Purpose of this investigation is to establish which one of both treatments is most effective in resorption of the calcific deposit in the tendon and diminishing pain.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disapearance/ resorption of calcification in the rotator cuff muscles as seen
on standard shoulder x-ray.
Secondary outcome
Effect on pain and function, using VAS, Constant and Oxford shoulder score.
Background summary
Calcific tendinitis of the shoulder is a self-limiting disease of unknown
origin in which calcium deposits are formed in the rotator cuff muscles.
Most important symptoms are the deposition of a calcification in the tendon of
the rotator cuff, pain and loss of function.
Needling and Radial Shockwave Therapy are both established treatments of
calcific tendinitis, with well discribed effect on pain and resorption of the
calcific deposit.
Which of these two is the better treatment is not known so far.
Ther are no studies which compare these to methods of treatment.
Study objective
Purpose of this investigation is to establish which one of both treatments is
most effective in resorption of the calcific deposit in the tendon and
diminishing pain.
Study design
Prospective (open) randomised controlled trial (RCT).
Intervention
Needling or Radial Shockwave therapy.
Study burden and risks
Needling: 15 minutes of treatment under local anaesthesia with lidocaine. At
the end of the procedure, a deposit of corticosteroids is left behind.
RSWT: 4 sessions of 2500 impulses with an interval of a week:
500 x 1.5 Bar at 4.5 Hz followed by 2000 x 2.5 Bar op 10 Hz.
Efd 0.10 mJ/ mm.
Impuls time 2 ms
Sportlaan 600
2566 MJ Den Haag
Nederland
Sportlaan 600
2566 MJ Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
Pain shoulder
Calcification rotator cuff type I or II according to Gartner and Simons/ type I according to Patte and Goutallier
Symptoms > 6 months
VAS > 4 cm at time of evaluation
failure of previous conservative treatments
Exclusion criteria
Non dutch speaking
Minor
no informed consent
rotator cuff tear, glenohumeral or acromioclavicular arthritis or acromioclavicular spur to rule out alternative explanations for the pain
Pregnancy
Implanted pacemaker
Blood coagulation disorders or use of anticoagulant drugs;
Inflammatory or neoplastic disorders
Presence of type III (cloudy and transparent) calcifications according to
the Gartner and Simons radiographic classification/type II according to Patte and Goutallier
Conservative treatments administered in the last 2 weeks
Participation in other medical trial
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24917.098.08 |