Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)
NCT ID: NCT01094782
Last Updated: 2022-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
254 participants
INTERVENTIONAL
2010-01-31
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
DIAGNOSTIC
TRIPLE
Study Groups
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Healthy - True Acupuncture
Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.This group received true acupuncture treatment (the needles punctured the skin).
Acupuncture
Subjects receive 6 acupuncture treatments for neck or back pain.
Healthy - Sham Acupuncture
Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin).
Sham Acupuncture
Subjects receive 6 sham acupuncture treatments for neck or back pain.
Healthy - No Treatment
Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
No interventions assigned to this group
Pain - True Acupuncture
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin).
Acupuncture
Subjects receive 6 acupuncture treatments for neck or back pain.
Pain - Sham Acupuncture
Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin).
Sham Acupuncture
Subjects receive 6 sham acupuncture treatments for neck or back pain.
Pain - No Treatment
Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.
No interventions assigned to this group
Interventions
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Acupuncture
Subjects receive 6 acupuncture treatments for neck or back pain.
Sham Acupuncture
Subjects receive 6 sham acupuncture treatments for neck or back pain.
Eligibility Criteria
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Inclusion Criteria
2. Subject should have had cervical or lumbar radicular pain for at least two months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
3. Subject has a pain score of 4 or above (Visual Analog Scale (VAS): 0 - 10 from no pain to worst pain).
4. Cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome.
5. For controls, healthy subjects without radicular pain for at least three months will be recruited. \*We are no longer accepting healthy volunteers.\*
Exclusion Criteria
2. Subject has scar tissue, infection, or acute injury at the site of QST.
3. Subject is on anticoagulation therapy.
4. Subject is pregnant.
5. Subject is tested positive on illicit drugs.
18 Years
65 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Jianren Mao, MD, PhD
Director
Principal Investigators
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Lucy Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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MGH Center for Translational Pain Research
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2009P 0001551
Identifier Type: -
Identifier Source: org_study_id
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