Trial Outcomes & Findings for Effects of 12-week Digital Treatment in Patients With Hand OA on Pain and Function (NCT NCT05499559)

NCT ID: NCT05499559

Last Updated: 2025-08-27

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

846 participants

Primary outcome timeframe

Change in pain intensity from baseline to 3 months of treatment.

Results posted on

2025-08-27

Participant Flow

Patients who did not complete 3 months of treatment was excluded from the study.

Participant milestones

Participant milestones
Measure
Joint Academy
The participants receive 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.
Overall Study
STARTED
846
Overall Study
COMPLETED
379
Overall Study
NOT COMPLETED
467

Reasons for withdrawal

Reasons for withdrawal
Measure
Joint Academy
The participants receive 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.
Overall Study
Lost to Follow-up
467

Baseline Characteristics

Distribution of different age groups of participants included in the analysis (participants who completed 3 months of treatment).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Included Participants
n=379 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.
Excluded Participants
n=467 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.
Total
n=846 Participants
Total of all reporting groups
Age, Continuous
All participants
64.6 years
STANDARD_DEVIATION 9.3 • n=379 Participants
62.7 years
STANDARD_DEVIATION 10.6 • n=467 Participants
63.6 years
STANDARD_DEVIATION 10.1 • n=846 Participants
Age, Customized
Participants included in analysis · 28-59 years old
108 Participants
n=379 Participants • Distribution of different age groups of participants included in the analysis (participants who completed 3 months of treatment).
108 Participants
n=379 Participants • Distribution of different age groups of participants included in the analysis (participants who completed 3 months of treatment).
Age, Customized
Participants included in analysis · 60-69 years old
147 Participants
n=379 Participants • Distribution of different age groups of participants included in the analysis (participants who completed 3 months of treatment).
147 Participants
n=379 Participants • Distribution of different age groups of participants included in the analysis (participants who completed 3 months of treatment).
Age, Customized
Participants included in analysis · 70 years old or older
124 Participants
n=379 Participants • Distribution of different age groups of participants included in the analysis (participants who completed 3 months of treatment).
124 Participants
n=379 Participants • Distribution of different age groups of participants included in the analysis (participants who completed 3 months of treatment).
Sex: Female, Male
Female
285 Participants
n=379 Participants
374 Participants
n=467 Participants
659 Participants
n=846 Participants
Sex: Female, Male
Male
94 Participants
n=379 Participants
93 Participants
n=467 Participants
187 Participants
n=846 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Sweden
379 Participants
n=379 Participants
467 Participants
n=467 Participants
846 Participants
n=846 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Joint Academy
n=379 Participants
The participants receive 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.
Change in Pain Intensity (Numerical Rating Scale NRS, Discrete Boxes 0-10, Higher Score Mean Worse Pain)
-1.30 Units on a scale
Interval -1.49 to -1.12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Joint Academy
n=379 Participants
The participants receive 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.
Functional Index for Hand OsteoArthritis (FIHOA 0 - 30 Higher Score Means Worse Outcome)
-0.81 score on a scale. Mean change.
Interval -1.02 to -0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Joint Academy
n=331 Participants
The participants receive 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.
Analgesic Use
22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Reduction in the number of participants wanting to undergo surgery from baseline to the 3-month follow-up.

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.

Outcome measures

Outcome measures
Measure
Joint Academy
n=379 Participants
The participants receive 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.
Willingness for Surgery
5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Reduction in the number of participants responding "yes" from baseline to the 3-month follow-up.

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.

Outcome measures

Outcome measures
Measure
Joint Academy
n=379 Participants
The participants receive 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.
Fear of Physical Activity
17 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and 3 months

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

Outcome measures

Outcome measures
Measure
Joint Academy
n=379 Participants
The participants receive 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.
Stiffness in Affected Joint (NRS, 0-10, Higher Score Mean Worse Outcome)
-0.81 Units on a scale
Interval -1.02 to -0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Reduction in the number of participants answering "yes" between baseline and 3 month follow up

In the past month, have you received an injection in your "index joint" for the pain?

Outcome measures

Outcome measures
Measure
Joint Academy
n=379 Participants
The participants receive 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.
Received Injection at the Affected Joint (Yes/no)
17 Participants

Adverse Events

Joint Academy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Arthro Therapeutics/Joint Academy

Phone: +46708971677

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place