Back to resultsA Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints
Primary Purpose
Acupuncture, Knee Osteoarthritis, Randomized Controlled Trial
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Acupuncture
Eligibility Criteria
Inclusion Criteria:
- Eligible patients are those aged 40 years or older who are diagnosed with KOA and have signed the informed consent.
- The diagnosis of KOA will follow the diagnostic criteria according to the Chinese Guidelines for the Medical Management of Osteoarthritis:
- refractory knee pain for most days in the last month;
- joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by X-ray);
- laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count < 2000/mm3;
- age 40 years or older;
- morning stiffness continues less than 30 minutes;
- bone sound exists when joints was taking flexion and/or extension. A person is confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1 and 2), or (1,3 and 5), or (1,4,5 and 6).
Exclusion Criteria:
Patients will be excluded if they:
- Can not adhere to the study protocol in the future 6 months;
- Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of knee/bone joint, rheumatoid arthritis;
- Have sprain or other trauma;
- Are unable to walk properly due to foot deformity or pain;
- Are present with mental disorders;
- Have comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus or blood disorder;
- Females who are pregnant or lactating;
- Were using physiotherapy treatments for osteoarthritis knee pain;
- Had used intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months;
- Received knee-replacement surgery;
- Were participating or had participated in the other clinical trials.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group: Acupuncture
Control group: Acupuncture
Arm Description
acupuncture on 5 most sensitized points/ acupoints
acupuncture on 5 least low/non-sensitized points
Outcomes
Primary Outcome Measures
The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function
Secondary Outcome Measures
The change of Short Form (SF)-12 health survey score from baseline to 16 weeks
It includes 12 items: 2 items on physical functioning, 2 items on role limitations because of physical health problems,
1 item on bodily pain, 1 item on general health perceptions, 1 item on vitality (energy/fatigue), 1 item on social functioning, 2 items on role limitations because of emotional problems, and 2 items on general mental health (psychological distress and psychological well-being)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03008668
Brief Title
A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints
Official Title
Acupuncture for Knee Osteoarthritis With Sensitized Acupoints: a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators plan to undertake a rigorous multicentre randomised controlled trial, comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture (waiting-list), to test if acupuncture on sensitized acupoints may result in improved treatment outcomes in patients with Knee osteoarthritis (KOA).The current pilot study aimed to assess the feasibility of performing the definitive randomised controlled trial.
Detailed Description
Patients in the intervention group received acupuncture treatment on the 5 most sensitized points/ acupoints.Patients in the control group received acupuncture treatment on the 5 least /non-sensitized points. All other treatment settings were the same as in the intervention group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Knee Osteoarthritis, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group: Acupuncture
Arm Type
Experimental
Arm Description
acupuncture on 5 most sensitized points/ acupoints
Arm Title
Control group: Acupuncture
Arm Type
Active Comparator
Arm Description
acupuncture on 5 least low/non-sensitized points
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
a stimulation of the body or auricular points
Primary Outcome Measure Information:
Title
The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
Description
It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function
Time Frame
Assessments will be conducted at baseline and 16 weeks after randomization
Secondary Outcome Measure Information:
Title
The change of Short Form (SF)-12 health survey score from baseline to 16 weeks
Description
It includes 12 items: 2 items on physical functioning, 2 items on role limitations because of physical health problems,
1 item on bodily pain, 1 item on general health perceptions, 1 item on vitality (energy/fatigue), 1 item on social functioning, 2 items on role limitations because of emotional problems, and 2 items on general mental health (psychological distress and psychological well-being)
Time Frame
Assessments will be conducted at baseline and 16 weeks after randomization
Other Pre-specified Outcome Measures:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Expected adverse events (AEs) of the acupuncture interventions include bleeding, nausea/vomiting, fainting, bruising at needle sites, feeling hot/burning, and transient pain at needle sites. We defined serious adverse events (SAEs) as: death, hospitalization, significant disability or incapacity, any life-threatening situations or any other medically significant events that were potentially related to the trial procedures or acupuncture treatments. The AEs or SAEs were identified by the certified treating acupuncturists.
Time Frame
Assessments will be conducted at 4 weeks after the acupuncture treatment and followed at 8, 12 and 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible patients are those aged 40 years or older who are diagnosed with KOA and have signed the informed consent.
The diagnosis of KOA will follow the diagnostic criteria according to the Chinese Guidelines for the Medical Management of Osteoarthritis:
refractory knee pain for most days in the last month;
joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by X-ray);
laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count < 2000/mm3;
age 40 years or older;
morning stiffness continues less than 30 minutes;
bone sound exists when joints was taking flexion and/or extension. A person is confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1 and 2), or (1,3 and 5), or (1,4,5 and 6).
Exclusion Criteria:
Patients will be excluded if they:
Can not adhere to the study protocol in the future 6 months;
Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of knee/bone joint, rheumatoid arthritis;
Have sprain or other trauma;
Are unable to walk properly due to foot deformity or pain;
Are present with mental disorders;
Have comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus or blood disorder;
Females who are pregnant or lactating;
Were using physiotherapy treatments for osteoarthritis knee pain;
Had used intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months;
Received knee-replacement surgery;
Were participating or had participated in the other clinical trials.
12. IPD Sharing Statement
Citations:
PubMed Identifier
33005432
Citation
Jia P, Liu J, Li L, Luo Y, Li Y, Zhao L, Liang F, Liu Z, Zou K, Tang L, Sun X. Acupuncture for knee osteoarthritis with sensitized acupoints: results from a pilot, feasibility randomized controlled trial. Pilot Feasibility Stud. 2020 Sep 28;6:144. doi: 10.1186/s40814-020-00687-x. eCollection 2020.
Results Reference
derived
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A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints
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