Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

Study Overview
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Brief Summary
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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
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The main novel features of this study: First aim to assess the effect of distal needling on knee pain 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: Distal needling - enables assessment of range of motion (ROM) and pain level during needling. Both acupuncture systems rely on minimal questioning, which simplifies the patient-practitioner interactions. 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.

Official Title
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Comparison of Different Acupuncture Methods on Knee Pain

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

Intervention / Treatment
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* Device: Pain relief by Acupuncture needle at non-specific site
* Device: Acupuncture needle
* Device: Acupuncture needle
* Device: Acupuncture needle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: deep needle non-site specific<br> | Device: Pain relief by Acupuncture needle at non-specific site<br> <br> |
| Active Comparator: contralateral elbow to the knee pain<br> | Device: Acupuncture needle<br> <br> |
| Active Comparator: Energy of Living Systems Needling<br> | Device: Acupuncture needle<br> <br> |
| Placebo Comparator: Sham acupuncture<br> | Device: Acupuncture needle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Distal Needling on Knee Pain Using Acupuncture Techniques | Effect of Distal Needling on Knee Pain Using 4 different Acupuncture Techniques by: Pain measurement by Visual Analogue Scale (VAS) Range of motion (ROM) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee pain, Acupuncture, Sham acupuncture