Effect of Ultrasound-Guided Injection of Local Ozone or Platelet Rich Plasma Versus Corticosteroid in Plantar Fasciitis

INTRODUCTION

Plantar fasciopathy is an inflammation of the thick ligament bridging between the heel and forefoot, substantiate foot arch and absorb shocks. The definite pathogenesis still not clear, but many causes are there as prominent heel spurs, overuse, repetitive microtrauma which could cause such pain and pathology.¹

Plasma is the liquid part of the blood in which the blood cells and platelets are suspended; it is a watery component that contains the different proteins and electrolytes.²

Platelet-rich plasma (PRP) is a high concentration of autologous platelets in a small volume of plasma produced by centrifugation of the patient’s blood. Due to the rich content of growth factors and mediators of their alpha granules (reworking boom aspect [TGF]-b1, platelet-derived boom aspect, simple fibroblast growth factor, vascular endothelial growth component, epidermal growth issue, insulin-like growth thing [IGF]-1), the (PRP) is being used to induce natural healing in injured tissues.³

Although the exact mechanism of action is unknown,The therapeutic effects of oxygen-ozone injection were reported in the management of various musculoskeletal diseases including low lower backache, herniated disc, failed low back syndrome, degenerative spine sickness, knee osteoarthritis and plantar fasciitis.⁴

One of the most common methods for management of PF  is the local injection of long-acting corticosteroid as it has rapid transitory pain relief. However, it may cause spontaneous rupture.⁵

Aim of the study: This study conducted to evaluate the effect of injection of local Ozone or Platelet Rich Plasma (PRP) versus conventional corticosteroid in the management of plantar fasciitis pain.

PATIENT AND MATERIALS

This a Prospective, randomized comparative study has done from January 2018 to June 2018 at Al-Azhar university hospitals (Al-Hussein and Sayed Galal).

Inclusion criteria: Patients ASA I-III, Patients aged 25-70, Patients with Plantar Fasciopathy for ≥ six months not copping with medication for six weeks, morning pain score > 5 on a visual analogue score (VAS).

Exclusion criteria: Patients ASA IV, repeated corticosteroid injections within the past three months, using Anti-inflammatory (NSAIDs) drug during the one week before receiving an intervention, BMI > 40, foot deformity, previous foot surgery, peripheral neuropathy.  

Fifty-one plantar fasciitis patients were included, and allocated randomly by opaque, closed envelopes into one of three groups (17 patients in each group) to have an ultrasound-guided injection of the plantar fascia with either corticosteroid (control group), platelet-rich plasma (PRP) or ozone O2-O3 after approval of the local and institutional ethics committee and written informed consent has signed by the participants.

Clinical evaluation and an ultrasound-guided measurement of the plantar fascia thickness was done before, at 1-month, 3-months, and 6-months following the injection.

Primary outcome measures included: pain Score using the visual analogue score (VAS). Secondary outcome measures included an ultrasonographic measurement of plantar fascia thickness, foot quality health by the foot pain domain of the foot health status (FHS) questionnaire.

FHSQ which is a diagnostic tool to determine the different aspects of foot health status as it contains 13 questions, which graded on a scale of 5 degrees (0-4); 4 for pain assessment, 3 for footwear, 4 for foot function evaluation, and two questions for the health of the foot .

Then each question score was recorded and analyzed by The Foot Health Status Questionnaire Data Analysis Software (Version 1.04) to give a score of 0-100 for each item.⁶

Clinical assessment and ultrasound-guided measuring the thickness of the plantar fascia was done before the injection and at 1-month, three and 6-months following the injection.

A linear array transducer (6-13 MHz) (Acuson Freestyle, Siemens, Germany) figure (1) was used to measure the plantar fascia thickness and injection of the study drugs. To minimize the pain during the intervention: a pre-procedure block of posterior tibial was done guided by the ultrasound using 2ml 1% lidocaine hydrochloride figure (3).

Using (10 mm,22 G) needle has been inserted at in-plane approach toward the peak of fascia thickness figure (2),

Participants in the control group received an ultrasound-guided injection of 2 mL of 0.25% Bupivacaine, and 2 mL of 80 mg methylprednisolone acetate (Depo-Medrol, Pfizer, UK) into the medial calcaneal tubercle.

In the PRP group a (10-15cc of patient's blood was collected and centrifuged in a Rotofix 32A at 1500 cycles/minute for 5 minutes to separate the platelets and prepare 4 cc of concentrated platelets to be injected near the medial calcaneal tuberosity. The third group (Ozone) injected with a blend of 3 mL O_2/O₃ (15 μg/mL) (Ozonibaric P® machine; Sedecal, Spain) and 2 mL of 0.25% Bupivacaine. Participants were instructed to stop running for no fewer than two weeks next to the therapy.

Figure 1: Ultrasound- guided measurement of plantar fascia thickness (white dots) and Acuson Freestyle Ultrasound System, Siemens .

Figure 2: Ultrasound- guided Plantar fascia injection. yellow dots: plantar fascia, violet dots: calcaneus, green arrows: needle.

Figure 3: Ultrasound-guided posterior tibial nerve (PTN) block. yellow dots (PTN), red dots: posterior tibial artery, green dot: medial malleolus

Sample size calculation:

This is a study of a continuous response variable from independent control and interventional participants with one control(s) for interventional ones.  McMillan et al., in a similar study, found that the distribution of the response is normal within the study groups with a standard deviation of 0.2. Suppose the proper difference in the interventional and control means is 0.2 [i]. So, we would need to study 17 participants in each group to be able to reject the null hypothesis that the population means of the interventional and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.

Statistical analysis:

Data entry and statistical analysis carried out using MedCalc ver. 18.11.3 (MedCalc, Belgium). Tests of significance (ANOVA, Kruskal-Wallis and Chi-square tests) were used.

RESULTS

In the studied population, the average age of all patients was (38.11 ± 8) years.

Regarding the gender of the patients, the majority (60.8%) of patients were females; while (39.2%) were males. Regarding baseline (pre-injection) data;

The average BMI of all patients was (26.85 ± 3.8); the average duration of symptoms was (12.4 ± 2.47) months, the average VAS score was (7 ± 0.77), the average FHSQ score was (49.11 ± 5.43), and the average plantar fascia thickness was (5.92 ± 0.2) mm. Regarding short-term outcome data (1-month post-injection) data;

The average VAS score was (3.27 ± 1.5), the average FHSQ score was (71 ± 12.6), and the average plantar fascia thickness was (5.3 ± 0.4) mm. Regarding long-term outcome data (3-months post-injection) data; the average VAS score was (2.82 ± 1.3),

The average FHSQ score was (72.66 ± 10), and the average plantar fascia thickness was (5 ± 0.43) mm. Regarding long-term outcome data (6-months post-injection) data; the average VAS score was (3.84 ± 1.89), the average FHSQ score was (69.2 ± 14.2), and the average plantar fascia thickness was (4.79 ± 0.54) mm.

Comparative studies: The 51 plantar fasciitis patients were classified according to outcomes into 4 independent groups: Control group “corticosteroid” (17 patients), Ozone group “O2-O3” (17 patients) and PRP group “PRP” (17 patients)

^{ANOVA: analysis of variance. *Percentage of Column Total. BMI: body mass index). FHSQ: foot health}

Table 1: Comparison between the 3 groups as regards baseline (pre-injection) data using ANOVA and Chi-square tests:

Table 2: Comparison between the 3 groups as regards short and long-term outcome data (1, 3 and 6-months post-injection) using ANOVA test

1-month post-injection: Comparative study between the 3 groups revealed; a highly significant decrease in 1-month VAS score and plantar fascia thickness in corticosteroid and Ozone groups; compared to the PRP group (p < 0.01 respectively).

Comparative study between the 3 groups revealed; a highly significant increase in 1-month FHSQ score in corticosteroid and Ozone groups; compared to the PRP group (p < 0.01), Table (2); Figure (4).

Figure 4: Comparison between the 3 groups of patients regarding serial VAS score assessments.

(3-month post-injection results): Comparative study between the 3 groups revealed; a highly significant decrease in 3-month VAS score and plantar fascia thickness in the corticosteroid group; compared to Ozone and PRP groups (p < 0.01 respectively).

Comparative study between the 3 groups revealed; a highly significant increase in 3-month FHSQ score in the corticosteroid group; compared to Ozone and PRP groups (p < 0.01), table (2); Figure (5).

Figure 5: Comparison between the 3 groups of patients regarding serial FHSQ score assessments.

(6-month post-injection results): Comparative study between the 3 groups revealed; a highly significant decrease in 6-month VAS score and plantar fascia thickness in the PRP group; compared to corticosteroid and Ozone groups (p < 0.01 respectively). Comparative study between the 3 groups revealed; a highly significant increase in 6-month FHSQ score in the PRP group; compared to corticosteroid and Ozone groups (p < 0.01), table (2); Figure (6).

Figure 6: Comparison between the 3 groups of patients regarding serial plantar fascia thickness assessments.