Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

Hadassah Medical Center

Status: Completed

Conditions: Complete Tear, Knee, Anterior Cruciate Ligament; Patellar Tendonitis

Treatments: Device: Pain relief by Acupuncture needle at non-specific site; Device: Acupuncture needle

Study type: Interventional

Funder types: Other

Identifiers

NCT01612663

007212-HNO-CTIL

Details and patient eligibility

About

The purpose of this study is to test if specific therapeutic benefits of acupuncture are mostly attributable to contextual and psychosocial factors, such as patients' beliefs and expectations.The investigators propose using the 2 acupuncture methods, which refrains from inserting needles in the affected area, in order to evaluate the short-term and long-term efficacy of acupuncture in a clinical setting compared with placebo and compared with invasive needling that does not adhere to "correct" acupuncture rules.

Full description

The main novel features of this study:

1. First aim to assess the effect of distal needling on knee pain
2. Second aim to directly compare two acupuncture techniques, placebo, needling at "wrong" places and "correct" needling for knee pain

Advantages of the study compared to published data:

1. Distal needling - enables assessment of range of motion (ROM) and pain level during needling.
2. Both acupuncture systems rely on minimal questioning, which simplifies the patient-practitioner interactions.
3. Exploratory studies in the clinic of DP show that it is possible to distinguish between "correct" and "incorrect" needling, at least in the short term. Long term effects have not been assessed yet.

Enrollment: 70 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (> 18 years old), suffering chronic stable pain score >40 mm on 100 mm VAS of the knee due to patellar tendonitis.
• Patients have had X-rays or other tests confirming they are not candidates for surgery nor are scheduled for steroid injections or hyaluronic acid injections within 8 weeks from the beginning of the study.
• Adult patients (> 18 years old), two weeks after ACL reconstruction surgery (with or without meniscal involvement), with pain score >40 mm on 100 mm VAS of the knee (all patients at this stage have significant ROM limitation).

Exclusion criteria

• Patient refusal
• Soldiers
• Pregnancy
• Morbid obesity
• Diabetes
• Peripheral vascular disease
• Lower limb neurological deficit (such as multiple sclerosis, nerve palsy), other serious co-morbidity (including severe back pain or hip pain)
• A history of prolonged or current steroid use
• Received hyaluronic acid injections within the previous 3 months
• Have needle phobia or allergy to sticking plaster.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 4 patient groups, including a placebo group

deep needle non-site specific

Active Comparator group

Treatment:

Device: Pain relief by Acupuncture needle at non-specific site

contralateral elbow to the knee pain

Active Comparator group

Treatment:

Device: Acupuncture needle

Device: Acupuncture needle

Device: Acupuncture needle

Energy of Living Systems Needling

Active Comparator group

Treatment:

Device: Acupuncture needle

Device: Acupuncture needle

Device: Acupuncture needle

Sham acupuncture

Placebo Comparator group

Treatment:

Device: Acupuncture needle

Device: Acupuncture needle

Device: Acupuncture needle