Managing Pain in Patients With MTP Arthritis

Completed · Not applicable

Conditions studied: Hallux Rigidus

In brief

Hallux rigidus is a degenerative disease of the first metatarsophalangeal (MTP) joint which affect 2.5% of people over the age of 50. As the arthritis progresses, patients pain levels increase and range of motion decreases. Non-operative management includes the use of NSAIDS, intra-articular injections, shoe modification, activity modifications, and physical therapy. Oral NSAID have been used extensively to reduce swelling and pain but have been found unsatisfactory in providing pain relief. Injections have been shown relieve pain in patients with grade 1 MTP arthritis. Shoe modifications and orthotics can modify the biomechanics of the MTP joint and thereby alleviate pain. Based on expert opinions, it seems the Morton extensions may alleviate pain but are also poorly tolerated by patients due to it's uncomfortable shape, coincidently leading to a low patient compliance rate. VKTRY insoles were initially designed to increase ground force leading to a harder push off for faster running or higher jumping. To enable energy return the insole needed to be extremely rigid and therefore consists out of a full-length Carbon-Fiber base. Unexpectedly the Carbon fiber base makes this a highly rigid construct which will likely benefit those patients with MTP arthritis as it will take away much movement of the MTP joint, without having an uncomfortable shape, i.e. patients can use this insole in their own shoes, possibly leading to a higher patient compliance and, simultaneously, to better outcome. Even though this insole is being widely used by athletes, no one has explored its role for treating patients with MTP joint arthritis. Therefore, the aim of this study is to compare the VKTRY insole to the current Morton extension insoles in a blinded randomized controlled trial

Key facts

Study ID: NCT04833608
Run by: Massachusetts General Hospital
People needed: 14
Starts: 2019-04-30
Expected to finish: 2020-05-31
Last updated by the study team: 2021-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult patients (over 18 years old) with MTP joint arthritis
Adults who were competent and able to consent on their behalf
Patients who were seen at Massachusetts General Hospital and Newton Wellesley Hospital

You may not qualify if…

Patients who had history of 1st MTP joint injection
Patients that have already used similar orthotics or had prior surgery to the foot
Patients who will be treated surgically

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States
Newton Wellesley Hospital — Newton, Massachusetts, United States

Full record on ClinicalTrials.gov

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