Early Intervention With Therapeutic Exercise in Plantar Fasciopathy

NCT ID: NCT06394336

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2025-02-10

Brief Summary

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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.

Detailed Description

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All patients will be informed about the study to be carried out and will give their prior informed consent. The programme has a first part of teaching directed to patients by physiotherapists, and a second part of application at home, with a duration of 12 weeks. An experimental study will be designed with random assignment of patients with similar characteristics to two groups. The non-experimental group will receive their usual treatment (medication and recommnendations as stretching) and the experimental group will follow their usual treatment and also participate in the therapeutic programe.

Conditions

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Plantar Fascitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental study with random allocation of patients with similar characteristics to the control and intervention groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

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.

Group Type EXPERIMENTAL

Muscle strengthening

Intervention Type OTHER

Strengthening exercises for the intrinsic muscles of the foot and hips

Non-experimental group

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

Group Type ACTIVE_COMPARATOR

Standard treatment (oral analgesic/anti-inflammatory drug)

Intervention Type DRUG

oral analgesic/anti-inflammatory drug. Education.

Interventions

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Muscle strengthening

Strengthening exercises for the intrinsic muscles of the foot and hips

Intervention Type OTHER

Standard treatment (oral analgesic/anti-inflammatory drug)

oral analgesic/anti-inflammatory drug. Education.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

OTHER

Sponsor Role collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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Javier Marco Lledó

Universidad Miguel Hernández

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Javier Marco, PhD

Role: STUDY_CHAIR

Universidad Miguel Hernandez de Elche

Locations

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Hospital General Universitario de Elche

Elche, Alicante, Spain

Site Status

Countries

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Spain

Central Contacts

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Javier Marco, PhD

Role: CONTACT

34 965 919405

Facility Contacts

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Jorge Roses-Conde, PT

Role: primary

+34 966616406

References

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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/

Reference Type BACKGROUND
PMID: 28613727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23369667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26655866 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 21916393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26654252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20046623 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27986277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27075037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29227320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25456717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19955706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25237175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31731071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29354574 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25145882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30203866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32384905 (View on PubMed)

Other Identifiers

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ProtocoloFP

Identifier Type: -

Identifier Source: org_study_id

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