A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints

Knee Osteoarthritis Clinical Trial

Official title:

Acupuncture for Knee Osteoarthritis With Sensitized Acupoints: a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008668
• Other study ID #: 201681590955
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 2017

Study information

• Verified date: July 2018
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Randomized Controlled Trial

Intervention

Other:
• acupuncture
a stimulation of the body or auricular points

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Assessments will be conducted at 4 weeks after the acupuncture treatment and followed at 8, 12 and 16 weeks
Primary	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
Secondary	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)	Assessments will be conducted at baseline and 16 weeks after randomization