Study design
This was a controlled, randomized, single-blind clinical trial. In Changning District, Shanghai, the Rehabilitation Department of Tianshan Hospital of Traditional Chinese Medicine recruited subjects. The patients will be divided into treatment and control groups using the random number table method, with the treatment group receiving electroacupuncture combined with exercise therapy and the control group receiving exercise therapy alone. The Ethics Committee of the China Clinical Trials Registry authorized the trial (approval number: ChiCTR2300071577) .The trial's flowchart is depicted in Figure 1. Table 1 depicts the timeline for enrollment, interventions, and evaluation.
Patient recruitment
This research was to recruit 66 patients meeting the diagnostic criteria, all from Shanghai Changning Tianshan Traditional Chinese Medicine Hospital. The researcher initiated the introduction of this study, and the participants volunteered to take part. After screening by clinicians based on inclusion and exclusion criteria, subjects may be included if they satisfy the criteria, and all patients must provide written informed consent.
Inclusion criteria
(1) those who meet the Western diagnostic criteria and Chinese diagnostic criteria for KOA as described above; (2) those who are in the age range of 40 to 75 years; (3) those who agree and have signed the informed consent form; (4) those who have not used Western or Chinese medication and other therapies related to the treatment of osteoarthritis of the knee within the last 1 month; (5) those with early to mid-stage osteoarthritis of the knee, i.e., those who are graded for joint function (ACR criteria) or graded for osteoarthritic radiological condition (Kellgren-Lawrence grading) grade II and grade III.
Exclusion criteria
(1) acute knee injury, osteoarthritic tuberculosis of the knee, tumour, rheumatic and rheumatoid osteoarthritis, etc.; (2) significant narrowing of the joint space or formation of bony bridging joints or even bony ankylosis on radiological imaging of the bone and joint; (3) significant knee deformity such as inversion and valgus; (4) history of vascular nerve injury to the affected limb; (5) combined cardiovascular, cerebrovascular, hepatic, renal, haematopoietic and other serious diseases; (6) psychiatric patients; (7) pregnant and lactating women; (8) those who have received medication or other treatments related to osteoarthritis of the knee within the last 1 month and have failed to terminate them.
Rejection criteria
(1) shedding: those who do not complete the full 12 sessions for various reasons; (2) contamination: those who consume calcium-containing agents while undergoing treatment; (3) non-compliance: those who do not follow the clinical trial regulations or do not follow the medical advice on their living conditions, making it impossible to accurately determine the efficacy of the treatment; (4) those who receive other treatments during the treatment period.
Trial design
Based on an estimate of the sample size, this study had at least 66 cases. Using SPSS 25.0 software and a random grouping method, a large enough number of random numbers (more than 66) were made and put in non-transparent boxes with sequential numbers. The numbered envelopes were given to the patients in the order they entered the clinical study. The random numbers were then taken out of the envelopes and put into the treatment group (electroacupuncture plus exercise therapy) and the control group (exercise therapy only). For this procedure study, the person who collected the data, the intervention therapist, and the person who analyzed the data were all blinded.
Interventions
Treatment group (electroacupuncture plus exercise therapy):
- Electroacupuncture therapy procedures:
Dubi(ST35),Neixiyan (EX-LE4), Xuehai(SP10), Liangqiu(ST34), Yanglingquan(GB34), and Zusanli(ST36) on the affected side. All acupoints were located according to the standard standards in the People's Republic of China National Standard Acupoint Location GB13346-90[16] . Acupuncture Locations and are exhibited in Table 2 and Figure 2.The patient is placed in a lying position, and the acupuncture points are first disinfected locally and then referred to the operation method of "Acupuncture and Moxibustion," edited by Wang Hua, the editor-in-chief of the "Eleventh Five-Year Plan" national higher education textbook of Chinese medicine[17]: use a No. 30 1 to 2 inch milli-needle, and pierce the body of the needle at 90° to the skin for 0.5 to 1.5 inches, respectively. Connect the G6805-2 electroacupuncture device, the calf nostril to the inner knee eye pair, and the blood sea to the Liangqiu pair after obtaining qi. The stimulation parameters are direct current, continuous wave, 2 Hz frequency, 0.5 ms wave width, and current intensity, which is the utmost intensity the patient can tolerate 20 minutes after the needle has been energized. Three times per week for four weeks, a total of 12 sessions were administered.
When exercise therapy is being used, the main focus is on building muscle power and improving joint mobility. Three times a week for about 20 minutes each (two sets of 10 reps each) for 4 weeks, or 12 workouts in total. Here is a list of what needs to be done:
(A) Building muscle strength: Strength training for the quadriceps and the vastus medialis muscle
a. Training the quadriceps
1) Isometric training of the quadriceps. This means that when the muscle is tightened, there is no movement of the joint. The exercise is split into two groups: those that raise the leg straight up and those that tighten the leg muscles. Straight leg raise exercise: Have the patient lie on his back, straighten the knee joint, raise the affected limb at an angle of about 30° to the bed, and raise the toe dorsiflexion position about 30–40 cm. The quadriceps muscle then contracts hard and holds this position for more than 5 seconds, then lets the knee joint rest for 5 seconds, and then repeats the exercise. Leg-tensing exercise: Straighten the knee joint, move the ankle joint dorsally, and tighten the quads so that the patella can't be moved. Hold for more than 5 seconds until you feel your muscles getting sore, then let go for a second and do it again. Weighted straight leg raise: This is the same movement as the straight leg raise, but with a weight on the raised leg at the ankle. The weight starts at 1kg and goes up to 3kg over time.
2) Isotonic training of the quadriceps: the tone of the muscles stays the same and joint movements are made. When the person is sitting in a chair, the injured knee is quickly straightened and the foot is bent backward. When the knee has been kept for more than 5 seconds, the muscles are relaxed and the knee is slowly moved away. Repeat the exercise, doing it twice a day for about 10 minutes each time until your thighs hurt. Long circle exercise with weights Sit the patient on the edge of the bed, bend the knee 90 degrees, lower the calf, start with a 5 kg weight on the back of the foot and gradually increase it to 10 kg, lift and straighten with the weight.
b. Training the vastus medialis muscle
In the supine position, put a soft pillow behind the patient's knee and tell him or her to bend the knee 20 degrees and straighten it the last 10 degrees, keeping the knee under the most pressure on the pillow until the knee is mostly sore. Each extension should last 5 seconds and there should be two sets of five exercises per day. For the weighted short arc exercise, the patient sits on the bed and a soft pillow is put under the affected knee to bend it 30°. This is followed by a weighted exercise of the affected limb, starting at 3kg and gradually rising to 5kg for leg raising and extension.
(B) Knee movement training: exercises that bend and straighten the knee
1) The knee bends forward It is enough to bend the knee until pain is felt in the front of the patella.
2) Extension training: lying on your back with your knees as straight as you can get them. Place the knee joint between the distal and proximal patella and press back on the knee joint until you feel pain behind the knee. This is hip abduction in the lateral position and knee adduction in the flat position.
Control group (Exercise therapy only):
This group did the same kinds of exercises as the treatment group. Over the course of four weeks, treatment was given three times a week, for a total of 12 lessons.
Outcomes
Pirmary outcome
WOMAC scale score[21, 22]: Checking on the state before the first treatment, after the first treatment, after the 12th treatment, and one month after treatment is done. The WOMAC scale was used to measure how well the joints were working. The scale has three parts: joint pain, joint stiffness, and trouble moving. These are the most common signs and symptoms of osteoarthritis in the whole knee. The pain section has five items that add up to 20 points, the stiffness section has two items that add up to 8 points, and the trouble moving around section has 17 items that add up to 68 points. Together, the three sections, which have 24 items, add up to 96 points. A special system is used to give points. The patient stands on the other side of the scale and moves it upstream until it is in the right place to show the application. The researcher looks at the scale on the front to figure out how bad the knee pain is. A score of 0 means there is no pain, a higher score means the pain is worse, and a score of 10 means the pain is the worst or even unbearable. The total score is the sum of all 24 VAS scores. A higher total score for each of the 24 items in the 3 sections means that the situation is worse. The WOMAC scale is a thorough and detailed way to measure how well a joint works in people with osteoarthritis of the knee. It gives a clear, accurate, and sensitive picture of how well the knee works before and after treatment.
Secondary outcomes
Determination of dynamic and static apparatus equilibrium function[15, 23, 24]: A balance feedback trainer (Tecnobody, Italy; Pro-Kin254P balance test instrument) is utilized. This instrument accurately measures the patient's equilibrium function. Before the first treatment, after the first treatment, after the 12th treatment, and one month after treatment completion, the instrument is measured. The static and dynamic balance assessment module is selected to conduct a static stability test in the standing position, and the four locking blocks that come with the system are positioned and secured beneath the balance board. Patients stand barefoot on the balance board and symmetrically in the center of the force measuring table, with their second toes facing the A2 and A8 lines of the balance board, their heels together on the A1 and A5 lines, and the highest point of their bilateral arches on the A3 and A7 axes. The upper extremities hang naturally on both sides of the body, while the chest is raised and the head is directed forward. The patient should make every effort to maintain an upright and stable position, with eyes open and closed three times each. Indicators include the mean center of pressure along the x-axis (C.O.P(x)), the mean center of pressure along the y-axis (C.O.P(y)), the standard deviation along the anterior-posterior axis (SDofap), the standard deviation along the lateral axis (SDofla), the mean speed of movement along the anterior-posterior axis (ASofap), the mean speed of movement along the lateral
VAS score[25]: monitor the condition at four time points: before the first treatment, after the first treatment, after the 12th treatment, and one month after treatment has concluded. Using a visual analogue scale (VAS), the reduction in discomfort is measured. As described above, a unique scoring scale was used. The patient confronts the reverse side of the scoring ruler and independently moves the ruler upstream to the position corresponding to pain. The researcher evaluates knee pain using the scale on the front: a score of 0 indicates no pain, a score of 1 indicates moderate pain, and a score of 10 indicates severe or even intolerable pain. The VAS scores are recorded in centimeters to the nearest millimeter, with one decimal place.
Five Times Sit-to-Stand Test (FTSST)[26, 27]:The 5-Times Sit-to-Stand Test is used to check how well older people's leg muscles are working, especially when they are sick or getting older. The sit-to-stand test is used to measure the lower limb strength, balance, and movement of older people[28, 29]. It is a very good way to predict how likely an older person is to fall. It can be used as a test of knee function and requires the participant to stand up as quickly as possible from a chair with a height of 46 cm and no armrests, with their hands crossed over their shoulders and without using their arms for support. They must do this five times in a row. If this isn't possible, the chance of falling needs to be looked at again.
SF-36[22, 30]: The SF-36 has been used a lot to measure people's quality of life, figure out how well clinical studies work, and make decisions about public health.The SF-36 is a simple health survey that measures the following effects of health on society: The Physical Functioning subscale measures the functional limitations caused by physical health problems. The Bodily Pain subscale measures the impact on daily life. The General Health subscale measures the individual's assessment of his or her health status and trends. The Vitality measures the individual's subjective feelings about his or her energy and fatigue. The Social Functioning subscale measures how physical and mental health problems affect the ability to interact with others. The Mental Health subscale measures four types of mental health: motivation, depression, behavioral or emotional problems, and psychological health. The interviewees' quality of life is looked at from eight different points of view, such as motivation, depression, behavioral or emotional control, and subjective feelings[31].
Adverse events
Incidence of adverse reactions: Clinical observation for possible signs of adverse reactions like dizziness, treatment site infection, and swelling, as well as systemic adverse reactions; observation for other unexpected adverse events and serious adverse events that happen. Based on the situation, the investigator decides if the person needs to see a doctor or get treatment, and if the observation should end. If a major side effect happens, the unit running the clinical study must treat the subject right away to make sure they are safe. The detective fills out the Serious Adverse Event Report Form, tells the Ethics Committee about it within 24 hours, signs and dates the report, and sends it to the committee.
Assessment of safety
Adverse events were found by asking the patient questions (being careful not to ask leading questions), measuring the patient's kinetic and static balance before and after treatment, using the Womac scale, the VAS score, doing a physical check, and figuring out what caused the adverse events.
Data collection, management and monitoring
All information about clinical trials is kept in good shape and handled by a dedicated person. The inspector fills out the case report form (CRF) honestly and doesn't change it as much as possible. If a mistake is made, it shouldn't be crossed out; instead, a line should be drawn through it, and the professional observer should sign next to it and write the date and reason. Adverse events were found by asking the patient questions (being careful not to ask leading questions), measuring the patient's kinetic and static balance before and after treatment, using the Womac scale, the VAS score, and a physical check, as well as figuring out why adverse events happened.
Sample size
The content of the sample was figured out using a randomized, controlled, two-sample rate comparison sample content estimation method in a clinical design based on previous studies and a lot of research. The method was worked out by looking at Medical Statistics, 2nd Edition, which came out in August 2007 from China Union Medical University Press[32]. Taking into account a shedding rate of no more than 10%, the sample rate difference was found to be 10%. The sample size needed was 66 cases, which were split evenly between the treatment group and the control group, with 33 cases in each group. Taking α = 0.05 and 1-β = 0.8, the following equations were used to figure out the sample size:
Quality Control
In this project, the study principal and the participating investigators all unified the standard operating procedures before starting the study.
The project leader and the clinical study supervisor will also train all investigators on the trial protocol so that they can understand and be familiar with the trial process, intervention protocol, clinical efficacy assessment and contingency planning for adverse events. The implementation of quality control and quality assurance systems for clinical trials should also be ensured. All observations and findings in clinical trials should be verified to ensure the reliability of the data and the traceability of the original data.Regular trial hospital site monitoring visits should be conducted to ensure proper implementation of the study protocol.During project execution, clinical interventionists, laboratory examiners and statisticians are set up blinded to ensure independent analysis to avoid data bias.
Statistical analysis
Standard operating procedures (SOP) for managing data from clinical studies were followed. SPSS 25.0 statistical analysis software was used to look at all of the collected data. First, the measurement values were checked to see if they were normal. Those that were normal were written as s. ANOVA was used to compare measurements before and after treatment within the same group. An independent samples t-test was used to compare measurements between groups at the same time point. A rank sum test was used for measurements that were not evenly spread out. The 2-test, which is a non-parametric test, was used to test information in the count data that was not ranked, while the Ridit test was used to test information that was ranked. (α= 0.05 test level, so a difference with P value of 0.05 is statistically significant.) During the process of analyzing data, statisticians did not work with the people who designed and ran the project study.