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Completed

NCT Number: NCT01249391

Splinting to Treat Hand Osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis and the hand is the most frequently affected site.Interphalangeal (IP) joints (the small joints of the fingers) are often involved causing pain, progressive loss of hand function and deformity. Deviation, or bending to the side, of IP joints (IPJs) with significant functional and cosmetic consequences for the individual is common. There are no drugs which can slow the disease process so there is reliance on symptomatic treatment such as pain relief and hand therapy. Joint thermoplastic splinting (moulded plastic splints that are custom-made) is employed by hand therapists in other settings, but to the investigators knowledge no studies have formally investigated the effect of splinting in IP OA.

By resting inflamed tissues and correcting joint alignment, a beneficial role for splinting in IP OA is likely. In this study, the investigators want to test whether thermoplastic splinting of deviated IP joints due to OA will 1) improve joint alignment 2) ameliorate soft tissue inflammation, and whether as a consequence 3) pain and overall hand function will be improved.

Adults with hand OA with 'affected' IP joints (symptoms from OA associated with deviation of the joint on X-ray)will be recruited from a specialist hand osteoarthritis clinic. Initially this will be for distal IP (DIP) joints. In the intervention group (30 patients), an 'intervention' joint for splinting will be identified as the most painful deviated DIP joint in the past week leading up to enrolment. Up to 3 other 'affected' DIP joints on either hand will not be splinted but will be monitored as 'control' joints. In the control group (15 patients), an affected joint will be monitored but not splinted. Assessment of joint pain, hand function by a hand therapist, deformity (by X-ray)and joint inflammation will take place at baseline, during and at the end of splinting period of 3 months, and also at 6 months,to assess whether any changes are persistent. In this way, the efficacy of splinting of IP joints in OA will be assessed.

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Key information

Conditions

Hand Osteoarthritis Arthritis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 - 90
  • Definite diagnosis of IPJ osteoarthritis (American College of Rheumatology criteria for OA)
  • A previous radiograph of the hands with changes consistent with OA
  • Either, Intervention group: At least 2 'affected' IPJs (symptomatic (>2/10 average pain on 0-10 scale in past week) and radiological OA associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on Xray)
  • OR Control group: At least 1 'affected' IPJ (symptomatic (>2/10 average pain on 0-10 scale in past week) and radiological OA associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on X-ray)
  • Stable oral therapy for month prior to study entry e.g. non steroidal anti-inflammatory drugs (NSAIDs)
  • Capable of providing written informed consent

Exclusion criteria

  • Contraindication to splinting e.g. allergy to materials
  • Planned surgery during study period
  • Oral, intramuscular or intraarticular steroids within 3 months of study entry
  • Intraarticular hyaluronans to any nominated IP joints within 6 months of study entry
  • Not resident in UK
  • Pregnancy
  • Other inflammatory arthritis
  • History of psoriasis
  • Participation in other intervention trials
  • Patients with any uncontrolled or severe medical problems which in the opinion of the investigator makes them unsuitable for study participation
  • Unable to give informed written consent in English

Treatment and study plan

Splinting

Device

Gutter thermoplastic custom-made splint for nominated joint, to be worn at night-time for consecutive nights for 3 months

Primary outcomes

  1. Pain in nominated joint

    Time frame: 3 months

    Assessed via numerical rating scale

Secondary outcomes

  1. Radiological deviation of nominated joint

    Time frame: 3 months

    Degrees of radial or ulnar deviation of joint will be assessed radiographically.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

Splinting to Treat Interphalangeal Joint Deformity in Hand Osteoarthritis(Splint OA Study)

Acronym: SPLINTOA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 29, 2010
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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