NCT07197710

Brief Summary

The goal of this clinical trial is to evaluate whether imagined acupuncture can reduce postoperative acute pain in adult patients undergoing spinal surgery. The main questions it aims to answer are: Does video-guided imagined acupuncture improve postoperative pain control? Does the intervention reduce opioid consumption and improve functional recovery in the immediate postoperative period? Researchers will compare the imagined acupuncture group to the control education video group to see if imagery-based intervention leads to better pain outcomes and reduced analgesic use. Participants will: Watch a 30-minute video once daily for 7 consecutive days after surgery Complete pain and function assessments during the hospital stay and postoperative follow-up

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Oct 2025Sep 2026

First Submitted

Initial submission to the registry

September 25, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2026

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

September 25, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

Postoperative Acute PainImagined Acupuncture

Outcome Measures

Primary Outcomes (3)

  • Pain Scores (VAS)

    Pain intensity will be assessed using the Visual Analog Scale (VAS) daily, including VAS at rest, VAS on movement

    During the first postoperative week (Days 0-6)

  • 2) Functional Scores (ODI)

    Functional status will be evaluated using the Oswestry Disability Index (ODI)

    On postoperative Day6

  • 3) Rescue Opioid Consumption

    The total amount of rescue opioid medication used during the first postoperative week will be recorded in milligrams (oral and intravenous)

    On postoperative Day6

Secondary Outcomes (5)

  • 1) Time to First Rescue Analgesia

    On postoperative Day6

  • 2) Total Analgesic Consumption

    On postoperative Day6

  • 3) Length of Hospital Stay

    On postoperative Day6

  • 4) Adverse Effects

    On postoperative Day6

  • 5) Additional Assessment Tools

    On postoperative Day6

Study Arms (2)

Group 1: Imagined Acupuncture Intervention

EXPERIMENTAL

Participants assigned to Group 1 will receive standard postoperative care and a daily VGAIT session once per day for seven consecutive days following surgery. Each session will last approximately 30 minutes and will be guided by a standardized video designed to induce acupuncture imagery and mental engagement. VGAIT will be administered at the same time each day (e.g., 9:00 AM ± 30 minutes). VAS and ODI assessments will be administered following the completion of the video session. The initial video session will be administered once the patient has fully regained consciousness in the post-anesthesia care unit (PACU) following surgery.

Other: video-guided acupuncture imagery treatment (VGAIT)

Group 2: Education video

SHAM COMPARATOR

Participants in the control group will receive standard postoperative care and Education video without any simulated acupuncture intervention. VAS and ODI assessments will be conducted at the same intervals as in Group 1 for consistency and comparison.

Other: Education video

Interventions

Unlike traditional acupuncture, VGAIT can be self-administered and does not require physical needle insertion, making it a practical alternative for patients seeking non-invasive pain management.

Group 1: Imagined Acupuncture Intervention

Education video about postoperative precautions

Group 2: Education video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing 1- to 2-level primary spine surgery
  • Aged 18 years or older
  • Willing and able to receive postoperative imagined acupuncture (VGAIT)
  • Able to provide written informed consent

You may not qualify if:

  • Undergoing revision surgery or procedures involving more than 3 spinal levels
  • History of prior spinal surgery
  • Intraoperative complications likely to interfere with postoperative pain assessment
  • Diagnosed with severe cognitive impairment or psychiatric disorders that impair participation or communication
  • Pregnant or breastfeeding
  • Unable to cooperate with treatment or pain assessments Individuals with uncorrectable vision impairment that would interfere with viewing study videos or completing study questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Kong J, Eshel MN. Applying the Power of the Mind in Acupuncture Treatment of Pain. Med Acupunct. 2020 Dec 1;32(6):367-372. doi: 10.1089/acu.2020.1477. Epub 2020 Dec 16.

    PMID: 33362889BACKGROUND
  • Kong J, Kaptchuk TJ, Polich G, Kirsch I, Vangel M, Zyloney C, Rosen B, Gollub RL. An fMRI study on the interaction and dissociation between expectation of pain relief and acupuncture treatment. Neuroimage. 2009 Sep;47(3):1066-76. doi: 10.1016/j.neuroimage.2009.05.087. Epub 2009 Jun 6.

    PMID: 19501656BACKGROUND
  • Cao J, Tu Y, Orr SP, Wilson G, Kong J. Modulatory Effects of Actual and Imagined Acupuncture on the Functional Connectivity of the Periaqueductal Gray and Ventral Tegmental Area. Psychosom Med. 2021 Oct 1;83(8):870-879. doi: 10.1097/PSY.0000000000000984.

    PMID: 34292206BACKGROUND
  • Cao J, Tu Y, Orr SP, Lang C, Park J, Vangel M, Chen L, Gollub R, Kong J. Analgesic Effects Evoked by Real and Imagined Acupuncture: A Neuroimaging Study. Cereb Cortex. 2019 Jul 22;29(8):3220-3231. doi: 10.1093/cercor/bhy190.

    PMID: 30137262BACKGROUND
  • Cao J, Tu Y, Wilson G, Orr SP, Kong J. Characterizing the analgesic effects of real and imagined acupuncture using functional and structure MRI. Neuroimage. 2020 Nov 1;221:117176. doi: 10.1016/j.neuroimage.2020.117176. Epub 2020 Jul 17.

    PMID: 32682992BACKGROUND
  • Kong Q, Sacca V, Walker K, Hodges S, Kong J. Thalamocortical Mechanisms Underlying Real and Imagined Acupuncture. Biomedicines. 2023 Jun 26;11(7):1830. doi: 10.3390/biomedicines11071830.

    PMID: 37509469BACKGROUND
  • Cao J, Orr SP, Wilson G, Kong J. Imagined and Actual Acupuncture Effects on Chronic Low Back Pain: A Preliminary Study. Neural Plast. 2020 Jul 1;2020:8579743. doi: 10.1155/2020/8579743. eCollection 2020.

    PMID: 32684925BACKGROUND

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor Staff Anesthesiologist & Pain Physician

Study Record Dates

First Submitted

September 25, 2025

First Posted

September 29, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

September 19, 2026

Study Completion (Estimated)

September 19, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to concerns about patient privacy and the sensitive nature of the data collected, including postoperative pain scores and behavioral intervention responses.