Helping Hand Program for Osteoarthritis

("Helping Hand" Trial)

Overseen By Dimitra Pouliopoulou, PT, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Neurological disorders, dementia, cognitive conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems you can continue your usual care, which may include your current medications.

What data supports the effectiveness of the Helping Hand - Joint Protection Program treatment for osteoarthritis?

Research shows that adding splints and exercises to a joint protection program can significantly reduce pain and stiffness, and improve grip strength and daily activities for people with thumb base osteoarthritis, compared to joint protection alone. ^{1 2 3 4 5}

Is the Helping Hand Program for Osteoarthritis safe for humans?

The Helping Hand Program, also known as joint protection programs, has been studied for hand osteoarthritis and rheumatoid arthritis. While high-quality reviews found no significant benefits, there were no specific safety concerns reported, suggesting it is generally safe for humans. ^{1 2 6 7 8}

How is the Helping Hand - Joint Protection Program treatment different from other treatments for hand osteoarthritis?

The Helping Hand - Joint Protection Program is unique because it likely combines multidisciplinary and multidimensional approaches, which are not commonly described in existing treatments for hand osteoarthritis. This program may include elements like exercise therapy, self-management, and education, delivered in a novel way to improve adherence and effectiveness. ^{5 9 10 11 12}

What is the purpose of this trial?

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)

Eligibility Criteria

This trial is for individuals with hand osteoarthritis who have been in pain for at least three months. Participants must be able to use digital devices and communicate in English. It's not suitable for those planning hand surgery soon or with neurological disorders, dementia, or cognitive conditions.

Inclusion Criteria

I have been diagnosed with hand osteoarthritis.

Ability to use a smartphone, tablet, or computer

I have been experiencing pain for at least 3 months.

Exclusion Criteria

I have hand surgery planned within the next 3 months.

I do not have any brain disorders that affect my thinking or memory.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants gain access to an online Joint Protection Program or continue to receive usual care for 12 weeks

12 weeks

Visit the clinic or complete online assessments once every 4 weeks

Follow-up

Participants are monitored for adherence and acceptability of the Joint Protection Program

4 weeks

Treatment Details

Interventions

• Helping Hand - Joint Protection Program

Trial Overview The study tests the Helping Hand program, which aims to protect joints affected by osteoarthritis. This phase doesn't measure effectiveness but focuses on feasibility and acceptability through surveys after a 12-week online program compared to usual care.

Participant Groups

Group I: Joint Protection Program Experimental Treatment 1 Intervention

The content will be organised into 6 modules (4 asynchronous, 2 live modules). Each module will focus on specific principles or activities. The first two modules will present general information on Hand Osteoarthritis and Joint Protection Principles, and the third module will be activity-based and will go through different tasks including Activities of Daily Living, Occupational Activities, Household Chores, Hobbies, and Various Functional Everyday Activities. The fourth module will be pre-recorded, and it will include a patient partner talking about their experiences living with hand osteoarthritis. The two live modules will happen bi-weekly interchangeably. The first module will be a community of practice, where people will get together and exchange information on tools, strategies, and resources for hand osteoarthritis. The second module will include open Q\&A sessions, where patients will get the chance to talk to a clinician and ask questions about managing hand osteoarthritis.

Group II: Waitlist Active Control 1 Intervention

The participants in this group will continue to receive Standard Care and they will be offered access to the program after the end of the 12 weeks.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

678

Recruited

421,000+

The Arthritis Society, Canada

Collaborator

Trials

27

Recruited

9,700+

Findings from Research

Splinting has been shown to significantly reduce pain in thumb carpometacarpal osteoarthritis and improve function in symptomatic hand osteoarthritis, with moderate certainty of evidence from 9 meta-analyses involving randomized controlled trials.

Resistance training and physical exercise also effectively reduce hand pain and stiffness, while intra-articular hyaluronic acid is the only pharmacological intervention that significantly improves function, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of conservative treatments for hand osteoarthritis : An umbrella review of interventional studies. Veronese, N., Smith, L., Bolzetta, F., et al.[2022]

In a study of 42 women with thumb base osteoarthritis, adding splints, hot packs, and home exercises to a joint protection program significantly reduced pain and stiffness and improved grip force and daily activities, both immediately after treatment and at a 1-year follow-up.

The control group, which only received the joint protection program, showed some initial improvements but did not maintain these benefits at the 1-year mark, highlighting the long-term efficacy of the combined treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a hand-joint protection programme with an addition of splinting and exercise: one year follow-up. Boustedt, C., Nordenskiöld, U., Lundgren Nilsson, A.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Joint Protection Programmes for People with Osteoarthritis and Rheumatoid Arthritis of the Hand: An Overview of Systematic Reviews. [2023]

2. Austria pubmed.ncbi.nlm.nih.gov

Efficacy of conservative treatments for hand osteoarthritis : An umbrella review of interventional studies. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Effects of a hand-joint protection programme with an addition of splinting and exercise: one year follow-up. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effects of rehabilitative interventions on pain, function and physical impairments in people with hand osteoarthritis: a systematic review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effect of assistive technology in hand osteoarthritis: a randomised controlled trial. [2011]

6. Turkey pubmed.ncbi.nlm.nih.gov

Systematic Review of Non-surgical Therapies for Osteoarthritis of the Hand: An Update. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Kinesiology taping reduces the pain of finger osteoarthritis: a pilot single-blinded two-group parallel randomized trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Methotrexate to treat hand osteoarthritis with synovitis (METHODS): an Australian, multisite, parallel-group, double-blind, randomised, placebo-controlled trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Curcuma longa and Boswellia serrata extract combination for hand osteoarthritis: an open-label pre-post trial. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

The effects of a mobile app-delivered intervention in people with symptomatic hand osteoarthritis: a pragmatic randomized controlled trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

A multidisciplinary and multidimensional intervention for patients with hand osteoarthritis. [2015]

12. England pubmed.ncbi.nlm.nih.gov

Self-management approaches for osteoarthritis in the hand: a 2×2 factorial randomised trial. [2022]