Managing Pain in Patients With MTP Arthritis

NCT04833608 | Completed

• 1 other identifier: 2018P002864
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hallux Rigidus

Keywords

1st metatarsophalangeal joint arthritis; 1st MTP arthritis; Hallux Rigidus; foot; Insole; carbon fiber insole; Morton extension insole

Outcome Measures

Primary Outcomes (5)

• Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) pain score at 2 weeks, 6 weeks, and 12 weeks

  PROMIS Bank v1.1 pain interference and PROMIS Scale v1.0 pain intensity were completed. Pain Interference instrument measures the self-reported impact of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The Pain Intensity instrument is universal rather than disease-specific. The initial items in the Pain Intensity item bank assess pain intensity utilizing a 7-day recall period (items include the phrase "the past 7 days") while the latter item asks patients to rate their pain intensity at the moment.

  At initial visit, 2 weeks, 6 weeks and 12 weeks

• Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Physical Function at 2 weeks, 6 weeks, and 12 weeks

  PROMIS Bank v2.0 Physical Function was completed. Items included in this reflect mobility, upper limb function (eg, carrying a bag of groceries), and full-body activities (eg, run errands and shop). For the PROMIS measure, the mean T-score in the United States general population is 50 with a SD of 10. Higher scores reflect better physical function.

  At initial visit, 2 weeks, 6 weeks and 12 weeks

• Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Global Health at 2 weeks, 6 weeks, and 12 weeks

  PROMIS SF v1.1 Global Health was completed. The PROMIS Global health was assessed to understand how patient's symptoms affected physical function, pain, fatigue, emotional distress, social health. The PROMIS global health consists of 10 items with 9 items using five-category response scales, and one item (rating of pain on average) using a response scale of 0-10 that is recoded to five categories.

  At initial visit, 2 weeks, 6 weeks and 12 weeks

• Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Depression at 2 weeks, 6 weeks, and 12 weeks

  PROMIS Bank v1.0 Depression was completed. The items in the questionnaire focus on the negative moods, emotions, self-image, social cognition and cognitive deficits. A 5-point verbal scale was used to measure patients experience related to their symptoms.

  At initial visit, 2 weeks, 6 weeks and 12 weeks

• Change from Baseline Compliance and activity Questionnaire at 2 weeks, 6 weeks, and 12 weeks

  Patient compliance was assessed by asking whether the patient used the orthosis - or not. This parameter had two choices that the patient would respond "Yes" or "No" which referred to whether they used the orthosis on the day they completed the questionnaire. Lastly, the comfort rate was measured with a 0-100 Likert scale, where a score of 0 indicated "least comfort" and a score of 100 reflected "best comfort".

  At initial visit, 2 weeks, 6 weeks and 12 weeks

Study Arms (2)

Vktory Carbon fiber insoles

ACTIVE COMPARATOR

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

Device: Vktory insoles

Morton's extension insoles

ACTIVE COMPARATOR

Based on expert opinions, it seems the Morton extensions may alleviate pain but are also poorly tolerated by patients due to its uncomfortable shape, coincidently leading to a low patient compliance rate.

Device: Morton's extension insoles

Interventions

Vktory insoles DEVICE

Patients were randomized into either the Carbon fiber insole group or Morton's extension group.

Also known as: Carbon fiber insoles

Vktory Carbon fiber insoles

Morton's extension insoles DEVICE

Patients were randomized into either the Vktory carbon fiber insole group or Morton's extension insole group.

Morton's extension insoles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• VKTRY Gear: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02120, United States

Location

Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

MeSH Terms

Conditions

Hallux Rigidus

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases

Study Officials

• Gregory Waryasz, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 6, 2021
• Study Start: April 30, 2019
• Primary Completion: February 27, 2020
• Study Completion: May 31, 2020
• Last Updated: April 6, 2021

Record last verified: 2021-03

Locations

US (2)