Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Helse Fonna | OTHER |
| Oslo University Hospital | OTHER |
| Sykehuset i Vestfold HF | OTHER |
| Haraldsplass Deaconess Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether the combination of removal of the calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection is more effective than corticosteroid or sham injection alone.
Barbotage is a sonographically guided percutaneous needle aspiration and lavage of the calcium deposit in calcific tendinitis of the shoulder. Persisting pain in cacific tendinitis is considered to be a consequence of increased tendon volume or changed tendon texture in the area of the calcification which leads to secondary impingement and inflammation. Consequently, removal of the deposit should be a causal treatment measure.
Scientific evidence for the efficacy of the barbotage procedure in patients with persistent symptoms from calcific tendinitis is still limited. The cyclic often self-limiting course of the disease, and an anticipated placebo effect, questions about the method's efficacy can only be answered by high-quality randomized studies. In this trial the investigators want to randomize a cohort of patients to (1) Ultrasound guided needling, lavage and subacromial steroid injection, (2) Ultrasound guided subacromial steroid injection or (3) Ultrasound guided lidocain injection (sham). The investigators want to follow the patients over two years with repeated testing with a set of validated outcome measures together with radiologic re-examinations. The investigators want to find out whether the active treatments (1, 2) are more effective than the sham treatment and whether there are differences in outcome between the two active treatments. To increase the generalizability of the investigators' results, the investigators want to perform the study as a multi-centre study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Barbotage | Experimental | Ultrasound guided needling, lavage and steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises |
|
| Corticosteroid injection | Active Comparator | Ultrasound guided steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) and home exercises |
|
| Lidocain injection (sham) | Sham Comparator | Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barbotage | Procedure | A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Shoulder Score | Shoulder pain and disability | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Shoulder Score | Shoulder pain and disability | after 2 and 6 weeks, and 8, 12 and 24 months |
| QuickDASH Disability of shoulder, arm and hand | Shoulder pain and disability |
| Measure | Description | Time Frame |
|---|---|---|
| Size of calcific deposits | Measured in millimeter AP radiographs | 4 and 24 months |
| Volume of removed calcific deposit | Volume of removed calcific deposit in milliliter |
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stefan Moosmayer, MD, PhD | MHH Martine Hansens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martina Hansen's Hospital | Sandvika | 1306 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28376756 | Background | Moosmayer S, Ekeberg OM, Hallgren HB, Heier I, Kvalheim S, Blomquist J, Pripp AH, Juel NG, Kjellevold SH, Brox JI; KALK study group. KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study. BMC Musculoskelet Disord. 2017 Apr 4;18(1):138. doi: 10.1186/s12891-017-1501-9. | |
| 37821118 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D052256 | Tendinopathy |
| D002114 | Calcinosis |
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| OTHER |
| University Hospital, Linkoeping | OTHER |
Not provided
Not provided
Not provided
Not provided
|
|
| Corticosteroid injection | Procedure | The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises. |
|
|
| Lidocain injection (sham) | Procedure | The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 10 ml of 1% Lidocain hydrochlorid will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises. |
|
|
| after 2 and 6 weeks, and 4, 8, 12 and 24 months |
| EQ 5D-5L | Health related quality of life | 4, 8, 12 and 24 months |
| Cross-over of patients | number of patients crossing over to other group or other treatment | 4, 8, 12 and 24 months |
| Adverse-events | Patient reported adverse events | 2 and 6 weeks, and 4 months |
| Baseline |
| Background |
| Robinson DM, McInnis KC, Rhim HC, Tsitsilianos N. Lavage treatments for calcific rotator cuff tendinopathy. BMJ. 2023 Oct 11;383:2248. doi: 10.1136/bmj.p2248. No abstract available. |
| 37821122 | Result | Moosmayer S, Ekeberg OM, Hallgren HB, Heier I, Kvalheim S, Juel NG, Blomquist J, Pripp AH, Brox JI. Ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder: randomised double blinded multi-arm study. BMJ. 2023 Oct 11;383:e076447. doi: 10.1136/bmj-2023-076447. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000070599 | Shoulder Injuries |