Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis.

NCT03054610 | Completed Phase 1 DMC

• 1 other identifier: OR15-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Plantar fasciitis is the most common cause of plantar heel pain and is commonly present in people 40 years of age or older, overweight, sedentary or with intense physical activity. It is caused by the over-stretching of the plantar fascia, which is a band of connective tissue that extends to the base of the phalanges. This produces micro-tears more commonly in its origin in the medial tuberosity of the calcaneus which causes an inflammatory process and pain. This pain usually occurs when the person gets up in the morning after sleeping or after sitting for a long time. That is when the fascia is stretched after being in a contraction position. There are a great variety of treatments for this pathology, of these, one of the most common is the use of intralesional steroids, which a weighing that reduces symptomatology in many cases also has undesirable effects such as subcutaneous fat atrophy, rupture of the plantar fascia, peripheral nerve injury, muscle damage and stress fractures. Other treatments are extracorporeal shock waves, application of platelet-rich plasma and application of botulinum toxin A intralesional. All of them are accompanied by insoles, night splints and stretching exercises of the Achilles tendon and the plantar fascia. Recent studies have shown that the application of botulinum toxin A intralesional in patients with plantar fasciitis helps to improve the symptomatology to decrease pain in both intensity and presentation time. Decreased inflammation of the plantar fascia has also been demonstrated. This is the sale of the usual form of action of the botulinum toxin, which is applied regularly in the muscles to block the release of acetylcholine in the neuromuscular plaque and obtain its relaxation and not directly in the pain points. We believe that the botulinum toxin can be applied intralesional currently, since there is information that the toxin has analgesic and anti-inflammatory effect and not just muscle relaxation. The aim of our work demonstrate that the use of botulinum toxin A and intralesional stretching exercises is superior to intralesional steroids and stretching trying to establish a safer and less painful therapy avoiding complications prior to the application of steroid application.

Conditions

Plantar Fascitis; Botulinum Toxins, Type A

Keywords

plantar fascitis; Botulinum toxin A; Betamethason Sodium Phosphate; infiltration; plantar fascia

Outcome Measures

Primary Outcomes (1)

• Foot and Ankle Disability Index

  We decided to include the FADI score because this type of pathology occurs in patients with sports activity and often causes disability in them, Values activities such as standing, walking on flat or uneven surfaces, inclined planes, time without discomfort while walking, and includes a module where sports activities are valued. Also it counts on an evaluation of the pain in foot and ankle. The best result obtained is 136 points.

  6 months

Secondary Outcomes (6)

• Maryland Foot Score

  6 months

• Ankle-Hindfoot Scale

  6 months

• Visual Analogue scale

  6 months

• Measurement of the plantar fascia using ultrasound

  6 months

• Body Mass Index

  15 minutes

Study Arms (3)

Control

ACTIVE COMPARATOR

5 ml of local anesthetic (ropivacaine 7.5%)

Drug: Ropivacaine

Steroid

ACTIVE COMPARATOR

1ml of steroid Betamethason Sodium Phosphate (Celestone®) and local anesthetic (ropivacaine 7.5%)

Drug: Betamethason Sodium Phosphate; Drug: Ropivacaine

BTX-A

EXPERIMENTAL

200U Botulinum Toxins, Type A

Drug: Botulinum Toxins, Type A

Interventions

Betamethason Sodium Phosphate DRUG

Also known as: Celestone Soluspan

Steroid

Ropivacaine DRUG

Also known as: Ropiconest

Control; Steroid

Botulinum Toxins, Type A DRUG

Also known as: Dysport

BTX-A

Eligibility Criteria

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

You may qualify if:

• Patients with chronic pain in the heel at the insertion of the plantar fascia in the posteroinferior tuberosity of the calcaneus.
• Patients who agreed to be part of the study and signed informed consent.
• Patients older than 18 years.
• Patients with two or more weeks of evolution.

