The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain

Pain, Postoperative Clinical Trial

Official title:

The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06380439
• Other study ID #: 23-10-1763
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2024
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Indonesia University
• Contact: Wijayani Mardiana, Doctor
• Phone: +6281805181366
• Email: wijayani.mardiana[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Fractures
• Hip Injuries
• Hip Osteoarthritis
• Osteoarthritis, Hip
• Pain, Postoperative

Intervention

Procedure:
• wrist ankle acupuncture
wrist ankle acupuncture: wrist ankle acupuncture using 0.25 x 25mm filiform needle on lower 1, lower 4, lower 5 area ipsilateral to the surgical side, then covered with 5cm long micropore, retention for 4 hours

Locations

Country	Name	City	State
Indonesia	Fatmawati Hospital	Jakarta
Indonesia	Persahabatan Hospital	Jakarta
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	Pain rating scale for measuring pain	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	recovery rate	the time when patient starts to learn to walk with assistive device	monitored since day 1 after surgery up to 4 days