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

NCT ID: NCT01094782

Last Updated: 2022-05-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2021-12-01

Brief Summary

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

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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).

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

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).

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

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).

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

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).

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

Subjects receive 6 acupuncture treatments for neck or back pain.

Intervention Type OTHER

Sham Acupuncture

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jianren Mao, MD, PhD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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R01AT005819

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009P 0001551

Identifier Type: -

Identifier Source: org_study_id

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