ElectroacupunctureNCT04189237
Electroacupuncture Improves Wrist Functionality and Pain
A study testing Electroacupuncture in people with Electroacupuncture, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Electroacupuncture improves pain and wrist functionality in patients undergoing rehabilitation therapy after distal radius fracture Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Electroacupuncture
- What is being tested?
- Electroacupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Dec 2019to 28 Nov 2020
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of distal radius fracture
- After internal fixation
- Age between 20 and 70 years old
Who cannot join
- serious heart rhythm
- epilepsy
- Severe pulmonary heart disease
- History of mental illness
- received acupuncture treatment 1 month ago
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, No. 2, Yude Rd, North District, Taichung City, 404
Chiu-Ming Chang, 886-982910198, asspiderman1982@gmail.com
About this study
Official title: Electroacupuncture Improves Pain and Wrist Functionality in Patients Undergoing Rehabilitation Therapy After Distal Radius Fracture
Electroacupuncture improves pain and wrist functionality in patients undergoing rehabilitation therapy after distal radius fracture Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. And, the postoperative goal is to restore the function of the forearm and the mobility of the wrist joint. Therefore, rehabilitation treatment is the key. However, postoperative patients often delay rehabilitation therapy due to pain, resulting in stiffer wrist joints. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. And it is already an alternative to postoperative pain relief. The investigators hope that by electroacupuncture, the investigators can help patients reduce pain, increase joint mobility, and make patients willing to start rehabilitation therapy, reduce joint stiffness, and restore wrist function as soon as possible, which will help patients return to work and normal life early.
Methods:
It is expected that 30 patients will be randomly assigned to the following groups: electroacupuncture group, control group without EA. Two groups of subjects started to rehabilitation at the 4th week after surgery.
Read the detailed description
Electroacupuncture improves pain and wrist functionality in patients undergoing rehabilitation therapy after distal radius fracture Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. And, the postoperative goal is to restore the function of the forearm and the mobility of the wrist joint. Therefore, rehabilitation treatment is the key. However, postoperative patients often delay rehabilitation therapy due to pain, resulting in stiffer wrist joints. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. And it is already an alternative to postoperative pain relief. The investigators hope that by electroacupuncture, the investigators can help patients reduce pain, increase joint mobility, and make patients willing to start rehabilitation therapy, reduce joint stiffness, and restore wrist function as soon as possible, which will help patients return to work and normal life early.
Methods:
It is expected that 30 patients will be randomly assigned to the following groups: electroacupuncture group, control group without EA. Two groups of subjects started to rehabilitation at the 4th week after surgery.
Mode of operation: Electroacupuncture group: At the 4th week after surgery, electroacupuncture was performed, and the activity of wrist joint on the affected side was performed at same time, and at a frequency of two times per week for six weeks, for a total of twelve times.
Control group: At the 4th week after surgery, only the activity of wrist joint on the affected side was performed, and at a frequency of two times per week for six weeks, for a total of twelve times.
Acupoint selection: needles were inserted to Taixi (KI3), Taichong (LR3), Zusanli(ST36), Yanglingquan (GB34), contralateral to the operated leg and deqi sensation elicited at acupoints.
Data collection:
The evaluator does not know the patient group to achieve a single blind effect.
- Use the visual analog scale (VAS) to assess the patient's pain level
- Use the Disabilities of the Arm, Shoulder and Hand questionnaire(DASH) to assess the patient's pain and the functionality.
- The degrees of wrist mobility were measured.
- Three time points were recorded: before the first electroacupuncture (4th week after surgery, when removing fixation), after the 6th, 12th (last) electroacupuncture.
- Conditions
- Electroacupuncture
- Being tested
- Electroacupuncture
- Keywords
- electroacupuncture, wrist functionality, distal radius fracture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
needles were inserted to Taixi (KI3), Taichong (LR3), Zusanli(ST36), Yanglingquan (GB34), contralateral to the operated leg and deqi sensation elicited at acupoints.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture | Experimental | At the 4th week after surgery, electroacupuncture was performed, and the activity of wrist joint on the affected side was performed at same time, and at a frequency of two times per week for six weeks, for a total of twelve times.
Acupoint selection: needles were inserted to Taixi (KI3), Taichong (LR3), Zusanli(ST36), Yanglingquan (GB34), contralateral to the operated leg and deqi sensation elicited at acupoints. Receives: Other: Electroacupuncture |
| Control group | No intervention | At the 4th week after surgery, only the activity of wrist joint on the affected side was performed, and at a frequency of two times per week for six weeks, for a total of twelve times. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of wrist motion
The degrees of wrist mobility measured with a goniometer, including flexion, extension, supination, pronation, ulnar deviation, radial deviation, and higher degrees mean a better outcome.
