An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorDr Iris Tang Yan Ki

About this trial

The goal of this trial is to evaluate the efficacy of an integrated self-management programme in improving clinical outcomes in patients with hand osteoarthritis (OA).

This is an open-labelled, randomized controlled trial with an objective to determine the efficacy of an integrated self-management programme versus routine clinical care for participants with symptomatic hand OA.

Participants will be randomized into early intervention group and routine clinical care groups in a 1:1 ratio. Patients who randomized into early intervention group will receive 8 week integrated self-management programme delivered by occupational therapists and rheumatology nurse on hand OA management. Patients who randomized into routine clinical care group will receive usual clinical care for OA for 26 weeks and then receive an identical 8 weeks integrated self-management programme. The primary outcome is the improvement in pain at 26 weeks between the two groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fulfil the American College of Rheumatology hand osteoarthritis classification criteria

Symptomatic hand osteoarthritis with a pain visual analogue score (VAS) equal to or more than 40/100mm within 2 weeks of study entry

Disqualifiers

Secondary hand osteoarthritis from inflammatory arthritis including rheumatoid arthritis, spondyloarthropathy, psoriatic arthritis, gouty arthropathy or connective tissue diseases;

Receive systemic corticosteroids (other than topical or inhalational) within 6 months of study entry

Inability to sign informed consent

Trial design

Design model

Crossover

Treatments tested in this trial

  • Integrated self-management programme

    Behavioral

    8 weeks integrated management programme with three educational sessions. Group therapy sessions (6-8 participants per group) delivered by occupational therapists and rheumatology nurses. 1. Disease pathology and Pain management 2. Joint protection and stretching exercise 3. Psychosocial education 4. Aids prescription Each session will consist of education session, exercise session and group sharing sessions.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Early intervention armExperimental treatment 1 intervention
Group B: Routine Clinical care (Control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Pain visual analogue scale (VAS)

Pain VAS reflects the severity of pain in a score of 0-100. A lower score indicates less pain.

Time frame
26 weeks

Secondary outcomes

1

Change in pain Visual Analogue Scale (VAS)

Pain VAS reflects the severity of pain in a score of 0-100. A lower score indicates less pain.

Time frame
12weeks, 52 weeks
2

Change in Functional index hand osteoarthritis (FIHOA)

FIHOA reflects hand function with a score of 0 to 30. A lower score indicates better hand function

Time frame
12 weeks, 26 weeks, 52 weeks
3

Change in Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score

QuickDASH is a self-reported 11-itemed questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability)

Time frame
12 weeks, 26 weeks, 52 weeks
4

Change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) 3.1

AUSCAN 3.1 hand osteoarthritis index is a self-administered questionnaire that assesses the three dimensions of pain, disability and joint stiffness in hand osteoarthritis using a battery of 15 questions. The score is expressed in 3 subscores: AUSCAN pain score (0 (least painful)-100 (most painful), the AUSCAN stiffness score (0: least stiffness-100: most stiffness), the AUSCAN function score (0: least function impairment-100: most severe function impairment)

Time frame
12 weeks, 26 weeks, 52 weeks

Other outcomes

1

Adverse events

Adverse events

Time frame
up to 52 weeks
2

Use of rescue pain medication

Use of rescue pain medication e.g. NSAIDS / steroids

Time frame
up to 52 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr Iris Tang Yan Ki

Lead sponsor

The University of Hong Kong

Sponsor institution

Hospital Authority, Hong Kong

Collaborator

This trial is not recruiting at the moment. You can still explore other options: