Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis With Botulinum Toxin A
- Registration Number
- NCT05218785
- Lead Sponsor
- Oslo University Hospital
- Brief 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).
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Botulinum toxin A injection Botox Patients will receive a total of 3 -three - injections of 75 IU Botulinum Toxin A in the proximal medial gastrocnemius muscle. Treatments will be performed by a specialist in neurology as a Ultra-Sound guided injection into the proximal medial gastrocnemius muscle Injections will be administered at baseline, 3 months and 6 months.
- Primary Outcome Measures
Name Time Method Manchester Oxford Foot Questionnaire 2 years 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
- Secondary Outcome Measures
Name Time Method Ankle dorsiflexion 2 years 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.
AOFAS (American Orthopeadic Foot and Ancle Society) hindfoot score 2 years 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.
Visual Analogue Scale (VAS) 2 years Visual Analogue Scale for pain during use om affected leg in the last 24 hours. 0 is no pain. 10 is worst pain imaginable
EQ5D5L 2 years 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)
Achilles function test battery 2 years 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.
Adverse events 2 years . I.e. infection, nerve injury, thrombosis.
Trial Locations
- Locations (1)
Oslo University Hospital, Orthopedic Department Ullevål
🇳🇴Oslo, Norway