Clinical trial NCT06380439: The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain
Official title: The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Hip Osteoarthritis
Hip Fractures
Hip Injuries
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total hip arthroplasty is one of the most cost-effective orthopedic surgical procedures which can restore hip function and improve the patient's quality of life. However, total hip arthroplasty is significantly associated with postoperative pain. Pain after total hip arthroplasty surgery can adversely affect the patient's early postoperative recovery, postoperative mobility, and hinder rehabilitation.

Wrist ankle acupuncture (WAA) is a simpler acupuncture technique, using fewer points, shallow needle insertion and lighter stimulation. Wrist-ankle acupuncture as multimodal analgesia after orthopedic surgery is useful for reducing pain and reduce the incidence of post-surgical side effects. The primary aim of this study is to investigate whether wrist ankle acupuncture therapy gives better and results for post total hip arthroplasty pain than sham wrist ankle acupuncture

Detailed description: This is a clinical trial study to evaluate and compare the effects of wrist ankle acupuncture and sham wrist ankle acupuncture as a therapy for post total hip arthroplasty pain. The subjects are 32 males/female who just undergone total hip arthroplasty surgery and has returned to inpatient ward. They will be randomly assigned to 2 groups: (1) wrist ankle acupuncture and (2) Sham wrist ankle acupuncture. The subjects will receive two sessions of treatment. The outcome will be assessed before treatment (baseline), after fist acupuncture session, after second acupuncture session and a day after the second session. Patients and the outcome assessors will be blinded to the group allocation.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing elective primary total hip arthroplasty surgery at dr. Cipto Mangunkusumo Hospital, Persahabatan Hospital, andFatmawati Hospital
2. Aged over 18 years
3. Willing to sign informed consent

Exclusion Criteria:

1. Have a history of malignancy
2. Revision total hip arthroplasty patient
3. Post-total hip surgery patient treated in ICU.
4. The patient has a mental disorder so he cannot understand the explanation given

Primary outcomes:
measure: Visual Analog Scale
timeFrame: after the surgery when the patient has returned to the inpatient ward (before the 1st acupuncture session), 4 hours since the 1st measure (after 1st acupuncture session), one day after the 1st measure (after 2nd acupuncture), 2 days after 1st measure
Secondary outcomes:
measure: recovery rate
timeFrame: monitored since day 1 after surgery up to 4 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Jakarta
city: Jakarta
country: Indonesia
facility: Fatmawati Hospital
city: Jakarta
country: Indonesia
facility: Persahabatan Hospital
Study officials:
affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM
name: KEPK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: