Plantar Fascitis Clinical Trial
— PIPex-FPOfficial title:
Efficacy of an Early Intervention Programme Using Therapeutic Exercise in Patients With Plantar Fasciopathy
The aim of this project is to evaluate the efficacy of a therapeutic exercise programme in patients with plantar fasciitis applied early and aimed at strengthening the hip and foot musculature.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | February 10, 2025 |
Est. primary completion date | May 10, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: - Patients with referred pain in the medial plantar area of the heel, accentuated with initial steps after a period of inactivity but also worsening after prolonged body weight bearing, of at least 3 months evolution prior to inclusion in the study. - Reproduction of the pain referred by the patient with palpation at the proximal insertion of the plantar fascia. Exclusion Criteria: - Pregnancy. - Injection of corticoids in the area in the 6 months prior to recruitment. - Previous illnesses that may alter gait (central or peripheral neurological pathology, degenerative and inflammatory arthropathies, systemic illnesses). - Existence of concomitant foot pathology (metatarsalgia, stress fractures, neuropathies due to entrapment, tendinitis, history of foot/ankle surgery, etc.). - People who do not have the capacity to understand and follow an exercise programme. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario de Elche | Elche | Alicante |
Lead Sponsor | Collaborator |
---|---|
Universidad Miguel Hernandez de Elche | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana |
Spain,
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Franettovich Smith MM, Collins NJ, Mellor R, Grimaldi A, Elliott J, Hoggarth M, Weber Ii KA, Vicenzino B. Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study. J Foot Ankle Res. 2020 May 8;13(1):20. doi: 10.1186/s13047-020-00384-1. — View Citation
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Kamonseki DH, Goncalves GA, Yi LC, Junior IL. Effect of stretching with and without muscle strengthening exercises for the foot and hip in patients with plantar fasciitis: A randomized controlled single-blind clinical trial. Man Ther. 2016 Jun;23:76-82. doi: 10.1016/j.math.2015.10.006. Epub 2015 Oct 30. — View Citation
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Pascual Huerta J. The effect of the gastrocnemius on the plantar fascia. Foot Ankle Clin. 2014 Dec;19(4):701-18. doi: 10.1016/j.fcl.2014.08.011. Epub 2014 Sep 26. — View Citation
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Riel H, Vicenzino B, Jensen MB, Olesen JL, Holden S, Rathleff MS. The effect of isometric exercise on pain in individuals with plantar fasciopathy: A randomized crossover trial. Scand J Med Sci Sports. 2018 Dec;28(12):2643-2650. doi: 10.1111/sms.13296. Epub 2018 Oct 1. — View Citation
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity | For its estimation a numerical pain rating scale will be used, where 0 represents no pain (at all) and 10, the worst pain imaginable. Using this instrument the patient should rate the intensity of pain at the start of walking in the morning (the first step), the worst time of the day and the average level of pain the participant has experienced in the last week. This is an easy to complete, quick and simple scale. A 2-point change on this scale is a clinically important difference in people with chronic pain. | It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention. | |
Primary | Disability | To be estimated using the Spanish version of the foot function index. The FFI consists of 23 items divided into 3 subscales that quantify the impact of foot pathology on pain, disability and activity limitation. | It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention. | |
Primary | General health and health-related quality of life: | Is a generic instrument for measuring health-related quality of life. It has 5 health dimensions: mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression. Each of these has three levels of severity | It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention. | |
Primary | Physical activity | t will be measured through the International Physical Activity Questionnaire (IPAQ). This questionnaire consists of 7 items. The aim of this instrument is to record the degree of physical activity, sitting hours and walking time of the subjects who complete it. | It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention. | |
Primary | Overall perception of clinical change | The overall rating of change will be obtained using an 11-point scale. It measures the overall perceived change in the condition of their heel pain from the time they started the study to the present as "worse", "no change" or "better". | It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention. |
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