None listed
Conditions
Brief summary
Knee osteoarthritis (KOA) is a major global healthcare concern necessitating effective rehabilitation strategies. Although acupuncture has shown promise in treating KOA, its integration into clinical practice is hindered by insufficient high-quality evidence. The efficacy of acupuncture combined with physiotherapy for pain relief and enhancing physical function in KOA remains uncertain, compounded by the lack of standardized treatment protocols across existing studies. This study aims to address these gaps by conducting a randomized placebo-controlled trial adhering to CONSORT guidelines, involving 40 adults with mild to moderate KOA recruited from Grand Care Rehab Malaysia. Participants will be assigned to either a computerized acupuncture group (Comp-AcuPhysio) or a manual acupuncture group (Man-AcuPhysio), alongside physiotherapy sessions, with outcomes measured through questionnaires and physical assessments at baseline and post-intervention.
Interventions
The recruited participants (n = 40) will be randomly allocated to one of two groups. The randomization process will be carried out using a simple block randomization method. Participants in Group 1 will receive computerized acupoint selection acupuncture and usual physiotherapy rehabilitation (Comp-AcuPhysio, n = 20), while participants in Group 2 will receive manual preference acupoint selection acupuncture with usual physiotherapy rehabilitation (Man-AcuPhysio, n = 20). Interventions for both groups will be conducted over 12 sessions, once a week for 12 consecutive weeks. Treatment (acupuncture and physiotherapy) for both groups (Comp-AcuPhysio and Man-AcuPhysio) will be administered by a single qualified physiotherapist cum acupuncturist who is not involved in the outcome assessment. In this study, participants in both groups will receive personalized physiotherapy rehabilitation exercises, based on individual needs, lasting approximately 40 minutes in conjunction with their respective acupuncture treatments. The physiotherapeutic exercises will be prescribed as supervised sessions. The exercise prescription and progression will be modified accordingly based on individual needs, following the established knee osteoarthritis (KOA) treatment guidelines specifically based on the Osteoarthritis Research Society International (OARSI) guidelines. Additionally, the components of the exercises will be adopted from previous studies that have proven to produce favorable outcomes in knee osteoarthritis (KOA) management (Ahmad et al., 2023; Button et al., 2015; Gay et al., 2016; Suzuki et al., 2019). Based on the OARSI guidelines, examples of exercise components include range of motion, stretching, strengthening, and functional training; however, the exercise prescription (mode, intensity, and modification) and progression will be adjusted based on individual participant needs and specific impairments. General examples of exercise selection and prescriptions are as follows: 1) Range of motion: Prone knee bend (2 sets, 10 repetitions each), Supine alternate knee bend (2 sets, 10 repetitions each) 2) Stretching: Standing quadriceps stretch (1 set, 3-5 repetitions, 15-second hold each), Calf stretch in long sitting (1 set, 3-5 repetitions, 15-second hold each), Supine hamstring stretch (1 set, 3-5 repetitions, 15-second hold each) 3) Strengthening: Sitting knee extension (Week 1-2: 1 set, 5 repetitions, 5-second hold; Week 3-5: 1 set, 7-10 repetitions, 5-10-second hold; Week 6-8: 2 sets, 10 repetitions, 10-second hold), Supine straight leg raise (Week 1-2: 1 set, 5 repetitions, 5-second hold; Week 3-5: 1 set, 7-10 repetitions, 5-10-second hold; Week 6-8: 2 sets, 10 repetitions, 10-second hold), Static quadriceps (Week 1-2: 1 set, 5 repetitions, 5-second hold; Week 3-5: 1 set, 7-10 repetitions, 5-10-second hold; Week 6-8: 2 sets, 10 repetitions, 10-second hold), Side-lying straight leg raise (Week 1-2: 1 set, 5 repetitions, 5-second hold; Week 3-5: 1 set, 7-10 repetitions, 5-10-second hold; Week 6-8: 2 sets, 10 repetitions, 10-second hold) 4) Functional training: Sitting to stand (10 repetitions), Standing mini-squat (10 repetitions), Walking exercise (approximately 2 minutes for each item) GROUP 1( Comp-AcuPhysio) In addition to the usual physiotherapy treatment, Group 1 (Comp-AcuPhysio) participants will receive acupuncture treatment (approximately 20 minutes) based on a computerized method of identifying point-specific acupuncture that is generated by the Acugraph system. For Group 1 (Comp-AcuPhysio), the process can be divided into two steps: first, the screening of treatment points using AcuGraph, and the second, the application of acupuncture treatment. Initially, Knee osteoarthritis (KOA) patients will be screened using the Acugraph system, which serves as an electrodermal screening device. It assesses energy flow and stress levels by measuring electrical conductance at specific acupuncture points on the skin. Analyzing these readings provides insights into overall health and meridian imbalances, playing a pivotal role in locating precise acupuncture points on the body for treatment. The monitoring computer records readings at specified points in a standard sequence, specifically at the Jing-Well acupuncture points on the fingers and toes, which are related to the main organs: Lung (LU), pericardium (PC), heart (HT), small intestine (SI), triple energizer (TE), large intestine (LI), spleen (SP), liver (LR), kidney (KI), bladder (BL), gallbladder (GB), and stomach (ST). Acupoints that are specific to each participant will then be generated by the computer to guide the specific point for treatment purpose. On average, the number of commonly applied acupoints in a typical acupuncture session for KOA may involve the use of approximately 4 to 12 acupuncture points in both groups. These acupoints are selected from Acugraph. Sterile, disposable needles are inserted into these points at the appropriate depth (0.30: 25mm, or 0.30: 40mm), and a penetration depth of 0.8 to 3cm is used for 20 minutes, using a gentle technique to minimize discomfort. The acupuncturist performs acupuncture one-on-one and face-to-face, monitors the patient for any adverse reactions, and adjusts needle placement or stimulation as needed. Strict safety protocols, including infection control and patient comfort, are followed throughout the procedure. To monitor adherence to the intervention, attendance records will be maintained for each participant's treatment sessions. Specifically, a treatment schedule outlining the dates and times of sessions will be given to participants. Any missed appointments will be documented, and efforts will be made to reschedule these sessions to ensure participants receive the full course of treatment.
Sponsors
Study design
Eligibility
Inclusion criteria
The study will include: (i) patients with mild to moderate KOA classified as grade 2 or grade 3 according to the Kellgren Lawrence classification; (ii) adults aged 18 and above of both sexes; (iii) diagnosed with unilateral or bilateral KOA by an orthopedic doctor and confirmed via X-ray less than 12 months ago.
Exclusion criteria
Exclusion criteria include: (i) patients unable to comply with the study; (ii) recent knee trauma; (iii) ligament damage; (iv) fracture; (v) surgery within the past 6 months causing pain or functional issues; (vi) local knee tumor/malignancy history; (vii) recent prolotherapy; (viii) intra articular injections less than 6 months; (ix) needle oversensitivity