To test if dry needling and aspiration treatment is more effective than arthroscopic shoulder decompression in patients with calcification of the supraspinatus tendon.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoints are pain at rest, shoulder function and amount of
calcification. Shoulder function is measured using the DASH questionnaire and
ROM. Shoulder pain is measured using a VAS score.
Secondary outcome
Secondary endpoints are quality of arm movement, safety of treatment and
involved costs. Quality of arm movement will be measured using accelerometers.
Safety is measured with recording of any (S)AE*s during the study. The costs
per patient will be analysed for each study group.
Background 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.
Study objective
To test if dry needling and aspiration treatment is more effective than
arthroscopic shoulder decompression in patients with calcification of the
supraspinatus tendon.
Study design
A single-center, non-blinded, randomised clinical trial with three treatment
arms.
Intervention
The study intervention group will receive dry needling and aspiration-treatment
of the calcification in the supraspinatus tendon. The first control group will
be treated with ASD surgery of the shoulder with debridement of the
calcification if possible. The second control group will be treated with an
ultrasound guided injection leaving a depot of corticosteroids in the bursa
subacromialis and the supraspinatus tendon.
Study burden and risks
Patients consenting to participate will have to return for longer follow ups
and more often. Extra scheduled follow ups are once before treatment and three
times after treatment. Each visit will take approximately 30 minutes. The
involved risks with participation are the standard risks involved with surgery
and the expected risks with DNaA-treatment are expected to be less than with
surgery, although there is no literature to confirm this. Expected benefits are
improvement in shoulder pain and function with less stress placed upon the
patient in case of randomisation into the group receiving DNaA-treatment. If
patients are allocated to the second control group, they will receive a
ultrasound guided injection leaving a depot of corticosteroids in the bursa
subacromialis and the supraspinatus tendon, but without the DNaA-treatment.
Patients from this group with insufficient relief of symptoms three months
after the injection will be offered immediate and appropriate further
orthopedic treatment.
Postbus 90
5660 AB
NL
Postbus 90
5660 AB
NL
Listed location countries
Age
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
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL30628.015.09 |
| OMON | NL-OMON22357 |