Clinical trial NCT05499559: Effects of 12-week Digital Treatment in Patients With Hand OA on Pain and Function
Official title: Effects of 12-week Digital Treatment in Patients With Hand OA on Pain and Function: a Register-based Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hand Osteoarthritis
Wrist Osteoarthritis
Thumb Osteoarthritis
Finger Osteoarthritis
Keywords: Telemedicine
Telehealth
Mobile Health
eHealth
mHealth
Lead sponsor: Joint Academy
Sponsor class: INDUSTRY
Collaborators: name: Lund University
First posted: 2022-08-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participats joined the programme through recommendation by their local physiotherapist (PT), occupational therapist (OT) or orthopaedic surgeon, via online advertisements and campaigns placed on search engines and social networks, or through their insurance company. A majority of included participants had a clinical diagnosis of hand osteoarthritis from a PT, OT or physician, and all had a physical visit with a healthcare provider regarding their hand OA prior to joining JA. The clinical diagnosis of OA was confirmed by a PT or OT via telephone, or if deemed necessary the patient was recommended to seek face-to-face care before inclusion in the programme.

Brief summary: The purpose of this study is to evaluate the effect of a 12 week digital treatment program for patients with hand osteoarthritis. The treatment consisted of exercises and educational sessions with respect to the disease, its natural course and recommended treatment strategies.

Design: An observational longitudinal cohort study.

The investigators will include participants who participated in the digital treatment of Joint Academy® for 3 months.

Outcomes: Investigators will analyze pain with Numeric Rating Scale (NRS) 0-10 (best to worst), function with the Functional Index for Hand OsteoArthritis (FIHOA) and HRQL with EQ-5D-5L at baseline and at 3 months. Main outcome will be change in pain. The investigators will also analyze minimally clinical important changes (improved or not) and mean changes in EQ-5D-5L index score, pain and function.

Detailed description: Osteoarthritis (OA) is one of the leading causes of disability worldwide and due to its rising prevalence, the identification of appropriate care and care delivery modalities is a priority for the health care systems. Exercise and education constitute the first-line intervention for people with knee, hip and hand OA and have been shown to be effective regardless of symptoms and disease severity. International guidelines recommend that first-line interventions for the majority of musculoskeletal conditions should involve nonsurgical management with exercise and education guided by a physiotherapist (PT) and based on a personalised care approach.

OA of the hand is probably the most common form of OA and almost 50% of women and 25% of men will be affected during the life course. Self-management strategies includes a wide range of strategies such as education for strengthening or stretching exercises, joint protection education for activity and pacing, use of proper body mechanics, and assistive devices to improve pain, reduce inflammation, lower additional risk of deformities, and enhance performance. Systematic reviews that compared joint protection strategies to usual care have shown similar effects at short-term and superior effects at mid- and long-term compared to usual care.

To implement the guidelines, the Better Management of Patients with OsteoArthritis (BOA), a face-to-face concept including education and an option to exercise, has been developed and is offered at primary care clinics in Sweden since 2008 for patients with hip- knee- and hand OA. BOA has previously been found to reduce pain and improve function and quality of life in patients with hip and knee OA. Unfortunately, there is a discrepancy between recommended treatment and what patients receive and around 30% of people with OA seeking care go through first line management.

Traditional face-to-face interventions present barriers, such as limited access and lack of flexibility, which may limit the patients' adherence with the interventions. Digital delivery of the management program may be one way of overcoming such barriers. Telehealth, defined as the 'delivery of healthcare at a distance using information and communication technology' could be a solution to many access barriers and has been rapidly adopted by many healthcare professions and accelerating even more throughout the COVID-19 pandemic.

Literature investigating the use of telehealth for the management of musculoskeletal pain is growing. Systematic reviews have demonstrated that telehealth can provide improvements in pain, physical function and disability that are similar to that of usual face-to-face care for individuals with musculoskeletal conditions such as osteoarthritis for the knee and hip. The use of telehealth also seems to increase exercise adherence for a variety of musculoskeletal conditions. To our knowledge, digital self-management programs for OA of the hand have not yet been evaluated.

Joint Academy® (JA), a digitally delivered treatment program with exercise and patient education was developed to increase access to and facilitate implementation of guideline derived and evidence-based treatment for OA. The first JA program was introduced in 2016 for persons with hip- and knee OA and participants reported reduced pain and improved function during up to 48 weeks of treatment. A recent randomised controlled trial on patients with knee OA showed that the digital program was superior to usual care. Since late 2021, a digital program for OA of the hand is also available on the platform.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years (often much older)
* Previous physical examination regarding hand symptoms
* Long-lasting hand pain where osteoarthritis is suspected l(for example joint-specific load and/or rest pain, impaired function with stiffness, decreased grip strength, clumsiness, bone roughening of joints).
* started the treatment between 2022-XX-XX to 2022-XX-XX

Exclusion Criteria:

* Pegnancy
* Tendon disease (trigger finger, tendinopathy)
* Nerve entrapment
* Arthritis
* Acute injuries (fracture and/or distortion)

Primary outcomes:
measure: Change of pain intensity
timeFrame: Pain levels were reported for all patients at baseline, 3 months and weekly until treatment week 6. From week 7 reporting pain levels weekly were optional.
Secondary outcomes:
measure: Functional Index for Hand OsteoArthritis (FIHOA)
timeFrame: Patients answered compulsory questionnaires at baseline and at 3 months of treatment.
Other outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: Patients answered compulsory questionnaires at baseline and at 3 months of treatment.
measure: Work situation
timeFrame: At baseline and 3 months
measure: Medication use
timeFrame: At baseline and 3 months
measure: Willingness for surgery
timeFrame: At baseline and 3 months
measure: Fear of physical activity
timeFrame: At baseline and 3 months
measure: Work productivity and activity questionnaire (WPAI)
timeFrame: At baseline and 3 months
measure: Stiffness in affected joint (NRS, 0-10, 10 = extreme stiffness)
timeFrame: At baseline and 3 months
measure: Received injection at the affected joint (yes/no)
timeFrame: At baseline and 3 months
Locations:
city: Malmö
country: Sweden
facility: Joint Academy
state: Skåne
Study officials:
affiliation: Arthro Therapeutics /Joint Academy
name: Leif Dahlberg, Professor
role: STUDY_DIRECTOR
References:
citation: Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
citation: Dreiser RL, Maheu E, Guillou GB. Sensitivity to change of the functional index for hand osteoarthritis. Osteoarthritis Cartilage. 2000;8 Suppl A:S25-8. doi: 10.1053/joca.2000.0332.
citation: Kim SK, Jung UH, Choe JY. Functional index for hand osteoarthritis (FIHOA) is associated with pain, muscle strength, and EQ-5D in hand osteoarthritis. Adv Rheumatol. 2021 Mar 19;61(1):19. doi: 10.1186/s42358-021-00177-5.