Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Specifically Optimized Off-the-counter Foot Orthosis for the Subtle Cavus Foot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04941469
Recruitment Status : Not yet recruiting
First Posted : June 28, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Ng Chuan Guan, Tan Tock Seng Hospital

Brief Summary:

As off-the-counter foot orthoses are readily available and have an economic advantage, they are increasingly being used by healthcare professionals to treat mechanical foot pains in place of custom foot orthosis. However, there is a lack of available evidence to determine if a plain off-the-counter foot orthosis that aims to contours to the foot or a specifically optimized off-the-counter foot orthosis utilizing the type of orthotic design proposed by Abbasian and Pomeroy is more effective in the management of mechanical foot pains in the Subtle Cavus foot type.

This study proposal seeks to fill the gap in this area.

Primary Aim:

To investigate the effectiveness of specifically optimized off-the-counter foot orthosis designed for the Subtle Cavus foot type in improving patient reported outcomes in patients with mechanical foot pains when compared to plain off-the-counter foot orthosis.

Primary Null Hypothesis:

There is no difference in pain and functional scores reported by patients between specifically optimized off-the-counter foot orthosis and plain off-the-counter foot orthosis in patients with mechanical foot pains at four, eight and twelve weeks of intervention.

In our study, the Subtle Cavus foot refers to the flexible idiopathic forefoot-driven Pes Cavus that can be clinically recognised with a positive "Peek a Boo" sign, inverted hindfoot position in weight bearing stance and Positive Coleman Block Test as reported by Manoli and Graham in 2005.

Also, for our study, mechanical foot pains are limited to clinically diagnosed Plantar Fasciitis, Achilles Tendinopathy, Peroneal Strain or Metatarsalgia:

Plantar Fasciitis is clinically diagnosed using the following history and physical examination findings:

  • Plantar medial heel pain /or pain along the plantar fascia: most noticeable with initial steps after a period of inactivity but also worse following prolonged weight bearing
  • Heel pain /or pain along the plantar fascia precipitated by a recent increase in weightbearing activity
  • Pain with palpation of the proximal insertion of the plantar fascia /or along the band of plantar fascia structure

Achilles Tendinopathy is clinically diagnosed using the following history and physical examination findings:

Midportion Achilles Tendinopathy:

  • Self-reported localized pain and perceived stiffness in the Achilles tendon following a period of inactivity (eg, sleep, prolonged sitting) lessen with an acute bout of activity and may increase after the activity.
  • Symptoms are frequently accompanied by Achilles tendon tenderness.
  • Pain located 2 to 6 cm proximal to the Achilles tendon insertion that began gradually and pain with palpation of the midportion of the tendon to diagnose midportion Achilles tendinopathy

Insertional Achilles Tendinopathy:

  • Self-reported pain that is aggravated by activity and stiffness that is associated with prolonged periods of rest.
  • Pain and tenderness with palpation within the distal 2 cm of the Achilles tendon.
  • Redness and swelling over area of Achilles Tendon insertion over posterior heel

Peroneal Strain is clinically diagnosed using the following history and physical examination findings:

  • Pain and swelling posterior to the lateral malleolus
  • Pain with active eversion and dorsiflexion against resistance
  • May have a history of chronic lateral ankle pain and instability
  • Pain and tenderness with palpation along the course of the peroneal tendons

Metatarsalgia is clinically diagnosed using the following history and physical examination findings:

  • Self-reported pain during the propulsive phase of gait. The pain is localized underneath the prominent metatarsal heads
  • The plantar soft tissue can be swollen and inflamed.
  • Presence of hyperkeratosis over tender areas may be present
  • Pain and tenderness with palpation of plantar metatarsophalangeal joints

Secondary Aim:

To investigate the effectiveness of specifically optimized off-the-counter foot orthosis designed for the Subtle Cavus foot type in improving patient reported outcomes in patients with mechanical foot pains pre- and post-intervention.

Secondary Null Hypothesis:

There is no difference in pain and functional scores reported by patients after introduction of specifically optimized off-the counter foot orthosis pre- and post-intervention at initial to four, initial to eight and initial to twelve weeks of intervention.


