The objective of this study is to analyse the longterm effectiveness of high-energy ESWT and ultrasound-guided needling in patients with symptomatic calcific tendinitis of the rotator cuff. The assessment parameters are the functional outcome, pain…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to analyse the difference in functional
outcome, measured by the Constant Murley Scale at midterm follow-up, after
treatment with high-energy ESWT versus ultrasound-guided needling in patients
with symptomatic calcific tendinitis of the rotator cuff.
Secondary outcome
* VAS (pain) scale
* VAS (satisfaction) scale
* Patient reported change in symptoms (7 point likert scale)
* Disability of the Arm Shoulder and Hand (DASH) score
* The presence or resorption of the calcific deposits on conventional
radiography of the shoulder
* Work-ability score questionnaire
Background summary
Calcific tendinitis of the rotator cuff is a disorder characterized by
inflammation around deposits of calcium hydroxyapatite crystals in the tendons.
It is a common source of pain in the shoulder. The initial treatment of
calcific tendinopathy is conservative and patients are treated with
physiotherapie, analgesics and a subacromial corticosteroid injection when
indicated. When a conserative treatment fails, various minimal invasive
treatment options are available of which high-energy ESWT and ultrasound-guided
needling are the most thoroughly investigated options. This is confirmed by
the one-year clinical outcome of our RCT, investigating the effectiveness of
high-energy ESWT and ultrasound-guided needling.
Study objective
The objective of this study is to analyse the longterm effectiveness of
high-energy ESWT and ultrasound-guided needling in patients with symptomatic
calcific tendinitis of the rotator cuff. The assessment parameters are the
functional outcome, pain, satisfaction, work ability and presence or resorption
of the calcific deposits on radiographs.
Study design
Midterm follow-up of a randomized controlled trial with two treatment arms:
high-energy extracorporeal shockwave therapy and ultrasound-guided needling.
Intervention
Group 1. High-intensity extra corporeal shockwave therapy (2000 pulses, 4Hz,
0.3 mJ/mm2). Two sessions with 1 week in between.
Group 2. Ultrasound guided double percutaneous needling.
Both groups will follow a standardized physical therapy program after the
intervention.
Study burden and risks
Burden
- Visit to the outpatient clinic (20 minutes)
- Time it takes to fill in the questionnaires (10 minutes)
Risks
- There is a theoretical risk of stochastic effects caused by the ionising
radiation used for the radiographs of the shoulder. With a estimated effective
dose of 0.015 mSv this risk is neglectable.
Spaarnepoort 1
Hoofddorp 2134TM
NL
Spaarnepoort 1
Hoofddorp 2134TM
NL
Listed location countries
Age
Inclusion criteria
Participation in original KALK study
Exclusion criteria
No participation in original KALK study
Design
Recruitment
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 | NL76148.029.21 |