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

Pain Clinical Trial

Official title:

Evaluating the Effect of Acupuncture on Pain Relief Using QST

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094782
• Other study ID #: 2009P 0001551
• Secondary ID: R01AT005819
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: December 1, 2021
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	MGH Center for Translational Pain Research	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants	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.	Start of Week 1
Primary	Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants	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.	End of Week 2
Primary	Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants	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.	End of Week 4
Primary	Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants	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.	Start of Week 1
Primary	Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants	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.	End of Week 2
Primary	Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants	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.	End of Week 4