Condition or disease Intervention/treatment Phase
Subtle Cavus Foot Mechanical Foot Pains Plantar Fasciitis Achilles Tendinopathy Insertional Achilles Tendinopathy Strain of Peroneal Tendon Metatarsalgia Pes Cavus Pes Cavus, Bilateral Pes Cavovarus Device: Specifically optimized off-the-counter foot orthosis (Medical grade foot orthosis) Device: Plain off-the-counter foot orthosis (Medical grade foot orthosis) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a Pilot Randomized Controlled Trial designed to compare the effectiveness of specifically optimized off-the-counter foot orthosis versus plain off-the-counter foot orthosis in managing mechanical foot pains in the Subtle Cavus foot type

  • Subjects recruited will be randomly assigned to either the plain off-the-counter foot orthosis group (Control Group) or the specifically optimized off-the-counter foot orthosis group (Intervention Group) based on a pre-specified randomization list during the Screening Visit.
  • Randomization was performed using the Randomized Permuted Block Randomization method with blocks of six.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Specifically Optimized Off-the-counter Foot Orthosis for the Management of Mechanical Foot Pains in the Subtle Cavus Foot Type: A Pilot-controlled Study
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Specifically optimized off-the-counter foot orthosis
The study device is a specifically optimized off-the-counter foot orthosis modified by an additional wedging added onto the original Formthotics (Original Dual Hard) with standard arch fill reduction to achieve a foot orthosis that is "tailored" for the management of mechanical foot pains in the Subtle Cavus foot type.
Device: Specifically optimized off-the-counter foot orthosis (Medical grade foot orthosis)
The study device is a specifically optimized off-the-counter foot orthosis modified by an additional wedging added onto the original Formthotics (Original Dual Hard) with standard arch fill reduction to achieve a foot orthosis that is "tailored" for the management of mechanical foot pains in the Subtle Cavus foot type. The original Formthotics (Original Dual Hard) is currently in use and is considered a Class A medical device according to the Health Science Authority of Singapore risk classification system. At the moment, the original Formthotics (Original Dual Hard) is also available in the retail market, abeit, without assessment guided optimisations for specific feet types.
Other Names:
  • Specifically optimized prefabricated foot orthosis
  • Specifically optimized prefabricated Insoles

Active Comparator: Plain off-the-counter foot orthosis
The control device for this study would be the plain original Formthotics (Original Dual Hard).
Device: Plain off-the-counter foot orthosis (Medical grade foot orthosis)
The control device for this study would be the plain original Formthotics (Original Dual Hard).
Other Names:
  • Plain prefabricated foot orthosis
  • Plain prefabricated Insoles




Primary Outcome Measures :
  1. The Foot Function Index (FFI) total score [ Time Frame: Study Visit 2 (Week 4) ]
    • The FFI is a self-reported measure of pain, function, and activity level associated with foot dysfunction consisting of 23 items divided into 3 sub-scales. The scores range from 0 to 10, with the higher scores indicating more disability.
    • The FFI has been validated and is recommended as a reliable measurement scale for use in foot orthotic interventions study.
    • The evaluation of the study device efficacy will be conducted with the main outcome measure, the FFI between the control and treatment groups.

  2. The Foot Function Index (FFI) total score [ Time Frame: Study Visit 3 (Week 8) ]
    • The FFI is a self-reported measure of pain, function, and activity level associated with foot dysfunction consisting of 23 items divided into 3 sub-scales. The scores range from 0 to 10, with the higher scores indicating more disability.
    • The FFI has been validated and is recommended as a reliable measurement scale for use in foot orthotic interventions study.
    • The evaluation of the study device efficacy will be conducted with the main outcome measure, the FFI between the control and treatment groups.

  3. The Foot Function Index (FFI) total score [ Time Frame: Study Visit 4 (Week 12) ]
    • The FFI is a self-reported measure of pain, function, and activity level associated with foot dysfunction consisting of 23 items divided into 3 sub-scales. The scores range from 0 to 10, with the higher scores indicating more disability.
    • The FFI has been validated and is recommended as a reliable measurement scale for use in foot orthotic interventions study.
    • The evaluation of the study device efficacy will be conducted with the main outcome measure, the FFI between the control and treatment groups.

  4. The Change in Foot Function Index (FFI) total score from baseline at Week 4 [ Time Frame: Study Visit 2 (Week 4) vs Study Visit 1 (Week 0) ]
    • The FFI is a self-reported measure of pain, function, and activity level associated with foot dysfunction consisting of 23 items divided into 3 sub-scales. The scores range from 0 to 10, with the higher scores indicating more disability.
    • The FFI has been validated and is recommended as a reliable measurement scale for use in foot orthotic interventions study.
    • The evaluation of the study device efficacy will be conducted with the main outcome measure, the FFI before and after intervention.

  5. The Change in Foot Function Index (FFI) total score from baseline at Week 8 [ Time Frame: Study Visit 3 (Week 8) vs Study Visit 1 (Week 0) ]
    • The FFI is a self-reported measure of pain, function, and activity level associated with foot dysfunction consisting of 23 items divided into 3 sub-scales. The scores range from 0 to 10, with the higher scores indicating more disability.
    • The FFI has been validated and is recommended as a reliable measurement scale for use in foot orthotic interventions study.
    • The evaluation of the study device efficacy will be conducted with the main outcome measure, the FFI before and after intervention.

