Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder

NCT04549051 | Completed Results DMC FDA Device

• 1 other identifier: 2020-11998
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous Interruption of the Coracohumeral Ligament for the treatment of Frozen Shoulder.

Conditions

Adhesive Capsulitis

Outcome Measures

Primary Outcomes (1)

• Comparison of Range of Motion of the Shoulder

  Change in shoulder range of motion (ROM) (external rotation and abduction) procedure by at least 100%, measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.

  Immediately following procedure, up to 60 minutes

Secondary Outcomes (6)

• Durability of Local Anesthetic - Change in Range Of Motion (ROM)

  Baseline (Before the procedure) and at 1 month

• Durability of the TENEX - Change in Range Of Motion (ROM)

  Immediately after the procedure and at the long term follow-up (10 months to 2 years)

• Change of Pain Intensity Score for Local Anesthetic Group

  at the Baseline visit (Before the procedure) and at the 1-month visit

• Change of Pain Intensity Score for TENEX Group

  at the Baseline visit (before the procedure) and at the long-term follow-up (10 months to 2 years)

• Change of the Oxford Shoulder Score for Local Anesthetic Group

  at the baseline (before the procedure) and at the 1-month visit

Study Arms (2)

Tenex plus local anesthetic

EXPERIMENTAL

Use of the TENEX device for sectioning of the CHL

Device: Tenex; Drug: Local anesthetic

Local Anesthetic

OTHER

Only Local anesthetic will be injected into the CHL. This arm will have the option to cross over into Tenex arm at 1 month

Drug: Local anesthetic

Interventions

Tenex DEVICE

Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis

Tenex plus local anesthetic

Local anesthetic DRUG

Only local anesthetic into the coracohumeral ligament for adhesive capsulitis

Local Anesthetic; Tenex plus local anesthetic

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established Diagnosis of Adhesive capsulitis (AC) Ligament Flavum \>3mm, diagnosed by US evaluation decreased shoulder ROM in external rotation and abduction (50% of unaffected side)
• Patients who have tried other conventional therapies like steroid treatments, surgical treatments, physiotherapy with little (defined by less than 20 degrees improvement in shoulder ROM - external rotation) to no improvement in the shoulder ROM

You may not qualify if:

• Age less than 18 years and greater than 89 years
• Patients with AC but showing improvement in shoulder ROM progressively (defined by improvement in ROM \> 200 external rotation or 20 degrees per week when undergoing physiotherapy)
• Patients who are currently pregnant

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Montefiore Medical Center

New York, New York, 10461, United States

Location

Related Publications (16)

• Wu CH, Chen WS, Wang TG. Elasticity of the Coracohumeral Ligament in Patients with Adhesive Capsulitis of the Shoulder. Radiology. 2016 Feb;278(2):458-64. doi: 10.1148/radiol.2015150888. Epub 2015 Aug 31.

  PMID: 26323030 BACKGROUND

• Mengiardi B, Pfirrmann CW, Gerber C, Hodler J, Zanetti M. Frozen shoulder: MR arthrographic findings. Radiology. 2004 Nov;233(2):486-92. doi: 10.1148/radiol.2332031219. Epub 2004 Sep 9.

  PMID: 15358849 BACKGROUND

• Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.

  PMID: 16356983 BACKGROUND

• Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7.

  PMID: 28405218 BACKGROUND

• Maund E, Craig D, Suekarran S, Neilson A, Wright K, Brealey S, Dennis L, Goodchild L, Hanchard N, Rangan A, Richardson G, Robertson J, McDaid C. Management of frozen shoulder: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2012;16(11):1-264. doi: 10.3310/hta16110.

  PMID: 22405512 BACKGROUND

• Hagiwara Y, Sekiguchi T, Ando A, Kanazawa K, Koide M, Hamada J, Yabe Y, Yoshida S, Itoi E. Effects of Arthroscopic Coracohumeral Ligament Release on Range of Motion for Patients with Frozen Shoulder. Open Orthop J. 2018 Sep 18;12:373-379. doi: 10.2174/1874325001812010373. eCollection 2018.

