Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis With Botulinum Toxin A

Plantar Fascitis Clinical Trial

— PLATOX  

Official title:

Botulinum Toxin Injection as Treatment for Proximal Medial Gastrocnemius Muscle Tightness With Subsequent Chronic Plantar Fasciitis - A Prospective Clinical Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218785
• Other study ID #: REK351430
• Status: Recruiting
• Start date: January 13, 2022
• Est. completion date: January 2026

Study information

• Verified date: March 2023
• Source: Oslo University Hospital
• Contact: Elisabet Ellingsen Husebye, MD PhD
• Phone: +47 91 50 27 70
• Email: uxngng[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective clinical cohort study will follow 40 patients who recieve botulinum toxin A treatment for proximal medial gastrocnemius tightness with subsequent Chronic Plantar Fasciitis for two years. Three injections of botulinum toxin (75IU) will be administered with intervals of three months. Participants will be followed at baseline, 3 months, 6 months, 1 year and 2 years with Patient Related Outcome Measures (PROMS) and physical test (Ergotest and ankle dorsiflexion).

Description:

The connection between gastrocnemius tightness and plantar fasciitis has been demonstrated in several clinical studies. Patients with chronic pathology, and unsatisfactory results from physical therapy, may benefit from gastrocnemius lengthening. This is usually obtained with proximal medial gastrocnemius recession surgery (PMGR), but recent studies and recent experience from our hospital suggest that similar effect may be obtained with ultrasound guided- injections of Botulinum Toxin A injections in the proximal medial gastrocnemius muscle.

This study will follow patients with gastrcnemius tightness (demonstrated by the Silferskiolds test) and subsequent chronic (MRI-verified) plantar fasciitits who has not recieved satisfactiory results from at least three months of guided physcial therapy.

Participants will recieve three ultrasound guided injections of 75IU of Botulinum Toxin A with three month intervals.

They will be followed with clinical controls for two years after the first injection.

THe main outcome is the Manchester Oxford Foot Questionnaire (MOxFQ).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

1. Age 18-75 years.

2. An isolated gastrocnemius contracture must be verified with the Silfverskiölds test before inclusion.

3. Diagnosis plantar fasciitis verified clinically by an orthopaedic surgeon.

4. Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological signal changes in the plantar fascia (35)

5. Duration of symptoms must be at least 12 months prior to first BTA injection.

6. Conventional Physical Therapy must have been tried at least three months without a significant reduction of symptoms in the affected foot.

Exclusion criteria:

1. Previously undergone surgery for plantar fasciitis.

2. Patients with severe talocrural pathology or serious malalignment of foot and ankle

3. Severely reduced peripheral circulation

4. History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.

5. Patients with a contraindication/non-compliance for MRI examination.

6. History of allergic reaction/anaphylactic reaction or other contraindication to botulinum toxin.

7. Not able to read and/or speak a Scandinavian language or English adequately.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Drug:
• Botox
75 U in medial gastrocbemius head. x 3

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Orthopedic Department Ullevål	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manchester Oxford Foot Questionnaire	MOxFQ (Manchester Oxford Foot Questionnaire) is a PROM consisting of 16 questions in three domains (pain, walking/standing, social interaction) leading to a total score from 0-100, 0 being the best possible score. It is validated as a reliable tool to measure results of foot and ankle surgery	2 years
Secondary	Achilles function test battery	The test battery consists of three jump tests, a counter movements jump (CMJ), a drop counter movement jump (drop CMJ) and hopping, and two strength tests, concentric toe-raises (resistance 13+23 kg), eccentric-concentric toe-raises (resistance 13+23 kg) and toe-raises for endurance. All recorded through the MuscleLab software.	2 years
Secondary	Ankle dorsiflexion	measured by device that measures the ankle's range of motion that has been previously tested and found to be valid, reliable, and responsive in detecting isolated gastrocnemius contractures (IGCs). (40) An electric goniometer, Biometrics SG150 (Units 25-26, Biometrics Ltd, Newport, UK), with an accuracy of ±2 degrees and a repeatability of 1 degree will be used. The device will be calibrated before every new participant. Force applied directly beneath the head of the second metatarsal until the end range of dorsiflexion with a dynamometer.	2 years
Secondary	Visual Analogue Scale (VAS)	Visual Analogue Scale for pain during use om affected leg in the last 24 hours. 0 is no pain. 10 is worst pain imaginable	2 years
Secondary	EQ5D5L	Quality of life is measured by the EuroQol questionnaire (EQ-5D). EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three possible answers ("no problems", "some problems", and "major problems"). EQ5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)	2 years
Secondary	AOFAS (American Orthopeadic Foot and Ancle Society) hindfoot score	AOFAS score measures pain, function, movement and deformity. It ranges from 0-100, 100 being the best possible score. The score is in our opinion not especially fit to measure the symptoms and change in symptoms in plantar fasciitis patients, but we include it to be able to compare our results to Abassain et al.	2 years
Secondary	Adverse events	. I.e. infection, nerve injury, thrombosis.	2 years