NCT03839901

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

January 28, 2019

Last Update Submit

February 12, 2019

Conditions

Wrist StrainWrist SprainScaphoid-Lunate Instability

Keywords

Scaphoid-Lunateinstabilitywrist

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • numerical rating scale

    assessed at 0, 4 and 8 weeks

  • Patient Rated Wrist Evaluation

    assessed at 0, 4 and 8 weeks

Study Arms (2)

isometric training programme

EXPERIMENTAL

'Home exercise programme' consisting of isometric exercises with participants followed up at week 1, 4, 6 and 8.

Other: Home exercise program

isotonic training programme

EXPERIMENTAL

'Home exercise programme' consisting of isotonic exercises with participants followed up at week 1, 4, 6 and 8.

Other: Home exercise program

Interventions

Home exercise programOTHER

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

isometric training programmeisotonic training programme

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bradford Royal Infirmary

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 15, 2019

Study Start

August 1, 2017

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)