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

NCT04941469 | Completed

• 1 other identifier: 2020/01043
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Mechanical foot pains; Prefabricated insoles; Off the counter insoles; Optimized insoles

Outcome Measures

Primary Outcomes (6)

• The Foot Function Index (FFI) total score

  * 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.

  Study Visit 2 (Week 4)

• The Foot Function Index (FFI) total score

  * 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.

  Study Visit 3 (Week 8)

• The Foot Function Index (FFI) total score

  * 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.

  Study Visit 4 (Week 12)

• The Change in Foot Function Index (FFI) total score from baseline at 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 before and after intervention.

  Study Visit 2 (Week 4) vs Study Visit 1 (Week 0)

• The Change in Foot Function Index (FFI) total score from baseline at 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 before and after intervention.

  Study Visit 3 (Week 8) vs Study Visit 1 (Week 0)

• The Change in Foot Function Index (FFI) total score from baseline at 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 before and after intervention.

  Study Visit 4 (Week 12) vs Study Visit 1 (Week 0)

Secondary Outcomes (22)

• The FFI sub-scale scores in the domain of pain

  Study Visit 2 (Week 4)

• The FFI sub-scale scores in the domain of pain

  Study Visit 3 (Week 8)

• The FFI sub-scale scores in the domain of pain

  Study Visit 4 (Week 12)

• The FFI sub-scale scores in the domain of disability

  Study Visit 2 (Week 4)

• The FFI sub-scale scores in the domain of disability

  Study Visit 3 (Week 8)

Other Outcomes (6)

• Patient reported Verbal Compliance Ratings

  Study Visit 2 (Week 4)

• Patient reported Verbal Compliance Ratings

  Study Visit 3 (Week 8)

• Patient reported Verbal Compliance Ratings

  Study Visit 4 (Week 12)

Study Arms (2)

Specifically optimized off-the-counter foot orthosis

EXPERIMENTAL

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)

Plain off-the-counter foot orthosis

ACTIVE COMPARATOR

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)

Interventions

Specifically optimized off-the-counter foot orthosis (Medical grade foot orthosis) DEVICE

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.

Also known as: Specifically optimized prefabricated foot orthosis, Specifically optimized prefabricated Insoles

Specifically optimized off-the-counter foot orthosis

Plain off-the-counter foot orthosis (Medical grade foot orthosis) DEVICE

The control device for this study would be the plain original Formthotics (Original Dual Hard).

Also known as: Plain prefabricated foot orthosis, Plain prefabricated Insoles

Plain off-the-counter foot orthosis

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Foot Care and Limb Design Centre

Singapore, 308433, Singapore

Location

Related Publications (10)

• Manoli A 2nd, Graham B. The subtle cavus foot, "the underpronator". Foot Ankle Int. 2005 Mar;26(3):256-63. doi: 10.1177/107110070502600313.

  PMID: 15766431 BACKGROUND

• Chilvers M, Manoli A 2nd. The subtle cavus foot and association with ankle instability and lateral foot overload. Foot Ankle Clin. 2008 Jun;13(2):315-24, vii. doi: 10.1016/j.fcl.2008.01.003.

  PMID: 18457776 BACKGROUND

• 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.

  BACKGROUND

• Beals TC, Manoli A. The'peek-a-boo'heel sign in the evaluation of hindfoot varus. The Foot. 1996;4(6):205-6.

  BACKGROUND

• Coleman SS, Chesnut WJ. A simple test for hindfoot flexibility in the cavovarus foot. Clin Orthop Relat Res. 1977 Mar-Apr;(123):60-2. No abstract available.

  PMID: 852192 BACKGROUND

• Burns J, Crosbie J, Ouvrier R, Hunt A. Effective orthotic therapy for the painful cavus foot: a randomized controlled trial. J Am Podiatr Med Assoc. 2006 May-Jun;96(3):205-11. doi: 10.7547/0960205.

  PMID: 16707631 BACKGROUND

• Burns J, Landorf KB, Ryan MM, Crosbie J, Ouvrier RA. Interventions for the prevention and treatment of pes cavus. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD006154. doi: 10.1002/14651858.CD006154.pub2.

  PMID: 17943889 BACKGROUND

• LoPiccolo M, Chilvers M, Graham B, Manoli A 2nd. Effectiveness of the cavus foot orthosis. J Surg Orthop Adv. 2010 Fall;19(3):166-9.

  PMID: 21086930 BACKGROUND

• Abbasian A, Pomeroy G. The idiopathic cavus foot-not so subtle after all. Foot Ankle Clin. 2013 Dec;18(4):629-42. doi: 10.1016/j.fcl.2013.08.004.

  PMID: 24215829 BACKGROUND

• Landorf KB, Twyford GN, Cotchett MP, Whittaker GA. Revised minimal important difference values for the visual analogue scale and Foot Health Status Questionnaire when used for plantar heel pain. J Foot Ankle Res. 2024 Dec;17(4):e70021. doi: 10.1002/jfa2.70021.

  PMID: 39682003 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar; Metatarsalgia; Talipes Cavus

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Talipes; Foot Deformities, Acquired; Foot Deformities; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Chuan Guan Ng

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Podiatrist

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 28, 2021
• Study Start: October 20, 2021
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

SG (1)