Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Pain

NCT ID: NCT03046030

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2021-06-30

Brief Summary

The aim of this proposal is to investigate brain response and connectivity changes evoked by video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in healthy and patient populations to elucidate the underlying brain mechanisms of mind-body interaction, imagery, and acupuncture.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy Volunteers

In this experiment, we will apply a crossover design in healthy subjects. Each subject will receive four treatments in four separate sessions: 1) VGAIT, 2) VGAIT control condition, 3) real acupuncture, and 4) sham acupuncture. Each session will be separated by at least 7 days. Subjects will participate in five experimental sessions: a training and familiarity behavioral session and four fMRI sessions during which the subject will receive one of the four treatments.

Group Type: EXPERIMENTAL

Real acupuncture

Intervention Type: OTHER

Verum acupuncture will be applied on the right SP6 and SP9. For each subject, leg position, acupoint location, and needling parameters (1-2 cm depth, 120 rotations / minute, 90˚ insertion angle, moderate deqi sensations on a 0-10 scale) will be kept constant. For the low dose acupuncture group, needles will be rotated at one point and then the other in 15-second rotations with 20-30 second breaks. The specific starting acupoint will be randomized across subjects but kept consistent for each subject across sessions.

Sham acupuncture

Intervention Type: OTHER

Placebo acupuncture will be applied at two sham points using specially designed sham acupuncture needles \[20, 35, 104-106\]. The sham needles differ from regular needles by possessing blunt and retractable tips. Instead of penetrating the skin, the point of the Streitberger needle retracts up the handle shaft when the acupuncturist presses it against the skin. This sham device has been validated by studies showing that subjects cannot distinguish between genuine and sham needling \[20, 35, 104\]. Two sham points will be used during placebo acupuncture: sham point 1 is located 1 cun posterior to the superior 1/3 of K9 and K10. Sham 2 is located 1 cun posterior to K8. Both points are located on the leg where there is no meridian passing through. Sham acupuncture treatment will be the same as verum acupuncture.

VGAIT

Intervention Type: OTHER

In Session 1, all patients will first be introduced to acupuncture treatment, particularly the sensation evoked by acupuncture needles. This will be followed by a five-minute acupuncture exposure applied by a licensed acupuncturist. The exposure will include multiple acupuncture needle manipulations across the two acupoints (SP 6 and SP 9) used in this study. The paradigm applied will be identical to real acupuncture treatment, and the procedure will also be video recorded for the following session. At the beginning of the VGAIT session, patients will be trained for imagery acupuncture outside the fMRI scan. Subjects will first read a script introducing the imagery acupuncture treatment. Then, VGAIT will be applied during scanning. Identical to the acupuncture treatment, there are two fMRI scans during VGAIT, each lasting about 10 minutes. We will ask the patient to measure the sensations they feel during treatment using the MGH Acupuncture Sensation Scale (MASS) after treatment.

VGAIT control

Intervention Type: OTHER

The control condition will be the same as VGAIT, except we will use cotton swabs repeatedly touching at non-acupoints with a frequency of about 1 Hz using the same paradigm of verum / sham acupuncture. They will also read a script describing what they are about to see. Then, VGAIT control will be applied during scanning. We will ask the patient to measure the sensations they feel during treatment using the MASS after treatment.

Interventions

Real acupuncture

Verum acupuncture will be applied on the right SP6 and SP9. For each subject, leg position, acupoint location, and needling parameters (1-2 cm depth, 120 rotations / minute, 90˚ insertion angle, moderate deqi sensations on a 0-10 scale) will be kept constant. For the low dose acupuncture group, needles will be rotated at one point and then the other in 15-second rotations with 20-30 second breaks. The specific starting acupoint will be randomized across subjects but kept consistent for each subject across sessions.

Intervention Type: OTHER

Sham acupuncture

Placebo acupuncture will be applied at two sham points using specially designed sham acupuncture needles \[20, 35, 104-106\]. The sham needles differ from regular needles by possessing blunt and retractable tips. Instead of penetrating the skin, the point of the Streitberger needle retracts up the handle shaft when the acupuncturist presses it against the skin. This sham device has been validated by studies showing that subjects cannot distinguish between genuine and sham needling \[20, 35, 104\]. Two sham points will be used during placebo acupuncture: sham point 1 is located 1 cun posterior to the superior 1/3 of K9 and K10. Sham 2 is located 1 cun posterior to K8. Both points are located on the leg where there is no meridian passing through. Sham acupuncture treatment will be the same as verum acupuncture.

Intervention Type: OTHER

VGAIT

In Session 1, all patients will first be introduced to acupuncture treatment, particularly the sensation evoked by acupuncture needles. This will be followed by a five-minute acupuncture exposure applied by a licensed acupuncturist. The exposure will include multiple acupuncture needle manipulations across the two acupoints (SP 6 and SP 9) used in this study. The paradigm applied will be identical to real acupuncture treatment, and the procedure will also be video recorded for the following session. At the beginning of the VGAIT session, patients will be trained for imagery acupuncture outside the fMRI scan. Subjects will first read a script introducing the imagery acupuncture treatment. Then, VGAIT will be applied during scanning. Identical to the acupuncture treatment, there are two fMRI scans during VGAIT, each lasting about 10 minutes. We will ask the patient to measure the sensations they feel during treatment using the MGH Acupuncture Sensation Scale (MASS) after treatment.

Intervention Type: OTHER

VGAIT control

The control condition will be the same as VGAIT, except we will use cotton swabs repeatedly touching at non-acupoints with a frequency of about 1 Hz using the same paradigm of verum / sham acupuncture. They will also read a script describing what they are about to see. Then, VGAIT control will be applied during scanning. We will ask the patient to measure the sensations they feel during treatment using the MASS after treatment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Right handed healthy male and female adults aged 18-60
• No contraindications to fMRI scanning

Exclusion Criteria

• Current or past history of major medical, neurological, or psychiatric illness
• Any pain disorder
• Pregnancy
• Non-fluent speaker of English

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jian Kong

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jian Kong

Role: CONTACT

jkong2@mgh.harvard.edu

617-726-7893

Facility Contacts

Jian Kong, MS, MPH

Role: primary

jkong2@mgh.harvard.edu

617-726-7893

Other Identifiers

2016P001293

Identifier Type: -

Identifier Source: org_study_id