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

NCT06380439 | Completed

• 1 other identifier: 23-10-1763
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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

Conditions

Pain, Postoperative; Hip Osteoarthritis; Hip Fractures; Hip Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• recovery rate

  monitored since day 1 after surgery up to 4 days

Study Arms (2)

wrist ankle acupuncture

EXPERIMENTAL

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

Procedure: wrist ankle acupuncture

sham wrist ankle acupuncture

SHAM COMPARATOR

0.25 x 25mm filiform needle pricked and placed on the surface of the skin on lower 1, lower 4, lower 5 area ipsilateral to the surgical side, covered with 5cm long micropore, retention for 4 hours

Procedure: wrist ankle acupuncture

Interventions

wrist ankle acupuncture PROCEDURE

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

sham wrist ankle acupuncture; wrist ankle acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (3)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Fatmawati Hospital

Jakarta, 12430, Indonesia

Location

Persahabatan Hospital

Jakarta, 13230, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis, Hip; Hip Fractures; Hip Injuries

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• KEPK FKUI-RSCM

  The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctore

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 23, 2024
• Study Start: April 23, 2024
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)