We’re quite excited that a new clinical trial is going forward. It is designed to evaluate whether carbon fibre inserts are effective in reducing pain associated with osteoarthritis (OA) of the first metatarsophalangeal joint (MTPJ). The BigTOE OstEarthritis Inserts Trial, led by chief investigator Michael Backhouse, aims to assess whether these specialized shoe inserts can provide significant relief compared to a sham insole. This trial has the potential to really improve the quality of life for people living with osteoarthritis. It is an important step forward in the treatment of this frequently overlooked malady.
The BigTOE trial is being funded by the National Institute for Health and Care Research. Their goal is to enroll 438 individuals who fit carefully defined eligibility requirements. Persons need to be at least 18 years of age or older. Participants must have a diagnosis of OA in one or both feet and report activity-related pain in the affected joint for ≥3 months. Participants with a history of surgical or traumatic intervention to the foot or ankle are excluded. Moreover, those who are expecting to undergo surgery in the coming 12 months are excluded, too. Participants are excluded from the trial if they have received a corticosteroid injection to the affected foot within three months prior to randomisation. This results in those people being unable to attend.
The Need for Effective Treatments
Disease affecting OA of the first MTPJ may greatly limit mobility and quality of life. Backhouse points out that doctors typically diagnose OA without imaging. Research shows that nearly 1 in 5 people over age 50 have foot OA, highlighting how prevalent this condition is among older adults.
A recent UK/Australian cross-sectional survey of podiatrists and physiotherapists provided an important first step in exploring these questions. It identified more than 50 diverse therapeutic modalities in the treatment of osteoarthritis of the first MTPJ. Backhouse remarked that “the survey reflects the lack of evidence” regarding effective treatments. This reinforces the need for innovative, gold standard clinical trials such as BigTOE to develop and validate standardized approaches for how to safely treat and control this progressive disease.
The BigTOE trial specifically examines whether the use of carbon fibre inserts can effectively reduce pain in individuals suffering from OA. Backhouse cautioned that the real effectiveness of this approach is still unknown. “The truth is, we don’t know if this approach works, which is why we are doing the trial,” he stated.
Trial Methodology and Participant Engagement
The BigTOE trial uses a randomized, multicenter design to maintain objectivity and minimize biases. Participants will be unaware of whether they are receiving an active carbon fibre insert or a sham insert that appears identical. Backhouse explained that “we’re working with one supplier; the sham and the active insert appear the same.” This approach is intended to minimize any psychological effects that come with knowing if a participant is receiving the treatment.
Helen Branthwaite, a co-creator of the trial, wanted to stress the significance of this design decision. She noted, “What’s really unique about this trial is that they are going to have a multicentred population that will be randomised.” This method increases the robustness of the findings and captures a wide range of experiences from various participants.
Participants will be provided with more information about the study without revealing exactly what carbon fibre and stiff insert are. Backhouse mentioned, “We don’t tell them that we’re looking at carbon fibre inserts, and we don’t tell them that we’re looking at stiff inserts. We tell them we’re looking at inserts, maybe different materials.” This approach provides both a check on the original research goals and a way to keep participants hot and bothered.
Looking Toward Future Outcomes
The outcomes of the BigTOE trial could have significant implications for treatment options available to individuals living with OA of the first MTPJ. As Branthwaite noted, “Osteoarthritis of the first MP joint, or any joint, is progressive.” Knowing how different behavioral and pharmacological interventions can best improve the management of these bothersome symptoms should directly translate into better patient care.
With recruitment still underway at 25-30 general practice sites, researchers are hopeful they’ll lock in their target number of participants. The results of the BigTOE OstEarthritis Inserts Trial are very optimistic. Or, they might inform new behavioral interventions that help people with arthritis feel less pain and move better.
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