N/A
N=46
Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder
Adhesive Capsulitis
Bottom Line
View on ClinicalTrials.gov: NCT04549051 ↗Enrolled (actual)
46
Serious AEs
8.7%
Results posted
May 2024
Primary outcome: Primary: Comparison of Range of Motion of the Shoulder — 61; 49; 80; 64 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tenex (Device); Local anesthetic (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Range of Motion of the Shoulder |
61; 49; 80; 64 | — |
| SECONDARY Durability of Local Anesthetic - Change in Range Of Motion (ROM) |
29; 32; 53; 57 | — |
| SECONDARY Durability of the TENEX - Change in Range Of Motion (ROM) |
63; 62; 78; 77 | — |
| SECONDARY Change of Pain Intensity Score for Local Anesthetic Group |
8; 8 | — |
| SECONDARY Change of Pain Intensity Score for TENEX Group |
8; 3 | — |
| SECONDARY Change of the Oxford Shoulder Score for Local Anesthetic Group |
10.8; 13.8 | — |
| SECONDARY Change of the Oxford Shoulder Score for TENEX Group |
7.4; 31.8 | — |
Summary
Percutaneous Interruption of the Coracohumeral Ligament for the treatment of Frozen Shoulder.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04549051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.