  PMID: 30288192 BACKGROUND

• Yukata K, Goto T, Sakai T, Fujii H, Hamawaki J, Yasui N. Ultrasound-guided coracohumeral ligament release. Orthop Traumatol Surg Res. 2018 Oct;104(6):823-827. doi: 10.1016/j.otsr.2018.01.016. Epub 2018 Mar 19.

  PMID: 29567320 BACKGROUND

• Austgulen OK, Oyen J, Hegna J, Solheim E. [Arthroscopic capsular release in treatment of primary frozen shoulder]. Tidsskr Nor Laegeforen. 2007 May 17;127(10):1356-8. Norwegian.

  PMID: 17519989 BACKGROUND

• Chen SK, Chien SH, Fu YC, Huang PJ, Chou PH. Idiopathic frozen shoulder treated by arthroscopic brisement. Kaohsiung J Med Sci. 2002 Jun;18(6):289-94.

  PMID: 12355929 BACKGROUND

• Sanchez PJ, Grady JF, Saxena A. Percutaneous Ultrasonic Tenotomy for Achilles Tendinopathy Is a Surgical Procedure With Similar Complications. J Foot Ankle Surg. 2017 Sep-Oct;56(5):982-984. doi: 10.1053/j.jfas.2017.06.015.

  PMID: 28842108 BACKGROUND

• Kamineni S, Butterfield T, Sinai A. Percutaneous ultrasonic debridement of tendinopathy-a pilot Achilles rabbit model. J Orthop Surg Res. 2015 May 20;10:70. doi: 10.1186/s13018-015-0207-7.

  PMID: 25986341 BACKGROUND

• Chimenti RL, Stover DW, Fick BS, Hall MM. Percutaneous Ultrasonic Tenotomy Reduces Insertional Achilles Tendinopathy Pain With High Patient Satisfaction and a Low Complication Rate. J Ultrasound Med. 2019 Jun;38(6):1629-1635. doi: 10.1002/jum.14835. Epub 2018 Oct 2.

  PMID: 30280399 BACKGROUND

• Barnes DE, Beckley JM, Smith J. Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study. J Shoulder Elbow Surg. 2015 Jan;24(1):67-73. doi: 10.1016/j.jse.2014.07.017. Epub 2014 Oct 8.

  PMID: 25306494 BACKGROUND

• Koh JS, Mohan PC, Howe TS, Lee BP, Chia SL, Yang Z, Morrey BF. Fasciotomy and surgical tenotomy for recalcitrant lateral elbow tendinopathy: early clinical experience with a novel device for minimally invasive percutaneous microresection. Am J Sports Med. 2013 Mar;41(3):636-44. doi: 10.1177/0363546512470625. Epub 2013 Jan 9.

  PMID: 23302261 BACKGROUND

• Zhu J, Hu B, Xing C, Li J. Ultrasound-guided, minimally invasive, percutaneous needle puncture treatment for tennis elbow. Adv Ther. 2008 Oct;25(10):1031-6. doi: 10.1007/s12325-008-0099-6.

  PMID: 18791678 BACKGROUND

• Homsi C, Bordalo-Rodrigues M, da Silva JJ, Stump XM. Ultrasound in adhesive capsulitis of the shoulder: is assessment of the coracohumeral ligament a valuable diagnostic tool? Skeletal Radiol. 2006 Sep;35(9):673-8. doi: 10.1007/s00256-006-0136-y. Epub 2006 May 25.

  PMID: 16724200 BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Limitations and Caveats

This study represents a small population of patients with a CHL-related ROM deficit.

Results Point of Contact

• Title: Sayed Wahezi, M.D.
• Organization: Albert Einstein College of Medicine

swahezi@montefiore.org

718-920-7246

Study Officials

• Sayed Wahezi, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: November 17, 2020
• Primary Completion: March 16, 2022
• Study Completion: January 19, 2023
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)