Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

NCT ID: NCT01612663

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-06-01

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.

Conditions

Patellar Tendonitis; Complete Tear, Knee, Anterior Cruciate Ligament

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

deep needle non-site specific

Group Type: ACTIVE_COMPARATOR

Pain relief by Acupuncture needle at non-specific site

Intervention Type: DEVICE

contralateral elbow to the knee pain

Group Type: ACTIVE_COMPARATOR

Acupuncture needle

Intervention Type: DEVICE

Energy of Living Systems Needling

Group Type: ACTIVE_COMPARATOR

Acupuncture needle

Intervention Type: DEVICE

Sham acupuncture

Group Type: PLACEBO_COMPARATOR

Acupuncture needle

Intervention Type: DEVICE

Interventions

Pain relief by Acupuncture needle at non-specific site

Intervention Type: DEVICE

Acupuncture needle

Intervention Type: DEVICE

Acupuncture needle

Intervention Type: DEVICE

Acupuncture needle

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Elyad Davidson

PI Head Pain Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elyad Davidson, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, Please Select, Israel

Countries

Israel

Other Identifiers

007212-HNO-CTIL

Identifier Type: -

Identifier Source: org_study_id