Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Elad Davidson, Hadassah Medical Organization Identifier:
First received: June 3, 2012
Last updated: June 5, 2012
Last verified: May 2012
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 (Participant)
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 ]

    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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01612663

Contact: Hadas Lemberg, PhD 00 972 2 6777572

Hadassah Medical Organization Not yet recruiting
Jerusalem, Please select, Israel, 91120
Contact: Hadas Lemberg, PHD    972 507874098   
Contact: Elyad Davidson, MD    972 507874098   
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
Principal Investigator: Elyad Davidson, MD Hadassah Medical Organization
  More Information

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

Keywords provided by Hadassah Medical Organization:
Knee pain
Sham acupuncture

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries processed this record on May 23, 2017