Clinical trial NCT03008668: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Knee Osteoarthritis
Randomized Controlled Trial
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
timeFrame: Assessments will be conducted at baseline and 16 weeks after randomization
Secondary outcomes:
measure: The change of Short Form (SF)-12 health survey score from baseline to 16 weeks
timeFrame: Assessments will be conducted at baseline and 16 weeks after randomization
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Assessments will be conducted at 4 weeks after the acupuncture treatment and followed at 8, 12 and 16 weeks
Locations:
Study officials:
References:
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.