Hallux RigidusNCT04833608
Managing Pain in Patients With MTP Arthritis
A study testing Vktory insoles and Morton's extension insoles in people with Hallux Rigidus, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Rigidus
- What is being tested?
- Vktory insoles and Morton's extension insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Apr 2019to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02120
Newton Wellesley Hospital
Newton, Massachusetts, 02462
About this study
Official title: Using Flexible Carbon Fiber Insoles for 1st Metatarsophalangeal Arthritis Lead to Pain Reduction and High Compliance Rate: A Randomized Controlled Trial
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
Read the detailed description
Subject Enrollment:
Patients were introduced to the study by Foot and Ankle orthopaedic surgeons if they were identified as having hallux rigidis. If the patient agreed, an authorized member of the study staff went through the study in detail and addressed any questions the patients had. If the patient was willing to participate, informed consent was obtained. We emphasized that not participating in the study will not affect their care now or in the future.
Once informed consent was obtained, the patient was randomized into one of two groups.
- Morton Extensions along with current pain management protocol
- VKTRY insoles along with the current pain management protocol
Explanatory variables gathered:
- Basic patient characteristics
- Range of motion at 1st MTP joint
- Hallux Rigidus severity grading
Patients were evaluated at the initial appointment, 2 weeks, 6 weeks, and 12 weeks following their initial appointment. The surveys were given to the patients during each evaluation time point.
Sample Size Calculation:
Based on power analysis to detect a minimal clinically important difference of 10.6 (+/- 4.6 SD) points in the PROMIS pain intensity score between patients using the Vktory carbon fiber insole and patients using Morton's extension insole with an overall two-tailed Type-1 rate of 5%, 80% statistical power and accounting for a 30% lost to follow up, we needed 14 patients in total.
- Conditions
- Hallux Rigidus
- Being tested
- Vktory insoles, Morton's extension insoles
- Keywords
- 1st metatarsophalangeal joint arthritis, 1st MTP arthritis, Hallux Rigidus, foot, Insole, carbon fiber insole, Morton extension insole
- Medical subject headings
- Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vktory insolesDevice
Also called Carbon fiber insoles
Patients were randomized into either the Carbon fiber insole group or Morton's extension group.
Morton's extension insolesDevice
Patients were randomized into either the Vktory carbon fiber insole group or Morton's extension insole group.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Morton's extension insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: At initial visit, 2 weeks, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start30 Apr 2019
- Primary completion27 Feb 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux RigidusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- VKTRY Gear
- Responsible party
- Principal investigator, Gregory Waryasz, M.D., Massachusetts General Hospital
- Investigators
- Gregory Waryasz, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833608
- Sponsor's protocol ID
- 2018P002864
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Flexible Carbon Fiber Insoles for 1st Metatarsophalangeal Arthritis Lead to Pain Reduction and High Compliance Rate: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04833608
- Acronym / sponsor ID
- 2018P002864
- Conditions
- Hallux Rigidus
- Keywords
- 1st metatarsophalangeal joint arthritis, 1st MTP arthritis, Hallux Rigidus, foot, Insole, carbon fiber insole, Morton extension insole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- VKTRY Gear
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Subject Enrollment:
Patients were introduced to the study by Foot and Ankle orthopaedic surgeons if they were identified as having hallux rigidis. If the patient agreed, an authorized member of the study staff went through the study in detail and addressed any questions the patients had. If the patient was willing to participate, informed consent was obtained. We emphasized that not participating in the study will not affect their care now or in the future.
Once informed consent was obtained, the patient was randomized into one of two groups.
- Morton Extensions along with current pain management protocol
- VKTRY insoles along with the current pain management protocol
Explanatory variables gathered:
- Basic patient characteristics
- Range of motion at 1st MTP joint
- Hallux Rigidus severity grading
Patients were evaluated at the initial appointment, 2 weeks, 6 weeks, and 12 weeks following their initial appointment. The surveys were given to the patients during each evaluation time point.
Sample Size Calculation:
Based on power analysis to detect a minimal clinically important difference of 10.6 (+/- 4.6 SD) points in the PROMIS pain intensity score between patients using the Vktory carbon fiber insole and patients using Morton's extension insole with an overall two-tailed Type-1 rate of 5%, 80% statistical power and accounting for a 30% lost to follow up, we needed 14 patients in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vktory Carbon fiber insoles | Active comparator | Device: Vktory insolesVKTRY 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 |
| Morton's extension insoles | Active comparator | Device: Morton's extension insolesBased 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vktory insolesAlso: Carbon fiber insolesPatients were randomized into either the Carbon fiber insole group or Morton's extension group. | Device | Vktory Carbon fiber insoles |
| Morton's extension insolesPatients were randomized into either the Vktory carbon fiber insole group or Morton's extension insole group. | Device | Morton's extension insoles |
Primary outcome
Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) pain score at 2 weeks, 6 weeks, and 12 weeks
Time frame: At initial visit, 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.
Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Physical Function at 2 weeks, 6 weeks, and 12 weeks
Time frame: At initial visit, 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.
Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Global Health at 2 weeks, 6 weeks, and 12 weeks
Time frame: At initial visit, 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.
Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Depression at 2 weeks, 6 weeks, and 12 weeks
Time frame: At initial visit, 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.
Change from Baseline Compliance and activity Questionnaire at 2 weeks, 6 weeks, and 12 weeks
Time frame: At initial visit, 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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
Related trials for Hallux Rigidus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Recruiting
Kinetic Control Versus Dynamic Taping on First Metatarsophalangeal Joint in Athletes With Functional Hallux Limitus
Hallux Limitus
Not yet recruitingObservational study
Return to Cross Country Skiing and Other Physical Activities After Arthrodesis of the First Metatarsophalangeal Joint
Hallux Rigidus, Hallux Valgus
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
Not yet recruiting
Effect of Foot Core Control Training on Dorsiflexion Function and Gait Biomechanical Characteristics of Patients With Chronic Plantar Fasciitis
Chronic Plantar Fasciitis, Functional Hallux Limitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Waryasz, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vktory insoles and Morton's extension insoles in people with Hallux Rigidus, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) pain score at 2 weeks, 6 weeks, and 12 weeks (time frame: At initial visit, 2 weeks, 6 weeks and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.