|- candidate number||8530|
|- NTR Number||NTR2554|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-okt-2010|
|- Secondary IDs||NL30628.015.09 / 1001 CCMO / METC Maxima Medische Centrum Veldhoven|
|- Public Title||Het PRIC onderzoek 'Is poliklinische behandeling met aanprikken van de verkalking op korte termijn effectiever dan een kijkoperatie van de schouder?'|
|- Scientific Title||Dry needling and aspiration treatment versus arthroscopic shoulder decompression in patients with supraspinatus tendon calcification: A randomised clinical trial.
|- ACRONYM||The 'PRIC' study|
|- hypothesis||Dry Needling and Aspiration-treatment is more effective than arthroscopic subacromial decompression in patients with calcification of the supraspinatus tendon.|
|- Healt Condition(s) or Problem(s) studied||Supraspinatus tendon calcification|
|- Inclusion criteria||1. Patients of either sex who have been clinically diagnosed with shoulder impingement. Calcification of the supraspinatus tendon has to be confirmed with both radiography and diagnostic ultrasound;|
2. Integrity of the supraspinatus tendon;
3. Calcification diameter > 6 mm visible on a diagnostic radiograph less than six weeks old;
4. Patients may have calcification in one or both shoulders. For patients with bilateral calcifications, both shoulders will be included as separate cases;
5. Shoulder symptoms should be present > 6 months;
6. Non-surgical treatment other than dry needling or aspiration has failed to improve symptoms in the previous six months;
7. Patients over 18 years old;
8. Patients who are legally competent and able to understand the nature, scope and aim of the clinical investigation and have given written informed consent to participate;
9. Patients who are able and willing to return for follow-up evaluations.
|- Exclusion criteria||1. Patients with radiographic or diagnostic ultrasound confirmed calcification of the subacromial bursa or calcification of the subscapularis tendon;|
2. Previous shoulder surgery of any kind on the affected shoulder;
3. Total or partial rotator cuff rupture;
4. Shoulder instability;
5. Clinically verified acromioclavicular joint osteoarthritis;
6. Patients who received no non-surgical treatment for their shoulder symptoms;
7. Neurological symptoms or conditions (ie MS, Parkinson, CVA etc);
8. Injections in subacromial space in the previous three months;
9. Patients with psychosomatic complaints defined as a VAS-score for pain of ≥ 90mm;
10. Patients with very mild shoulder pain, defined as a VAS-score < 30mm;
11. Patients who report spontaneous improvement of their shoulder pain in the last days or weeks when their history is taken;
12. Patients not willing to consent or to return for follow up visits.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||4-okt-2010|
|- planned closingdate||31-dec-2011|
|- Target number of participants||111|
|- Interventions||The intervention group will be treated with DNA” (also known as barbotage) for calcification of the supraspinatus tendon. Patients are treated by an experienced radiologist. Patients are placed in a side lying position. First the calcification is located with use of ultrasound imaging. The entrance site is marked on the skin. Next, the skin is cleaned using chloorhexidine and a needle is inserted to deposit Lidocaļne 2% near the calcification providing a local anaesthetic to the patient. Following this, a 19 gauge treatment needle is inserted into the subacromial space directed at the supraspinatus tendon using ultrasound for guidance. When the tip of the needle is located at the calcification pressure is exerted with the tip of the needle to desintegrate the calcification. Force may be directed in several directions to desintegrate a maximum amount of calcium from the tendon. Extra pressure is exerted with saline directed to the calcification area. Average treatment duration is ten minutes. Finally a local deposit with 40 mg Depomedrol and 5 ml Marcaļne (0.25%) is left behind in the bursa. After the needle is removed, the skin is covered with a small plaster. Standard pain medication is prescribed (Arthrotec, 50 mg three times per day for three days).
The main control group will be treated with arthroscopic surgery during which excess bone is removed from the distal part of acromion, resulting in more space for the rotator cuff tendons to prevent impingement while moving the arm. If accessible to the surgeon, calcifications will be removed from the tendon and affected bursa tissue is removed. Average surgery time is 20 minutes. Standard discharge from hospital is the day after surgery. For pain management patients receive Arthrotec.
The second control group will be treated with a local deposit of corticosteroids in the bursa subacromialis and the supraspinatus tendon, injected under ultrasound guidance.
All three groups receive similar standard post treatment care consisting of physiotherapy using a rehabilitation protocol. Patients are instructed to consult their orthopedic surgeon if they think they are in need for other post operative therapy.
|- Primary outcome||Main study endpoints are short term shoulder function and shoulder pain, measured with the DASH and Oxford shoulder questionnaire, shoulder ROM and a VAS scale. |
|- Secondary outcome||1. Difference between pre-treatment and post treatment calcification size as measured on a standardised shoulder radiograph;|
2. Quality of life, measured with the EQ-5D questionnaire.
|- Timepoints||1. Initial screening;|
3. 1 week follow up;
4. 1 month follow up;
5. 3 month follow up;
6. 6 month follow up.
|- Trial web site||www.orthopediegeldrop.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. W. Weegen, van der|
|- CONTACT for SCIENTIFIC QUERIES||Drs. W. Weegen, van der|
|- Sponsor/Initiator ||Maatschap orthopedie St. Anna ziekenhuis|
(Source(s) of Monetary or Material Support)
|St. Anna ziekenhuis, Maatschap orthopedie|
|- Brief summary||After failed standard non-surgical treatment of supraspinatus tendon calcification, arthroscopic subacromial decompression (ASD) surgery is considered the treatment of choice. A not often used non-surgical treatment option is dry needling and aspiration-treatment (DNaA). This treatment imposes considerable fewer burdens upon the patient, avoiding a general anaesthetic, shoulder surgery and an overnight stay in hospital. We have some promising experience with this treatment but scientific evidence is lacking. We therefore planned to conduct this clinical trial, comparing DNaA to ASD surgery. Since patients treated with DNaA receive corticosteroids at the end of the procedure, a third study group will be incorporated. This group will be treated with an ultrasound guided injection leaving a depot of corticosteroids in the bursa subacromialis and the supraspinatus tendon, but without the DNaA-treatment.|
|- Main changes (audit trail)|
|- RECORD||4-okt-2010 - 30-okt-2010|