Effect of Distal Needling on Knee Pain Using Acupuncture... | NCT01612663

Studies
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

NCT01612663

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Mar 22, 2022Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Patellar Tendonitis
Complete Tear, Knee, Anterior Cruciate Ligament

Interventions

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

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 1, 2014Actual

Completion Date

Jun 1, 2015Actual

First Submitted Date

Jun 3, 2012

First Submission Date that Met QC Criteria

Jun 5, 2012

First Posted Date

Jun 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2022

Last Update Posted Date

Mar 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pain relief by Acupuncture needle at non-specific site	Device		deep needle non-site specific
Acupuncture needle

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elyad Davidson, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem	Please Select	91120	Israel