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

K

Khoo Teck Puat Hospital

Status

Active, not recruiting

Conditions

Hip Fracture Surgeries
Post-operative Hip Fractures Recovery

Treatments

Other: Post-operative standard care
Procedure: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT07178756
2019/01168

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

40 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who undergone surgery due to unilateral hip fracture. Patients aged 40-99 (male), 55-99 (female). Ambulatory with or without aid prior to hip fracture. Able provide consent for the study and acupuncture treatment. Able to attend all treatment sessions

Exclusion criteria

Patients with morbid obesity (Body Mass Index >40) . Patients with communication barriers such as aphasia or language . Local or systemic infection or dermatological disease affecting sites of acupuncture. Existing treatment with anti-neoplastic, oral corticoid or immunosuppressive drugs. Needle phobia or inability to stay still for 30 min during acupuncture retention . History of psychiatric disease, kidney failure on peritoneal dialysis, substance abuse . If there exist any postoperative complications that deviate from standard management, resulting in interference of patient's clinical evaluation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 2 patient groups

Acupuncture Group (Group A)
Experimental group
Description:
In addition to standard postoperative management program, acupuncture treatment will be added
Treatment:
Procedure: Acupuncture
Control Group (Group B)
Other group
Description:
Only receive standard postoperative management which includes: conventional analgesia and physiotherapy. No acupuncture given
Treatment:
Other: Post-operative standard care

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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