Acupuncture Imagery for Low Back Pain

Overseen By Georgia Wilson, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cancer, Fractures, Infections, others

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

In this study, the investigators will examine the analgesic effects of acupuncture imagery treatment in patients with chronic low back pain. The intervention used in this study is "video-guided acupuncture imagery treatment" (VGAIT) treatment. The control used in this study is sham (fake) VGAIT. Participants in each group will participate in 8 study sessions (including 6 treatment sessions) over the course of 6 weeks. The primary outcome measure for this study is change in low back pain severity score after each treatment session.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with chronic low back pain lasting more than 6 months, rated at least 4/10 in intensity. Participants must have had their condition evaluated by a healthcare provider and be able to understand English well. Excluded are those with specific causes of back pain like cancer or fractures, intent to undergo surgery soon, unresolved legal claims related to back pain, active substance abuse within the last two years, prior complicated back issues including surgery, contraindications for acupuncture such as pregnancy or coagulation disorders.

Inclusion Criteria

At least 4/10 clinical pain on the 11-point low back pain intensity scale.

Must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. Documentation of this evaluation will be sought from Partners or outside medical records and kept in the subject's research record.

At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria

Specific causes of back pain (e.g. cancer, fractures, infections),

The intent to undergo surgery during the time of involvement in the study.

Unresolved medical legal/disability/workers compensation claims in connection with low back pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo initial assessment to establish baseline measures

1 week

1 visit (in-person)

Treatment

Participants receive 6 treatment sessions of either verum or sham VGAIT over 6 weeks

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for changes in low back pain severity and other outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham VGAIT
• Verum VGAIT

Trial Overview The study tests 'video-guided acupuncture imagery treatment' (VGAIT) against sham VGAIT for relieving chronic low back pain. Over six weeks, participants will attend eight sessions which include six treatments. The main goal is to see if there's a change in the severity of low back pain after each session using VGAIT compared to fake treatments.

How Is the Trial Designed?

Group I: Verum VGAIT Group Experimental Treatment 1 Intervention

Participants in this group will receive verum (real) acupuncture and verum video-guided acupuncture imagery treatment (VGAIT).

Group II: Sham VGAIT Group Placebo Group 1 Intervention

Participants in this group will receive sham acupuncture and sham VGAIT.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+