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Cryotherapy in the recovery of bursectomy for subacromial pain syndrome. A pragmatic randomized controlled trial.

Cryotherapy in the recovery of bursectomy for subacromial pain syndrome. A pragmatic randomized controlled trial. - CRYO-study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43182
Enrollment
70
Registered
2016-12-21
Start date
2017-04-20
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Impingement Subacromial Pain syndrome

Interventions

Groep A: Computer-assisted cryotherapie Groep B: Usual Care with subacromial levobupivaicaine 20mL (5mg/mL, 0,5% chirocaine).
cryotherapy
Impingement syndrome
shoulder

Sponsors

Rijnland Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Pain localized in the deltoid region - Complaints for more than 6 months - Unsuccessful physical therapy for at least six weeks - Exacerbation of pain when raising the arm - A positive Neer impingement sign, and an only temporarily effect of ultrasound guided subacromial infiltration (lidocain + corticosteroids). - A positive Hawkins-Kennedy test - A painful arc - Scheduled for arthroscopic bursectomy

Exclusion criteria

Exclusion criteria: - No informed consent is obtained - Language barrier - Age

Design outcomes

Primary

MeasureTime frame
Quality of life reported by the patient using a disease specific questionaire (Westen Ontario Rotator Cuff Index (WORC)) 8 weeks after surgery.

Secondary

MeasureTime frame
Pain reported on a Visuele Analogue Scale (VAS) (baseline, 2 weeks, 8 weeks , 3 months and 1 year after surgery). Postoperative pain reported on a numeric rating scale (NRS), first 8 weeks after surgery using a pain-diary. Postoperative use of painkillers, first 2 weeks after surgery using a pain-diary. Simple Shoulder Test (baseline, 2 weeks, 8 weeks, 3 months and 1 year after surgery) Constant Score (baseline, 2 weeks, 8 weeks, 3 months and 1 year after surgery) Range of motion (baseline, 2 weeks, 8 weeks, 3 months and 1 year after surgery) Schouderkracht (baseline, 2 weeks, 8 weeks, 3 months and 1 year after surgery) WORC (baseline, 2 weeks, 3 months and 1 year after surgery)

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)