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Adhesive Capsulitis of the ShoulderNCT01961219

Manipulation Under Anesthesia Versus Arthroscopic Capsular Release in the Treatment of Adhesive Capsulitis

A study testing Manipulation Under Anesthesia and Arthroscopic capsular release in people with Adhesive Capsulitis of the Shoulder, run by Akin Cil at 1 site 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

Shoulder pain is one of the most common causes of musculoskeletal disability in the adult population. Adhesive capsulitis is one of a multitude of reasons that can cause shoulder pain and dysfunction. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Adhesive Capsulitis of the Shoulder
What is being tested?
Manipulation Under Anesthesia and Arthroscopic capsular release
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
Nov 2013to 25 Apr 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients must be diagnosed as having idiopathic adhesive capsulitis in the 'frozen' or 'thawing' phase of disease and have tried and failed at least 3 months of nonoperative therapy.
  • OR
  • patient with adhesive capsulitis who presents already in the 'frozen' or 'thawing' phase who demands a quicker return to function and will not try 3 months of nonoperative therapy first.
  • Age 18 or older

Who cannot join

  • pregnancy
  • previously operated shoulder (same side)
  • other documented source of shoulder pain and stiffness (same side)
  • rotator cuff tear (same side)
  • glenohumeral osteoarthritis (same side)
  • calcific tendonitis (same side)
Show all 13Show fewer
  • impingement (same side)
  • osteonecrosis
  • neoplasm
  • cervical radiculopathy
  • patients who are medically unfit to undergo a general anesthetic
  • patients who are unable to comply with the post-operative protocol
  • non-English Speaking patients

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Truman Medical Centers

    Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Manipulation Under Anesthesia Versus Arthroscopic Capsular Release in the Treatment of Adhesive Capsulitis: A Comparison.

Shoulder pain is one of the most common causes of musculoskeletal disability in the adult population. Adhesive capsulitis is one of a multitude of reasons that can cause shoulder pain and dysfunction. It is a painful and disabling condition that can cause frustration for patients and caregivers due to slow recovery time. It is important to meticulously diagnose the source of the symptoms. Adhesive capsulitis is treatment by non-operative therapies such as physical therapy, exercise, steroids \& pain medications. For some patients a quicker return to function is necessary; in th is situation an operative treatment is an option. This study will compare two surgical techniques for adhesive capsulitis.

Purpose

  1. To directly compare outcomes of patients with adhesive capsulitis who have failed pain management and failed improvement in range of motion after at least 3 months of supervised, regimented conservative treatment and have subsequently been randomized to either closed manipulation under anesthesia or arthroscopic capsular release.
  2. To blind both patient and assessing physician/nurse study coordinator to the treatment that was received for the duration of the study. This will reduce the effect of any potential bias on the results as much as possible.
  3. To collect outcome data, both subjectively from the patient using proven outcome measures, and objectively from regularly spaced follow up visits with blinded assessors.
  4. To collect and comment on data from the two treatment groups regarding duration of post-operative narcotic use, duration of post-operative physical therapy required, post-operative pain levels, and elapsed time until back to work/activity post-operatively.
Read the detailed description

Shoulder pain is one of the most common causes of musculoskeletal disability in the adult population. Adhesive capsulitis is one of a multitude of pathologic entities that can cause shoulder pain and dysfunction. The condition is seen frequently in the clinics of primary care providers and orthopedic surgeons. Patients who develop adhesive capsulitis will typically present with complaints of pain and a progressive loss of active and passive motion of the shoulder.

The disease course of adhesive capsulitis has been extensively studied. Despite this, controversy remains as to the natural history of the disease. It is generally believed that adhesive capsulitis is a self-limiting process typically lasting twelve to thirty-six months. In one retrospective study of 50 patients with 10 year follow up, Miller et al7 found significant improvement in range of motion and resolution of pain in all patients treated conservatively. In another study, it was shown that 90% of patients treated with a stretching exercise program alone reported satisfactory outcomes at a mean follow up of 22 months8. This would mean that up to 10% of patients suffer from long-term problems. Shaffer et al9, however, reported that 50% of patients treated nonoperatively still complained of some residual pain, stiffness, or both at an average follow up of 7 years. Despite evidence that the disease improves without any intervention, many patients do not want to wait potentially as long as two to three years for resolution. For these patients, it is not unreasonable to proceed with interventions aimed at resolution of pain and improvement of motion. Levine et al10 provided some insight into predicting which patients might benefit most from proceeding with surgery. He found that patients who report more severe symptoms, are younger in age at symptom onset, and continue to have a reduction in motion after at least four months of physical therapy were more likely to eventually require surgery.

