Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Elad Davidson, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01612663
First received: June 3, 2012
Last updated: June 5, 2012
Last verified: May 2012

June 3, 2012
June 5, 2012
June 2012
June 2014   (final data collection date for primary outcome measure)
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Effect of Distal Needling on Knee Pain Using 4 different Acupuncture Techniques by:

  1. Pain measurement by Visual Analogue Scale (VAS)
  2. Range of motion (ROM)
Same as current
Complete list of historical versions of study NCT01612663 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
Comparison of Different Acupuncture Methods on Knee Pain

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Patellar Tendonitis
  • Complete Tear, Knee, Anterior Cruciate Ligament
  • Device: Pain relief by Acupuncture needle at non-specific site
  • Device: Acupuncture needle
  • Active Comparator: deep needle non-site specific
    Intervention: Device: Pain relief by Acupuncture needle at non-specific site
  • Active Comparator: contralateral elbow to the knee pain
    Intervention: Device: Acupuncture needle
  • Active Comparator: Energy of Living Systems Needling
    Intervention: Device: Acupuncture needle
  • Placebo Comparator: Sham acupuncture
    Intervention: Device: Acupuncture needle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
June 2015
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il
Israel
 
NCT01612663
007212-HNO-CTIL
Yes
Elad Davidson, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Elyad Davidson, MD Hadassah Medical Organization
Hadassah Medical Organization
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP