Splinting to Treat Hand Osteoarthritis

NCT01249391 | Completed Phase 2 DMC

• 1 other identifier: JROHH051
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand Osteoarthritis

Keywords

Hand; osteoarthritis; splint; pain; deformity; function

Outcome Measures

Primary Outcomes (1)

• Pain in nominated joint

  Assessed via numerical rating scale

  3 months

Secondary Outcomes (1)

• Radiological deviation of nominated joint

  3 months

Study Arms (2)

Intervention (splinting)

ACTIVE COMPARATOR

Splinting of nominated joint in this group

Device: Splinting

Control

NO INTERVENTION

Observation and usual treatment only.

Interventions

Splinting DEVICE

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

Intervention (splinting)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (1)

• Watt FE, Kennedy DL, Carlisle KE, Freidin AJ, Szydlo RM, Honeyfield L, Satchithananda K, Vincent TL. Night-time immobilization of the distal interphalangeal joint reduces pain and extension deformity in hand osteoarthritis. Rheumatology (Oxford). 2014 Jun;53(6):1142-9. doi: 10.1093/rheumatology/ket455. Epub 2014 Feb 8.

  PMID: 24509405 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Pain; Congenital Abnormalities

Interventions

Splints

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Fiona Watt

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2010
• First Posted: November 29, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 17, 2016

Record last verified: 2011-07

Locations

GB (1)