Acupuncture at the P6 acupoint for pain control in teenagers after triple repair surgery of patellar dislocation
| ISRCTN | ISRCTN75218899 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75218899 |
- Submission date
- 06/05/2024
- Registration date
- 14/05/2024
- Last edited
- 14/05/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The triple surgery of adolescent patellar dislocation (TSAPD) can preferably correct patellar dislocation (a dislocated kneecap), but pain management after surgery is challenging, especially for teenagers whose medication is restricted. This study will investigate the effectiveness of motion pain control with an Indwelling acupuncture needle added to standard therapy in teenagers after triple surgery of TSAPD.
Who can participate?
Patients aged 13-18 years undergoing TSAPD
What does the study involve?
Patients will be randomly allocated to an experimental group or a control group. The experimental group will be treated with real acupuncture needles while the control group will be treated with false needles on the same points. The needles will be indwelling for 72 hours. Pain is measured at 24, 48, and 72 hours after rehabilitation exercise. The total amount of additional analgesics used, the rate of analgesic side effects, the satisfaction of patients with postoperative analgesia, and quality of life will be recorded.
What are the possible benefits and risks of participating?
The patients may have better pain control after surgery, and this study will also help determine which treatments can be used more safely and effectively with similar conditions. There are few adverse reactions, such as local skin allergy, mild pain and discomfort during the experiment.
Where is the study run from?
West China Hospital of Sichuan University (China)
When is the study starting and how long is it expected to run for?
August 2023 to August 2028
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Pengcheng Li, 16699411@qq.com
Contact information
Public, Scientific, Principal Investigator
No.37, Guoxue Lane
Wuhou District
Chengdu City
610041
China
| Phone | +86 (0)18980601911 |
|---|---|
| 16699411@qq.com |
Study information
| Study design | Singal-center interventional double-blind placebo-controlled randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Acupuncture at the P6 acupoint for pain control in teenagers after triple repair operation of patellar dislocation: a randomized, placebo-controlled, double-blind trial |
| Study objectives | Using an indwelling press needle at Neiguan point can improve the pain intensity or reduce the amount of analgesic drugs during resting and rehabilitation exercises after triple repair operation of patellar dislocation in adolescents under general anesthesia. |
| Ethics approval(s) |
Approved 27/09/2023, Biomedical Ethics Review Committee of West China Hospital, Sichuan University (Room 412~413, Laobajiao, No.37, Guoxue Lane, Wuhou District, Chengdu, 610044, China; +86 (0)28 65423237; huaxilunli@163.com), ref: 2023年审（1530）号 |
| Health condition(s) or problem(s) studied | Pain control of patellar dislocation patients undergoing triple repair surgery |
| Intervention | Patients will be randomly allocated to an experimental group and a control group using a random number table. An indwelling press needle (0.2 x 1.5 mm, Pyonex, Seirin Corporation, Shizuoka, Japan) will be used as an acupoint intervention in the experiment group. Bilateral Neiguan points are chosen as the acupoints. The experimental group will use real needles while the control group use false needles on the same points (false indwelling acupuncture). The needles will be indwelling for 72 hours. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain intensity measured using visual analogue score (VAS) at 24 h, 48 h, and 72 h after the rehabilitation exercise |
| Secondary outcome measures | 1. Intensity of maximum and minimum resting pain measured using VAS at 24 h, 48 h, 72 h after surgery 2. Total amount of additional analgesics used: the researchers will record the total amount of different drugs according to the doctor's order after surgery for 72 hours. 3. Rate of analgesic side effects: if the patient displays any analgesic side effect symptoms, it will be recorded as "once", such as vomiting once or twice, etc. 4. Satisfaction of patients with postoperative analgesia measured using a visual analogue scale at discharge 5. Quality of life items disturbed by pain, measured by asking and recording the patients' subjective cognition every morning until the press needle is removed 6. Successful blinding of patients: a special researcher will ask the question "Do you know which group are you in?" when they finish data collection. The researcher judges whether the blinding is a success or not according to the answer. |
| Overall study start date | 10/08/2023 |
| Completion date | 10/08/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 48 |
| Key inclusion criteria | 1. Adolescent patients aged 13-18 years 2. Patients who underwent this procedure for the first time 3. Patients with unilateral surgery 4. Junior high school or above 5. Patients undergoing general anesthesia 6. No previous history of opioid and psychotropic medication 7. No previous history of smoking or alcoholism 8. Informed consent |
| Key exclusion criteria | 1. Changes in surgical methods for various reasons 2. Patients with combined cardiovascular and cerebrovascular disease 3. Patients with mental cognitive impairment or a history of mental illness 4. Skin damage in the needle prick site or patients with infection 5. Femoral nerve block in anesthetized patients 6. Patients with forced braking for various causes 7. Patients who cannot adhere to all treatment and follow-up |
| Date of first enrolment | 15/05/2024 |
| Date of final enrolment | 15/05/2028 |
Locations
Countries of recruitment
- China
Study participating centre
Chengdu, Sichuan
610044
China
Sponsor information
Hospital/treatment centre
No.37, Guoxue Lane
Wuhou District
Chengdu
610041
China
| Phone | +86 (0)17857314966 |
|---|---|
| 624513481@qq.com | |
| Website | https://www.wchscu.cn/ |
"ROR" |
https://ror.org/007mrxy13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 10/08/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Li Pengcheng (16699411@qq.com) |
Editorial Notes
07/05/2024: Study's existence confirmed by the Biomedical Ethics Review Committee of West China Hospital of Sichuan University.
