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Adhesive CapsulitisDS-SDHNCT00873158

Dynamic Splinting for Patients With Adhesive Capsulitis

A study testing Dynasplint in people with Adhesive Capsulitis, run by Dynasplint Systems, Inc. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to compare two treatments for adhesive capsulitis. Read more about this study

Who is it for?
Ages 40 to 64 years
Conditions the study is for
Adhesive Capsulitis
What is being tested?
Dynasplint
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesUnited States
Study dates
Jan 2006to Jan 2014
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 40 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of idiopathic adhesive capsulitis
  • greater than 50% limitation in active flexion, internal rotation, or external rotation
  • Tight GHJ capsule in at least 2 directions
  • Capsular end-feel primarily limits ROM
  • Age 40- 64
  • Normal X-Rays

Who cannot join

  • Acute adhesive capsulitis
  • History of Diabetes Mellitus
  • Evidence of a cuff tear
  • Recent history of trauma
  • Evidence of glenohumeral DJD
  • History of shoulder surgery
Show all 21Show fewer
  • Calcification of tendonitis demonstrated on a current X-Ray
  • Abnormal X-Ray
  • Cervical Radiculopathy/brachial plexus lesions
  • Less than 2+/5 muscle strength during mid-line manual muscle testing
  • Muscle Atrophy
  • Presence of associated systematic conditions
  • History of prior therapy for current condition
  • Manipulation under anesthesia
  • Non compliance
  • Shoulder-Hand syndrome, Complex Regional Pain Syndrome
  • History of prior injections for the current problem
  • Patient receiving worker's compensation
  • Shoulder symptoms with cervical provocative testing
  • Positive X-ray findings in the acromioclavicular or sternoclavicular joints
  • Abnormal physical signs or symptoms in the A-C or S-C joint

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Andrews Research & Education Institute

    Gulf Breeze, Florida, 32561

  • Gaspar Physical Therapy

    Solana Beach, California, 92075

  • University Orthopedics Center

    State College, Pennsylvania, 16801

Other trials in United States

About this study

Official title: Outcomes Following Dynamic Splinting and/or Physical Therapy for Patients With Adhesive Capsulitis

The purpose of this study is to compare two treatments for adhesive capsulitis.

Read the detailed description

The purpose of this study is to examine the effects of two treatment regimens for adhesive capsulitis: dynamic splinting and/or manual physical therapy.

Being tested
Dynasplint
Keywords
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

    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

Study groups in NCT00873158
Study groupRoleWhat they receive
Physical Therapy GroupNo interventionPatient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention
Dynasplint GroupExperimentalAlong 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of physical therapy treatments required

    Measured: throughout trial

  2. Weeks of Dynasplint treatment

    Measured: throughout trial

Secondary outcomes (3)

  1. Shoulder Range Of Motion

    Measured: initial consultation, first visit following injection, and monthly following injection

  2. Sharp FAS Neck and Shoulder

    Measured: initial consultation, immediatly prior to first treatment following injection, and monthly following injection

  3. Disabilities of Arm, Hand, and Shoulder Questionnaire

    Measured: initial visit, first visit following injection, and weekly until discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2009 (estimated)
  2. Study startJan 2006
  3. Primary completionJan 2014 (estimated)

Why it stopped: Unrelated to trial

Resources

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
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00873158
Sponsor's protocol ID
Shoulder 100
Acronym
DS-SDH
Status last verified
Aug 2013
First submitted
31 Mar 2009
Last updated
12 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Hamdan TA, Al-Essa KA. Manipulation under anaesthesia for the treatment of frozen shoulder. Int Orthop. 2003;27(2):107-9. doi: 10.1007/s00264-002-0397-6. Epub 2002 Sep 13.

    PubMed 12700935

  • Othman A, Taylor G. Manipulation under anaesthesia for frozen shoulder. Int Orthop. 2002;26(5):268-70. doi: 10.1007/s00264-002-0348-2. Epub 2002 Mar 27.

    PubMed 12378350

  • Placzek JD, Roubal PJ, Freeman DC, Kulig K, Nasser S, Pagett BT. Long-term effectiveness of translational manipulation for adhesive capsulitis. Clin Orthop Relat Res. 1998 Nov;(356):181-91. doi: 10.1097/00003086-199811000-00025.

    PubMed 9917683

  • Omari A, Bunker TD. Open surgical release for frozen shoulder: surgical findings and results of the release. J Shoulder Elbow Surg. 2001 Jul-Aug;10(4):353-7. doi: 10.1067/mse.2001.115986.

    PubMed 11517365

  • Pollock RG, Duralde XA, Flatow EL, Bigliani LU. The use of arthroscopy in the treatment of resistant frozen shoulder. Clin Orthop Relat Res. 1994 Jul;(304):30-6.

    PubMed 8020231

  • Warner JJ, Allen A, Marks PH, Wong P. Arthroscopic release for chronic, refractory adhesive capsulitis of the shoulder. J Bone Joint Surg Am. 1996 Dec;78(12):1808-16. doi: 10.2106/00004623-199612000-00003.

    PubMed 8986657

  • Carette S, Moffet H, Tardif J, Bessette L, Morin F, Fremont P, Bykerk V, Thorne C, Bell M, Bensen W, Blanchette C. Intraarticular corticosteroids, supervised physiotherapy, or a combination of the two in the treatment of adhesive capsulitis of the shoulder: a placebo-controlled trial. Arthritis Rheum. 2003 Mar;48(3):829-38. doi: 10.1002/art.10954.

    PubMed 12632439

  • Arslan S, Celiker R. Comparison of the efficacy of local corticosteroid injection and physical therapy for the treatment of adhesive capsulitis. Rheumatol Int. 2001 Sep;21(1):20-3. doi: 10.1007/s002960100127.

    PubMed 11678298

  • Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.

    PubMed 10738419

  • Vermeulen HM, Obermann WR, Burger BJ, Kok GJ, Rozing PM, van Den Ende CH. End-range mobilization techniques in adhesive capsulitis of the shoulder joint: A multiple-subject case report. Phys Ther. 2000 Dec;80(12):1204-13.

    PubMed 11087307

  • Hsu 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 12036396

  • Hsu AT, Ho L, Ho S, Hedman T. Joint position during anterior-posterior glide mobilization: its effect on glenohumeral abduction range of motion. Arch Phys Med Rehabil. 2000 Feb;81(2):210-4. doi: 10.1016/s0003-9993(00)90143-6.

    PubMed 10668777

  • Hsu AT, Ho L, Ho S, Hedman T. Immediate response of glenohumeral abduction range of motion to a caudally directed translational mobilization: a fresh cadaver simulation. Arch Phys Med Rehabil. 2000 Nov;81(11):1511-6. doi: 10.1053/apmr.2000.9389.

    PubMed 11083357

  • Kirkley A, Griffin S, Dainty K. Scoring systems for the functional assessment of the shoulder. Arthroscopy. 2003 Dec;19(10):1109-20. doi: 10.1016/j.arthro.2003.10.030.

    PubMed 14673454

  • Gaspar PD, Willis FB. Adhesive capsulitis and dynamic splinting: a controlled, cohort study. BMC Musculoskelet Disord. 2009 Sep 7;10:111. doi: 10.1186/1471-2474-10-111.

    PubMed 19735563

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 3 sites 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 6 inclusion and 21 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 3 sites 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?

Number of physical therapy treatments required (time frame: throughout trial). The study lists 2 primary outcomes in all. 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 NCT00873158, which also lists 15 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.

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DS-SDH Clinical Trial NCT00873158 | AzTrials