NCT05499559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
846

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 27, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

August 2, 2022

Results QC Date

November 1, 2023

Last Update Submit

August 26, 2025

Conditions

Keywords

TelemedicineTelehealthMobile HealtheHealthmHealth

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • 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

Other Outcomes (5)

  • Analgesic Use

    Reduction in the number of participants using analgesics from baseline to the 3-month follow-up.

  • Willingness for Surgery

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

  • Fear of Physical Activity

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

  • +2 more other outcomes

Study Arms (1)

Joint Academy

The participants receive the digital treatment of Joint Academy.

Behavioral: Joint Academy digital treatment

Interventions

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.

Joint Academy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Academy

Malmo, Skåne County, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 16000093BACKGROUND
  • 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.

    PMID: 11156490BACKGROUND
  • 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.

    PMID: 33741081BACKGROUND
  • Walter MM, Sirard P, Nero H, Horder H, Dahlberg LE, Tveter AT, Kjeken I, Kiadaliri A. Digitally delivered education and exercises for patients with hand osteoarthritis-An observational study. Musculoskeletal Care. 2023 Dec;21(4):1154-1160. doi: 10.1002/msc.1796. Epub 2023 Jul 8.

Results Point of Contact

Title
Study Director
Organization
Arthro Therapeutics/Joint Academy

Study Officials

  • Leif Dahlberg, Professor

    Arthro Therapeutics /Joint Academy

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 12, 2022

Study Start

July 7, 2021

Primary Completion

July 31, 2022

Study Completion

June 26, 2023

Last Updated

August 27, 2025

Results First Posted

August 27, 2025

Record last verified: 2025-08

Locations