Effects of 12-week Digital Treatment in Patients With Hand OA on Pain and Function

Hand Osteoarthritis Clinical Trial

Official title:

Effects of 12-week Digital Treatment in Patients With Hand OA on Pain and Function: a Register-based Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499559
• Other study ID #: HandOA2022
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2022
• Source: Joint Academy
• Contact: Helena Hörder, Med dr
• Phone: +46406550292
• Email: helena[@]jointacademy.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis
• Thumb Osteoarthritis
• Wrist Osteoarthritis

Intervention

Behavioral:
• Joint Academy digital treatment
The Joint Academy® (www.jointacademy.com) program for people with hand OA consists of video instructed and progressively adaptable daily exercises, patient education through text lessons, possibility for a social chat group with other patients and a continuous asynchronous chat function with a personal reg. physiotherapist who supervises the patient during the full participation period. The program also contains three telephone consultations with a physiotherapist that were compulsory, one at the start, one after six weeks and one after three months.

Locations

Country	Name	City	State
Sweden	Joint Academy	Malmö	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Joint Academy	Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Dreiser RL, Maheu E, Guillou GB. Sensitivity to change of the functional index for hand osteoarthritis. Osteoarthritis Cartilage. 2000;8 Suppl A:S25-8. — View 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. — View Citation

Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-related quality of life (HRQoL)	Health-related quality of life was assessed with the EuroQol - 5 dimension descriptive system (EQ-5D-5L) from no problems (0) to extreme problems (5). A higher score means higher levels of perceived problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state; for instance, 21111 means slight problems in the mobility dimension and no problems in any of the other dimensions.	Patients answered compulsory questionnaires at baseline and at 3 months of treatment.
Other	Work situation	"Which alternative describes your current situation best?"(working, studying, sick leave full-time, sick leave part-time, retired, unemployed)	At baseline and 3 months
Other	Medication use	"In the past months, have you taken any medication for the pain in your hand ?"(yes or no)	At baseline and 3 months
Other	Willingness for surgery	Based on your symptoms, are you considering to undergo surgery of your hand? "No, I'm not; Yes, I'm considering surgery but it's not yet scheduled; Yes, surgery is scheduled; Surgery has been performed (THIS OPTION ONLY FOR FOLLOW-UP); I don't know"	At baseline and 3 months
Other	Fear of physical activity	Are you concerned that your finger joints may be damaged by physical activity or exercise? (yes/no)	At baseline and 3 months
Other	Work productivity and activity questionnaire (WPAI)	The Work Productivity and Activity Impairment (WPAI) questionnaire is an instrument to measure impairments in both paid work and unpaid work. WPAI outcomes are expressed as impairment percentage, where a higher number indicates a greater impairment.	At baseline and 3 months
Other	Stiffness in affected joint (NRS, 0-10, 10 = extreme stiffness)	Question "Mark on the scale how much stiffness you have felt in your left/right hand due to your osteoarthritis during the past week" with a NRS ranging from 0 (none) to 10 (extreme stiffness) where a higher score equals more stiffness	At baseline and 3 months
Other	Received injection at the affected joint (yes/no)	In the past month, have you received an injection in your XX for the pain?	At baseline and 3 months
Primary	Change of pain intensity	Pain was assessed using the Numerical Rating Scale (NRS, discrete boxes 0-10) with the instruction: "Mark on this scale how much pain you had the last week in your hand", followed by a 0-10 scale where 0 was defined as no pain and 10 was defined as maximum pain. A higher score equals more pain.; Patients answered compulsory questionnaires at baseline and at 3 months of treatment. All outcomes were self-assessed and self-entered using the digital program interface.	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	Functional Index for Hand OsteoArthritis (FIHOA)	The FIHOA is a 10-item questionnaire based on a semi-quantitative assessment scoring the disease on a 4-point scale with a total scoring from 0 to 30 where a higher score equals more functional impairments. The FIHOA has been shown to be valid, sensitive, clinically relevant for the population and shown consistency and acceptable reliability. The literature also suggests it is associated with pain, muscle strength and health related quality of life in people with hand OA. All outcomes were self-assessed and self-entered using the digital program interface.	Patients answered compulsory questionnaires at baseline and at 3 months of treatment.