Hip Fracture SurgeriesAFTPROHFPNCT07178756
ACUPUNCTURE FOR THE POSTOPERATIVE RECOVERY OF HIP FRACTURE PATIENTS: A PILOT RANDOMIZED CONTROLLED TRIAL
A study testing Acupuncture in people with Hip Fracture Surgeries and Post-operative Hip Fractures Recovery, run by Khoo Teck Puat Hospital at 2 sites in Singapore.
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… Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Hip Fracture Surgeries, Post-operative Hip Fractures Recovery
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSingapore
- Study dates
- 21 Oct 2021to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Singapore2 sites
Admiralty Medical Centre (Khoo Teck Puat Hospital- KTPH @ ADMC )
Singapore, 730676
Khoo Teck Puat Hospital
Singapore, 768828
About this study
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:
Read more
- Postoperative pain
- 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.
- Being tested
- Acupuncture, Post-operative standard care
- Keywords
- Acupuncture, Hip fracture surgery, Post hip fracture surgery recovery, Hip fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Also called Acupuncture in addition to standard care, Acupuncture AND physiotherapy, Acupuncture in addition to standard post operative management for hip fracture patients
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.
Post-operative standard careOther
Also called Standard post-operative management program for hip fracture
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
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group (Group A) | Experimental | In addition to standard postoperative management program, acupuncture treatment will be added Receives: Procedure: Acupuncture |
| Control Group (Group B) | Other | Only receive standard postoperative management which includes: conventional analgesia and physiotherapy. No acupuncture given Receives: Other: Post-operative standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Modified Harris Hip Score
Assessing pain and function
Measured: postoperative Week (POW) 0, 6, postoperative month (POM) 6 and POM 12
Visual Analogue Scale (VAS)-100
For assessing the pain intensity
Measured: postoperative Week (POW) 0, 6, postoperative month (POM) 6 and POM 12
Secondary outcomes (2)
Timed get Up and Go (TUG) test
Test for assessing function (Gait and speed). The TUG will be performed thrice during each assessment and the average time will be taken.
Measured: POW 6, POM 6 and 12
Lower extremity muscle strength
Lower extremity muscle strength will be measured using a portable dynamometer. The subject's operated and non-operated side will be measured.
Measured: POW 6, POM 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start21 Oct 2021
- Primary completion15 Sep 2025 (estimated)
- Study completion14 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip Fracture SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khoo Teck Puat Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Responsible party
- Principal investigator, Ong Zhi Lin Melissa, Khoo Teck Puat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178756
- Sponsor's protocol ID
- 2019/01168
- Other IDs
- 2019
- Acronym
- AFTPROHFP
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24472282Chan 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.
PubMed 28611366Usichenko 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.
PubMed 15777857Mikashima 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.
PubMed 23427386
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACUPUNCTURE FOR THE POSTOPERATIVE RECOVERY OF HIP FRACTURE PATIENTS: A PILOT RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07178756
- Acronym / sponsor ID
- AFTPROHFP / 2019/01168
- Keywords
- Acupuncture, Hip fracture surgery, Post hip fracture surgery recovery, Hip fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Khoo Teck Puat HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 14 Nov 2025 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Postoperative pain
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group (Group A) | Experimental | Procedure: AcupunctureIn addition to standard postoperative management program, acupuncture treatment will be added |
| Control Group (Group B) | Other | Other: Post-operative standard careOnly receive standard postoperative management which includes: conventional analgesia and physiotherapy. No acupuncture given |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Acupuncture in addition to standard care, Acupuncture AND physiotherapy, Acupuncture in addition to standard post operative management for hip fracture patientsBoth 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. | Procedure or surgery | Acupuncture Group (Group A) |
| Post-operative standard careAlso: Standard post-operative management program for hip fractureStandard 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 | Other | Control Group (Group B) |
Primary outcome
1. Modified Harris Hip Score
Time frame: postoperative Week (POW) 0, 6, postoperative month (POM) 6 and POM 12
Assessing pain and function
Visual Analogue Scale (VAS)-100
Time frame: postoperative Week (POW) 0, 6, postoperative month (POM) 6 and POM 12
For assessing the pain intensity
2 secondary outcomes
Timed get Up and Go (TUG) test
Time frame: POW 6, POM 6 and 12
Lower extremity muscle strength
Time frame: POW 6, POM 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 24472282Seitz 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.
- Background: PubMed 28611366Chan 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.
- Background: PubMed 15777857Usichenko 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.
- Background: PubMed 23427386Mikashima 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Hip Fracture Surgeries and Post-operative Hip Fractures Recovery, run by Khoo Teck Puat Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Modified Harris Hip Score (time frame: postoperative Week (POW) 0, 6, postoperative month (POM) 6 and POM 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07178756, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.