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

NCT07178756 | Active Not Recruiting DMC

• 1 other identifier: 2019/01168
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Conditions

Hip Fracture Surgeries; Post-operative Hip Fractures Recovery

Keywords

Acupuncture; Hip fracture surgery; Post hip fracture surgery recovery; Hip fracture

Outcome Measures

Primary Outcomes (2)

• 1. Modified Harris Hip Score

  Assessing pain and function

  postoperative Week (POW) 0, 6, postoperative month (POM) 6 and POM 12

• Visual Analogue Scale (VAS)-100

  For assessing the pain intensity

  postoperative Week (POW) 0, 6, postoperative month (POM) 6 and POM 12

Secondary Outcomes (2)

• Timed get Up and Go (TUG) test

  POW 6, POM 6 and 12

• Lower extremity muscle strength

  POW 6, POM 6 and 12

Study Arms (2)

Acupuncture Group (Group A)

EXPERIMENTAL

In addition to standard postoperative management program, acupuncture treatment will be added

Procedure: Acupuncture

Control Group (Group B)

OTHER

Only receive standard postoperative management which includes: conventional analgesia and physiotherapy. No acupuncture given

Other: Post-operative standard care

Interventions

Acupuncture PROCEDURE

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.

Also known as: Acupuncture in addition to standard care, Acupuncture AND physiotherapy, Acupuncture in addition to standard post operative management for hip fracture patients

Acupuncture Group (Group A)

Post-operative standard care OTHER

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

Also known as: Standard post-operative management program for hip fracture

Control Group (Group B)

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khoo Teck Puat Hospital: lead
• Ministry of Health, Singapore: collaborator

Study Sites (2)

Admiralty Medical Centre (Khoo Teck Puat Hospital- KTPH @ ADMC )

Singapore, 730676, Singapore

Location

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

Related Publications (4)

• Seitz DP, Anderson GM, Austin PC, Gruneir A, Gill SS, Bell CM, Rochon PA. Effects of impairment in activities of daily living on predicting mortality following hip fracture surgery in studies using administrative healthcare databases. BMC Geriatr. 2014 Jan 28;14:9. doi: 10.1186/1471-2318-14-9.

  PMID: 24472282 BACKGROUND

• Chan MWC, Wu XY, Wu JCY, Wong SYS, Chung VCH. Safety of Acupuncture: Overview of Systematic Reviews. Sci Rep. 2017 Jun 13;7(1):3369. doi: 10.1038/s41598-017-03272-0.

  PMID: 28611366 BACKGROUND

• Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann C. Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. Pain. 2005 Apr;114(3):320-327. doi: 10.1016/j.pain.2004.08.021.

  PMID: 15777857 BACKGROUND

• Mikashima Y, Takagi T, Tomatsu T, Horikoshi M, Ikari K, Momohara S. Efficacy of acupuncture during post-acute phase of rehabilitation after total knee arthroplasty. J Tradit Chin Med. 2012 Dec;32(4):545-8. doi: 10.1016/s0254-6272(13)60068-0.

  PMID: 23427386 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Acupuncture Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization/Allocation Concealment: 1) KTPH CRU Biostatistician (non-study team member) will use a random number generator to create a random sequence for the subjects. There will be a corresponding subject number in running sequence to each randomized generated number. The randomized numbers will then be categorized into 2 groups, odd numbers into either acupuncture or control group then even numbers into the other. 2) 90 opaque sealed envelopes will be prepared for 90 subjects. The subject number will be written on the front of each envelope. Inside each envelope, there is an insert stating the group which the subject is allocated to. 3) These sealed envelopes will be handed over to the study team. The study team member will take the relevant envelope in accordance with the subject number to check what group the subject is allocated to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Antony Xavier Rex Premchand, Senior Consultant; Specialties/Sub-Specialties Orthopaedic Surgery

Model Details: Randomization: Patients will be randomized to either Group A, where they receive postoperative management AND acupuncture, or Group B, where they receive postoperative management ONLY. Acupuncture will be performed on patients in Group (A) 2x/week from 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 used for this study are Kinhong/MAC sterile acupuncture needles for single use. The depth of needle insertion will range from 1-1.5cm and needles will be left in situ for 20 minutes. The following acupuncture points will be used bilaterally for this study: 1) Li 4 (Hegu), 2) St 36 (Zusanli) , 3) Sp 6 (Sanyinjiao), 4) Sp 9 (Yinlingquan), 5) Sp 10 (Xuehai), 6) Kd 3 (Taixi) 7) Gb 34 (Yanglinquan), 8) Ren 6 (Qihai), 9), Auricular point - Kuan 10) Auricular point - Shen Men

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: October 21, 2021
• Primary Completion: September 15, 2025
• Study Completion: November 14, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)