Effect of Immobilization of the Metacarpophalangeal Joint in Thumb Osteoarthritis
Condition: Hand Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

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.
    

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.
    

Intervention name(s): Whale orthosis; Colditz orthosis
Intervention type(s): Device; Device
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Osteoarthritis; hand; orthotic; rehabilitation