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.

Study Overview

• Status: Completed
• Conditions: Complete Tear, Knee, Anterior Cruciate Ligament; Patellar Tendonitis
• Intervention / Treatment: Device: Pain relief by Acupuncture needle at non-specific site; 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Please Select
    • Jerusalem, Please Select, Israel, 91120
      • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Elyad Davidson, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 3, 2012
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (Estimate): June 6, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 20, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture; Knee pain; Sham acupuncture
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: 007212-HNO-CTIL