Rheumatoid ArthritisNCT03561688
Foot Orthotic for Early Stage Rheumatoid Arthritis
A study testing Foot orthotics and Standard insole in people with Rheumatoid Arthritis and Rheumatoid Arthritis of Foot (Disorder), run by Regionshospital Nordjylland at 3 sites in Denmark.
Trial summary
The overall purpose of this project is to investigate the neuro adaptations of pain and biomechanical differences between placebo and a custom-made foot orthoses for patients with RA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Rheumatoid Arthritis of Foot (Disorder)
- What is being tested?
- Foot orthotics and Standard insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 3 sitesDenmark
- Study dates
- 10 Oct 2018to 1 Dec 2019
- 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
- Patients with RA (EUALAR 2010) without significant damage or with small erosions but without radiological subluxation in the feet, max Larsen rheumatoid arthritis score 224.
- With clinical (medical) assessed needs for orthotics (e.g. valgus ankle, pes planus, pes planus transversus, and metatarsophalangeal instability).
- In stable disease phase (no clinically recognizable, swollen joints (but sore joints)).
- In stable treatment (no change in DMARD, NSAIDs and steroid treatment the last 4 weeks).
Who cannot join
- • Patients with RA using, or regularly used FO, or orthopedic shoes within the last 3 months.
- Clinically significant joint disease (inflammatory or degenerative) of the knee or hip joints (according to the clinician).
- Clinically significant back disorder (according to the clinician).
- Patients with severe ischemic or neurological sequelae in the lower extremities.
- BMI above 32.
- Not suitable for a MRI scan (e.g. pacemaker, pregnancy or metal within the body).
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aalborg University Hospital
Aalborg, 9000
King Christian X's Hospital for Rhuematic Diseases
Gråsten, 6300
Department for Rheumatology
Hjørring, 9800
About this study
The overall purpose of this project is to investigate the neuro adaptations of pain and biomechanical differences between placebo and a custom-made foot orthoses for patients with RA.
Read the detailed description
Rheumatoid arthritis (RA) is an autoimmune, chronic, progressive, systemic inflammatory disease leading to substantial pain, disability, and other morbidities. In Denmark there are 40.000 patients with RA. In RA, synovitis, effusion, eventually erosive arthritis, bone loss and weakening of the muscle and tendon apparatus are thought to cause clinically recognizable valgus heel or pes planovalgus deformity. These symptoms gradually cause irreversible joint deformities and changes in the locomotion of muscles3. Over 85% of patients with RA experience painful feet and ankles during the course of the disease. Despite medical developments, foot orthotics (FO) are still an important adjunct treatment and are often prescribed with the intention to stabilize and align the foot. This is due to a number of reasons: 1) persistent foot and ankle problems still occuring even after clinical remission is reached. 2) patients with increased disease activity may have mechanical foot impairments that need treatment in conjunction with systemic management. and 3) patients, who have not responded to or are ineligible for biologic agents, continue to have active foot impairments. However, the scientific research literature within FO treatment has lagged behind clinical practice, often leading the clinician to recommend interventions based on opinion and past experience rather than published evidence9.
Production of FO is an enormous industry. Consequently, there is a great variety of products with different materials, design, manufacturing techniques and procedures. In the literature, some FO have been shown to reduce pain however there is a considerable amount for which the studies are either inconclusive or refute the effect of FO. This might be due to differences in methodology, sparse description of the orthotics and limited information on patient's disease type and stage. However, multidisciplinary studies are still limited and it is, therefore, too early to come up with guidelines about how these interventions affect the human body mechanically from current knowledge. Previous studies have primarily focused on how foot orthotics affect pain, foot function, walking speed, forefoot plantar pressure and gait parameters, while not considering the mechanical principles on which the rationales for FO were originally based. This has led to an abundance of clinical trials that are challenging to interpret, as FO clinical outcomes and FO gait mechanics have not been studied together.
- Being tested
- Foot orthotics, Standard insole
- Keywords
- Biomechanics, Pain, Gait, Foot orthotics, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot orthoticsDevice
Insoles for shoes
Standard insoleDevice
Sham foot orthotic
| Study group | Role | What they receive |
|---|---|---|
| Standard insole | Sham comparator | a flat insole Receives: Device: Standard insole |
| Foot orthotics | Experimental | Custom-made foot orthoses Receives: Device: Foot orthotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait mechanics
Gait analysis will be performed using a 3D marker-based motion capture system from Qualisys, Sweden.
