Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis with Botulinum Toxin a
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorOslo University Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years.
An isolated gastrocnemius contracture must be verified with the Silfverskiölds test before inclusion.
Diagnosis plantar fasciitis verified clinically by an orthopaedic surgeon.
Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological signal changes in the plantar fascia (35)
Disqualifiers
Previously undergone surgery for plantar fasciitis.
Patients with severe talocrural pathology or serious malalignment of foot and ankle
Severely reduced peripheral circulation
History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
Trial population
The population consists of patients who recieve routine care at our hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Botox
Drug75 U in medial gastrocbemius head. x 3
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Botulinum toxin A injection1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
2 yearsSecondary outcomes
1
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.
Time frame
2 years2
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.
Time frame
2 years3
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
Time frame
2 years4
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)
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov