Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

Not Applicable

Completed

• Conditions: Complete Tear, Knee, Anterior Cruciate Ligament; Patellar Tendonitis
• Interventions: Device: Acupuncture needle; Device: Pain relief by Acupuncture needle at non-specific site

• Registration Number: NCT01612663
• Lead Sponsor: Hadassah Medical Organization

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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-03
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-06
• Primary Completion: 2014-06-01
• Study Completion: 2015-06-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-20
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Energy of Living Systems Needling	Acupuncture needle	-
deep needle non-site specific	Pain relief by Acupuncture needle at non-specific site	-
contralateral elbow to the knee pain	Acupuncture needle	-
Sham acupuncture	Acupuncture needle	-

Primary Outcome Measures

Name	Time	Method
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques	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)

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Please Select, Israel