 Aug;85(8):1236-40. doi: 10.1016/j.apmr.2003.12.032.
PubMed 15295746Farrell CM, Sperling JW, Cofield RH. Manipulation for frozen shoulder: long-term results. J Shoulder Elbow Surg. 2005 Sep-Oct;14(5):480-4. doi: 10.1016/j.jse.2005.02.012.
PubMed 16194738Hsu AT, Hedman T, Chang JH, Vo C, Ho L, Ho S, Chang GL. Changes in abduction and rotation range of motion in response to simulated dorsal and ventral translational mobilization of the glenohumeral joint. Phys Ther. 2002 Jun;82(6):544-56.
PubMed 12036396Rundquist PJ, Anderson DD, Guanche CA, Ludewig PM. Shoulder kinematics in subjects with frozen shoulder. Arch Phys Med Rehabil. 2003 Oct;84(10):1473-9. doi: 10.1016/s0003-9993(03)00359-9.
PubMed 14586914Vermeulen HM, Rozing PM, Obermann WR, le Cessie S, Vliet Vlieland TP. Comparison of high-grade and low-grade mobilization techniques in the management of adhesive capsulitis of the shoulder: randomized controlled trial. Phys Ther. 2006 Mar;86(3):355-68.
PubMed 16506872
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adhesive Capsulitis and Dynamic Splinting: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01874821
- Acronym / sponsor ID
- 2010.005
- Conditions
- Adhesive Capsulitis
- Keywords
- Frozen Shoulder, Adhesive Capsulitis, ROM, Dynasplint
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unrelated to trial
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dynasplint Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 11 Jun 2013 (estimated)
- 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.
The purpose of this study is to examine the efficacy of dynamic splinting in reducing contracture following diagnosis of adhesive capsulitis.
Detailed description
This randomized controlled trial will explore the efficacy of dynamic splinting in conjunction with the current standard of care as compared to standard of care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynasplint | Experimental | Device: Dynasplint, Other: Standard of CareAlong with standard manual physical therapy, patients will have a stretching device (Dynasplint) used in rehabilitation to regain ROM in stiff joints. Patients will use this device 20-30 minutes 2 times per day at home. |
| Control | Other | Other: Standard of CarePatient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 25% reduction in maximal external rotation plus greater than 25% reduction in at least one other plane of motion (elevation or abduction), as compared to the asymptomatic shoulder, measure supine with humerus abducted to 90º
- Duration from onset less than 12 months.
- Pain that is worsened by moving the arm in that direction
Key exclusion criteria (8 listed)
- Any previous shoulder surgery.
- Brachial plexus injuries
- Neurologically mediated pain and fibromatosis-like contracture
- Concomitant neurologic complaints or abnormalities
- Glenohumeral impingement or mechanical blockage
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 |
|---|---|---|
| DynasplintAlso: ShoulderDynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen | Device | Dynasplint |
| Standard of CareThe current Standard of Care for treating this condition includes corticosteroid injections and physical therapy. | Other | Control, Dynasplint |
Primary outcome
Efficacy
Time frame: 6 months
The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH).
Results and safety
The study was stopped early (reason given: Unrelated to trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Background: PubMed 17031613Baums MH, Spahn G, Nozaki M, Steckel H, Schultz W, Klinger HM. Functional outcome and general health status in patients after arthroscopic release in adhesive capsulitis. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):638-44. doi: 10.1007/s00167-006-0203-x. Epub 2006 Oct 10.
- Background: PubMed 15295746Castellarin G, Ricci M, Vedovi E, Vecchini E, Sembenini P, Marangon A, Vangelista A. Manipulation and arthroscopy under general anesthesia and early rehabilitative treatment for frozen shoulders. Arch Phys Med Rehabil. 2004 Aug;85(8):1236-40. doi: 10.1016/j.apmr.2003.12.032.
- Background: PubMed 16194738Farrell CM, Sperling JW, Cofield RH. Manipulation for frozen shoulder: long-term results. J Shoulder Elbow Surg. 2005 Sep-Oct;14(5):480-4. doi: 10.1016/j.jse.2005.02.012.
- Background: PubMed 12036396Hsu AT, Hedman T, Chang JH, Vo C, Ho L, Ho S, Chang GL. Changes in abduction and rotation range of motion in response to simulated dorsal and ventral translational mobilization of the glenohumeral joint. Phys Ther. 2002 Jun;82(6):544-56.
- Background: PubMed 14586914Rundquist PJ, Anderson DD, Guanche CA, Ludewig PM. Shoulder kinematics in subjects with frozen shoulder. Arch Phys Med Rehabil. 2003 Oct;84(10):1473-9. doi: 10.1016/s0003-9993(03)00359-9.
- Background: PubMed 16506872Vermeulen HM, Rozing PM, Obermann WR, le Cessie S, Vliet Vlieland TP. Comparison of high-grade and low-grade mobilization techniques in the management of adhesive capsulitis of the shoulder: randomized controlled trial. Phys Ther. 2006 Mar;86(3):355-68.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynasplint in people with Adhesive Capsulitis, run by Dynasplint Systems, Inc. at 1 site in United States.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Unrelated to trial). Results are not available in the source record.
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?
Efficacy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01874821, which also lists 6 linked publications.
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 12 Aug 2013.