Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis
- Conditions
- Chronic Plantar Fasciitis
- Interventions
- Procedure: Proximal Medial Gastrocnemius Recession
- Registration Number
- NCT05162144
- Lead Sponsor
- Ostfold Hospital Trust
- Brief Summary
This prospective kohort study will follow 150 patients treated with proximal medial gastrocnemius recession for plantar fasciitts. Follow up time is two years and the main outcome is the Manchester Oxford Foot Questionnaire.
A regression analasys will be performed to identify possible patient baseline factors that may affect the effect of surgery,
- Detailed Description
Recent studies indicate that chronic plantar fasciitis can be treated effectively with Proximal Medial Gastrocnemius Recession (PMGR). In our hospital this treatment has been inocorporated into routine care. This prospective kohort study will follow 150 patients with chronic planatar fasciitis operated with PMGR study. The follow up time is 2 years and the study aims at documenting the effect of the surgery with PROMS (patient related outcome measures), MRI (magnetic resonnance imaging) and ankle movement measurements. 26 patient-related baseline factors will also be registered. A regression analysis will be performed to identify factors that may be predictive to the effect of PMGR surgery.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Proximal Medial Gastrocnemius Recession Surgery Proximal Medial Gastrocnemius Recession All patients included in the Cohort Study will recieve this PMGR-surgery
- Primary Outcome Measures
Name Time Method Manchester Oxford Foot Questionnaire (MOxFQ) 2 years postoperatively Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
- Secondary Outcome Measures
Name Time Method Adverse events Baseline, 6 weeks, 12 weeks, 1 year, 2 years infection, nerve injury, thrombosis.
Ankle movement Baseline, 12 weeks, 2 years Ankle dorsiflexion measured in degrees, through a validated gonimeter
MRI (magnetic resonancd imaging) findings Baseline, 2years Thickness of plantar fascia at insertion, pathological signals in the fascia yes/no more, less or same as before, presence of oedema in the calcaneal bone yes/no.
Assessment of treatment success at 2 years If you were to continue having the same level of symptoms in the next few months, would you consider that acceptable.
YES/NOGait analysis - Maximal ankle dorsiflexion during stance (degrees) Baseline, 3 months A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
- Maximal ankle dorsiflexion during stance (degrees)Gait analysis (Length of stride. Centimeters) Baseline, 3 months A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
Assessment of treatment success - other treatments at 2 years Likert question:I have pain and/or discomfort in the calf that was operated two years ago Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
EQ5D (EuroQol questionnaire ) Baseline, 12 weeks, 1 year, 2 years 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
Gait analysis Knee extension while maximal dorsiflexion of ankle during stance (degrees) Baseline, 3 months A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
Assessment of treatment success -pain at 2 years Likert question: I have pain in the heel pain in the leg that was operated two years ago Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
Assessment of treatment success - patient acceptable symptom state at 2 years I have received other treatments for plantar fasciitis since surgery was performed two years ago YES/NO
VAS (visual analogue scale) Baseline, 12 weeks, 1 year, 2 years Visual analogue scale for pain during use of affected leg in the last 24 hours. 0 is no pain. 10 is worst pain imaginable.
Gait analysis Maximal external rotation of ankle during stance (degrees) Baseline, 3 months A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
* Maximal ankle dorsiflexion during stance (degrees)
* Length of stride. Centimeters
* Cadence (steps/minute)
* Ankle power
* Maximal external rotation of ankle during stance (degrees)
* Knee extension while maximal dorsiflexion of ankle during stance (degrees)Assessment of treatment success - physical activity at 2 years Likert question:Heel pain prevents me from performing physical acitvity Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
Gait analysis Ankle power Baseline, 3 months A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
Gait analysis Cadence (steps/minute) Baseline, 3 months A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
Assessment of treatment success - daily living at 2 years Likert question:Heel pain prevents me from performing activities of daily living Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
Trial Locations
- Locations (1)
Østfold Hospital Trust
🇳🇴Sarpsborg, Norway