PRP IN Planter Fascitis
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|ClinicalTrials.gov Identifier: NCT03938896|
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : August 14, 2019
The present study was carried out on fifty patients with chronicunilateral PF. Patients were recruited from Outpatient Clinic of Physical medicine, Rheumatology and Rehabilitation at Mansoura University Hospital during the period from January 2016 to September 2016. Patients were classifiedrandomly into two groups:the 1stgroup included 25 patients (20 females and 5 males) treated by local corticosteroid injectionand the 2ndgroup included 25 patients (20 females and 5males) treated by PRP injection.
We obtain an informed written consent from each participant sharing in the study. We take approval on our study by the research board of faculty of medicine, Mansoura University, code: MS/15.10.08.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Plantar Fasciitis||Other: platelet rich plasma Other: corticosteroid||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness of Platelet Rich Plasma in Treatment of Chronic Planter Fasciitis|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||January 1, 2020|
platelet rich plasma
It started with puncture of the vein and taking specific amount of autologous blood from the participantnearly a sample of 20 ml of venous blood (Co AY, 2012).The blood sample was put in a sterile tube containing an anticoagulant as sodium citrate.Then the blood sample wascentrifuged for 15 minutes at 1800 rpmwhich leads to separation of the plasma at the top layer from the packed RBCs at the bottom layer. The RBCs layer is removedthenanother centrifugationwas done at 3500 rpm for 10 minuteswhich leads to formation of a more concentratedplatelet layer after removal of PPP(Anitua et al., 2012).Patients were put in supine position. Betadine was used to disinfect the skin of the heel. 1 ml of local anesthesitic (lidocaine) was injected;then, by the same syringe, 2.5 ml of PRP was injected in the tenderestarea.After extraction of the needle, a bandage was puton the injected area.
Other: platelet rich plasma
Patients were put in supine position. Betadine was used to disinfect the skin of the heel. 1 ml of local anesthesitic (lidocaine) was injected;then, by the same syringe, 2.5 ml of PRP was injected in the tenderestarea.After extraction of the needle, a bandage was puton the injected area. The patient was kept in the supine position for twentyminutes and then discharged
Patients were put in the supine position. Injection was done usingthe medial technique. Identification of the tenderest point of the heel was done by palpation. Antiseptic solution was used to disinfect the skin overlying theheel. Then1ml of 40 mg methylprednisolone acetate and 1 ml of local anaesthetic as lidocaine 2% were injected into the plantar fascia by a 22gauge needle.
Patients were put in the supine position. Injection was done usingthe medial technique. Identification of the tenderest point of the heel was done by palpation. Antiseptic solution was used to disinfect the skin overlying theheel. Then1ml of 40 mg methylprednisolone acetate and 1 ml of local anaesthetic as lidocaine 2% were injected into the plantar fascia by a 22gauge needle. After injection, participants were advised to stay sitting without foot movement for 15 minutes
- change of pain from base line [ Time Frame: immediately before injection,1 month after injection,3 monthes after injection,6 monthes after injection ]VAS is a one-dimensionalmethod used largely in adult patients who also haverheumatic diseases for measuring pain intensity.The VAS score is composed of a continuous linewhich may be a horizontal (HVAS) or vertical (VVAS) line. This line is usually 10 cm (100 mm) in length. To measure the intensity of pain, the score is anchored by "no pain" (0 score) and "pain is as bad as it could be" or "worst imaginable pain"(100 score)on the 100 mm scale. The patient can complete the VAS score by himself. The patientplaces a perpendicular line to the VAS line at the point whichrepresents the intensity of his pain.We can usea ruler to determine the score by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a score range from 0 to 100. According tothe measurement of VAS score in postsurgical
- change from base linePlantar fasciitis pain and disability scale (PFPS [ Time Frame: immediately before injection,1 month after injection,3 monthes after injection,6 monthes after injection ]
The score consists of:
- VAS: Rate your pain on a scale of 1 to 100÷ 8.3 = score of _______
- How many days a week does pain affect your mobility? (1-7) _____
Is the pain on the surface or deep? ___ Surface = 1, Deep = 3
- Where is your pain located? 0= Toes, 1= Ball of foot, 2= Mid sole, 3= Bottom of Heel
- In the past 6 weeks how often have you had pain? 0= Every other week 1= Once a week 2= Once a day 3= Many times a day
- How often since the onset of pain, have you been pain free? 0= weeks, 1= days, 2= hours, 3= minutes
- How long does the pain last? 0= only when I over exert, 1= pain lasts for less than one hour, 2= pain lasts for one to two hours, 3= pain lasts for more than two hours
- In the past 6 weeks what time of day is your pain the worst? (Note this specifically for diagnosis of different problems).
0= Always the same, 1 = Only in the afternoon, 2 = Both day & night, 3 = Only when you first get up 9-
- change from base lineThe modified criteria of the Roles and Maudsley score [ Time Frame: immediately before injection,1 month after injection,3 monthes after injection,6 monthes after injection ]
Patient satisfaction was assessed using the modified criteria of the Roles and Maudsleyscore. The levels on this scale were as follows:
- Excellent: no pain, patient satisfied with the treatment outcome and unlimited walking without pain.
- Good: symptoms substantiallydecreased, patient satisfied with the treatment outcome and ability to walk without pain for >1 hour.
- Acceptable: symptoms somewhat decreased, pain at a more tolerable level than before treatment and patient slightly satisfied with the treatment outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938896
|Contact: Reham M. Shaatemail@example.com|
|Reham Magdy Shaat||Recruiting|
|Mansoura, Dakahlia Provence, Egypt, 050|
|Contact: Reham Magdy Shaat, associate professor 01224082636 firstname.lastname@example.org|