Effect of Immobilization of the Metacarpophalangeal Joint in Thumb Osteoarthritis

May 23, 2016 updated by: Raquel Cantero-Téllez, University of Malaga

Effect of Immobilization of the Metacarpophalangeal Joint in Thumb Osteoarthritis on Pain and Function Three Months Follow up: Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A hand therapy blinded to the subjects' intervention took baseline measurements (Spanish- Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and pain intensity) prior to randomization.

Participants were introduced in an Excel database in order of arrival and were randomized into 2 equal groups by an automatic program (Group A : Whale orthotic. Group B Colditz Orthotic). The same low temperature thermoplastic material was used for both orthoses (Orfit Colors NS 2.0 mm, micro perforated/ Orfit Industries, Wijnegem, Belgium). The orthoses were custom -fabricated for each patient by a hand therapy clinician experienced in orthopedic cases.

Both groups of patients received identical orthotic wearing instructions. Patients were asked to use the orthosis during the nighttime and also during daytime ADL's for three to four hours per day. Each patient was also provided with a data collection sheet in order to control treatment adherence. All patients were asked to report any discomfort when using the orthosis. The orthosis was the only treatment intervention received by the participants. No therapeutic exercises, modalities or other complementary treatments were offered to the patients in order not to interfere with the individual effectiveness of the orthosis. Patients were contacted by telephone a week after and were ask about pain intensity. Three months after first evaluation, participants were cited in hand therapy clinic in order to collect again outcomes measurements.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Málaga
      • Malaga, Málaga, Spain, 29012
        • Raquel Cantero-Téllez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
It is a thumb orthotic that does not include wrist joint but includes the metacarpophalangeal joint.
Device: Whale orthosis
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
Active Comparator: Control group
It is a thumb orthotic that does not include wrist joint neither metacarpophalangeal joint.
Device: Colditz orthosis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Pain intensity
Time Frame: Change from Baseline and at 3-month post-interventions
Visual analogue scale
Change from Baseline and at 3-month post-interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of DASH questionnaire
Time Frame: Change from Baseline and at 3-month post-interventions
Upper limb function
Change from Baseline and at 3-month post-interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Investigators

  • Principal Investigator: Cantero-Tellez Raquel, PhD, University of Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 24, 2016

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19761

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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