Finger Osteoarthritis, Hand Osteoarthritis, Thumb Osteoarthritis, Wrist Osteoarthritis
Conditions
Keywords
Telemedicine, Telehealth, Mobile Health, eHealth, mHealth
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 health related quality of life with EuroQol-5 Dimensions-5 Levels (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.
Interventions
BEHAVIORALJoint 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.
Sponsors
Joint Academy
Lund University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* Pregnancy * Tendon disease (trigger finger, tendinopathy) * Nerve entrapment * Arthritis * Acute injuries (fracture and/or distortion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity (Numerical Rating Scale NRS, Discrete Boxes 0-10, Higher Score Mean Worse Pain) | Change in pain intensity from baseline to 3 months of treatment. | Pain intensity was assessed using the Numerical Rating Scale (NRS, discrete boxes 0-10) with the instruction: "Mark on this scale how much pain you had in your hand over the past week." The NRS ranged from 0, representing no pain, to 10, representing the maximum pain imaginable. A higher score indicated greater pain intensity. Participants completed mandatory self-assessment questionnaires at baseline and again at 3 months of treatment. All responses were self-reported and entered directly via the digital program interface. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Index for Hand OsteoArthritis (FIHOA 0 - 30 Higher Score Means Worse Outcome) | Change of Functional Index for Hand OsteoArthritis-score between baseline to 3 months of treatment | 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. |
Countries
Sweden
Contacts
STUDY_DIRECTORLeif Dahlberg, Professor
Arthro Therapeutics /Joint Academy
Participant flow
Pre-assignment details
Patients who did not complete 3 months of treatment was excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Included Participants The participants received 3 months of the digital treatment of Joint Academy.
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. | 379 |
| Excluded Participants Participants who enrolled to Joint Academys digital treatment but did not complete three months treatment.
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. | 467 |
| Total | 846 |
Baseline characteristics
| Characteristic | Included Participants | Excluded Participants | Total |
|---|---|---|---|
| Age, Continuous All participants | 64.6 years STANDARD_DEVIATION 9.3 | 62.7 years STANDARD_DEVIATION 10.6 | 63.6 years STANDARD_DEVIATION 10.1 |
| Age, Customized Participants included in analysis 28-59 years old | 108 Participants | — | 108 Participants |
| Age, Customized Participants included in analysis 60-69 years old | 147 Participants | — | 147 Participants |
| Age, Customized Participants included in analysis 70 years old or older | 124 Participants | — | 124 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Sweden | 379 Participants | 467 Participants | 846 Participants |
| Sex: Female, Male Female | 285 Participants | 374 Participants | 659 Participants |
| Sex: Female, Male Male | 94 Participants | 93 Participants | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change in Pain Intensity (Numerical Rating Scale NRS, Discrete Boxes 0-10, Higher Score Mean Worse Pain)
Pain intensity was assessed using the Numerical Rating Scale (NRS, discrete boxes 0-10) with the instruction: Mark on this scale how much pain you had in your hand over the past week. The NRS ranged from 0, representing no pain, to 10, representing the maximum pain imaginable. A higher score indicated greater pain intensity. Participants completed mandatory self-assessment questionnaires at baseline and again at 3 months of treatment. All responses were self-reported and entered directly via the digital program interface.
Time frame: Change in pain intensity from baseline to 3 months of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Joint Academy | Change in Pain Intensity (Numerical Rating Scale NRS, Discrete Boxes 0-10, Higher Score Mean Worse Pain) | -1.30 Units on a scale |
Secondary
Functional Index for Hand OsteoArthritis (FIHOA 0 - 30 Higher Score Means Worse Outcome)
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.
Time frame: Change of Functional Index for Hand OsteoArthritis-score between baseline to 3 months of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Joint Academy | Functional Index for Hand OsteoArthritis (FIHOA 0 - 30 Higher Score Means Worse Outcome) | -0.81 score on a scale. Mean change. |
Other Pre-specified
Analgesic Use
Analgesic use was assessed with the question: In the past month, have you taken any medication for the pain in your hand? (response options: Yes or No). This measure represents the absolute count of participants who reported a decrease in analgesic use from baseline to the 3-month follow-up (saying Yes at baseline but No at follow up.
Time frame: Reduction in the number of participants using analgesics from baseline to the 3-month follow-up.
Population: Not all participants answered the question regarding analgesic use.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Joint Academy | Analgesic Use | 22 Participants |
Other Pre-specified
Fear of Physical Activity
Fear of physical activity was assessed with the question: Are you concerned that your finger joints may be damaged by physical activity or exercise? (response options: Yes or No). This measure represents the absolute count of participants reporting a reduction in fear of physical activity from baseline to the 3-month follow-up.
Time frame: Reduction in the number of participants responding yes from baseline to the 3-month follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Joint Academy | Fear of Physical Activity | 17 Participants |
Other Pre-specified
Received Injection at the Affected Joint (Yes/no)
In the past month, have you received an injection in your index joint for the pain?
Time frame: Reduction in the number of participants answering yes between baseline and 3 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Joint Academy | Received Injection at the Affected Joint (Yes/no) | 17 Participants |
Other Pre-specified
Stiffness in Affected Joint (NRS, 0-10, Higher Score Mean Worse Outcome)
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
Time frame: At baseline and 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Joint Academy | Stiffness in Affected Joint (NRS, 0-10, Higher Score Mean Worse Outcome) | -0.81 Units on a scale |
Other Pre-specified
Willingness for Surgery
Question: Based on your symptoms, are you considering to undergo surgery of your hand? Options: No, I'm not; Yes, I'm considering surgery but it's not yet scheduled; Yes, surgery is scheduled; Surgery has been performed (only asked at follow up); I don't know This measure represents the absolute count of participants reporting reduced willingness to undergo surgery from baseline to the 3-month follow-up.
Time frame: Reduction in the number of participants wanting to undergo surgery from baseline to the 3-month follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Joint Academy | Willingness for Surgery | 5 Participants |