Integrated Traditional Chinese and Western Medicine for Patellar Dislocation Pain: A Concurrent Non-Randomized Controlled Trial
A Concurrent Non-Randomized Controlled Trial on Integrated Traditional Chinese and Western Medicine for Patellar Dislocation Pain
This study is a concurrent non-randomized controlled pilot trial. We plan to recruit 80 patients following patellar dislocation surgery from Peking University Third Hospital in China, with at least 40 participants in each group. The study aims to evaluate the safety and efficacy of acupuncture for the treatment of postoperative pain after patellar dislocation. The treatment regimen (pharmacological therapy or acupuncture) will be determined by the clinician and the patient based on the patient's condition and preference.
Participants will be assigned to two groups according to the treatment they receive in clinical practice: a medication group and an acupuncture group. All participants will enter a follow-up phase lasting up to 3 months.
Assessments include pain intensity (Visual Analog Scale, VAS), the Lysholm Knee Score, the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, the Tegner Activity Score, a sleep score, and the degree of joint swelling. VAS pain score, sleep score, and joint swelling will be evaluated preoperatively and on postoperative days 3, 4, 7, 14, 30, and at 3 months. The remaining outcomes will be measured at 3 months postoperatively.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100191
- Peking University Third Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- patients with recurrent patellar dislocation, male or female;
- patients with acute patellar dislocation complicated by a tangential osteochondral fracture requiring surgical treatment;
- patients who voluntarily participated in the clinical trial, signed the informed consent form, and were able to comply with clinical follow-up;
Exclusion Criteria:
- participation in other drug or medical device clinical trials within the past 6 months;
- joint fibrosis, ankylosis, or significant limitation of movement;
- contraindications to MRI examination;
- other conditions that, in the physician's judgment, preclude participation in the trial.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Acupuncture group
Patients received basic treatment (rest, elevation, ice therapy 20 min 6 times daily, extension brace for 4 weeks) and rehabilitation (supine straight leg raise 30 min daily, wall squats 30 min daily, medial quadriceps strengthening every other day).
In addition, they received traditional Chinese acupuncture at LI11 and SI4 on the day of surgery and the day after surgery.
|
The acupuncture points for Traditional Chinese Medicine (TCM) treatment are Quchi (LI11) and Zhisi Ma (SI4).
For Quchi, the needle is inserted at the point of marked tenderness around the Quchi point on the contralateral Hand Yangming Large Intestine Meridian.
For Zhisi Ma, the needle is inserted at the junction of red and white skin on the back of the hand, penetrating to the subcutaneous tissue on the palm side.
Needling is manipulated every 15 minutes, while the patient is guided to gently move the affected knee joint, with the needles retained for 45 minutes.
Treatment is performed once on the day of surgery and once on the day following surgery.
|
|
Actieve vergelijker: Pharmacological group
Patients received the same basic treatment and rehabilitation as the acupuncture group.
In addition, they received oral Voltaren sustained-release tablets (diclofenac) at 0.5 mg/kg twice daily.
|
Drug therapy refers to oral or topical medication, specifically oral Voltaren sustained-release tablets at a dose of 0.5 mg/kg twice daily.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
VAS
Tijdsspanne: Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30, and at 3 months.
|
0-10, with 0 representing no pain and 10 representing the most severe pain
|
Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30, and at 3 months.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Lysholm Knee Function Score
Tijdsspanne: 3 months after surgery
|
It can assess specific symptoms and functional impairments of the knee joint, and has particular advantages in reflecting instability and limitations in daily activities.
It consists of 8 items, with a total score of 100.
The higher the score, the better the function.
Function classification (widely accepted standard): Excellent: 95 - 100 points; Good: 84 - 94 points; Average: 65 - 83 points; Poor: < 65 points.
|
3 months after surgery
|
|
Tegner Activity Scale
Tijdsspanne: 3 months after surgery
|
It is a one-dimensional scale ranging from 0 to 10, used to assess the activity level of patients in terms of sports and daily work.
The higher the score, the higher the activity level of knee joint.
High score (8-10 points): Indicates the level of competitive sports, with extremely high requirements for the knee joint.
Medium score (4-7 points): Represents recreational sports and physical labor, which is the level of most active people.
Low score (0-3 points): Represents daily life and sedentary work, with a lower load on the knee joint.
|
3 months after surgery
|
|
International Knee Documentation Committee (IKDC)-2000
Tijdsspanne: 3 months after surgery
|
It can comprehensively assess the knee joint's functionality, consisting of 18 questions, covering three dimensions: symptoms, sports activity function, and daily activity function. The higher the score, the better the knee joint's functionality and the fewer the symptoms. Generally, a score of >90 indicates excellent function, while a score of <70 indicates significant functional impairment. The minimum clinically important difference is approximately 10-12 points. |
3 months after surgery
|
|
sleep score
Tijdsspanne: Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
|
The sleep score ranging from 1 to 5 was used to assess sleep quality, with 1 indicating very good sleep and 5 indicating inability to fall asleep.
|
Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Joint swelling
Tijdsspanne: Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
|
Measure the leg circumference 5 cm above the superior border of the patella using a soft tape measure.
|
Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
|
|
Adverse events
Tijdsspanne: postoperatively at 3 days, 4 days, 14 days, 30 days, and 3 months.
|
This study will systematically monitor and record all adverse events and serious adverse events that occur from the start of treatment until the last follow-up.
Adverse events refer to any adverse medical events that occur in patients after receiving treatment.
These include, but are not limited to, common complications related to surgery, recurrent dislocation, impaired mobility, etc.
|
postoperatively at 3 days, 4 days, 14 days, 30 days, and 3 months.
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M2024595
- 2404-01-19 (Ander subsidie-/financieringsnummer: Peking University Third Hospital)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .