Plantar Fasciitis of Both FeetPhase 1fascitisNCT06788158
Clinical Effects of Incobotulinum Toxin vs Corticosteroid in Plantar Fascitis
A Phase 1 study testing Incobotulinum Toxin A and Glucocorticoid in people with Plantar Fasciitis of Both Feet and Pain, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Objectives: To evaluate the clinical effects of intralesional application of incobotulinum toxin vs corticosteroid in patients with plantar fasciitis . Material and methods: Prospective, experimental, randomized, controlled clinical study; the population will be recruited in the outpatient clinic of the rehabilitation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis of Both Feet, Pain, Function
- What is being tested?
- Incobotulinum Toxin A and Glucocorticoid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2024to 1 Nov 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years.
- Any sex.
- Diagnosis of plantar fasciitis (pain in the medial plantar calcaneal tubercle which gives rise to the site of plantar fascial insertion into the heel bone and/or pain along the path of its three bands) made by a physician specializing in Physical Medicine and Rehabilitation.
- Voluntary acceptance of participation in the study.
- Patients entitled to the Mexican Social Security Institute.
Who cannot join
- Diagnosis of ankylosing spondylitis.
- Pregnant women.
- Previous infiltration treatment with any medication or substance applied to the plantar fascia or gastrocnemius muscles in the last six months.
- Anticoagulant treatment.
- History of local infection in the plantar fascia in the last three months.
- Allergic to lidocaine, incobotulinum toxin or dexamethasone.
- Patients not entitled to the Mexican Social Security Institute.
- Patient's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.
Mérida, Yucatán, 97000
About this study
Official title: Clinical Effects of the Intralesional Application of Incobotulinum Toxin vs Corticosteroid in Patients With Plantar Fascitis
Objectives: To evaluate the clinical effects of intralesional application of incobotulinum toxin vs corticosteroid in patients with plantar fasciitis .
Material and methods: Prospective, experimental, randomized, controlled clinical study; the population will be recruited in the outpatient clinic of the rehabilitation service meeting the inclusion criteria, two randomized study groups will be formed: GROUP A: Patients who accept intralesional infiltration with incobotulinum toxin . GROUP B: Patients who accept intralesional infiltration with dexamethasone.
Both groups will be assessed before application, at 1 month, at 2 and 4 months post intervention. The visual analogue scale (VAS), the American Orthopaedic Foot and Ankle Society (AOFAS) scale and the Foot and Ankle Disability Index (FADI) will be used to assess pain, foot functionality, functional disability index in activities of daily living, in physical activity and measurement of the dorsiflexion arch in 2 visits at the beginning of diagnosis and at 4 months, collecting the variables and establishing a hypothesis analysis to accept or discard normality criteria of the same with tendency and its significance in relation to p <0.05 to establish contrast of the results with parametric or non-parametric variables according to whether or not the hypothesis of normality is discarded.
Read the detailed description
The investigators want to compare the effects on pain, ankle and foot functionality, as well as activities of daily living; of the application of incobotulinum toxin vs corticosteroid in people suffering from plantar fasciitis.
- Conditions
- Plantar Fasciitis of Both Feet, Pain, Function
- Being tested
- Incobotulinum Toxin A, Glucocorticoid
- Keywords
- botulinum toxin, plantar fasciitis, corticosteroid, pain, foot functionality
- Medical subject headings
- Pain, Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incobotulinum Toxin ADrug
will be administered 2 ampoules (200 IU) of Incobotulinum toxin , injectable solution presentation 100 IU ampoule with powder diluted in 1 ml of 0.9% saline solution in a single application at 4 points, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot).
GlucocorticoidDrug
Program in which 2 ml of dexamethasone will be administered in an 8 mg/2 ml ampoule diluted in 2 ml of lidocaine injectable solution in a 50 ml bottle (20 mg/ml) in a single application at 1 point, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot).
| Study group | Role | What they receive |
|---|---|---|
| incobotulinum toxin + rehabilitation | Experimental | will be administered 2 ampoules (200 IU) of Incobotulinum toxin , injectable solution presentation 100 IU ampoule with powder diluted in 1 ml of 0.9% saline solution in a single application at 4 points, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot). Receives: Drug: Incobotulinum Toxin A |
| glucocorticoid + rehabilitation | Active comparator | 2 ml of dexamethasone will be administered in an 8 mg/2 ml ampoule diluted in 2 ml of lidocaine injectable solution in a 50 ml bottle (20 mg/ml) in a single application at 1 point, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot). Receives: Drug: Glucocorticoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Pain Scale
zero is equivalent to no pain and 10 indicates the worst possible pain
Measured: Initially, 4, 8 and 16 weeks.
Clinical Functional Status of the Ankle and Foot
Result of the total summative score of the American Foot and Ankle Society Scale, Excellent=90-100, Good =80-89, Medium=70-79, Poor=<70.
Measured: Initially, 4, 8 and 16 weeks.
Index of Functional Disability of the Foot and Ankle in Activities of Daily Living
Result of the total summative score of the Ankle disability index scale. Absence of disability or pain = 100 Mild=80-99 Moderate=50-79 Severe:1-49 Maximum disability level = 0
Measured: Initially, 4, 8 and 16 weeks.
Index of Functional Disability of the Foot and Ankle in Sports Activities
Result of the total summative score of the ankle disability index scale. Absence of disability or pain = 100 Mild=80-99 Moderate=50-79 Severe:1-49 Maximum disability level = 0
Measured: Initially, 4, 8 and 16 weeks.
Secondary outcomes (1)
Mobility Arc
Range of motion (degree of travel) or total angular/axial displacement allowed at ankle joint, dosiflexion degrees at the time of data collection, will be expressed in the results by mobility range groups according to the American Academy of Orthopedic Surgeons AAOS.
Measured: Initially and 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Sep 2024
- Primary completion1 Jan 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Plantar Fasciitis of Both FeetStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Roberto Carlos Pech Arguelles, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788158
- Sponsor's protocol ID
- R-2024-3201-115
- Acronym
- fascitis
- Status last verified
- Nov 2026
- First submitted
- 3 Jan 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dressler D. Clinical Pharmacology of Botulinum Toxin Drugs. Handb Exp Pharmacol. 2021;263:93-106. doi: 10.1007/164_2019_273.
PubMed 32886157Dressler D, Johnson EA. Botulinum toxin therapy: past, present and future developments. J Neural Transm (Vienna). 2022 Jun;129(5-6):829-833. doi: 10.1007/s00702-022-02494-5. Epub 2022 Apr 9.
PubMed 35396965Camargo CP, Xia J, Costa CS, Gemperli R, Tatini MD, Bulsara MK, Riera R. Botulinum toxin type A for facial wrinkles. Cochrane Database Syst Rev. 2021 Jul 5;7(7):CD011301. doi: 10.1002/14651858.CD011301.pub2.
PubMed 34224576Choudhury S, Baker MR, Chatterjee S, Kumar H. Botulinum Toxin: An Update on Pharmacology and Newer Products in Development. Toxins (Basel). 2021 Jan 14;13(1):58. doi: 10.3390/toxins13010058.
PubMed 33466571Chou AC, Ng SY, Koo KO. Endoscopic Plantar Fasciotomy Improves Early Postoperative Results: A Retrospective Comparison of Outcomes After Endoscopic Versus Open Plantar Fasciotomy. J Foot Ankle Surg. 2016 Jan-Feb;55(1):9-15. doi: 10.1053/j.jfas.2015.02.005. Epub 2015 May 23.
PubMed 26007627Li Z, Xia C, Yu A, Qi B. Ultrasound- versus palpation-guided injection of corticosteroid for plantar fasciitis: a meta-analysis. PLoS One. 2014 Mar 21;9(3):e92671. doi: 10.1371/journal.pone.0092671. eCollection 2014.
PubMed 24658102Elizondo-Rodriguez J, Araujo-Lopez Y, Moreno-Gonzalez JA, Cardenas-Estrada E, Mendoza-Lemus O, Acosta-Olivo C. A comparison of botulinum toxin a and intralesional steroids for the treatment of plantar fasciitis: a randomized, double-blinded study. Foot Ankle Int. 2013 Jan;34(1):8-14. doi: 10.1177/1071100712460215.
