Pain, PostoperativeNCT06380439
The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain
A study testing wrist ankle acupuncture in people with Pain, Postoperative and Hip Osteoarthritis, run by Universitas Indonesia at 3 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Hip Osteoarthritis, Hip Fractures
- What is being tested?
- wrist ankle acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 3 sitesIndonesia
- Study dates
- 23 Apr 2024to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Fatmawati Hospital
Jakarta, 12430
Persahabatan Hospital
Jakarta, 13230
Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
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
Read the detailed description
This is a clinical trial study to evaluate and compare the effects of wrist ankle acupuncture and sham wrist ankle acupuncture as a therapy for post total hip arthroplasty pain. The subjects are 32 males/female who just undergone total hip arthroplasty surgery and has returned to inpatient ward. They will be randomly assigned to 2 groups: (1) wrist ankle acupuncture and (2) Sham wrist ankle acupuncture. The subjects will receive two sessions of treatment. The outcome will be assessed before treatment (baseline), after fist acupuncture session, after second acupuncture session and a day after the second session. Patients and the outcome assessors will be blinded to the group allocation.
- Conditions
- Pain, Postoperative, Hip Osteoarthritis, Hip Fractures, Hip Injuries
- Being tested
- wrist ankle acupuncture
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Hip, Hip Fractures, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wrist ankle acupunctureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: wrist ankle acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain rating scale for measuring pain
Measured: 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
the time when patient starts to learn to walk with assistive device
Measured: monitored since day 1 after surgery up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start23 Apr 2024
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wijayani Mardiana, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380439
- Sponsor's protocol ID
- 23-10-1763
- Status last verified
- Aug 2024
- First submitted
- 8 Apr 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain
- ClinicalTrials.gov ID
- NCT06380439
- Acronym / sponsor ID
- 23-10-1763
- Conditions
- Pain, Postoperative, Hip Osteoarthritis, Hip Fractures, Hip Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 23 Apr 2024 (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.
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
Detailed description
This is a clinical trial study to evaluate and compare the effects of wrist ankle acupuncture and sham wrist ankle acupuncture as a therapy for post total hip arthroplasty pain. The subjects are 32 males/female who just undergone total hip arthroplasty surgery and has returned to inpatient ward. They will be randomly assigned to 2 groups: (1) wrist ankle acupuncture and (2) Sham wrist ankle acupuncture. The subjects will receive two sessions of treatment. The outcome will be assessed before treatment (baseline), after fist acupuncture session, after second acupuncture session and a day after the second session. Patients and the outcome assessors will be blinded to the group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wrist ankle acupuncture | Experimental | Procedure: wrist ankle acupuncturewrist 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 | Sham comparator | Procedure: wrist ankle acupuncture0.25 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| wrist ankle acupuncturewrist 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 | Procedure or surgery | sham wrist ankle acupuncture, wrist ankle acupuncture |
Primary outcome
Visual Analog Scale
Time frame: 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
Pain rating scale for measuring pain
1 secondary outcome
recovery rate
Time frame: monitored since day 1 after surgery up to 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- 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.
KEPK FKUI-RSCM principal investigator
The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wrist ankle acupuncture in people with Pain, Postoperative and Hip Osteoarthritis, run by Universitas Indonesia at 3 sites in Indonesia.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.