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Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

Primary Purpose

Patellar Tendonitis, Complete Tear, Knee, Anterior Cruciate Ligament

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pain relief by Acupuncture needle at non-specific site
Acupuncture needle
Acupuncture needle
Acupuncture needle
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Patellar Tendonitis focused on measuring Knee pain, Acupuncture, Sham acupuncture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

deep needle non-site specific

contralateral elbow to the knee pain

Energy of Living Systems Needling

Sham acupuncture

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
June 3, 2012
Last Updated
March 20, 2022
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01612663
Brief Title
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
Official Title
Comparison of Different Acupuncture Methods on Knee Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 1, 2014 (Actual)
Study Completion Date
June 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: First aim to assess the effect of distal needling on knee pain 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: Distal needling - enables assessment of range of motion (ROM) and pain level during needling. Both acupuncture systems rely on minimal questioning, which simplifies the patient-practitioner interactions. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendonitis, Complete Tear, Knee, Anterior Cruciate Ligament
Keywords
Knee pain, Acupuncture, Sham acupuncture

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
deep needle non-site specific
Arm Type
Active Comparator
Arm Title
contralateral elbow to the knee pain
Arm Type
Active Comparator
Arm Title
Energy of Living Systems Needling
Arm Type
Active Comparator
Arm Title
Sham acupuncture
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Pain relief by Acupuncture needle at non-specific site
Intervention Type
Device
Intervention Name(s)
Acupuncture needle
Intervention Type
Device
Intervention Name(s)
Acupuncture needle
Intervention Type
Device
Intervention Name(s)
Acupuncture needle
Primary Outcome Measure Information:
Title
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
Description
Effect of Distal Needling on Knee Pain Using 4 different Acupuncture Techniques by: Pain measurement by Visual Analogue Scale (VAS) Range of motion (ROM)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elyad Davidson, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
State/Province
Please Select
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

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Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

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