PubMed 23386757Lee WC, Wong WY, Kung E, Leung AK. Effectiveness of adjustable dorsiflexion night splint in combination with accommodative foot orthosis on plantar fasciitis. J Rehabil Res Dev. 2012;49(10):1557-64. doi: 10.1682/jrrd.2011.09.0181.
PubMed 23516059Probe RA, Baca M, Adams R, Preece C. Night splint treatment for plantar fasciitis. A prospective randomized study. Clin Orthop Relat Res. 1999 Nov;(368):190-5.
PubMed 10613168Schneider HP, Baca JM, Carpenter BB, Dayton PD, Fleischer AE, Sachs BD. American College of Foot and Ankle Surgeons Clinical Consensus Statement: Diagnosis and Treatment of Adult Acquired Infracalcaneal Heel Pain. J Foot Ankle Surg. 2018 Mar-Apr;57(2):370-381. doi: 10.1053/j.jfas.2017.10.018. Epub 2017 Dec 25.
PubMed 29284574He C, Ma H. Effectiveness of trigger point dry needling for plantar heel pain: a meta-analysis of seven randomized controlled trials. J Pain Res. 2017 Aug 18;10:1933-1942. doi: 10.2147/JPR.S141607. eCollection 2017.
PubMed 28860848van de Water AT, Speksnijder CM. Efficacy of taping for the treatment of plantar fasciosis: a systematic review of controlled trials. J Am Podiatr Med Assoc. 2010 Jan-Feb;100(1):41-51. doi: 10.7547/1000041.
PubMed 20093544Whittaker GA, Munteanu SE, Menz HB, Tan JM, Rabusin CL, Landorf KB. Foot orthoses for plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018 Mar;52(5):322-328. doi: 10.1136/bjsports-2016-097355. Epub 2017 Sep 21.
PubMed 28935689Diaz Lopez AM, Guzman Carrasco P. [Effectiveness of different physical therapy in conservative treatment of plantar fasciitis: systematic review]. Rev Esp Salud Publica. 2014 Jan-Feb;88(1):157-78. doi: 10.4321/S1135-57272014000100010. Spanish.
PubMed 24728397Acosta-Olivo C, Simental-Mendia LE, Vilchez-Cavazos F, Pena-Martinez VM, Elizondo-Rodiguez J, Simental-Mendia M. Clinical Efficacy of Botulinum Toxin in the Treatment of Plantar Fasciitis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2022 Feb;103(2):364-371.e2. doi: 10.1016/j.apmr.2021.10.003. Epub 2021 Oct 22.
PubMed 34688605
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of the Intralesional Application of Incobotulinum Toxin vs Corticosteroid in Patients With Plantar Fascitis
- ClinicalTrials.gov ID
- NCT06788158
- Acronym / sponsor ID
- fascitis / R-2024-3201-115
- Conditions
- Plantar Fasciitis of Both Feet, Pain, Function
- Keywords
- botulinum toxin, plantar fasciitis, corticosteroid, pain, foot functionality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 23 Jan 2025 (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.
Objectives: To evaluate the clinical effects of intralesional application of incobotulinum toxin vs corticosteroid in patients with plantar fasciitis .
Material and methods: Prospective, experimental, randomized, controlled clinical study; the population will be recruited in the outpatient clinic of the rehabilitation service meeting the inclusion criteria, two randomized study groups will be formed: GROUP A: Patients who accept intralesional infiltration with incobotulinum toxin . GROUP B: Patients who accept intralesional infiltration with dexamethasone.
Both groups will be assessed before application, at 1 month, at 2 and 4 months post intervention. The visual analogue scale (VAS), the American Orthopaedic Foot and Ankle Society (AOFAS) scale and the Foot and Ankle Disability Index (FADI) will be used to assess pain, foot functionality, functional disability index in activities of daily living, in physical activity and measurement of the dorsiflexion arch in 2 visits at the beginning of diagnosis and at 4 months, collecting the variables and establishing a hypothesis analysis to accept or discard normality criteria of the same with tendency and its significance in relation to p <0.05 to establish contrast of the results with parametric or non-parametric variables according to whether or not the hypothesis of normality is discarded.