Measured: 4 weeks
Secondary outcomes (1)
Disabilities of the Arm, Shoulder and Hand(DASH)
Assess the patient's pain and the inability, the DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start5 Dec 2019
- Primary completion28 Nov 2020 (estimated)
- Study completion28 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroacupunctureStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yung-Cheng Chiu, MD, Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189237
- Sponsor's protocol ID
- CMUH108-REC1-141
- Status last verified
- Jan 2020
- First submitted
- 4 Dec 2019
- Last updated
- 27 Jan 2020
- Results posted
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture Improves Pain and Wrist Functionality in Patients Undergoing Rehabilitation Therapy After Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT04189237
- Acronym / sponsor ID
- CMUH108-REC1-141
- Conditions
- Electroacupuncture
- Keywords
- electroacupuncture, wrist functionality, distal radius fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 28 Nov 2020 (estimated)
- Study completion
- 28 Nov 2020 (estimated)
- First posted
- 6 Dec 2019 (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.
Electroacupuncture improves pain and wrist functionality in patients undergoing rehabilitation therapy after distal radius fracture Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. And, the postoperative goal is to restore the function of the forearm and the mobility of the wrist joint. Therefore, rehabilitation treatment is the key. However, postoperative patients often delay rehabilitation therapy due to pain, resulting in stiffer wrist joints. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. And it is already an alternative to postoperative pain relief. The investigators hope that by electroacupuncture, the investigators can help patients reduce pain, increase joint mobility, and make patients willing to start rehabilitation therapy, reduce joint stiffness, and restore wrist function as soon as possible, which will help patients return to work and normal life early.
Methods:
It is expected that 30 patients will be randomly assigned to the following groups: electroacupuncture group, control group without EA. Two groups of subjects started to rehabilitation at the 4th week after surgery.
Detailed description
Electroacupuncture improves pain and wrist functionality in patients undergoing rehabilitation therapy after distal radius fracture Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. And, the postoperative goal is to restore the function of the forearm and the mobility of the wrist joint. Therefore, rehabilitation treatment is the key. However, postoperative patients often delay rehabilitation therapy due to pain, resulting in stiffer wrist joints. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. And it is already an alternative to postoperative pain relief. The investigators hope that by electroacupuncture, the investigators can help patients reduce pain, increase joint mobility, and make patients willing to start rehabilitation therapy, reduce joint stiffness, and restore wrist function as soon as possible, which will help patients return to work and normal life early.
Methods:
It is expected that 30 patients will be randomly assigned to the following groups: electroacupuncture group, control group without EA. Two groups of subjects started to rehabilitation at the 4th week after surgery.
Mode of operation: Electroacupuncture group: At the 4th week after surgery, electroacupuncture was performed, and the activity of wrist joint on the affected side was performed at same time, and at a frequency of two times per week for six weeks, for a total of twelve times.
Control group: At the 4th week after surgery, only the activity of wrist joint on the affected side was performed, and at a frequency of two times per week for six weeks, for a total of twelve times.
Acupoint selection: needles were inserted to Taixi (KI3), Taichong (LR3), Zusanli(ST36), Yanglingquan (GB34), contralateral to the operated leg and deqi sensation elicited at acupoints.
Data collection:
The evaluator does not know the patient group to achieve a single blind effect.
- Use the visual analog scale (VAS) to assess the patient's pain level
- Use the Disabilities of the Arm, Shoulder and Hand questionnaire(DASH) to assess the patient's pain and the functionality.
- The degrees of wrist mobility were measured.
- Three time points were recorded: before the first electroacupuncture (4th week after surgery, when removing fixation), after the 6th, 12th (last) electroacupuncture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture | Experimental | Other: ElectroacupunctureAt the 4th week after surgery, electroacupuncture was performed, and the activity of wrist joint on the affected side was performed at same time, and at a frequency of two times per week for six weeks, for a total of twelve times. Acupoint selection: needles were inserted to Taixi (KI3), Taichong (LR3), Zusanli(ST36), Yanglingquan (GB34), contralateral to the operated leg and deqi sensation elicited at acupoints. |
| Control group | No intervention | –At the 4th week after surgery, only the activity of wrist joint on the affected side was performed, and at a frequency of two times per week for six weeks, for a total of twelve times. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of distal radius fracture
- After internal fixation
- Age between 20 and 70 years old
Key exclusion criteria (5 listed)
- serious heart rhythm
- epilepsy
- Severe pulmonary heart disease
- History of mental illness
- received acupuncture treatment 1 month ago
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 |
|---|---|---|
| Electroacupunctureneedles were inserted to Taixi (KI3), Taichong (LR3), Zusanli(ST36), Yanglingquan (GB34), contralateral to the operated leg and deqi sensation elicited at acupoints. | Other | electroacupuncture |
Primary outcome
Range of wrist motion
Time frame: 4 weeks
The degrees of wrist mobility measured with a goniometer, including flexion, extension, supination, pronation, ulnar deviation, radial deviation, and higher degrees mean a better outcome.
1 secondary outcome
Disabilities of the Arm, Shoulder and Hand(DASH)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- 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.
Yung-Cheng Chiu, MD study director
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Electroacupuncture, run by China Medical University Hospital at 1 site in Taiwan.
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 5 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: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiu-Ming Chang (886-982910198, asspiderman1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of wrist motion (time frame: 4 weeks). 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 27 Jan 2020; AzTrials last refreshed its copy on 28 Oct 2026.