Plantar Fasciitis Clinical Trial
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
Verified date | October 2023 |
Source | Tan Tock Seng Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | July 27, 2023 |
Est. primary completion date | July 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Foot Care and Limb Design Centre | Singapore |
Lead Sponsor | Collaborator |
---|---|
Tan Tock Seng Hospital |
Singapore,
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. — View Citation
Beals TC, Manoli A. The'peek-a-boo'heel sign in the evaluation of hindfoot varus. The Foot. 1996;4(6):205-6.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.
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.
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. — View Citation
Manoli A 2nd, Graham B. The subtle cavus foot, "the underpronator". Foot Ankle Int. 2005 Mar;26(3):256-63. doi: 10.1177/107110070502600313. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient reported Verbal Compliance Ratings | 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. | Study Visit 2 (Week 4) | |
Other | Patient reported Verbal Compliance Ratings | 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. | Study Visit 3 (Week 8) | |
Other | Patient reported Verbal Compliance Ratings | 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. | Study Visit 4 (Week 12) | |
Other | Patient Satisfaction Ratings | Collection of Patient Satisfaction Ratings using a verbal compliance ratings form administered by the investigators during the study visit will be carried out. | Study Visit 2 (Week 4) | |
Other | Patient Satisfaction Ratings | Collection of Patient Satisfaction Ratings using a verbal compliance ratings form administered by the investigators during the study visit will be carried out. | Study Visit 3 (Week 8) | |
Other | Patient Satisfaction Ratings | Collection of Patient Satisfaction Ratings using a verbal compliance ratings form administered by the investigators during the study visit will be carried out. | Study Visit 4 (Week 12) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | The FFI sub-scale scores in the domain of pain | - 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. | Study Visit 2 (Week 4) | |
Secondary | The FFI sub-scale scores in the domain of pain | - 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. | Study Visit 3 (Week 8) | |
Secondary | The FFI sub-scale scores in the domain of pain | - 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. | Study Visit 4 (Week 12) | |
Secondary | The FFI sub-scale scores in the domain of disability | - 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. | Study Visit 2 (Week 4) | |
Secondary | The FFI sub-scale scores in the domain of disability | - 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. | Study Visit 3 (Week 8) | |
Secondary | The FFI sub-scale scores in the domain of disability | - 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. | Study Visit 4 (Week 12) | |
Secondary | The FFI sub-scale scores in the domain of activity limitation | - 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. | Study Visit 2 (Week 4) | |
Secondary | The FFI sub-scale scores in the domain of activity limitation | - 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. | Study Visit 3 (Week 8) | |
Secondary | The FFI sub-scale scores in the domain of activity limitation | - 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. | Study Visit 4 (Week 12) | |
Secondary | The Change in FFI sub-scale scores in the domain of pain from baseline at Week 4 | - 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. | Study Visit 2 (Week 4) vs Study Visit 1 (Week 0) | |
Secondary | The Change in FFI sub-scale scores in the domain of pain from baseline at Week 8 | - 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. | Study Visit 3 (Week 8) vs Study Visit 1 (Week 0) | |
Secondary | The Change in FFI sub-scale scores in the domain of pain from baseline at Week 12 | - 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. | Study Visit 4 (Week 12) vs Study Visit 1 (Week 0) | |
Secondary | The Change in FFI sub-scale scores in the domain of disability from baseline at Week 4 | - 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. | Study Visit 2 (Week 4) vs Study Visit 1 (Week 0) | |
Secondary | The Change in FFI sub-scale scores in the domain of disability from baseline at Week 8 | - 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. | Study Visit 3 (Week 8) vs Study Visit 1 (Week 0) | |
Secondary | The Change in FFI sub-scale scores in the domain of disability from baseline at Week 12 | - 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. | Study Visit 4 (Week 12) vs Study Visit 1 (Week 0) | |
Secondary | The Change in FFI sub-scale scores in the domain of activity limitation from baseline at Week 4 | - 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. | Study Visit 2 (Week 4) vs Study Visit 1 (Week 0) | |
Secondary | The Change in FFI sub-scale scores in the domain of activity limitation from baseline at Week 8 | - 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. | Study Visit 3 (Week 8) vs Study Visit 1 (Week 0) | |
Secondary | The Change in FFI sub-scale scores in the domain of activity limitation from baseline at Week 8 | - 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. | Study Visit 4 (Week 12) vs Study Visit 1 (Week 0) | |
Secondary | 100mm Visual Analogue Scale (VAS) with the end-points "no pain" and "worst pain possible" | It is a reliable and valid measure of self-reported pain intensity
VAS is administered before and after intervention to evaluate acute pain levels |
Study Visit 1 (Week 0) | |
Secondary | 100mm Visual Analogue Scale (VAS) with the end-points "no pain" and "worst pain possible" | It is a reliable and valid measure of self-reported pain intensity
VAS is administered before and after intervention to evaluate acute pain levels |
Study Visit 2 (Week 4) | |
Secondary | 100mm Visual Analogue Scale (VAS) with the end-points "no pain" and "worst pain possible" | It is a reliable and valid measure of self-reported pain intensity
VAS is administered before and after intervention to evaluate acute pain levels |
Study Visit 3 (Week 8) | |
Secondary | 100mm Visual Analogue Scale (VAS) with the end-points "no pain" and "worst pain possible" | It is a reliable and valid measure of self-reported pain intensity
VAS is administered before and after intervention to evaluate acute pain levels |
Study Visit 4 (Week 12) |
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