To investigate gait mechanics, detailed patient-specific musculoskeletal (MS) computer models will be created based on clinical medical images (MRI), anthropometrics and motion capture data. The models will be created utilizing a musculoskeletal computer modeling software AnyBody Modeling System (AMS). A detailed cadaver-based model The Twente Lower Extremity Model 2.0 (TLEM 2.0) is developed for AMS to obtain patient-specific architecture, scale bones, joints, and muscles attachments relative to the patient in combination with image-based morphing techniques. These models will be used to estimate joint angles, joint torques, muscle forces and joint forces of the ankle, knee and hip joint.
Measured: Week 4 and 8
Secondary outcomes (6)
Change in foot pressure distribution
Motion capture
A pressure insole (2-3 mm thick) system (PedarX, Novel) will be placed in the patient's shoe attached to a small computer. It is a commercial available system that can measure accurate and reliable pressure distribution for monitoring local loads between the foot and the FO.
Measured: Week 4 and 8
Questionnaire - Pain - Visual analog scale
0-10 scale from no pain to highest possible.
Measured: Week 0, 4 and 8
Insole wearing time
Measured by temperature sensor (Orthotimer). Orthotimer is an electronic microsensor that documents the wearing time of orthopaedic devices. It is small and flat thermometer, (9 x 1 x 4.5 mm) and will be integrated in the handed-out FO. The sensor stores time, date and temperature every 15 minutes. This information allow for accurate measurements of how often the patients uses the FO.
Measured: From week 4 to 8
Pain - Pressure pain threshold
To investigate pressure pain threshold (PPT) a handheld algometer will be used. An algometer is an instrument used to measure the pain threshold in relevant areas of the leg, foot and arm. The pain threshold is defined as the point where the pressure is experienced as pain. The pressure increases gradually with an interval until the pain is experienced and the patient presses a stop button. Each measurement is repeated 3 times in each session.
Measured: Week 0, 4 and 8
Pain mapping
Subjects will be asked to draw their perceived pain on pain mapping drawings. Drawings will be scanned and layered and averaged though MATLAB, version 2017B (The MathWorks, Inc., Natick, Massachusetts, USA). The area of Pain will be measured using ImangeJ v.1.8.0_112 (National Institutes of Health, Madison, Wisconsin, USA).
Measured: Week 0, 4 and 8
Wearable activity monitor
A commercial available accelerometer based activity monitor (Polar M200) will be lent to the participants. The device will be used to monitor the participant's activity. Participants will be instructed to use the device during the two months they are involved in the project, during the placebo period and during FO treatment.
Measured: From week 0 to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start10 Oct 2018
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The study design is a cross over study. Patients is instructed in using a placebo FO for one month and receive a custom-made FO, which they will be using for one month.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Collaborators
- TrygFonden, Denmark, The Danish Rheumatism Association, Aalborg University, King Christian X´Hospital for Rheumatic Diseases
- Responsible party
- Principal investigator, Morten Bilde Simonsen, Regionshospital Nordjylland
- Investigators
- Morten B Simonsen, MSc, Principal investigator, Aalborg University, Department of Health Science and Technology and Centre for Clinical Research, North Denmark Regional Hospital, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561688
- Sponsor's protocol ID
- RHN_MBS_01
- Status last verified
- Feb 2020
- First submitted
- 8 May 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simonsen MB, Hirata RP, Naesborg-Andersen K, Leutscher PDC, Horslev-Petersen K, Woodburn J, Andersen MS. Different types of foot orthoses effect on gait mechanics in patients with rheumatoid arthritis. J Biomech. 2022 Jun;139:110496. doi: 10.1016/j.jbiomech.2021.110496. Epub 2021 Apr 30.
PubMed 33994179
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Orthotic for Early Stage Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03561688
- Acronym / sponsor ID
- RHN_MBS_01
- Keywords
- Biomechanics, Pain, Gait, Foot orthotics, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Collaborators
- TrygFonden, Denmark, The Danish Rheumatism Association, Aalborg University, King Christian X´Hospital for Rheumatic Diseases
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 19 Jun 2018 (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.
The overall purpose of this project is to investigate the neuro adaptations of pain and biomechanical differences between placebo and a custom-made foot orthoses for patients with RA.
Detailed description
Rheumatoid arthritis (RA) is an autoimmune, chronic, progressive, systemic inflammatory disease leading to substantial pain, disability, and other morbidities. In Denmark there are 40.000 patients with RA. In RA, synovitis, effusion, eventually erosive arthritis, bone loss and weakening of the muscle and tendon apparatus are thought to cause clinically recognizable valgus heel or pes planovalgus deformity. These symptoms gradually cause irreversible joint deformities and changes in the locomotion of muscles3. Over 85% of patients with RA experience painful feet and ankles during the course of the disease. Despite medical developments, foot orthotics (FO) are still an important adjunct treatment and are often prescribed with the intention to stabilize and align the foot. This is due to a number of reasons: 1) persistent foot and ankle problems still occuring even after clinical remission is reached. 2) patients with increased disease activity may have mechanical foot impairments that need treatment in conjunction with systemic management. and 3) patients, who have not responded to or are ineligible for biologic agents, continue to have active foot impairments. However, the scientific research literature within FO treatment has lagged behind clinical practice, often leading the clinician to recommend interventions based on opinion and past experience rather than published evidence9.
