A RCT of Supportive Finger Tape for PIPJ Osteoarthritis

NCT02220374 | Completed

• 1 other identifier: 14/YH/1040
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Oesteoarthritis of the joints of the finger(s) is a common problem. The first-line treatment involves pain killers taken either as tablets, gels, or patches. Secondly, some joints are amenable to injections of steroids and anaesthetic agents. Finally, as a last resort, some joints may be fused or replaced with prosthetic joints by Hand Surgeons. We are investigating whether supportive taping of the painful finger joint reduces pain and improves function, and whether this treatment could be used to substitute pain killers, injections or surgery. We hypothesise that supportive finger tape may improve pain, improve the stability of the joint and thereby improve day-to-day hand function too. We will investigate this through a two-group parallel randomised controlled trial whereby one group will receive the treatment taping and the other group will receive a theoretically placebo taping configuration. We will measure pain daily, hand function and adverse events.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Finger; Supportive; Tape; Pain; Function; Trial

Outcome Measures

Primary Outcomes (1)

• Change in Pain

  We will measure the change in pain in the trial PIPJ by comparing reported pain without supportive tape over 7 days, to the reported pain over 7 days with supportive tape applied to the finger

  1 week

Secondary Outcomes (2)

• Hand Function

  3 weeks

• Adverse outcomes

  3 weeks

Other Outcomes (1)

• Economic impact

  3 weeks

Study Arms (1)

Supportive Finger Tape

EXPERIMENTAL

Participants will be randomised to either placebo or supportive taping

Other: Supportive Finger Tape

Interventions

Supportive Finger Tape OTHER

Dorsally applied elasticated tape may or may not improve the kinetics of the PIPJ and therefore reduce pain as well as improve function

Supportive Finger Tape

Eligibility Criteria

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

You may qualify if:

• All adult patients (≥18 years old) with chronic osteoarthritis of the PIPJ of any finger.

You may not qualify if:

• Patients meeting any of the below criteria will be excluded:
• Patients lacking capacity to consent (unable to understand, retain, weigh up or communicate their decision)
• Patients (and/or their carers) who lack the dexterity to cut and apply the Suture Strips to the painful finger.
• Patients with active infection or unhealed wounds on the same hand as this may confound the level of pain experienced.
• Dermatological conditions or vulnerable dorsal finger skin on the proposed trial finger, which may be exacerbated or damaged respectively by the applicable/removal of tape

Sponsors & Collaborators

• Mid Yorkshire Teaching NHS Trust: lead

Study Sites (1)

Pinderfields General Hospital

Wakefield, WF1 4DG, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Southern, MBBS FRCS(Plast)

  Pinderfields General Hospital, Wakefield

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Core Surgical Trainee

Study Record Dates

• First Submitted: August 16, 2014
• First Posted: August 19, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

GB (1)