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Trial registered on ANZCTR

Registration number

ACTRN12624000646549

Ethics application status

Approved

Date submitted

24/03/2024

Date registered

20/05/2024

Date last updated

21/07/2024

Date data sharing statement initially provided

20/05/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of Point Specific Acupuncture Combined with Physiotherapy in Knee Osteoarthritis

Scientific title

Effects of Computerized Point Specific Acupuncture Combined with Physiotherapy on Pain and Functional Outcome in Adults with Mild to Moderate Knee Osteoarthritis: A Randomized Controlled Trial

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1305-4127

Trial acronym

Comp-AcuPhysio= Computerized acupuncture point selection and physiotherapy Man-AcuPhysio= Manual preference acupoint selection and physiotherapy

Linked study record

None

Health condition

Health condition(s) or problem(s) studied:

knee osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Group 2 (Man- AcuPhysio)
In addition to the usual physiotherapy treatment, participants in Group 2 (Man- AcuPhysio) will receive acupuncture treatment (approximately 20 minutes) based on manual preferences. For the purpose of blinding the participants, placebo Acugraph analysis will be conducted. Participants from Group 2 will receive an Acugraph examination; however, the acupuncture treatment will be administered based on the acupuncturist's manual preferences rather than relying on Acugraph analysis. The acupoints for the control group are manual preferences, such as Yanglingquan (GB34), Yinlingquan (SP9), Dubi (ST35), and Neixiyan (EX-LE4). At the same time, depending on the patient's condition, two local acupuncture points can be added following the acupuncturist's preferences. Later, acupuncture treatment will be carried out. The acupuncturist performs a thorough assessment of the patient's condition, considering any contraindications and ensuring a sterile environment. The location of these acupoints can vary based on the pathway of Qi flow. They may include points close to the knee joint, particularly distal and proximal points around the antero-medial and antero-lateral parts of the knee joint, and acupoints that are located away from the knee joints, such as those on the stomach and spleen meridian channels that pass through the knee area.

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.

Control group

Active

Outcomes

Primary outcome [1]

Participant's pain, symptoms, activities of daily living, sports and recreation, and quality of life assessed using Knee Injury and Osteoarthritis Outcome Score (KOOS)

Timepoint [1]