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Mid-term follow-up of a randomized controlled trial comparing ultrasound-guided double percutaneous needling versus high-energy extracorporeal shockwave therapy in the treatment of calcific tendinitis of the rotator cuff.

Mid-term follow-up of a randomized controlled trial comparing ultrasound-guided double percutaneous needling versus high-energy extracorporeal shockwave therapy in the treatment of calcific tendinitis of the rotator cuff. - KALK

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51922
Enrollment
81
Registered
2022-06-23
Start date
2022-03-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

calcific tendinitis shoulder pain

Interventions

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 wil

Sponsors

Spaarne Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participation in original KALK study

Exclusion criteria

Exclusion criteria: No participation in original KALK study

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
* 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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)