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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group: Acupuncture | Experimental | acupuncture on 5 most sensitized points/ acupoints |
|
| Control group: Acupuncture | Active Comparator | acupuncture on 5 least low/non-sensitized points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | a stimulation of the body or auricular points |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessments will be conducted at baseline and 16 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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. |
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded if they:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33005432 | Derived | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Assessments will be conducted at baseline and 16 weeks after randomization |
| Assessments will be conducted at 4 weeks after the acupuncture treatment and followed at 8, 12 and 16 weeks |
| D012216 |
| Rheumatic Diseases |