  6. The Change in Foot Function Index (FFI) total score from baseline at Week 12 [ Time Frame: Study Visit 4 (Week 12) vs Study Visit 1 (Week 0) ]
    • The FFI is a self-reported measure of pain, function, and activity level associated with foot dysfunction consisting of 23 items divided into 3 sub-scales. The scores range from 0 to 10, with the higher scores indicating more disability.
    • The FFI has been validated and is recommended as a reliable measurement scale for use in foot orthotic interventions study.
    • The evaluation of the study device efficacy will be conducted with the main outcome measure, the FFI before and after intervention.


Secondary Outcome Measures :
  1. The FFI sub-scale scores in the domain of pain [ Time Frame: Study Visit 2 (Week 4) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of pain between the control and treatment groups.

  2. The FFI sub-scale scores in the domain of pain [ Time Frame: Study Visit 3 (Week 8) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of pain between the control and treatment groups.

  3. The FFI sub-scale scores in the domain of pain [ Time Frame: Study Visit 4 (Week 12) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of pain between the control and treatment groups.

  4. The FFI sub-scale scores in the domain of disability [ Time Frame: Study Visit 2 (Week 4) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of disability between the control and treatment groups.

  5. The FFI sub-scale scores in the domain of disability [ Time Frame: Study Visit 3 (Week 8) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of disability between the control and treatment groups.

  6. The FFI sub-scale scores in the domain of disability [ Time Frame: Study Visit 4 (Week 12) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of disability between the control and treatment groups.

  7. The FFI sub-scale scores in the domain of activity limitation [ Time Frame: Study Visit 2 (Week 4) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of activity limitation between the control and treatment groups.

  8. The FFI sub-scale scores in the domain of activity limitation [ Time Frame: Study Visit 3 (Week 8) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of activity limitation between the control and treatment groups.

  9. The FFI sub-scale scores in the domain of activity limitation [ Time Frame: Study Visit 4 (Week 12) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of activity limitation between the control and treatment groups.

  10. The Change in FFI sub-scale scores in the domain of pain from baseline at Week 4 [ Time Frame: Study Visit 2 (Week 4) vs Study Visit 1 (Week 0) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of pain before and after intervention.

  11. The Change in FFI sub-scale scores in the domain of pain from baseline at Week 8 [ Time Frame: Study Visit 3 (Week 8) vs Study Visit 1 (Week 0) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of pain before and after intervention.

  12. The Change in FFI sub-scale scores in the domain of pain from baseline at Week 12 [ Time Frame: Study Visit 4 (Week 12) vs Study Visit 1 (Week 0) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of pain before and after intervention.

  13. The Change in FFI sub-scale scores in the domain of disability from baseline at Week 4 [ Time Frame: Study Visit 2 (Week 4) vs Study Visit 1 (Week 0) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of disability before and after intervention.

  14. The Change in FFI sub-scale scores in the domain of disability from baseline at Week 8 [ Time Frame: Study Visit 3 (Week 8) vs Study Visit 1 (Week 0) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of disability before and after intervention.

  15. The Change in FFI sub-scale scores in the domain of disability from baseline at Week 12 [ Time Frame: Study Visit 4 (Week 12) vs Study Visit 1 (Week 0) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of disability before and after intervention.

  16. The Change in FFI sub-scale scores in the domain of activity limitation from baseline at Week 4 [ Time Frame: Study Visit 2 (Week 4) vs Study Visit 1 (Week 0) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of activity limitation before and after intervention.

  17. The Change in FFI sub-scale scores in the domain of activity limitation from baseline at Week 8 [ Time Frame: Study Visit 3 (Week 8) vs Study Visit 1 (Week 0) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of activity limitation before and after intervention.

  18. The Change in FFI sub-scale scores in the domain of activity limitation from baseline at Week 8 [ Time Frame: Study Visit 4 (Week 12) vs Study Visit 1 (Week 0) ]
    - The evaluation of the study device efficacy will be conducted with the FFI sub-scale scores in the domain of activity limitation before and after intervention.

