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Virtual Reality Guided Acupuncture Imagery Treatment for Chronic Low Back Pain

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Mass General Brigham

Status

Completed

Conditions

Chronic Low-back Pain

Treatments

Other: Virtual reality guided imagery acupuncture treatment (VRGAIT)
Other: Virtual reality guided imagery acupuncture treatment control

Study type

Interventional

Funder types

Other

Identifiers

NCT06814470
2018p002553-1

Details and patient eligibility

About

Testing the effect of Virtual Reality - guided imagery acupuncture

Full description

The aim of this study is to develop a Virtual Reality guided acupuncture imagery treatment system for the treatment of chronic low back pain. This product will provide a new cost-effective treatment option for chronic low back pain and potentially other chronic pain disorders.

Enrollment

31 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Volunteers 18-75 years of age.
  • Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
  • At least 4/10 clinical pain on the 11-point LBP 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),
  • Complicated back problems (e.g. prior back surgery, medico legal issues),
  • Possible contraindications for acupuncture (e.g. coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
  • Conditions making study participation difficult (eg, paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)
  • 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.
  • Lacking the capacity to consent for oneself
  • Do not have access to zoom or other software regularly to complete the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

31 participants in 2 patient groups

Virtual Reality - guided acupuncture imagery treatment (VRGAIT)
Experimental group
Treatment:
Other: Virtual reality guided imagery acupuncture treatment (VRGAIT)
Virtual Reality -guided acupuncture imagery treatment (VRGAIT) Control
Active Comparator group
Treatment:
Other: Virtual reality guided imagery acupuncture treatment control

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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