You may not qualify if:

• Patients with another associated pathology such as knee or ankle dysfunction, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, etc.
• Neurological abnormalities: mental retardation or some psychiatric abnormality.
• Pregnant patients.
• Previous surgery on the heel.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (14)

• Irving DB, Cook JL, Menz HB. Factors associated with chronic plantar heel pain: a systematic review. J Sci Med Sport. 2006 May;9(1-2):11-22; discussion 23-4. doi: 10.1016/j.jsams.2006.02.004. Epub 2006 Apr 3.

  PMID: 16584917 BACKGROUND

• Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A retrospective case-control analysis of 2002 running injuries. Br J Sports Med. 2002 Apr;36(2):95-101. doi: 10.1136/bjsm.36.2.95.

  PMID: 11916889 BACKGROUND

• May TJ, Judy TA, Conti M, Cowan JE. Current treatment of plantar fasciitis. Curr Sports Med Rep. 2002 Oct;1(5):278-84. doi: 10.1249/00149619-200210000-00005.

  PMID: 12831690 BACKGROUND

• Kim C, Cashdollar MR, Mendicino RW, Catanzariti AR, Fuge L. Incidence of plantar fascia ruptures following corticosteroid injection. Foot Ankle Spec. 2010 Dec;3(6):335-7. doi: 10.1177/1938640010378530. Epub 2010 Sep 3.

  PMID: 20817847 BACKGROUND

• Acevedo JI, Beskin JL. Complications of plantar fascia rupture associated with corticosteroid injection. Foot Ankle Int. 1998 Feb;19(2):91-7. doi: 10.1177/107110079801900207.

  PMID: 9498581 BACKGROUND

• Glazer JL. An approach to the diagnosis and treatment of plantar fasciitis. Phys Sportsmed. 2009 Jun;37(2):74-9. doi: 10.3810/psm.2009.06.1712.

  PMID: 20048512 BACKGROUND

• Sampson S, Gerhardt M, Mandelbaum B. Platelet rich plasma injection grafts for musculoskeletal injuries: a review. Curr Rev Musculoskelet Med. 2008 Dec;1(3-4):165-74. doi: 10.1007/s12178-008-9032-5.

  PMID: 19468902 BACKGROUND

• Rompe JD, Cacchio A, Weil L Jr, Furia JP, Haist J, Reiners V, Schmitz C, Maffulli N. Plantar fascia-specific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy. J Bone Joint Surg Am. 2010 Nov 3;92(15):2514-22. doi: 10.2106/JBJS.I.01651.

  PMID: 21048171 BACKGROUND

• Soomekh DJ. Current concepts for the use of platelet-rich plasma in the foot and ankle. Clin Podiatr Med Surg. 2011 Jan;28(1):155-70. doi: 10.1016/j.cpm.2010.09.001.

  PMID: 21276524 BACKGROUND

• Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. doi: 10.2106/JBJS.E.01281.

  PMID: 16882901 BACKGROUND

• Tsai WC, Hsu CC, Chen CP, Chen MJ, Yu TY, Chen YJ. Plantar fasciitis treated with local steroid injection: comparison between sonographic and palpation guidance. J Clin Ultrasound. 2006 Jan;34(1):12-6. doi: 10.1002/jcu.20177.

  PMID: 16353228 BACKGROUND

• Placzek R, Deuretzbacher G, Meiss AL. Treatment of chronic plantar fasciitis with Botulinum toxin A: preliminary clinical results. Clin J Pain. 2006 Feb;22(2):190-2. doi: 10.1097/01.ajp.0000169674.34191.0e.

  PMID: 16428954 BACKGROUND

• Seyler TM, Smith BP, Marker DR, Ma J, Shen J, Smith TL, Mont MA, Kolaski K, Koman LA. Botulinum neurotoxin as a therapeutic modality in orthopaedic surgery: more than twenty years of experience. J Bone Joint Surg Am. 2008 Nov;90 Suppl 4:133-45. doi: 10.2106/JBJS.H.00901. No abstract available.

  PMID: 18984726 BACKGROUND

• Elizondo-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.

  PMID: 23386757 BACKGROUND

MeSH Terms

Interventions

betamethasone sodium phosphate; betamethasone acetate phosphate; Ropivacaine; Botulinum Toxins, Type A; abobotulinumtoxinA

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Carlos Acosta-Olivo, MD, PhD

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: January 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)