ACUPUNCTURE FOR THE POSTOPERATIVE RECOVERY OF HIP FRACTURE PATIENTS: A PILOT RANDOMIZED CONTROLLED TRIAL

Summary

Hip surgery is a common and safe medical intervention to restore the functionality and mobility of the hip joint in patients suffering from hip fractures. Despite the advances in surgical techniques, a relatively large proportion of patients suffer from postoperative pain, joint dysfunction and loss of muscle strength. These outcomes hinder rehabilitation, which consequently imposes significant economic burden for health systems.

This study aims to assess if the addition of acupuncture to existing postoperative management will improve the following patient outcomes post hip surgery:

1. Postoperative pain
2. Function (muscular strength and mobility)

Methods Patients who underwent hip surgery due to unilateral hip fracture, who fulfill the inclusion and exclusion criteria, will be randomly allocated to either receive postoperative management ONLY (Conventional analgesics and physiotherapy) or with the addition of acupuncture post hip surgery.

In additional to standard care, acupuncture will be performed on patients in Group A twice a week from post-operative week (POW) 5 to 8, a total of 8 acupuncture treatments will be administered. From the 2nd to 8th treatment, electroacupuncture and infrared therapeutic lamp will be used. Group B will receive only standard post-operative management.

For patients in both Group A and B, primary outcomes will be assessed at the following time points: Post- Operative Week (POW) 0, 6, Post-Operative Month (POM) 6 and 12, while the secondary outcomes will be assessed at the following time points: POW 6, POM 6 and 12. The Primary Outcomes include:1. Modified Harris Hip Score 2. Visual Analogue Scale (VAS-100). The Secondary Outcomes include: 1. Timed Up and Go (TUG) assessment. The TUG assessment will be performed thrice during each assessment and an average time will be taken. 2. Lower extremity muscle strength measured using a portable dynamometer. The subject's operated and non-operated side will be measured.

Hypothesis The addition of acupuncture to existing postoperative management will reduce pain and enhance functional recovery, better and faster than with postoperative management alone.

Conditions

• Hip Fracture Surgeries
• Post-operative Hip Fractures Recovery

Interventions

PROCEDURE

Acupuncture

Both groups A and B will undergo standard postoperative management program. This includes conventional analgesia and physiotherapy POD 1, 2 and 3, followed by 5x/week until discharge, post-discharge, patients will continue physiotherapy 1-2x/ week for 3 months depending on their rate of recovery. In addition, acupuncture treatment will be delivered for the treatment group. Acupuncture will be performed 2x/week from postoperative week (POW) 5 to POW 8, a total of 8 acupuncture treatments will be administered. From the 2nd to 8th treatment, electroacupuncture and infrared therapeutic lamp will be used. The acupuncture needles to be used for this study are Kinhong/MAC sterile acupuncture needles for single use. The needles will be left in situ for 20 minutes. Electrical stimulation will be delivered at 2Hz for 20 min, at an intensity below individual patient's pain threshold. 4 acupuncture points will be stimulated in pairs.

OTHER

Post-operative standard care

Standard postoperative management program includes: conventional analgesia and physiotherapy POD 1, 2 and 3, followed by 5x/week until discharge. Post-discharge, patients will continue physiotherapy 1-2x/ week for 3 months depending on their rate of recovery. No acupuncture given

Sponsors & Collaborators

• Ministry of Health, Singapore

  collaborator OTHER_GOV

• Khoo Teck Puat Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-21

Primary Completion

2025-09-15

Completion

2025-11-14

Countries

• Singapore

Study Locations