The course of progression of untreated adhesive capsulitis is described as a continuum of three clinical phases4. The first phase is characterized by pain and is termed the 'freezing' phase. In this phase, patients experience a gradual onset of diffuse shoulder pain that is progressive over a course of weeks to months. In general, pain will begin before any restriction of motion. Patients may report pain at night and often relate difficulty sleeping on the affected side. As use of the arm decreases secondary to pain, stiffness begins to set in. Phase two is characterized by stiffness and is known as the 'frozen' phase. This phase may last four to twelve months. Patients will see their pain slowly decrease, however, the limitation in motion continually increases. Phase three is known as the 'thawing' phase and may last from five to twenty-six months. This is characterized by resolution of pain and slow improvement in range of motion. Most authors agree that a longer 'freezing' phase is associated with a longer 'thawing' phase.

Adhesive capsulitis is initially treated with nonoperative therapies. The goals of conservative management are control of pain and improvement or maintenance of range of motion. Nonsteroidal anti-inflammatory medications may be prescribed to help control pain. Physical therapy with or without a home exercise program is always employed. This should be done in a gentle manner and without causing too much pain. Treatment with oral or injectable corticosteroids makes theoretical sense given the proven inflammatory nature of the condition. Studies examining treatment with oral steroids versus placebo or no treatment have yielded only short-term improvement of a few weeks. No improvement has been shown at long-term follow up of six to eight months1. There have also been many studies examining the role of intra-articular steroid injections in the treatment of adhesive capsulitis. Similarly, these studies have also shown short term (3weeks) improvement in pain and function but this improvement does not hold up at longer follow up (3-6 months)1. Jones et al11 looked at the role of suprascapular nerve blocks as a treatment option and found significant improvement in pain and shoulder range of motion at three months follow up compared to the group of patients receiving an intra-articular injection of corticosteroid. This suggests a benefit in the short-term but there is no long-term data to reveal if this improvement is lasting. Limited investigation has been performed to determine a role for hydrodilation as a viable treatment option. This involves injection of enough fluid intra-articularly to cause capsular rupture. No level I studies have been performed and only one level II study has been done which suggests some improvement in pain and Constant score up to six months1. Closed Manipulation Under Anesthesia (MUA) has been tested in short and long-term follow up and is proven to be a beneficial tool in the treatment of adhesive capsulitis in patients who have failed other nonoperative therapies. In a report on the results of MUA performed for patients with stage 2 adhesive capsulitis, Dodenhoff et al12 reported that 94% were satisfied with the procedure at mean follow up of 11 months. In a look at long-term outcomes of MUA, Farrell et al13 showed improvement in pain and motion that was continued at an average of 15 year follow up via patient questionnaire. There has been a recent trend toward arthroscopic capsular release in the treatment of refractory adhesive capsulitis and this treatment option has now become more popular than MUA. This rise in popularity of arthroscopic capsular release has occurred because of the perceived benefits of improved outcome and lower risk of complications even though there have not been any higher level trials comparing the two options. Ogilvie-Harris et al14, in a level III study, reported on a cohort of his patients treated with arthroscopic capsular release. He noted that his patients were twice as likely to be pain free at 2 year follow up as a similar cohort who underwent manipulation under anesthesia. Pollock et al15 reported in a level IV study, 83% excellent or satisfactory results after arthroscopic debridement of the rotator interval had been performed concomitantly with MUA. Warner et al16 was able to demonstrate significant improvement in all of his patients treated with arthroscopic capsular release who had failed MUA. This level IV study was performed on patients being treated for postoperative shoulder stiffness, however; not adhesive capsulitis. Both surgical methods (MUA and arthroscopic capsular release are used in our practice.

Being tested
Manipulation Under Anesthesia, Arthroscopic capsular release
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manipulation Under AnesthesiaProcedure or surgery

    Also called MUA

    Closed manipulation under anesthesia.

  • Arthroscopic capsular releaseProcedure or surgery

    Arthroscopic capsular release

Study groups in NCT01961219
Study groupRoleWhat they receive
Adhesive Capsulitis with MUAActive comparatorSubjects with idiopathic adhesive capsulitis in the "frozen" or "thawing" phase who have failed pain management and failed improvement in range of motion after at least 3 months of supervised, regimented conservative treatment; or who after less than 3 months of conservative treatment demand a quicker return to function. Treatment closed manipulation under anesthesia.
Receives: Procedure: Manipulation Under Anesthesia
Adhesive Capsulitis with ArthroscopyActive comparatorSubjects with idiopathic adhesive capsulitis in the "frozen" or "thawing" phase who have failed pain management and failed improvement in range of motion after at least 3 months of supervised, regimented conservative treatment; or who after less than 3 months of conservative treatment demand a quicker return to function. Treatment Arthroscopic Capsular Release
Receives: Procedure: Arthroscopic capsular release

What is being measured

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

  1. quick Disabilities of the arm, shoulder, and hand (quickDASH) score.

    The primary analysis will compare the quickDASH score at the twelve month evaluation between closed manipulation under anesthesia and arthroscopic capsular release using analysis of covariance using the baseline assessment of quickDASH ast he covariate

    Measured: 12 months post-operatively

Secondary outcomes (5)
  1. quickDASH score

    Secondary analysis will look at all longitudinal evaluation time points of quickDASH using a mixed linear regression model to account for correlations across subjects at multiple time points.

