| BackgroundKnee Osteoarthritis (KOA) is a chronic, degenerative, joint disease that affects mostly middle-aged and older adults. As the most common form of arthritis, KOA is firstly characterized by a series of pathological changes in the whole joint such as cartilage,subchondral bone plate and synovium, including cartilage loss, subchondral bone sclerosis, cystic degeneration, inflammation in the synovium (synovitis), and compensatory osteophyte formation, which cause joint pain, stiffness, deformity and dysfunction.Evidences gathered have shown that osteoarthritis usually begins after middle age and is progressive. The incidence rises with age, and is higher in women than men. With the arrival of our aging society more and more people are suffering from knee osteoarthritis, which presents a sognificant obstacle in maintaining their health and quality of life. Although it is not as threatening as cancer that takes lives away, not as much disability incidence as rheumatic or rheumatoid arthritis, or ankylosing spondylitis, its incidence increases and never decreases. KOA still need to be taken seriously, for the severe effect onpatients’ quality of life and the public health service. So far, KOA has caused widespread concern in the international community.ObjectiveRandomized controlled method was used in the research, and WOMAC scale, VAS score, SF-36scale were included, while using warming needle moxibustion as control group. The evaluation on patients’ degree of improvement in joint function and quality of life was carried out through the observation of salt-partitioned moxibustion. All the data were provided as clinical basis for the treatment of KOA.Methods1Participants1.1Case SourceAll the patients were collected from the Acupuncture clinic of NanFang Hospital and the Acupuncture and massage clinic of Integrative Medicine Hospital between March2012to December2013.90cases were met the diagnostic criteria for osteoarthritis and Informed consents were signed when the patients participate in this study voluntarily.2Research Methods2.1Stochastic approachA patient number identified all patients included in the study after signing the informed consent form. Each patient was identified by a numerical code. Randomization scheme was based on serial numbers (1-90) of the EXCEL table.The correspondence between the number of patients and their treatment was performed by use of specific software for randomization, keeping that relation in a sealed envelope. This envelope was not opened until the moment before the treatment was applied. The response was assessed by researchers not involved in the application of treatment (blinded). Then the90patients were randomly divided into warming needle moxibustion and salt-partitioned moxibustion according to the order of inclusion criteria.2.4Intervention2.4.1Salt-partitioned moxibustionMoxibustion instrument:plasticcopper tubing,18cm (inside diameter) x18cm (height), one side is about45°, one side is horizontal.Moxibustion materials:Pure moxa cone moxibustion of Huai an (HUJ),12cm (diameter)×15cm (height), table salt of Chrysanthemum brand.Acupoints selection:ipsilateral acupoints, acupoints in turn, no more than four acupoints each time.Main acupoints:Neiwaixiyan(EX-LE5), Ququan(LR8), Heding(EX-LE2), Xiyangguan(GB33), Ashi;Adjunct points:kidney marrow deficiency:Taixi(KI3), Yanglingquan(GB34), Juegu(GB39); Yang deficiency and cold coagulation:Zusanli(ST36), Liangqiu(ST34); Blood stasis block:Xuehai(SP10).Operation:The patients were asked to lie in bed, and their knees were in comfort position padded with pillows. After routine skin disinfection, the doctor put the45°ide of moxibustion instrument on the acupoints and made sure the other side as horizontal as possible. Then moxibustion instrument should be fixed on the skin with adhesive tape. And plasticcopper tubing should be80%filled by the table salt, whose3mm vacancy left for the moxibustion ash after burning.Everytime there was one moxa cone burning on the salt. After its complete combustion and dispersion of Sweltering, doctor should take the moxibustion instrument away, clean the surface and skin of patients, and apply the cream to the areas gently.Two days one time, three times a week, for4weeks.12times in all.2.4.2warming needle moxibustion Acupoints selection:same as the group of salt-partitioned moxibustion.Operation:The patients were asked to lie in bed, and their knees were in comfort position padded with pillows.After routine skin disinfection,1.5-inch acupuncture needles were impelled in the acupoints.In addition the moxa cone about2cm was ignited and set on the handle of the acupuncture needle.2Zhuang(unit of moxa cone) each acupoint each time, about40minutes. Two days one time, three times a week, for4weeks.12timesinall.3) Accident treatment:pain occurs when the needle is impelled in pores, doctor should readjust the direction of the needle.If the needles are impelled in blood vessels, press the bleeding site when the needles are withdrawn.2.5Clinical evaluation method2.51main outcome measureswestern ontario and macmaster university osteoarthritis index (WOMAC):to evaluate patients with knee osteoarthritis by24questions, the higher score means the worse degree of the disease, including5assessed dimensions such as the pain, joint stiffness, physical function, social function and emotion.In details like there is5questions in pain,2questions in stiffness,17questions in physical function,6questions in social function,10questions in emotion.Every question will be given4points,3points,2points,1point, O pointsdepending on the different individual circumstances.Besides, some researchers only use3dimensions(pain, joint stiffness, and physiological functions)of the WOMAC.Also, the higher the score, the more severe the disease.2.5.2Secondary Indicator1) short-form-36health survey SF-36(Chinese):assessment is divided into mental health, physical health. Higher scores indicate better quality of life.2) tenderness score. Using a visual analogue scale (visual analogue scale, VAS) to evaluate tenderness score. VAS is designed to show the degree of pain by pain expression and the ruler which is marked the scale of1-10,0means painless, while1-3means mild pain,4-6moderate pain,7-9severe pain,10extreme pain. Mark on the ruler using the most representative point of pain intensity, and measure the distance from0to the mark.Finally the scores we got from VAS would bethe pain intensity scores.2.5.3Quality AssessmentAccording to the WOMAC and nimodipine therapy, namely:efficacy index=[(symptom score before treatment-symptom score after treatment)÷symptom score before treatment]×100%. Clinical recovery correspond to efficacy index≥80%; while markedly effectiveto50%(including50%)-80%; effective to25%(including25%)-50%; ineffective to<25%.2.5.4observation cycleObservation cycle is12times. The relevant data were observed and recorded before and after the trail. If the patient reaches clinical recovery within two courses, the ovservation can be stopped.2.6Accident treatment(1) Mild:refers to pain, or bleeding during the needling or after the needling.The physical examination shows no positive signs.The patient is still willing to participate in the study. Not need special treatment.(2) severe:accidents such as broken needle and faintng during acupuncture treatment.All these need to pause the trail immediately and make the patients stay in hospital for observation.Invite the surgery to give corresponding diagnosis and treatment.(3) All theaccidents occurred will be documentedby the researchers including the happening, duration and severity, and these records will be analyzed in the end of the experiment.Results(1)90patients in all, all patients completed treatment and clinical observations.In the research there was no loss or excluding cases.(2) This study contained90patients observed,42male patients (46.67%),48female patients (53.33%). The ratio of male to female was1:1.14.Age distribution was between40-75years old, mean age:57.99±10.60; duration distribution:4-10months, the average duration was6.68±1.89months.(3) baseline comparison:WOMAC score of the two groups of patients before treatmentby t test, there were no significant difference in subjective symptoms, clinical signs, activities of daily living and JOA scores (P>0.05). VAS, SF-36score were the same as WOMAC score and were comparable.(4) Statistical analysis before and after treatment in group2(warming needle moxibustion group):After the intervention, the VAS scores, WOMAC scores and pain, joint stiffness and daily activity scores of the patients were significantly reduced comparing with the situation before treatment. The difference was statistically significant.Meanwhile the SF-36scores after the intervention were significantly higher than the scores before treatment, and there was significant difference between them. All the data indicated that warming needle moxibustion can effectively relieve the pain of KOA patients and improve their joints stiffness and daily activities significantly, thus improve the quality of life of patients significantly.(5) Statistical analysis before and after treatment in group1(salt-partitioned moxibustion):After the intervention, the VAS scores, WOMAC scores and pain, joint stiffness and daily activity scores of the patients were significantly reduced comparing with the situation before the treatment. The difference was statistically significant. Meanwhile the SF-36scores after the intervention were significantly higher than the scores before treatment, and there was significant difference between them. All the data indicated that salt-partitioned moxibustion on the knee can be analgesic and improve the joints stiffness and daily activities significantly.Meanwhile it can improve the health status of patients and relieve physiological and psychological problems caused by the disease.(6) Statistical analysis between the two groups After treatment:It was found that several indicators observed such as WOMAC scores, pain, daily activities and VAS scores in salt-partitioned moxibustion group was lower than warming needle moxibustion group.But there was no significant difference between the two groups in terms of improving the level of SF-36scores. There was no significant difference between the groups after the treatment in the comparison of the total efficacy. All the data implied that salt-partitioned moxibustion can improve the quality of life of the patients and make better effect on improvement of pain and daily life than warming needle moxibustion.Conclusion(1) Salt-partitioned moxibustion of the knee, possibly analgesic when participating in the intervention, can effectively improve the situation of stiffness of KO A patients and their daily activities, thus improve the quality of life of patients.(2) The therapeutic effect of salt-partitioned moxibustion is better than warming needle moxibustion. Thus its impact in reducing pain and improving the quality of life is better than warming needle moxibustion. |
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