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NCT Number: NCT06963164

Testing of a New Joint Protection Program

The goal of this study is to to examine the feasibility of a full-scale trial on Helping Hand, a new Joint Protection Program for Hand Osteoarthritis and to examine the acceptability of the new Joint Protection Program.

This study will not assess the effectiveness of the program, as it is not designed or powered to do so. Instead, the information gathered will be used to refine the trial design and ensure the future full-scale trial that will assess the effectiveness of the program is robust and successful. The acceptability of the new Joint Protection Program will be assessed through a survey that will be administered to the intervention group at the end of the trial, which will be based on a standardized acceptability framework

Participants will:

Gain access to an online Joint Protection Program or continue to receive usual care for 12 weeks Visit the clinic or complete online assessments once every 4 weeks Keep a diary of their symptoms and the number of times they used other interventions to manage their symptoms (i.e. painkillers)

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Key information

Conditions

Hand Osteoarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roth | McFarlane Hand and Upper Limb Centre (HULC)

London, Ontario, N6A 4V2, Canada

Location contact

Dimitra Pouliopoulou, PT, MSc

CONTACT

519-646-6100 ext. 64544

Katrina Munro, MPT

CONTACT

[email protected]

519-646-6100 ext. 64544

About this study

The goal of this study is to to examine the feasibility of a definite trial on Helping Hand, a new Joint Protection Program for Hand Osteoarthritis and to examine the acceptability of the new Joint Protection Program.

Joint protection refers to a set of techniques and strategies that help reduce stress on the joints, manage pain, and prevent further joint damage. These techniques are particularly important for people with hand arthritis, as the small joints in the hands are often affected, leading to pain, stiffness, and difficulty performing daily tasks. Key principles of joint protection include:

  • Using larger, stronger joints whenever possible (e.g., using the forearm instead of the fingers to push open a door).
  • Reducing strain by spreading the load across multiple joints (e.g., carrying items with two hands instead of one).
  • Avoid tight gripping or pinching motions that can overstrain the joints.
  • Incorporating assistive devices to reduce effort during tasks (e.g., jar openers or ergonomic tools).
  • Pacing and prioritizing activities to avoid overuse of the joints and allow for adequate rest.

By adopting these strategies, people with hand arthritis can minimize discomfort and preserve their ability to perform daily activities. This research is important because hand arthritis can make everyday tasks-like opening jars, getting dressed, or gardening-painful and difficult. Current resources for managing arthritis often lack a focus on practical, evidence-based strategies tailored to the needs of people with hand arthritis.

This feasibility study will test the practicality of running a future full-scale randomized controlled trial and the acceptability of the intervention. The feasibility testing includes evaluating key trial processes such as recruitment rates (how many people agree to participate), randomization (how well participants are assigned to groups), attrition rates (how many people stay in the study until the end), adherence (whether participants follow the program as intended), and clinical outcome completion rates (how many participants complete the required assessments). The acceptability of the intervention will be assessed through a survey that will be administered to the intervention group at the end of the trial, which will be based on a standardized acceptability framework. Importantly, this study will not assess the effectiveness of the program, as it is not designed or powered to do so. Instead, the information gathered will be used to refine the trial design and ensure the future full-scale trial is robust and successful.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of hand osteoarthritis Pain symptoms for at least 3 months Ability to use a smartphone, tablet, or computer Ability to communicate in English

Exclusion criteria

Presence of neurological disorders, dementia, or other cognitive conditions that could interfere with trial procedures Scheduled hand surgery within the next 3 months

Treatment and study plan

Helping Hand - Joint Protection Program

Other

Joint protection refers to a set of techniques and strategies that help reduce stress on the joints, manage pain, and prevent further joint damage. These techniques are particularly important for people with hand arthritis, as the small joints in the hands are often affected, leading to pain, stiffness, and difficulty performing daily tasks. Key principles of joint protection include:

  • Using larger, stronger joints whenever possible (e.g., using the forearm instead of the fingers to push open a door).
  • Reducing strain by spreading the load across multiple joints (e.g., carrying items with two hands instead of one).
  • Avoid tight gripping or pinching motions that can overstrain the joints.
  • Incorporating assistive devices to reduce effort during tasks (e.g., jar openers or ergonomic tools).
  • Pacing and prioritizing activities to avoid overuse of the joints and allow for adequate rest

Primary outcomes

  1. Recruitment Rates

    Time frame: 4, 8, and 12-weeks after randomization

    Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Recruitment rates will be classified as proceed if they achieve or surpass the predefined threshold set at 8-10 participants on average per month.

  2. Adherence

    Time frame: 4, 8, and 12-weeks after randomization

    Uptake/participation will be tracked electronically by recording when participants log onto the website and monitoring whether participants show up in the live sessions. Adherence will also be measured by having the participants track the weekly modifications they performed through a self-reported diary. Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Adherence to the intervention protocol will be categorized as "proceed" if it achieves a minimum adherence rate of 85%.

  3. Clinical outcome measure completion

    Time frame: baseline, 4, 8, and 12-weeks after randomization

    Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Outcome completeness will be considered "proceed" when data collection for at least 90% of the intended outcomes is achieved.

  4. Attrition Rates

    Time frame: 4, 8, and 12-weeks after randomization

    Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Attrition rates will be classified as "proceed" if they remain below the predefined threshold, typically set at 20% or lower

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitra Pouliopoulou, PT, MSc

CONTACT

[email protected]

519-646-6100 ext. 64544

Joy MacDermid, PT, PHD

CONTACT

[email protected]

519-646-6000 ext. 64636

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • The Arthritis Society, Canada

Registry information

Official study title

Feasibility of a Remotely-Delivered, Technology-Enabled, Joint Protection Program

Acronym: "Helping Hand"

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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