    Measured: 2 weeks post-operatively

  2. quickDASH score

    Secondary analysis will look at all longitudinal evaluation time points of quickDASH using a mixed linear regression model to account for correlations across subjects at multiple time points.

    Measured: 4 weeks post-operatively

  3. quickDASH score

    Secondary analysis will look at all longitudinal evaluation time points of quickDASH using a mixed linear regression model to account for correlations across subjects at multiple time points.

    Measured: 6 weeks post-operatively

  4. quickDASH score

    Secondary analysis will look at all longitudinal evaluation time points of quickDASH using a mixed linear regression model to account for correlations across subjects at multiple time points.

    Measured: 12 weeks post-operatively

  5. quickDASH

    Secondary analysis will look at all longitudinal evaluation time points of quickDASH using a mixed linear regression model to account for correlations across subjects at multiple time points.

    Measured: 6 months post-operatively

Timeline

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

  1. First posted11 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completion25 Apr 2022
  4. Study completion25 Apr 2022

Why it stopped: insufficent enrollment

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01961219
Sponsor's protocol ID
13-775
Status last verified
Oct 2023
First submitted
4 Oct 2013
Last updated
2 Nov 2023
Results posted
No
Data monitoring committee
No

Publications

  • Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.

    PubMed 20110457
  • Neviaser JS: Adhesive capsulitis of the shoulder. JBJS 1945;27:211-222.

  • Neviaser RJ, Neviaser TJ. The frozen shoulder. Diagnosis and management. Clin Orthop Relat Res. 1987 Oct;(223):59-64.

    PubMed 3652593
  • Emig EW, Schweitzer ME, Karasick D, Lubowitz J. Adhesive capsulitis of the shoulder: MR diagnosis. AJR Am J Roentgenol. 1995 Jun;164(6):1457-9. doi: 10.2214/ajr.164.6.7754892.

    PubMed 7754892
  • Sofka CM, Ciavarra GA, Hannafin JA, Cordasco FA, Potter HG. Magnetic resonance imaging of adhesive capsulitis: correlation with clinical staging. HSS J. 2008 Sep;4(2):164-9. doi: 10.1007/s11420-008-9088-1. Epub 2008 Aug 20.

    PubMed 18815860
  • Miller MD, Wirth MA, Rockwood CA Jr. Thawing the frozen shoulder: the "patient" patient. Orthopedics. 1996 Oct;19(10):849-53. doi: 10.3928/0147-7447-19961001-06.

    PubMed 8905857
  • Griggs SM, Ahn A, Green A. Idiopathic adhesive capsulitis. A prospective functional outcome study of nonoperative treatment. J Bone Joint Surg Am. 2000 Oct;82(10):1398-407.

    PubMed 11057467
  • Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992 Jun;74(5):738-46.

    PubMed 1624489
  • Levine WN, Kashyap CP, Bak SF, Ahmad CS, Blaine TA, Bigliani LU. Nonoperative management of idiopathic adhesive capsulitis. J Shoulder Elbow Surg. 2007 Sep-Oct;16(5):569-73. doi: 10.1016/j.jse.2006.12.007. Epub 2007 May 24.

    PubMed 17531513
  • Jones DS, Chattopadhyay C. Suprascapular nerve block for the treatment of frozen shoulder in primary care: a randomized trial. Br J Gen Pract. 1999 Jan;49(438):39-41.

    PubMed 10622015
  • Dodenhoff RM, Levy O, Wilson A, Copeland SA. Manipulation under anesthesia for primary frozen shoulder: effect on early recovery and return to activity. J Shoulder Elbow Surg. 2000 Jan-Feb;9(1):23-6. doi: 10.1016/s1058-2746(00)90005-3.

    PubMed 10717858
  • Farrell 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 16194738
  • Ogilvie-Harris DJ, Biggs DJ, Fitsialos DP, MacKay M. The resistant frozen shoulder. Manipulation versus arthroscopic release. Clin Orthop Relat Res. 1995 Oct;(319):238-48.

    PubMed 7554636
  • 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 AA, Marks PH, Wong P. Arthroscopic release of postoperative capsular contracture of the shoulder. J Bone Joint Surg Am. 1997 Aug;79(8):1151-8. doi: 10.2106/00004623-199708000-00006.

    PubMed 9278074

Questions about this trial

What is this clinical trial studying?

A study testing Manipulation Under Anesthesia and Arthroscopic capsular release in people with Adhesive Capsulitis of the Shoulder, run by Akin Cil 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 4 inclusion and 13 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 2 Nov 2023. 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: insufficent enrollment). 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?

quick Disabilities of the arm, shoulder, and hand (quickDASH) score. (time frame: 12 months post-operatively). 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 NCT01961219, which also lists 26 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 2 Nov 2023.

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