  19. 100mm Visual Analogue Scale (VAS) with the end-points "no pain" and "worst pain possible" [ Time Frame: Study Visit 1 (Week 0) ]
    • It is a reliable and valid measure of self-reported pain intensity
    • VAS is administered before and after intervention to evaluate acute pain levels

  20. 100mm Visual Analogue Scale (VAS) with the end-points "no pain" and "worst pain possible" [ Time Frame: Study Visit 2 (Week 4) ]
    • It is a reliable and valid measure of self-reported pain intensity
    • VAS is administered before and after intervention to evaluate acute pain levels

  21. 100mm Visual Analogue Scale (VAS) with the end-points "no pain" and "worst pain possible" [ Time Frame: Study Visit 3 (Week 8) ]
    • It is a reliable and valid measure of self-reported pain intensity
    • VAS is administered before and after intervention to evaluate acute pain levels

  22. 100mm Visual Analogue Scale (VAS) with the end-points "no pain" and "worst pain possible" [ Time Frame: Study Visit 4 (Week 12) ]
    • It is a reliable and valid measure of self-reported pain intensity
    • VAS is administered before and after intervention to evaluate acute pain levels


Other Outcome Measures:
  1. Patient reported Verbal Compliance Ratings [ Time Frame: Study Visit 2 (Week 4) ]
    Patient reported Verbal Compliance Ratings towards the use of the foot orthosis fitted and other standard podiatry management using a verbal compliance ratings form administered by the investigators during the study visit will be carried out.

  2. Patient reported Verbal Compliance Ratings [ Time Frame: Study Visit 3 (Week 8) ]
    Patient reported Verbal Compliance Ratings towards the use of the foot orthosis fitted and other standard podiatry management using a verbal compliance ratings form administered by the investigators during the study visit will be carried out.

  3. Patient reported Verbal Compliance Ratings [ Time Frame: Study Visit 4 (Week 12) ]
    Patient reported Verbal Compliance Ratings towards the use of the foot orthosis fitted and other standard podiatry management using a verbal compliance ratings form administered by the investigators during the study visit will be carried out.

  4. Patient Satisfaction Ratings [ Time Frame: Study Visit 2 (Week 4) ]
    Collection of Patient Satisfaction Ratings using a verbal compliance ratings form administered by the investigators during the study visit will be carried out.

  5. Patient Satisfaction Ratings [ Time Frame: Study Visit 3 (Week 8) ]
    Collection of Patient Satisfaction Ratings using a verbal compliance ratings form administered by the investigators during the study visit will be carried out.

  6. Patient Satisfaction Ratings [ Time Frame: Study Visit 4 (Week 12) ]
    Collection of Patient Satisfaction Ratings using a verbal compliance ratings form administered by the investigators during the study visit will be carried out.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 21-80 years old
  2. Able to provide informed consent
  3. Clinically diagnosed mechanical foot pains limited to Plantar Fasciitis, Achilles Tendinopathy, Peroneal Strain or Metatarsalgia.
  4. Clinically recognized Subtle Cavus foot type
  5. Positive "Peek a boo" sign
  6. Hind foot / Rearfoot / Heel in varus position in weight bearing stance
  7. Positive Coleman Block Test (rearfoot inversion correctable)
  8. Able to comply with all study procedures

Exclusion Criteria:

  1. Age < 21 Years old
  2. History of surgery in the lower limb
  3. History of trauma or falls prior to onset of symptoms or after
  4. Pregnancy or breastfeeding women
  5. Pes Planus foot type
  6. Rigid Pes Cavus (Negative Coleman Block Test)
  7. Nervous system problems (e.g., stroke, dementia, seizures)
  8. Peripheral vascular pathology
  9. Acute infection
  10. Rheumatic joint disease
  11. Inability to comply to wearing appropriate footwear and foot orthosis
  12. Lack of willingness to return for follow-up
  13. Musculoskeletal pathology other than Plantar Fasciitis, Achilles Tendinopathy, Peroneal Strain or Metatarsalgia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04941469


Contacts
Layout table for location contacts
Contact: Chuan Guan Ng +65-6357-7000 chuan_guan_ng@ttsh.com.sg

Sponsors and Collaborators
Tan Tock Seng Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chuan Guan Ng Tan Tock Seng Hospital
Publications:
Desai SN, Grierson R, Manoli II A. The cavus foot in athletes: fundamentals of examination and treatment. Operative Techniques in Sports Medicine. 2010 Mar 1;18(1):27-33.
Beals TC, Manoli A. The'peek-a-boo'heel sign in the evaluation of hindfoot varus. The Foot. 1996;4(6):205-6.
Landorf KB, Radford JA (2008): Minimal important difference: values for the foot health status questionnaire, foot function index and visual analogue scale. The Foot, 18(1): 15-19.

Layout table for additonal information
Responsible Party: Ng Chuan Guan, Senior Podiatrist, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT04941469    
Other Study ID Numbers: 2020/01043
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ng Chuan Guan, Tan Tock Seng Hospital:
Mechanical foot pains
Prefabricated insoles
Off the counter insoles
Optimized insoles
Additional relevant MeSH terms:
Layout table for MeSH terms
Tendinopathy
Fasciitis
Fasciitis, Plantar
Metatarsalgia
Talipes Cavus
Talipes
Foot Deformities
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Foot Diseases
Joint Diseases
Pain
Neurologic Manifestations
Foot Deformities, Acquired
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities