Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

NCT01612663 | Completed DMC

• 1 other identifier: 007212-HNO-CTIL
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patellar Tendonitis; Complete Tear, Knee, Anterior Cruciate Ligament

Keywords

Knee pain; Acupuncture; Sham acupuncture

Outcome Measures

Primary Outcomes (1)

• Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

  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)

  2 years

Study Arms (4)

deep needle non-site specific

ACTIVE COMPARATOR

Device: Pain relief by Acupuncture needle at non-specific site

contralateral elbow to the knee pain

ACTIVE COMPARATOR

Device: Acupuncture needle

Energy of Living Systems Needling

ACTIVE COMPARATOR

Device: Acupuncture needle

Sham acupuncture

PLACEBO COMPARATOR

Device: Acupuncture needle

Interventions

Pain relief by Acupuncture needle at non-specific site DEVICE

deep needle non-site specific

Acupuncture needle DEVICE

contralateral elbow to the knee pain

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Please Select, 91120, Israel

Location

Study Officials

• Elyad Davidson, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI Head Pain Unit

Study Record Dates

• First Submitted: June 3, 2012
• First Posted: June 6, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

IL (1)