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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
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:

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.

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Condition or disease Intervention/treatment Phase
Chronic Plantar Fasciitis Other: platelet rich plasma Other: corticosteroid Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

corticosteroid
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.
Other: corticosteroid
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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:

    1. VAS: Rate your pain on a scale of 1 to 100÷ 8.3 = score of _______
    2. How many days a week does pain affect your mobility? (1-7) _____
    3. Is the pain on the surface or deep? ___ Surface = 1, Deep = 3

      Pain description:

    4. Where is your pain located? 0= Toes, 1= Ball of foot, 2= Mid sole, 3= Bottom of Heel
    5. 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
    6. How often since the onset of pain, have you been pain free? 0= weeks, 1= days, 2= hours, 3= minutes
    7. 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
    8. 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-


  2. 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.



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study included fifty patients with chronic unilateral PF who were diagnosed by history and physical examination.Patients have heel pain (with VAS more than 50 mm) and tightness after waking upin the morning or after sitting for longperiod. Heel pain will typically improve with movement but maybe increasedatthe end of the day with continuouswalking or standing for a long period.On examining the patients,to avoid placing pressure on the painful heel, patients may walk with their affected foot in an equine position. Palpation of the medial plantar calcaneal region will cause a sharp stabbing pain. Passive ankle/first toe dorsiflexion can cause discomfort in the proxi¬mal plantar fascia(Goff and Crawford, 2011).

Exclusion Criteria:

  • Patients with the following conditions were excluded:
  • Patients with bilateral heel pain.
  • Patients who had received previous local steroid injection.
  • Patients who had received NSAIDs within one week.
  • Patients having anemia with hemoglobin below 10 gm%, bleeding dyscrasias or thrombocytopenia.
  • Patients having earlier injury or surgery to the sole.
  • Patients having calcaneal stress fracture, Achilles tendinopathy, tarsal tunnel syndrome or seronegativespondyloarthropathy.
  • Patients havingpsychiatric disorders.
  • Patients having metabolic or endocrine disease.
  • Patients with arthritis of the foot.
  • Patients having infections, tumours, vascular abnormalities or neuropathy.
  • Patients with hepatic

Information from the National Library of Medicine

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


Contacts
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Contact: Reham M. Shaat 01224082636 rehamshaat@gmail.com

Locations
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Egypt
Reham Magdy Shaat Recruiting
Mansoura, Dakahlia Provence, Egypt, 050
Contact: Reham Magdy Shaat, associate professor    01224082636    rehamshaat@gmail.com   
Sponsors and Collaborators
Mansoura University

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03938896     History of Changes
Other Study ID Numbers: code: MS/15.10.08.
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Methylprednisolone Acetate
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents