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OpenTrials
Completed

NCT Number: NCT01612663

Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, Please Select, 91120, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain relief by Acupuncture needle at non-specific site

Device

Acupuncture Needle

Device

Primary outcomes

  1. Effect of Distal Needling on Knee Pain Using Acupuncture Techniques

    Time frame: 2 years

    Effect of Distal Needling on Knee Pain Using 4 different Acupuncture Techniques by:

    • Pain measurement by Visual Analogue Scale (VAS)
    • Range of motion (ROM)

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Comparison of Different Acupuncture Methods on Knee Pain

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jun 6, 2012
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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