Detailed description
The investigators want to compare the effects on pain, ankle and foot functionality, as well as activities of daily living; of the application of incobotulinum toxin vs corticosteroid in people suffering from plantar fasciitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| incobotulinum toxin + rehabilitation | Experimental | Drug: Incobotulinum Toxin Awill be administered 2 ampoules (200 IU) of Incobotulinum toxin , injectable solution presentation 100 IU ampoule with powder diluted in 1 ml of 0.9% saline solution in a single application at 4 points, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot). |
| glucocorticoid + rehabilitation | Active comparator | Drug: Glucocorticoid2 ml of dexamethasone will be administered in an 8 mg/2 ml ampoule diluted in 2 ml of lidocaine injectable solution in a 50 ml bottle (20 mg/ml) in a single application at 1 point, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years.
- Any sex.
- Diagnosis of plantar fasciitis (pain in the medial plantar calcaneal tubercle which gives rise to the site of plantar fascial insertion into the heel bone and/or pain along the path of its three bands) made by a physician specializing in Physical Medicine and Rehabilitation.
- Voluntary acceptance of participation in the study.
- Patients entitled to the Mexican Social Security Institute.
Key exclusion criteria (8 listed)
- Diagnosis of ankylosing spondylitis.
- Pregnant women.
- Previous infiltration treatment with any medication or substance applied to the plantar fascia or gastrocnemius muscles in the last six months.
- Anticoagulant treatment.
- History of local infection in the plantar fascia in the last three months.
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 |
|---|---|---|
| Incobotulinum Toxin Awill be administered 2 ampoules (200 IU) of Incobotulinum toxin , injectable solution presentation 100 IU ampoule with powder diluted in 1 ml of 0.9% saline solution in a single application at 4 points, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot). | Drug | incobotulinum toxin + rehabilitation |
| GlucocorticoidProgram in which 2 ml of dexamethasone will be administered in an 8 mg/2 ml ampoule diluted in 2 ml of lidocaine injectable solution in a 50 ml bottle (20 mg/ml) in a single application at 1 point, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot). | Drug | glucocorticoid + rehabilitation |
Primary outcome
Visual Analogue Pain Scale
Time frame: Initially, 4, 8 and 16 weeks.
zero is equivalent to no pain and 10 indicates the worst possible pain
Clinical Functional Status of the Ankle and Foot
Time frame: Initially, 4, 8 and 16 weeks.
Result of the total summative score of the American Foot and Ankle Society Scale, Excellent=90-100, Good =80-89, Medium=70-79, Poor=<70.
Index of Functional Disability of the Foot and Ankle in Activities of Daily Living
Time frame: Initially, 4, 8 and 16 weeks.
Result of the total summative score of the Ankle disability index scale. Absence of disability or pain = 100 Mild=80-99 Moderate=50-79 Severe:1-49 Maximum disability level = 0
Index of Functional Disability of the Foot and Ankle in Sports Activities
Time frame: Initially, 4, 8 and 16 weeks.
Result of the total summative score of the ankle disability index scale. Absence of disability or pain = 100 Mild=80-99 Moderate=50-79 Severe:1-49 Maximum disability level = 0
1 secondary outcome
Mobility Arc
Time frame: Initially and 16 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 32886157Dressler D. Clinical Pharmacology of Botulinum Toxin Drugs. Handb Exp Pharmacol. 2021;263:93-106. doi: 10.1007/164_2019_273.
- Background: PubMed 35396965Dressler D, Johnson EA. Botulinum toxin therapy: past, present and future developments. J Neural Transm (Vienna). 2022 Jun;129(5-6):829-833. doi: 10.1007/s00702-022-02494-5. Epub 2022 Apr 9.
- Background: PubMed 34224576Camargo CP, Xia J, Costa CS, Gemperli R, Tatini MD, Bulsara MK, Riera R. Botulinum toxin type A for facial wrinkles. Cochrane Database Syst Rev. 2021 Jul 5;7(7):CD011301. doi: 10.1002/14651858.CD011301.pub2.