Production of FO is an enormous industry. Consequently, there is a great variety of products with different materials, design, manufacturing techniques and procedures. In the literature, some FO have been shown to reduce pain however there is a considerable amount for which the studies are either inconclusive or refute the effect of FO. This might be due to differences in methodology, sparse description of the orthotics and limited information on patient's disease type and stage. However, multidisciplinary studies are still limited and it is, therefore, too early to come up with guidelines about how these interventions affect the human body mechanically from current knowledge. Previous studies have primarily focused on how foot orthotics affect pain, foot function, walking speed, forefoot plantar pressure and gait parameters, while not considering the mechanical principles on which the rationales for FO were originally based. This has led to an abundance of clinical trials that are challenging to interpret, as FO clinical outcomes and FO gait mechanics have not been studied together.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is a cross over study. Patients is instructed in using a placebo FO for one month and receive a custom-made FO, which they will be using for one month.
| Arm | Type | Receives |
|---|---|---|
| Standard insole | Sham comparator | Device: Standard insolea flat insole |
| Foot orthotics | Experimental | Device: Foot orthoticsCustom-made foot orthoses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with RA (EUALAR 2010) without significant damage or with small erosions but without radiological subluxation in the feet, max Larsen rheumatoid arthritis score 224.
- With clinical (medical) assessed needs for orthotics (e.g. valgus ankle, pes planus, pes planus transversus, and metatarsophalangeal instability).
- In stable disease phase (no clinically recognizable, swollen joints (but sore joints)).
- In stable treatment (no change in DMARD, NSAIDs and steroid treatment the last 4 weeks).
Key exclusion criteria (6 listed)
- • Patients with RA using, or regularly used FO, or orthopedic shoes within the last 3 months.
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 |
|---|---|---|
| Foot orthoticsInsoles for shoes | Device | Foot orthotics |
| Standard insoleSham foot orthotic | Device | Standard insole |
Primary outcome
Change in gait mechanics
Time frame: Week 4 and 8
Gait analysis will be performed using a 3D marker-based motion capture system from Qualisys, Sweden. To investigate gait mechanics, detailed patient-specific musculoskeletal (MS) computer models will be created based on clinical medical images (MRI), anthropometrics and motion capture data. The models will be created utilizing a musculoskeletal computer modeling software AnyBody Modeling System (AMS). A detailed cadaver-based model The Twente Lower Extremity Model 2.0 (TLEM 2.0) is developed for AMS to obtain patient-specific architecture, scale bones, joints, and muscles attachments relative to the patient in combination with image-based morphing techniques. These models will be used to estimate joint angles, joint torques, muscle forces and joint forces of the ankle, knee and hip joint.
6 secondary outcomes
Change in foot pressure distribution
Time frame: Week 4 and 8
Questionnaire - Pain - Visual analog scale
Time frame: Week 0, 4 and 8
Insole wearing time
Time frame: From week 4 to 8
Pain - Pressure pain threshold
Time frame: Week 0, 4 and 8
Pain mapping
Time frame: Week 0, 4 and 8
Wearable activity monitor
Time frame: From week 0 to week 8
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 3 Mar 2020.
- Derived from this study: PubMed 33994179Simonsen MB, Hirata RP, Naesborg-Andersen K, Leutscher PDC, Horslev-Petersen K, Woodburn J, Andersen MS. Different types of foot orthoses effect on gait mechanics in patients with rheumatoid arthritis. J Biomech. 2022 Jun;139:110496. doi: 10.1016/j.jbiomech.2021.110496. Epub 2021 Apr 30.
- Individual participant dataSharing planned: Undecided
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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.
Morten B Simonsen, MSc principal investigator
Aalborg University, Department of Health Science and Technology and Centre for Clinical Research, North Denmark Regional Hospital, Aalborg University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot orthotics and Standard insole in people with Rheumatoid Arthritis and Rheumatoid Arthritis of Foot (Disorder), run by Regionshospital Nordjylland at 3 sites in Denmark.
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 4 inclusion and 6 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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. Some participants in this study may receive a placebo. 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 in gait mechanics (time frame: Week 4 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03561688, which also lists 1 linked publication.
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 3 Mar 2020.