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Preliminary study on analgesic and sedative effects of percutaneous acupoint electrical stimulation in vertebroplasty in OVCF patients

Preliminary study on analgesic and sedative effects of percutaneous acupoint electrical stimulation in vertebroplasty in OVCF patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006455
Enrollment
Unknown
Registered
2022-08-08
Start date
2022-08-08
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoporotic vertebral compression fracture

Interventions

Control group 2:Sham percutaneous acupoint electrical stimulation was performed 30 minutes before operation until the end of operation. Midazolam 1mg and sufentanil citrate 5 minutes before operation
Control group 1:Sham percutaneous acupoint electrical stimulation was performed 30 minutes before operation until the end of operation. Midazolam 1mg was given intravenously 10 minutes before operatio
Experimental group:Transcutaneous acupoint electrical stimulation was performed 30 minutes before the operation until the end of the operation. Midazolam 1mg was given intravenously 10 minutes before

Sponsors

Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of OVCF and t9-l5 single segment percutaneous vertebroplasty; (2) Age 60 to 80 years old; (3) ASA class I-II; (4)18kg/m 2 < BMI < 30kg/m 2 (5)Voluntarily participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Taking sedative and analgesic drugs, or taking drugs or drinking alcohol within 48 hours before operation; (2) Communication disorders, including language disorders, previous nervous system diseases and mental disorders; (3) Those who have contraindications to transcutaneous electrical stimulation, including those who stimulate local skin damage or infection, have implants in the body Sexual electrophysiological device; (4) Allergic to narcotic drugs; (5) Severe heart, liver, kidney and other organ dysfunction, blood system and autoimmune diseases, acute and slow sex appeal Infected, malignant tumor or serious mental disease; (6)Unable to cooperate with the researcher to complete this study.

Design outcomes

Primary

MeasureTime frame
Agitation sedation score;Visual analogue scale of anxiety;Systolic blood pressure (SP), diastolic blood pressure (DP), mean arterial pressure (map), heart rate (HR), blood oxygen saturation (SpO2);Subjective satisfaction score; The number of additional drugs during operation;Bispectral index (BIS);Occurrence of adverse events;Anxiety self rating;VAS score of low back pain;

Countries

China

Contacts

Public ContactXu Huiqing
dr_xuhuiqing@sina.com13683395622

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026