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TerminatedNCT03839901Updated Feb 15, 2019

Rehabilitation Programmes for Scapholunate Instability

An interventional study of Home exercise program in Wrist Strain, Wrist Sprain and Scaphoid-Lunate Instability, sponsored by University of Bradford. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by University of Bradford · Not applicable, Interventional, and Treatment

Why this study was terminated
There were insufficient numbers recruited before the end of the student project

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Aug 2017, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Wrist Strain
  • Wrist Sprain
  • Scaphoid-Lunate Instability

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Keywords

  • Scaphoid-Lunate
  • instability
  • wrist
03

In context

Sprains and Strains

246 studies on the registry are indexed under Sprains and Strains; 49 are open to participants now.

This study's enrollment of 2 is below the median of 60 across 162 interventional studies indexed under Sprains and Strains.

Browse Sprains and Strains studies →

Lead sponsor

University of Bradford is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
2 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherHome exercise program

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

06

What researchers measure

Primary outcomes

  1. Grip strength using E-link dynamometer

    change of grip strength from baseline change of 20% in kg considered signifcant

    Time frame: assessed at 0, 4 and 8 weeks

Secondary outcomes

  1. numerical rating scale

    Pain scored on a numerical rating scale 0 (no pain) -10 (unbearable pain) Minimally Clinical Important Difference of 20mm

    Time frame: assessed at 0, 4 and 8 weeks

  2. 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

    Time frame: assessed at 0, 4 and 8 weeks

07

Study locations

1 site
  • Bradford Royal Infirmary
    Bradford, West Yorkshire BD9 6RJ, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03839901
Lead sponsor
University of Bradford
Collaborators
Bradford Teaching Hospitals NHS Foundation Trust
Responsible party
Sponsor
First posted
Feb 15, 2019
Start date
Aug 1, 2017
Primary completion
Jul 1, 2018
Completion
Aug 1, 2018
Last update
Feb 15, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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