2. Materials and Methods
Osteoarthritis, shock, osteoarthritis, metabolic inflammatory arthropathy, KOA, pain, disability, knee diseases, hematoma, monolater KOA, knee pain, NRS, trauma
RHEUMATOID ARTHRITIS, SYSTEMIC DISEASE, HAND JOINT EFFUSION, INFILTRATION, CARDIOVASCULAR DISEASE, OSTEOARTHRITIS, SHOCK, LIVER FAILURE, OSTEOARTHRITIS, DISEASE, RECRUITMENT, KNEE DISEASE, KIDNEY FAILURE, HEMATOMA, COMPLICATIONS
The study model is a double-blind prospective case-control study. The study was carried out in the period between March and August 2022. Patients were enrolled if they met the following criteria: age between 45 and 70 years; a clinical diagnosis of KOA according to the American College of Rheumatology criteria; knee pain ≥ 4 according to the Numeric Rating Scale (NRS) at the enrollment and in the previous 15 days; radiographic KOA classifiable as grade II-III according to Kellgren-Lawrence scale; ability to understand the purpose and design of the study, and to provide informed consent. Exclusion criteria were: KOA local complications (e.g., hematoma and joint effusion); knee pain due to trauma (during the previous month); any disease potentially interfering with medical evaluation different from KOA (e.g., rheumatoid arthritis, metabolic inflammatory arthropathy); local drug infiltration (hyaluronic acid, steroids, stem cells, polynucleotides, Platelet Rich Plasma) or physiotherapy (e.g., laser therapy, shock wave therapy, therapeutic exercise, etc.) within the previous 45 days; assumption of non-steroidal anti-inflammatory drugs or analgesics within 15 days prior the enrollment; assumption of slow-acting drugs or dietary supplements in the previous 3 months (e.g., chondroitin sulfate, diacerein, soybean and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for osteoarthritis); contraindications to acetaminophen; systemic diseases which contraindicate nutraceuticals assumption (liver failure, kidney failure, uncontrolled cardiovascular disease); pregnant or lactating women; pre-menopausal women not using contraception; and patients enrolled in other clinical trials within the past three months.Thirty-eight patients with monolater KOA were recruited and then divided into two groups, each consisting of nineteen subjects.At the time of recruitment (T0), all patients underwent a medical examination, which included medical history, standardized physical examination, and x-rays evaluation. Therefore, the weight and height of each patient were detected and the Body Mass Index (BMI) was calculated according to the formula: weight (Kg)/height (mNumeric Rating Scale (NRS): this is a one-dimensional scale that rates pain from 0, the absence of pain, to 10, the maximum perceived pain;Oswestry Disability Index (ODI): this is a scale that rates the percentage value of disability and ranges from 0%, no disability, to 100%, maximum disability;Short Form 12 (SF-12): this is a quality of life assessment scale. It is divided into physical domain (PCS) and mental domain (MCS). The higher the score, the better the patients’ quality of life;Knee Injury and Osteoarthritis Outcome Score (KOOS): this is a percentage value that quantifies clinical symptoms, disability, and quality of life in patients suffering from knee diseases. It ranges from 0% (severe disability) to 100% (optimal condition);Oxford Knee Score (OKS): this assesses the severity of osteoarthritis from 0 to 48 (severe osteoarthritis 0–19; moderate-severe osteoarthritis 20–29; mild-moderate osteoarthritis 30–39; no sign of osteoarthritis 40–48).Patients belonging to the control group underwent a 45 day treatment with a dietary supplement based on hemp seed oil (413 mg/capsule) in a softgel capsule format.Patients belonging to the treatment group underwent a 45 day treatment with a dietary supplement based on hemp seed oil (413 mg/capsule), β-caryophyllene (35 mg/capsule), myrcene (15 mg/capsule), and ginger extract titrated in gingerols (66 mg/capsule). The hemp seed oil contained in both dietary supplements was composed mainly of Linoleic (55.90%), gamma-Linolenic (19.10%) and Oleic (9.30%) acids. Patients were unaware of which of the two dietary supplements they were taking as they were not identifiable from the packaging. Similarly, the physicians performing the clinical assessments at T0 and T1 were unaware of which supplement the patients had taken, thus creating a double-blind study design. A third investigator was therefore responsible for the distribution of the supplements.All patients took two softgels of the assigned dietary supplement per day, one capsule with each main meal (usually during lunch and dinner).Patients were allowed to take paracetamol (up to a maximum of 3000 mg/day) and were asked to write down the dosage of the drug taken in a dedicated diary. The use of other medications during the treatment period was recorded, as were the eventual side effects.At the end of the treatment (T1), 45 days after T0, all of the outcome measures were collected from each patient in order to compare the clinical trend and the functional implications between the groups. The diaries used to register any drugs taken in addition to any side effects related to the proposed therapies were collected at the same time.All patients received the necessary information during the first medical examination and expressed their written informed consent. All of the performed procedures were carried out in accordance with the Helsinki Declaration (2016) of the World Medical Association. The study was approved by the Ethics Committee of Albania University, Tiran, Albania (Nr. 587 Prot.–Date: 13 December 2021).