Plantar FascitisPIPex-FPNCT06394336
Early Intervention With Therapeutic Exercise in Plantar Fasciopathy
A study testing Muscle strengthening and Standard treatment (oral analgesic/anti-inflammatory drug) in people with Plantar Fascitis, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Muscle strengthening and Standard treatment (oral analgesic/anti-inflammatory drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2024to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital General Universitario de Elche
Elche, Alicante, 03203
Jorge Roses-Conde, PT, +34 966616406, roses_jor@gva.es
About this study
Official 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.
Read the detailed description
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
- Plantar Fascitis
- Being tested
- Muscle strengthening, Standard treatment (oral analgesic/anti-inflammatory drug)
- Keywords
- therapeutic exercise, strengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strengtheningOther
Strengthening exercises for the intrinsic muscles of the foot and hips
Standard treatment (oral analgesic/anti-inflammatory drug)Drug
oral analgesic/anti-inflammatory drug. Education.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Standard treatment (oral analgesic/anti-inflammatory drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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".
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start10 May 2024 (estimated)
- Primary completion10 May 2024 (estimated)
- Study completion10 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental study with random allocation of patients with similar characteristics to the control and intervention groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Responsible party
- Principal investigator, Javier Marco Lledó, Universidad Miguel Hernandez de Elche
- Investigators
- Javier Marco, PhD, Study chair, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394336
- Sponsor's protocol ID
- ProtocoloFP
- Acronym
- PIPex-FP
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buchanan BK, Sina RE, Kushner D. Plantar Fasciitis. 2024 Jan 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK431073/
PubMed 28613727Budiman-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.
PubMed 23369667Cheung 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.
PubMed 26655866Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
PubMed 21916393Kamonseki 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.
PubMed 26654252Kamper 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.
PubMed 20046623Latey 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.
PubMed 27986277Lim 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.
PubMed 27075037Luffy 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.
PubMed 29227320Pascual 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.
PubMed 25456717Spink 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.
PubMed 19955706Sullivan 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.
PubMed 25237175Sullivan 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.
PubMed 31731071Yoo 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.
PubMed 29354574Rathleff 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.
PubMed 25145882
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Early Intervention Programme Using Therapeutic Exercise in Patients With Plantar Fasciopathy
- ClinicalTrials.gov ID
- NCT06394336
- Acronym / sponsor ID
- PIPex-FP / ProtocoloFP
- Conditions
- Plantar Fascitis
- Keywords
- therapeutic exercise, strengthening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 10 May 2024 (estimated)
- Study completion
- 10 Feb 2025 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental study with random allocation of patients with similar characteristics to the control and intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Muscle strengtheningPeople 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. |
| Non-experimental group | Active comparator | Drug: Standard treatment (oral analgesic/anti-inflammatory drug)Individuals with PF who will receive the usual treatment (oral analgesic/anti-inflammatory drug) prescribed by the primary care physician |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle strengtheningStrengthening exercises for the intrinsic muscles of the foot and hips | Other | Experimental group |
| Standard treatment (oral analgesic/anti-inflammatory drug)oral analgesic/anti-inflammatory drug. Education. | Drug | Non-experimental group |
Primary outcome
Pain intensity
Time frame: 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.
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.
Disability
Time frame: 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.
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.
General health and health-related quality of life:
Time frame: 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.
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
Physical activity
Time frame: 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.
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.
Overall perception of clinical change
Time frame: 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.
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 28613727Buchanan BK, Sina RE, Kushner D. Plantar Fasciitis. 2024 Jan 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK431073/
- Background: PubMed 23369667Budiman-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.
- Background: PubMed 26655866Cheung 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.
- Background: PubMed 21916393Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
- Background: PubMed 26654252Kamonseki 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.
- Background: PubMed 20046623Kamper 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.
- Background: PubMed 27986277Latey 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.
- Background: PubMed 27075037Lim 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.
- Background: PubMed 29227320Luffy 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.
- Background: PubMed 25456717Pascual 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.
- Background: PubMed 19955706Spink 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.
- Background: PubMed 25237175Sullivan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Marco, PhD study chair
Universidad Miguel Hernandez de Elche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle strengthening and Standard treatment (oral analgesic/anti-inflammatory drug) in people with Plantar Fascitis, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Marco, PhD (34 965 919405, jmarco@umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06394336, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.