Rehabilitation Programmes for Scapholunate Instability

Wrist Sprain Clinical Trial

Official title:

A Pilot Study to Investigate Two Different Physiotherapy Rehabilitation Programmes, to Treat the Conservatively Managed Scapholunate Instability.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03839901
• Other study ID #: IRAS 218328
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: February 2019
• Source: University of Bradford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two different exercises approaches were tested in patients with Scapho-Lunate (SL) instability; one to strengthen the tendons in static positions and the other to strengthen the tendons whilst the wrist is moving.

Description:

Scapho-Lunate (SL) instability is the most common form of wrist instability, but is complex to diagnose and is often missed entirely. The natural progression of SL instability has been suggested to lead to osteoarthritis. The management of SL instability can be broadly divided into conservative and surgical, with the former being the first option taken by most medical professionals, which primarily involves physiotherapy. The evidence base for physiotherapy management of SL instability is limited; however cadaver research has identified loading some of the wrist tendons may stabilise the scaphoid and lunate.There is currently no research as to whether this clinically makes any difference to the patients symptoms, or how to do it. This research therefore aimed to test the protocol and methods, and act as a platform for larger studies, to investigate this.

Two different exercises approaches were tested; one to strengthen the tendons in static positions and the other to strengthen the tendons whilst the wrist is moving.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Ages eighteen to sixty,

• wrist pain,

• confirmed scapholunate ligament disruption on MRA or XR (partial or full),

• referred from orthopaedic wrist specialist,

• for conservative management,

• consent to trial.

Exclusion Criteria:

• Under eighteen or over sixty years,

• previous fracture,

• degenerative changes in the wrist,

• previous surgery,

• complex regional pain syndrome or diagnosis of rheumatological conditions,

• no wrist injection in preceding twelve months or other wrist conditions.

Related Conditions & MeSH terms

• Scaphoid-Lunate Instability
• Wrist Sprain
• Wrist Strain

Intervention

Other:
• Home exercise program
Home exercise programme with participants followed up at week 1, 4, 6 and 8.

Locations

Country	Name	City	State
United Kingdom	Bradford Royal Infirmary	Bradford	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Bradford	Bradford Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grip strength using E-link dynamometer	change of grip strength from baseline change of 20% in kg considered signifcant	assessed at 0, 4 and 8 weeks
Secondary	numerical rating scale	Pain scored on a numerical rating scale 0 (no pain) -10 (unbearable pain) Minimally Clinical Important Difference of 20mm	assessed at 0, 4 and 8 weeks
Secondary	Patient Rated Wrist Evaluation	Used Patient Rated Wrist Evaluation PRWE questionnaire (A score of 100 represents the worst functional score, whereas 0 represents no disability) with Minimally Clinical Important Difference of 14 points	assessed at 0, 4 and 8 weeks