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| Name | Class |
|---|---|
| Regen Lab SA | INDUSTRY |
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There are various treatments for plantar fasciitis, including physical therapy, orthopedic inserts or steroid infiltrations. However, it is estimated that about 20% of patients do not respond to first-line treatment [Rompe, Sports Med Arthrosc Rev, 2009]. It is therefore necessary to be able to integrate new treatments into the management of this condition. The objective of the study is to assess the effect on pain and the safety of the percutaneous ultrasound-guided tenotomy associated with a platelet rich plasma injection to treat refractory plantar fasciitis.
After verification of all the inclusion and non-inclusion criteria, the following examinations will be performed during the inclusion visit before the procedure:
Signature of the consent by the patient and the investigator
Interrogatory including collection of concomitant treatments, evaluation of the walking perimeter, evaluation of sports activities
Clinical examination of the foot (Heel tenderness index)
Standard X-ray of the foot (if not performed at screening)
Plantar ultrasound = echogenicity of the plantar aponeurosis, measurement of thickness in mm, search for hypervascularization by Doppler
VAS pain during activity
FAAM self-questionnaire
Procedure in 3 steps:
Prescription of enoxaparin at a preventive dose for 7 days
The tolerance of the procedure will be evaluated immediately after the procedure, using a VAS for pain. This will be collected by a nurse. We will also collect the acceptability of the procedure as well as the immediate complications (vagal discomfort, bleeding at the injection site).
The patient will then be monitored for two hours (4 times) in order to verify the lifting of the sensory block and the pain during it.
At the end of the consultation, the patient will receive a patient logbook to be completed at home in the 7 days following the procedure and at 14 days (collection of pain at the injection site and possible side effects) and a second logbook to be completed 6 weeks after the procedure.
-First protocol follow-up at home: D7 The patient will have filled out a daily pain VAS and notified any side effects related to the procedure and the analgesic intake during the first week.
A telephone contact will be made at this date by an investigating physician, or a mandated person, in order to ensure that the logbook has been filled out correctly and that there are no complications. The call will also remind the patient to return the questionnaire by mail (stamped and addressed envelope provided).
- Second protocol follow-up at home: S6 +/- 3 days
Six weeks after the procedure, the patient will complete the patient booklet given at D0 at home:
During the consultation, the following examinations will be performed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| percutaneous tenotomy + PRP | Experimental | There will be a single arm receiving the treatment being evaluated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous tenotomy + PRP | Procedure | The patients will receive a percutaneous ultrasound-guided treatment including a needle tenotomy followed by a PRP injection in the plantar fasciitis. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the evolution of plantar pain after treatment combining needle tenotomy and PRP injection in refractory plantar fasciitis. | VAS pain at activity | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the tolerance of the procedure | To evaluate the tolerance of the procedure, a VAS [0 to 10] will be filled in by the patient to evaluate the pain felt during the procedure. | 6 weeks, 3 months, 6 months |
| Evaluate the acceptability of the procedure |
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Inclusion Criteria :
Patient with chronic inferior heel pain diagnosed as plantar fasciitis plantar fasciitis evolving for more than 3 months with a pain VAS at activity ≥ 4/10
Exclusion Criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | France | 44000 | France |
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The VAS pain data will be compared between before the procedure and 6 months after using a Wilcoxon ranks test for paired data.
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To assess the acceptability of the procedure, the following question will be asked: Would you be willing to repeat this procedure if necessary? |
| 6 weeks, 3 months, 6 months |
| Evaluate the evolution of the functional discomfort | To evaluate the effect on function, we will use two parameters: the FAAM self-questionnaire and the walking perimeter. The FAAM (Foot and Ankle Ability Measure) self-questionnaire will be completed by the patient before the procedure and then 6 weeks, 3 months and 6 months after the procedure. The score is composed of 21 items evaluating the discomfort in daily activities and 8 in sports activities. The walking perimeter (distance the patient can walk without stopping) will be evaluated at 6 weeks, 3 months and 6 months. It will be assessed by the following scale: Unlimited / More than 1 Km / From 500 to 1000m / From 100 to 500m / Less than 100m / Walking impossible. | 6 weeks, 3 months, 6 months |
| Evaluate the return to sports activities | To evaluate the return to sport, the following 3 questions will be asked to the patient: Have you resumed your sport activity? If yes, how long after the infiltration? Was it possible to resume the activity at the same level as before? This will be collected at 3 and 6 months. | 6 weeks, 3 months, 6 months |
| Evaluate the evolution of pain when pressing the insertion of the plantar fascia | The HTI (physician-assessed Heel Tenderness Index) score will be assessed before the procedure and after 3 and 6 months. It is a score ranging from 0 to 3 (0 = no pain; 1 = pain; 2 = pain and grimace; 3 = pain, grimace, and foot removal). | 6 weeks, 3 months, 6 months |
| Evaluate the evolution of the ultrasound data | Two items will be evaluated before the procedure and after 3 and 6 months:
| 6 weeks, 3 months, 6 months |
| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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