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Completed

NCT Number: NCT01094782

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

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

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MGH Center for Translational Pain Research

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject will be between ages 18 to 65 years. Both male and female subjects will be recruited.
  • 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.
  • Subject has a pain score of 4 or above (Visual Analog Scale (VAS): 0 - 10 from no pain to worst pain).
  • Cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome.
  • For controls, healthy subjects without radicular pain for at least three months will be recruited. *We are no longer accepting healthy volunteers.*

Exclusion criteria

  • 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.
  • Subject has scar tissue, infection, or acute injury at the site of QST.
  • Subject is on anticoagulation therapy.
  • Subject is pregnant.
  • Subject is tested positive on illicit drugs.

Treatment and study plan

Acupuncture

Other

Subjects receive 6 acupuncture treatments for neck or back pain.

Sham Acupuncture

Other

Subjects receive 6 sham acupuncture treatments for neck or back pain.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Evaluating the Effect of Acupuncture on Pain Relief Using QST

Important dates

Study start
2010
Primary completion
2016
Study completion
2021
First posted
Mar 29, 2010
Registry last updated
May 2, 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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