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Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)

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ClinicalTrials.gov Identifier: NCT01094782
Recruitment Status : Active, not recruiting
First Posted : March 29, 2010
Results First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to explore a new approach in assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions.

Condition or disease Intervention/treatment Phase
Pain Other: Acupuncture Other: Sham Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluating the Effect of Acupuncture on Pain Relief Using QST
Study Start Date : January 2010
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Active Comparator: 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).
Other: Acupuncture
Subjects receive 6 acupuncture treatments for neck or back pain.

Sham Comparator: 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).
Other: Sham Acupuncture
Subjects receive 6 sham acupuncture treatments for neck or back pain.

No Intervention: 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.
Active Comparator: 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).
Other: Acupuncture
Subjects receive 6 acupuncture treatments for neck or back pain.

Sham Comparator: 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).
Other: Sham Acupuncture
Subjects receive 6 sham acupuncture treatments for neck or back pain.

No Intervention: 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.



Primary Outcome Measures :
  1. Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants [ Time Frame: Start of Week 1 ]
    Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.

  2. Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants [ Time Frame: End of Week 2 ]
    Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.

  3. Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants [ Time Frame: End of Week 4 ]
    Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.

  4. Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants [ Time Frame: Start of Week 1 ]
    Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.

  5. Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants [ Time Frame: End of Week 2 ]
    Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.

  6. Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants [ Time Frame: End of Week 4 ]
    Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject will be between ages 18 to 65 years. Both male and female subjects will be recruited.
  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:

  1. Subject has detectable sensory deficits at the site of QST. Sensory deficits refer to such conditions resulting from neurological diseases or medical conditions causing peripheral polyneuropathy and sensory changes, which include but are not limited to diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, severe thyroid disease, and severe liver or kidney disorders.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094782


Locations
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United States, Massachusetts
MGH Center for Translational Pain Research
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Lucy Chen, MD Massachusetts General Hospital

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Responsible Party: Jianren Mao, MD, PhD, Director, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01094782     History of Changes
Other Study ID Numbers: 2009P 0001551
R01AT005819 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2010    Key Record Dates
Results First Posted: July 2, 2018
Last Update Posted: July 2, 2018
Last Verified: May 2018

Keywords provided by Jianren Mao, MD, PhD, Massachusetts General Hospital:
Pain
Pain management