NCT02780999

Brief Summary

The aim of this study is to compare the effect of Whale and Colditz static orthosis on pain and functional abilities of hand in thumb carpometacarpal osteoarthritis as a unique treatment. Patients with thumb CMC OA will be recruited at Tecan Hand Center Clinic. Participants will be assigned using a randomized allocation in two groups. For group A a "Whale orthotic" will be constructed and for group B a Colditz orthotic. Both static splint will endorse for 3 months. Inclusion criteria for this study were adult over 18 diagnosed with carpometacarpal joint osteoarthritis with a pain intensity during Activities of Daily Living (ADL's) up to 4 / 10 on the Visual Analog Scale (VAS). Patients were excluded from participation if they had: a neurological disorder affecting the upper limb; had received previous treatment for their hand problem in the last 6 months including an intra-articular joint injection to wrist, fingers or thumb; had fractures or a significant hand injury or previous surgery to the wrist or hand; had hand or finger tenosynovitis and/ or Dupuytren's disease. Were also excluded patients who did not complete Dash Spanish version questionnaire or if they did not sign the informed consent. The outcome measure will be pain intensity and functional abilities as measured with the Visual Analogue Scale (VAS) and Disabilities of the Arm, Shoulder and Hand (DASH), respectively. All measures will be collected at baseline and end of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

May 10, 2016

Last Update Submit

May 23, 2016

Conditions

Hand Osteoarthritis

Keywords

Osteoarthritishandorthoticrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change of Pain intensity

    Visual analogue scale

    Change from Baseline and at 3-month post-interventions

Secondary Outcomes (1)

  • Change of DASH questionnaire

    Change from Baseline and at 3-month post-interventions

Study Arms (2)

Experimental group

EXPERIMENTAL

It is a thumb orthotic that does not include wrist joint but includes the metacarpophalangeal joint.

Device: Whale orthosis

Control group

ACTIVE COMPARATOR

It is a thumb orthotic that does not include wrist joint neither metacarpophalangeal joint.

Device: Colditz orthosis

Interventions

Whale orthosisDEVICE

Participants will be teach how to use the Whale orthotic to be carried for a period of three months during night and during the day in dose activities that cause pain

Experimental group
Colditz orthosisDEVICE

Participants will be teach how to use the Colditz orthotic to be carried for a period of three months during night and during the day in dose activities that cause pain.

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Having diagnosed with carpometacarpal joint osteoarthritis
  • Had given their consent

You may not qualify if:

  • Had neurological disorder affecting the upper limb
  • Had received previous treatment for their hand problem in the last 6 months
  • Had hand or finger tenosynovitis
  • Suffering Dupuytren's disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raquel Cantero-Téllez

Málaga, Málaga, 29012, Spain

Location

Related Publications (1)

  • Cantero-Tellez R, Villafane JH, Valdes K, Berjano P. Effect of immobilization of metacarpophalangeal joint in thumb carpometacarpal osteoarthritis on pain and function. A quasi-experimental trial. J Hand Ther. 2018 Jan-Mar;31(1):68-73. doi: 10.1016/j.jht.2016.11.005. Epub 2017 Feb 22.

    PMID: 28237072DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Cantero-Tellez Raquel, PhD

    University of Malaga

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Profesor

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 24, 2016

Study Start

June 1, 2013

Primary Completion

June 1, 2013

Study Completion

February 1, 2016

Last Updated

May 24, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)