Early Intervention With Therapeutic Exercise in Plantar Fasciopathy

NCT06394336 | Not Yet Recruiting

• 1 other identifier: ProtocoloFP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plantar Fascitis

Keywords

therapeutic exercise; strengthening

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Experimental group

EXPERIMENTAL

People with PF who will receive the usual treatment (oral analgesic/anti-inflammatory drug) prescribed by the primary care physician and will also participate in the therapeutic exercise programme.

Other: Muscle strengthening

Non-experimental group

ACTIVE COMPARATOR

Individuals with PF who will receive the usual treatment (oral analgesic/anti-inflammatory drug) prescribed by the primary care physician

Drug: Standard treatment (oral analgesic/anti-inflammatory drug)

Interventions

Muscle strengthening OTHER

Strengthening exercises for the intrinsic muscles of the foot and hips

Experimental group

Standard treatment (oral analgesic/anti-inflammatory drug) DRUG

oral analgesic/anti-inflammatory drug. Education.

Non-experimental group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reproduction of the pain referred by the patient with palpation at the proximal insertion of the plantar fascia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: collaborator

Study Sites (1)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Related Publications (17)

• Buchanan BK, Sina RE, Kushner D. Plantar Fasciitis. 2024 Jan 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK431073/

  PMID: 28613727 BACKGROUND

• Budiman-Mak E, Conrad KJ, Mazza J, Stuck RM. A review of the foot function index and the foot function index - revised. J Foot Ankle Res. 2013 Feb 1;6(1):5. doi: 10.1186/1757-1146-6-5.

  PMID: 23369667 BACKGROUND

• Cheung RT, Sze LK, Mok NW, Ng GY. Intrinsic foot muscle volume in experienced runners with and without chronic plantar fasciitis. J Sci Med Sport. 2016 Sep;19(9):713-5. doi: 10.1016/j.jsams.2015.11.004. Epub 2015 Nov 22.

  PMID: 26655866 BACKGROUND

• Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.

  PMID: 21916393 BACKGROUND

• 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.

  PMID: 26654252 BACKGROUND

• Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

  PMID: 20046623 BACKGROUND

• Latey PJ, Burns J, Hiller CE, Nightingale EJ. Relationship between foot pain, muscle strength and size: a systematic review. Physiotherapy. 2017 Mar;103(1):13-20. doi: 10.1016/j.physio.2016.07.006. Epub 2016 Aug 4.

  PMID: 27986277 BACKGROUND

• Lim AT, How CH, Tan B. Management of plantar fasciitis in the outpatient setting. Singapore Med J. 2016 Apr;57(4):168-70; quiz 171. doi: 10.11622/smedj.2016069.

  PMID: 27075037 BACKGROUND

• Luffy L, Grosel J, Thomas R, So E. Plantar fasciitis: A review of treatments. JAAPA. 2018 Jan;31(1):20-24. doi: 10.1097/01.JAA.0000527695.76041.99.

  PMID: 29227320 BACKGROUND

• 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.

  PMID: 25456717 BACKGROUND

• Spink MJ, Fotoohabadi MR, Menz HB. Foot and ankle strength assessment using hand-held dynamometry: reliability and age-related differences. Gerontology. 2010;56(6):525-32. doi: 10.1159/000264655. Epub 2009 Dec 3.

  PMID: 19955706 BACKGROUND

• Sullivan J, Burns J, Adams R, Pappas E, Crosbie J. Musculoskeletal and activity-related factors associated with plantar heel pain. Foot Ankle Int. 2015 Jan;36(1):37-45. doi: 10.1177/1071100714551021. Epub 2014 Sep 18.

  PMID: 25237175 BACKGROUND

• Sullivan J, Pappas E, Burns J. Role of mechanical factors in the clinical presentation of plantar heel pain: Implications for management. Foot (Edinb). 2020 Mar;42:101636. doi: 10.1016/j.foot.2019.08.007. Epub 2019 Sep 3.

  PMID: 31731071 BACKGROUND

• Yoo SD, Kim HS, Lee JH, Yun DH, Kim DH, Chon J, Lee SA, Han YJ, Soh YS, Kim Y, Han S, Lee W, Han YR. Biomechanical Parameters in Plantar Fasciitis Measured by Gait Analysis System With Pressure Sensor. Ann Rehabil Med. 2017 Dec;41(6):979-989. doi: 10.5535/arm.2017.41.6.979. Epub 2017 Dec 28.

  PMID: 29354574 BACKGROUND

• Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21.

  PMID: 25145882 BACKGROUND

• 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.

  PMID: 30203866 BACKGROUND

• 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.

  PMID: 32384905 BACKGROUND

Study Officials

• Javier Marco, PhD

  Universidad Miguel Hernandez de Elche

  STUDY CHAIR

Central Study Contacts

Javier Marco, PhD

CONTACT

34 965 919405; jmarco@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Universidad Miguel Hernández

Model Details: Experimental study with random allocation of patients with similar characteristics to the control and intervention groups.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: May 10, 2024
• Primary Completion: May 10, 2024
• Study Completion: February 10, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

ES (1)