Clinical trial NCT01612663: Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
Official title: Comparison of Different Acupuncture Methods on Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellar Tendonitis
Complete Tear, Knee, Anterior Cruciate Ligament
Keywords: Knee pain
Acupuncture
Sham acupuncture
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
state: Please Select
Study officials:
affiliation: Hadassah Medical Organization
name: Elyad Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References: