Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention
Patellar Tendonitis
Complete Tear, Knee, Anterior Cruciate Ligament
Device: Pain relief by Acupuncture needle at non-specific site
Device: Acupuncture needle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Comparison of Different Acupuncture Methods on Knee Pain

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: deep needle non-site specific Device: Pain relief by Acupuncture needle at non-specific site
Active Comparator: contralateral elbow to the knee pain Device: Acupuncture needle
Active Comparator: Energy of Living Systems Needling Device: Acupuncture needle
Placebo Comparator: Sham acupuncture Device: Acupuncture needle

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612663

Contacts
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Please select, Israel, 91120
Contact: Hadas Lemberg, PHD    972 507874098    lhadas@hadassah.org.il   
Contact: Elyad Davidson, MD    972 507874098    EDAVIDSON@hadassah.org.il   
Principal Investigator: Adi Friedman, MD         
Hadassah Medical Organization Not yet recruiting
Jerusalem, Please select, Israel, 91120
Contact: Adi Friedman, MD    972 507874778      
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Elyad Davidson, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Elad Davidson, PI Head Pain Unit, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01612663     History of Changes
Other Study ID Numbers: 007212-HNO-CTIL
Study First Received: June 3, 2012
Last Updated: June 5, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Knee pain
Acupuncture
Sham acupuncture

ClinicalTrials.gov processed this record on November 20, 2014