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Patellofemoral Pain Syndrome and Chondromalacia: the Effect of Ozone on Pain, Function and Quality of Life. a Non-Randomized Control-Trial

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Patellofemoral Pain Syndrome and Chondromalacia: the Effect of Ozone on Pain, Function and Quality of Life. a Non-Randomized Control-Trial Central JSM Physical Medicine and Rehabilitation Bringing Excellence in Open Access Research Article *Corresponding author Marcos Edgar Fernández-Cuadros, Calle del Ánsar, 44, piso Segundo, CP 28047, Madrid, Spain, Tel: Patellofemoral Pain Syndrome 34-620314558; Email: [email protected]; Submitted: 23 November 2016 and Chondromalacia: The Effect Accepted: 05 December 2016 Published: 06 December 2016 of Ozone on Pain, Function Copyright © 2016 Fernández-Cuadros et al. and Quality of Life. A Non- OPEN ACCESS Keywords Randomized Control-Trial • Patellofemoral pain syndrome • Chondromalacia Marcos Edgar Fernández-Cuadros1,2*, Olga Susana Pérez-Moro1, • Pain and María Jesús Albaladejo-Florin1 • Ozone therapy • Quality of life 1Servicio de Rehabilitación, Hospital Universitario Santa Cristina, Spain 2de Rehabilitación, Fundación, Hospital General Santísima Trinidad, Spain Abstract Objectives: 1) To demonstrate the effectiveness of a treatment protocol with Ozone therapy on pain, function and quality of life in patients with Patellofemoral Pain Syndrome (PFPS) and Chondromalacia; and 2) to apply Ozone as a conservative treatment option with a demonstrable level of scientific evidence. Material and Methods: Prospective quasi-experimental before-after study (non-randomized control-trial) on 41 patients with PFPS and Chondromalacia grade 2 or more, who attended to Santa Cristina’s University Hospital, from January 2012 to November 2016 The protocol consisted of an intra articular infiltration of a medical mixture of Oxygen-Ozone (95% -5%) 20ml, at a 20ug / ml concentration, and a total number of 4 sessions (1 per week). Pain and quality of life were measured by Visual Analogical Scale (VAS) and Western Ontario and Mc Master Universities Index for Osteoarthritis (WOMAC) at the beginning / end of treatment. Results: Average age 46.63 years. Women 56.09% (n =23), men 43.91% (n=18).The most frequent Chondromalacia grade was 2nd degree (n = 27, 65.9%), followed by 3rd (n = 10, 24.3%) and 4th (n = 4, 9.8%). Post-puncture erythema 9.7% (n = 4). Pain measured by VAS significantly decreased (p<0.0001) from 6.87 to 1.46. The WOMAC-pain, WOMAC-stiffness and WOMAC-function subscales decreased significantly (p<0.0001) from 13.9 to 3 points, 2.34 to 0.41 and 41.14 to 14.09, respectively. Conclusion: Ozone is safe and improves significantly pain, stiffness and function in patients with Patellofemoral Pain Syndrome and Chondromalacia. The study shows a good level of evidence and grade of recommendation that allows us to consider Ozone as a conservative therapeutic option in the treatment of PFPS and chondromalacia. INTRODUCTION PFPS is the most common diagnosis in sports medicine, is present in active individuals in up to 25-40% with knee pain; even Patellofemoral pain syndrome (PFPS) is a frequent overuse though, the true incidence is unknown [6]. PFPS is multifactorial, disorder that affects the patellofemoral region and is present as resulting from an interaction of intrinsic and extrinsic factors. anterior knee pain. PFPS is the most common cause of knee pain To cite, overuse, malalignment and trauma are some causative seen by primary care physicians, traumatology, rehabilitation and sports medicine specialists [1,2]. PFPS involves pain on the patella synovial lining and fat pad tissues, retinacular neuromas, and retinaculum once intraarticular and peripatellar pathology is increasedfactors [7]. Abnormalintraosseous tissue pressure homeostasis and thatincreased include inflamedosseous metabolic activity of the patella are believed to cause pain and there is no consensus about the pathophysiology and the treatment dysfunction [8]. In a recent study, Fernández-Cuadros et al have remainsexcluded a [3]. challenge. In that Sometimes scenario, the chondromalacia diagnosis is difficult,is a term because used to describe PFPS. Chondromalacia patella describes the pathologic and dysfunction in knee OA [9,10]. Since chondromalacia and changes in the articular cartilage of the patella, such as softening, PFPSstated share that Ozone these iscommon capable features, to act over we inflammation; believe Ozone pain could relief be erosion and fragmentation [4]. Indeed, some authors consider an effective treatment option for both entities. chondromalacia patella as a precursor of Osteoarthritis (OA) [5]. PFPS describes complex symptoms and is a diagnosis of exclusion, PFPS diagnosis is based on clinical history, examination while chondromalacia patella is a pathologic diagnosis [4]. and the exclusion of alternative diagnosis [11]. PFPS has no Cite this article: Fernández-Cuadros ME, Pérez-Moro OS, Albaladejo-Florin MJ (2016) Patellofemoral Pain Syndrome and Chondromalacia: The Effect of Ozone on Pain, Function and Quality of Life. A Non-Randomized Control-Trial. JSM Physical Med Rehabil 1(1): 1002. Fernández-Cuadros et al. (2016) Email: Central Bringing Excellence in Open Access pathognomonic sign or symptom; however, the combination performed. Initial WOMAC Index and initial weight bearing of pain with resisted quadriceps contraction and pain with bilateral radiographies were taken. The Ozone protocol consisted squatting are the maneuvers with more diagnostic validity [12]. Plain radiographies are not necessary for initial management. of a medical mixture of Oxygen-Ozone (95%-5%) at a 20 µg/ml They are helpful to rule out any other sources of anterior knee concentration.of four sessions A (1 27G, session/week) 4cm Quincke of anneedle intra wasarticular used infiltration to deliver pain (bipartite patella, OA, loose bodies and occult fractures) Ozone into the joint. The skin was previously cleaned with 1% [13]. The treatment goals for PFPS are to reduce pain (on the withChlorhexidine. mild patella With subluxation, the knee to semi-flexed, expose the articularOzone was joint slowly space acute phase), improve patellofemoral tracking and alignment, infiltrated on the lateral aspect of the knee next to the patella, and and return the patient to as a high level of function as possible several times in and attempt to distribute the Oxygen-Ozone (on recovery phase). Physical therapy focused on improving mixture(Figure 2).all Afterover theinfiltration, articulation the andknee the was lateral flexed recesses, and extended and to muscles, included hip adductors and quadriceps, are effective the strength and flexibility of the lower extremity and core by listening a crepitus noise (Pérez-Moro Maneuver). in the treatment of PFPS [14-18]. NSAIDs (non-steroidal anti- confirm that the infiltration was delivered into the articulation, After four sessions are performed, a control with WOMAC (two to three weeks) [19]. With respect to physical therapies, iceinflammatory applied to thedrugs) anterior are onlyknee validrelieves for pain short associated term pain to PFPS.relief on, evaluations every 6 months are accomplished, depending on There is no empiric evidence to support the use of ultrasound, theIndex clinical is filled, symptoms. one-two If months treatment after is treatment.necessary, Froma new that4-session point iontophoresis, phonophoresis or electrical stimulation in the protocol is applied afterwards. treatment of PFPS [19-22]. Surgical intervention for PFPS is The symptoms severity is evaluated using the WOMAC Index considered when all previous therapies have failed. It is a last resort treatment; then, non-operative therapy should be pursued for 6 to 12 months prior to considering operative intervention [2]. The main objective of this study is to postulate Ozone as a conservative therapeutic option for pain relief, function and Ozone-therapy Protocol Final evaluation quality of life on PFPS and chondromalacia, since its treatment Initial evaluation (n=41) remains a challenge. A second objective is to provide clinical- 4 sessions of Ozone-therapy based-evidence on Ozone as a feasible treatment for such entities. Informed Consent MATERIAL AND METHODS (20 ml of a mixture of Final VAS Oxygen-Ozone A prospective before-and-after quasi experimental study Initial VAS Final WOMAC is been performed on 41 patients with PFPS/Chondromalacia 95%-5%, Initial WOMAC grade 2 or more (Figure 1). The follow-up period has been two at a 20 µg/ml concentration) years (from January 2014 to November 2016) to patients who attended the Rehabilitation Department at Santa Cristina’s University Hospital. All patients performed previous medical and Prospective quasi-experimental before-and-after study design Rehabilitation treatment but without symptomatic improvement. The study was approved by the Hospital Ethical Committee. Figure 1 Study design. Inclusion criteria: 1) patients with PFPS/Chondromalacia Note: VAS, Visual Analogical Scale. WOMAC, Western Ontario and Mc Master Universities Index for Osteoarthritis grade 2 or more diagnosed by MRI (magnetic Resonance Imaging); Protocol applied at the Department of Rehabilitation at Santa Cristina’s 2) with pain greater than 3 on the VAS (visual analogical scale) University Hospital. The study ran from January 2014 to November 2016. scale; 3) who have failed any other conservative treatments (NSAIDs, rehabilitation, physical therapy); 4) older than 18 years of age. Exclusion criteria: 1) any formal contraindication to Ozone Therapy (favism, pregnancy, angiotensin converting enzyme inhibitors treatment, hyperthyroidism, thrombocytopenia, serious cardiovascular instability and allergy to Ozone); 2) patients who failed to complete the whole Ozone therapy questionnaires applied (VAS/WOMAC or Western Ontario and Mctreatment Master Indexprotocol;
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