ITMCTR2100004526RecruitingPhase 1
The effect of acupuncture for patients with knee osteoarthritis: a protocol for a single-blinded, double-dummy randomised controlled trial
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 45 to 75 (—)
- Sex
- All
Inclusion Criteria
- •Participants who meet all of the following requirements will be considered for inclusion:
- •(1) Male or female, aged 45–75 years;
- •(2) Diagnosis of knee osteoarthritis according to the American College of Rheumatology (ACR) criteria;
- •(3) Radiologic confirmation of knee osteoarthritis[19] (Kellgren–Lawrence grade?to III);
- •(4) The average daily pain over 40 points (on a 0-to 100-point scale);
- •(5) Symptoms have been present for more than 6 months;
- •(6) Signed informed consent.
Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from the trial:
- •(1) are unable to walk;
- •(2) have a serious infection of the knee;
- •(3) have suspected tears in any ligaments or menisci or acute inflammation of the synovial capsule;
- •(4) have a history of trauma, ligament damage, fracture, or surgery on the knee(s) within 6 months, causing pain or functional problems (history of knee replacement will be excluded);
- •(5) have a history of local tumour/malignancy at the knee;
- •(6) have physical or laboratory findings indicating infection, presence of autoimmune disease or inflammatory arthritis;
- •(7) have knee pain caused by radiculopathy/herniation of an intervertebral disc;
- •(8) have end-stage diseases or other suspected severe conditions such as deep vein thrombosis of the lower limb, oedema related to cancer or cancer treatment, severe blood coagulation disorders, uncontrolled systemic arterial hypertension and severe diabetes;
- •(9) have a history of prolotherapy, hyaluronic acid injections or corticosteroids injections within 3 months;
- •(10) have received acupuncture, electro-acupuncture, Tui-na therapy, massage, or physiotherapy 8 weeks prior to enrolment in the trial;
- •(11) have severe pain in other regions;
- •(12) have severe mental disorder(s);
- •(13) are oversensitive to needles; and
- •(14) are insensitive to pain due to advanced diabetes, neuropathy or use of strong painkillers.
Investigators
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