Rehabilitation Programmes for Scapholunate Instability

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

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.

Study Overview

• Status: Terminated
• Conditions: Wrist Sprain; Wrist Strain; Scaphoid-Lunate Instability
• Intervention / Treatment: Other: Home exercise program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
      • Bradford Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: isometric training programme; 'Home exercise programme' consisting of isometric exercises with participants followed up at week 1, 4, 6 and 8.	Other: Home exercise program; Home exercise programme with participants followed up at week 1, 4, 6 and 8.
Experimental: isotonic training programme; 'Home exercise programme' consisting of isotonic exercises with participants followed up at week 1, 4, 6 and 8.	Other: Home exercise program; Home exercise programme with participants followed up at week 1, 4, 6 and 8.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Bradford
• Collaborators: Bradford Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: instability; wrist; Scaphoid-Lunate
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: IRAS 218328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No