Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

Complete Tear, Knee, Anterior Cruciate Ligament Clinical Trial

Official title:

Comparison of Different Acupuncture Methods on Knee Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612663
• Other study ID #: 007212-HNO-CTIL
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: June 1, 2015

Study information

• Verified date: March 2022
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 1, 2015
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complete Tear, Knee, Anterior Cruciate Ligament
• Patellar Tendonitis
• Tendinopathy

Intervention

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

• Acupuncture needle

• Acupuncture needle

• Acupuncture needle

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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