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A randomized, double-blind, sham-controlled clinical study on the treatment of postoperative pain after total hip arthroplasty with fire needle therapy

A randomized, double-blind, sham-controlled clinical study on the treatment of postoperative pain after total hip arthroplasty with fire needle therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001287
Enrollment
Unknown
Registered
2026-05-26
Start date
2025-01-13
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

After hip replacement surgery

Interventions

Fire needle group:Treatment on the 1st, 2nd and 3rd days after surgery. Acupoints selected: 1) The Ah-Shi points on the outer side of the thigh on the surgical side (2-3 points, 15 cm away from the su
2) The Zhanzhui, Yanglingquan and Zusanli points on the affected side (ST36) (Selection of acupoints: TENS stimulation of these points can reduce the need for opioids ). Procedure: Select the acupoint
The false fire needle group:The acupuncture points selected and the treatment time were the same as those in the fire needle group. Special retractable blunt-tipped imitation fire needles were used. W
it merely mimicked the heating action beside an alcohol lamp.

Sponsors

Wuhan Hankou Hospital, Wuhan City, Hubei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age between 50 and 80 years old ; (2) Planning to undergo the first unilateral total hip arthroplasty (THA), and the surgical approach is direct anterior approach (DAA); (3) Undergoing general anesthesia or intraspinal anesthesia; (4) American Society of Anesthesiologists (ASA) classification is grade I, II, or III; (5) Complicated with diabetes, and the blood sugar control was stable before enrollment (glycated hemoglobin HbA1c = 8.0%); (6) At 2 hours after surgery, moderate or higher pain occurred at rest (visual analogue score = 4 points); (7) Clear consciousness, normal awareness, and able to communicate effectively with researchers; (8) Voluntarily participate in this study and sign the written informed consent form; (9) Good compliance, willing and able to cooperate with all intervention treatments and follow-up evaluations.

Exclusion criteria

Exclusion criteria: (1) Patients with diabetes whose blood sugar levels are poorly controlled and who have severe complications; (2) Patients with skin damage, infection, or ulcers in the surgical area; (3) Patients with a bleeding tendency or abnormal coagulation function (defined as: international normalized ratio > 1.5 during screening, or platelet count <eighty times ten to the ninth power/L, or inability to discontinue anticoagulant/antiplatelet drugs as per routine before surgery); (4) Patients with other chronic pain histories other than hip joint pain (such as severe lumbar disc herniation, severe arthritis, etc.) before surgery, and those who have been using analgesics regularly within 1 month before surgery which may interfere with postoperative pain assessment; (5) Patients with a history of opioid use within 3 months before surgery, or those with known drug abuse history; (6) Patients with severe cardiovascular or cerebrovascular diseases, as determined by the investigators, who are not suitable to participate in this study; (7) Patients with schizophrenia, severe depression, dementia or other mental or cognitive impairments.

Design outcomes

Primary

MeasureTime frame
The visual analogue scale (VAS) for both resting and movement pain was evaluated before the operation;equivalent morphine consumption;Detect the levels of serum?Inter leukin-1ß?(IL-1ß), ?Interleukin-6(IL-6), tumor necrosis factor (TNF-a), C-reactive protein (CRP), and substance P.;

Secondary

MeasureTime frame
Harris Hip Function score;Life quality score.;Pain-related side effects.;Safety of Fire Needling Treatment.;Patient satisfaction and blind assessment;

Countries

China

Contacts

Public ContactCongjun Wang

Wuhan Hankou Hospital, Wuhan City, Hubei Province

403023727@qq.com+8615926315432

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026