Multifactorial Approach Training for Anterior Shoulder Instability in patients undergoing arthrosopic bankart repair, a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24933

Enrollment

100

Registered

2021-07-05

Start date

2021-11-01

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

Anterior Shoulder Instability

Interventions

One group receives a ‘standard’ postoperative physiotherapy treatment and the other group receives a ‘tailor-maid’ postoperative multifactorial physiotherapy scheme, which has been designed to reduce

Eligibility

Inclusion criteria

Inclusion criteria: Patients between the age of 18 and 67, undergoing arthroscopic bankart repair (ABR) without significant bone loss at OLVG Amsterdam, Amstelland Ziekehuis Amstelveen and/or Spaarne Gasthuis Hoofddorp/Haarlem

Exclusion criteria

Exclusion criteria: Patients are excluded when they are aged under 18 or above 67 years old. Furthermore, patients undergoing other types of shoulder surgery other than arthroscopic Bankart repair will be excluded. Also patients with: absence of sulcus sign at physical examination, presence of rotator cuff rupture, bilateral component (active subluxations on contralateral side), history of soft tissue repair or bone block procedure on one of both shoulder, connective tissue disorders (e.g. Ehler-Danlos) or hyperlaxity (Beighton score >5) and/or (Current) anxiety disorders or use of anxiety supressing drugs (e.g. anti-psychotics) will be excluded.

Design outcomes

Primary

Measure	Time frame
To determine if multifactorial approach of aftercare is more effective in fear reduction than the current standard of aftercare, in patients who underwent arthroscopic Bankart repair (ABR) without significant bone loss	—

Secondary

Measure	Time frame
• To assess if multifactorial approach reduces or changes specific brain activity, measured with a functional magnetic resonance imaging (fMRI) activated when anxious for potential dislocation • To assess patient expectations before ABR • To assess patient satisfaction before and after ABR • To assess the psychological readiness to return to sport after 12, 24 and 48 weeks • To modify and validate the TAMPA scale for Kinesiophobia in Shoulder Instablity	—

Measure

Time frame

• To assess if multifactorial approach reduces or changes specific brain activity, measured with a functional magnetic resonance imaging (fMRI) activated when anxious for potential dislocation • To assess patient expectations before ABR • To assess patient satisfaction before and after ABR • To assess the psychological readiness to return to sport after 12, 24 and 48 weeks • To modify and validate the TAMPA scale for Kinesiophobia in Shoulder Instablity

—

Contacts

Public ContactTed van Iersel

OLVG

t.vaniersel@olvg.nl0614564784

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)