- Background: PubMed 33466571Choudhury S, Baker MR, Chatterjee S, Kumar H. Botulinum Toxin: An Update on Pharmacology and Newer Products in Development. Toxins (Basel). 2021 Jan 14;13(1):58. doi: 10.3390/toxins13010058.
- Background: PubMed 26007627Chou AC, Ng SY, Koo KO. Endoscopic Plantar Fasciotomy Improves Early Postoperative Results: A Retrospective Comparison of Outcomes After Endoscopic Versus Open Plantar Fasciotomy. J Foot Ankle Surg. 2016 Jan-Feb;55(1):9-15. doi: 10.1053/j.jfas.2015.02.005. Epub 2015 May 23.
- Background: PubMed 24658102Li Z, Xia C, Yu A, Qi B. Ultrasound- versus palpation-guided injection of corticosteroid for plantar fasciitis: a meta-analysis. PLoS One. 2014 Mar 21;9(3):e92671. doi: 10.1371/journal.pone.0092671. eCollection 2014.
- Background: PubMed 23386757Elizondo-Rodriguez J, Araujo-Lopez Y, Moreno-Gonzalez JA, Cardenas-Estrada E, Mendoza-Lemus O, Acosta-Olivo C. A comparison of botulinum toxin a and intralesional steroids for the treatment of plantar fasciitis: a randomized, double-blinded study. Foot Ankle Int. 2013 Jan;34(1):8-14. doi: 10.1177/1071100712460215.
- Background: PubMed 23516059Lee WC, Wong WY, Kung E, Leung AK. Effectiveness of adjustable dorsiflexion night splint in combination with accommodative foot orthosis on plantar fasciitis. J Rehabil Res Dev. 2012;49(10):1557-64. doi: 10.1682/jrrd.2011.09.0181.
- Background: PubMed 10613168Probe RA, Baca M, Adams R, Preece C. Night splint treatment for plantar fasciitis. A prospective randomized study. Clin Orthop Relat Res. 1999 Nov;(368):190-5.
- Background: PubMed 29284574Schneider HP, Baca JM, Carpenter BB, Dayton PD, Fleischer AE, Sachs BD. American College of Foot and Ankle Surgeons Clinical Consensus Statement: Diagnosis and Treatment of Adult Acquired Infracalcaneal Heel Pain. J Foot Ankle Surg. 2018 Mar-Apr;57(2):370-381. doi: 10.1053/j.jfas.2017.10.018. Epub 2017 Dec 25.
- Background: PubMed 28860848He C, Ma H. Effectiveness of trigger point dry needling for plantar heel pain: a meta-analysis of seven randomized controlled trials. J Pain Res. 2017 Aug 18;10:1933-1942. doi: 10.2147/JPR.S141607. eCollection 2017.
- Background: PubMed 20093544van de Water AT, Speksnijder CM. Efficacy of taping for the treatment of plantar fasciosis: a systematic review of controlled trials. J Am Podiatr Med Assoc. 2010 Jan-Feb;100(1):41-51. doi: 10.7547/1000041.
- Individual participant dataSharing planned: No
Related trials for Plantar Fasciitis of Both Feet
Recruiting
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Plantar Fasciitis of Both Feet, Plantar Fascitis
Not yet recruiting
Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis
Plantar Fasciitis, Heel Pain
Active, not recruitingObservational study
Evaluation of Spinal Posture, Balance, and Core Muscle Endurance in Individuals With Plantar Fasciitis
Plantar Fasciitis of Both Feet
Enrolling by invitation
Effects Of Instrument Assisted Soft Tissue Mobilization as Compared With Manual Longitudinal Friction Massage in Individuals With Plantar Fasciitis.
Plantar Fasciitis of Both Feet
Recruiting
Platelet Rich Plasma for Musculoskeletal Conditions
Osteoarthritis (OA), Osteoarthritis (OA) of the Knee
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Incobotulinum Toxin A and Glucocorticoid in people with Plantar Fasciitis of Both Feet and Pain, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 3 Nov 2026. 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 Mexico. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Pain Scale (time frame: Initially, 4, 8 and 16 weeks.). The study lists 4 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 NCT06788158, which also lists 20 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 3 Nov 2026.