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

Mass General Brigham

Status: Completed

Conditions: Pain

Treatments: Other: Sham Acupuncture; Other: Acupuncture

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01094782

R01AT005819 (U.S. NIH Grant/Contract)

2009P 0001551

Details and patient eligibility

About

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

Enrollment: 254 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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254 participants in 6 patient groups

Healthy - True Acupuncture

Active Comparator group

Description:

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).

Treatment:

Other: Acupuncture

Healthy - Sham Acupuncture

Sham Comparator group

Description:

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).

Treatment:

Other: Sham Acupuncture

Healthy - No Treatment

No Intervention group

Description:

Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.

Pain - True Acupuncture

Active Comparator group

Description:

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).

Treatment:

Other: Acupuncture

Pain - Sham Acupuncture

Sham Comparator group

Description:

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).

Treatment:

Other: Sham Acupuncture

Pain - No Treatment

No Intervention group

Description:

Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment.