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Effect of Immobilization of the Metacarpophalangeal Joint in Thumb Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780999
First Posted: May 24, 2016
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Raquel Cantero-Téllez, University of Malaga
  Purpose

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.


Condition Intervention
Hand Osteoarthritis Device: Whale orthosis Device: Colditz orthosis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Immobilization of the Metacarpophalangeal Joint in Thumb Osteoarthritis on Pain and Function Three Months Follow up: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Raquel Cantero-Téllez, University of Malaga:

Primary Outcome Measures:
  • Change of Pain intensity [ Time Frame: Change from Baseline and at 3-month post-interventions ]
    Visual analogue scale


Secondary Outcome Measures:
  • Change of DASH questionnaire [ Time Frame: Change from Baseline and at 3-month post-interventions ]
    Upper limb function


Enrollment: 84
Study Start Date: June 2013
Study Completion Date: February 2016
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780999


Locations
Spain
Raquel Cantero-Téllez
Malaga, Málaga, Spain, 29012
Sponsors and Collaborators
University of Malaga
Investigators
Principal Investigator: Cantero-Tellez Raquel, PhD University of Malaga
  More Information

Responsible Party: Raquel Cantero-Téllez, Profesor, University of Malaga
ClinicalTrials.gov Identifier: NCT02780999     History of Changes
Other Study ID Numbers: 19761
First Submitted: May 10, 2016
First Posted: May 24, 2016
Last Update Posted: May 24, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Raquel Cantero-Téllez, University of Malaga:
Osteoarthritis
hand
orthotic
rehabilitation

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases