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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] 311711 0
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 333187 0
Condition category
Condition code
Musculoskeletal 329874 329874 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 329947 329947 0 0
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] 328172 0
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] 337703 0
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] 337703 0
Baseline & week -12 post intervention commencement
Secondary outcome [1] 432905 0
Active knee flexion ROM assessed using a standard goniometer
Timepoint [1] 432905 0
Baseline & week -12 post intervention commencement
Secondary outcome [2] 432906 0
Participant's functional mobility and balance assessed using Time Up and Go Test (TUG)
Timepoint [2] 432906 0
Baseline & week -12 post intervention commencement
Secondary outcome [3] 432907 0
Participant's pain levels assessed by Visual Analog Scale (VAS)
Timepoint [3] 432907 0
Baseline & week -12 post intervention commencement
Secondary outcome [4] 432908 0
Participant's health-related quality of life assessed using Short form 36 questionnaire (SF-36)
Timepoint [4] 432908 0
Baseline & week -12 post intervention commencement
Secondary outcome [5] 434516 0
Participant's balance of energy within the acupuncture meridians assessed using Pie Score from Acugraph
Timepoint [5] 434516 0
Baseline & week -12 post intervention commencement

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized simple block randomization method
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To examine differences between the treatment and control groups over time, a repeated measures ANOVA will be conducted. This analysis assess the main effects of time, treatment group, and the interaction between time and treatment group. Effect sizes will be calculated using Cohen's d to determine the magnitude of the observed treatment effects. The James Blinding Index (JBI) is a questionnaire that will be used to assess blinding success in clinical trials, particularly from the perspective of trial participants (Kolahi et al., 2009).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
1/07/2024
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 26206 0
Malaysia
State/province [1] 26206 0
NEGERI SEMBILAN

Funding & Sponsors
Funding source category [1] 316040 0
Other Collaborative groups
Name [1] 316040 0
Name of organisation: Grand care rehab
Country [1] 316040 0
Malaysia
Primary sponsor type
Other Collaborative groups
Name
Grand care rehab
Address
Country
Malaysia
Secondary sponsor category [1] 318202 0
None
Name [1] 318202 0
Address [1] 318202 0
Country [1] 318202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314862 0
Research Ethics Committee Universiti Kebangsaan Malaysia
Ethics committee address [1] 314862 0
Ethics committee country [1] 314862 0
Malaysia
Date submitted for ethics approval [1] 314862 0
19/01/2024
Approval date [1] 314862 0
12/06/2024
Ethics approval number [1] 314862 0
UKM PP1/111/8/JEP-2024-244

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132966 0
Dr Mohd Azzuan Ahmad
Address 132966 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur
Country 132966 0
Malaysia
Phone 132966 0
+60123297292
Fax 132966 0
Email 132966 0
[email protected]
Contact person for public queries
Name 132967 0
Lee Chai Li
Address 132967 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur
Country 132967 0
Malaysia
Phone 132967 0
+60166002435
Fax 132967 0
Email 132967 0
[email protected]
Contact person for scientific queries
Name 132968 0
Dr Mohd Azzuan Ahmad
Address 132968 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur
Country 132968 0
Malaysia
Phone 132968 0
+60123297292
Fax 132968 0
Email 132968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.