Clinical trial NCT06042465: Investigation on Efficacy Between TCM Treatment Using Acupuncture and Tui-na With Physiotherapy on Patellofemoral Pain Syndrome
Official title: Investigation on the Efficacy Between TCM Treatment Using Acupuncture and Tui-na Manipulation With Physiotherapy on Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Acupuncture
Physiotherapy
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Hong Kong Baptist Hospital
First posted: 2023-09-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee pain is one of common pain-causing diseases and it affects patients' mobility which in turn seriously affects the quality of patients' life. The most common cause of knee pain results from the inflammation occurred at the patello-femoral joint of the anterior knee. It is now commonly recognized as Patello-femoral pain syndrome (PFPS). It is categorized as anterior knee pain.

The exact pathogenesis of PFPS is still not clear but both Traditional Chinese Medicine (TCM) and Western Medicine (WM) have many treatment methods. Hence, it is important and meaningful to investigate the diagnosis and treatment in detail. Through reviewing the literature about PFPS, the investigators would like to achieve the following objectives in the study design. Under the principle of evidence-based medicine, the investigators compare the clinical effectiveness of TCM acupuncture and Tui-na manipulations treatment with the physiotherapy on the PFPS management. The study is to determine whether which are effective in improving knee function and lessening the pain in PFPS patients.

Detailed description: The target sample size will be 180 patients approximately, each group namely Traditional Chinese Medicine (TCM)/ Physiotherapy (PT)/ Education group respectively will contain minimum 60 patients respectively. Patients are initially screened with questionnaire implying the PFPS scouring system. Patients will be recruited and firstly screened from Chinese Medicine Practitioner (CMP). Then the secondary screening will be conducted by the WM practitioner in Hong Kong Baptist Hospital (HKBH) to confirm diagnosis and enrollment based on the inclusion and exclusion criteria. X-ray imaging diagnosis and reporting are done in HKBH.

The investigators will design a randomized controlled trial, compared with TCM group and PT group. Patients are requested to sign a consent form before entering the washout period for 2 weeks before they start their interventions. TCM group will receive acupuncture and Tui-na. PT group will receive physiotherapy training. Patients will be treated twice a week and rest on 3rd and 6th week. Total 12 sessions treatments within 8 weeks. The investigators set up a control group named "education group", the control group will be used to compare with the other two groups. Included patients in this group are provided with educational talk on knee health protection. Patients are advised with daily-life protection on their PFPS. After 8 weeks of control intervention, patients are given with treatment same as TCM group or PT group in 1:1 basis. Phone-follow up will start from 3-month after the treatment.

Statistical analysis will be performed using the Social Science Statistics Package (SPSS) for Windows version. The investigators are going to (1) analysis of the PFPS diagnostic criteria; (2)Comparison between the questionnaire and examinations before and after the treatment intervention.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 70, male and female, knee pain as main complaint;
2. Diagnosed as PFPS using our diagnostic standard;
3. Knee pain for more than 1 month;
4. Patients could be able to finish all questionnaires, treatment;
5. Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6 weeks;
6. Able to cooperate with questionnaires, examination and treatment and follow-up cycles;
7. Agree to receive regular Chinese medicine diagnosis and assist in the designated examinations in the study.
8. Agree to record physical condition indicators and report the situation at each follow-up consultation.
9. During the entire plan period, the subjects must agree not to use any type of Chinese medicine health care products until the end of the trial.

Exclusion Criteria:

1. Age below 18 and above 70; Patients with Body Mass Index (BMI)≧30;
2. Patients with acute traumatic bone fracture, dislocation or acute soft tissue injury at knee joint;
3. Patients with infections at knee joint;
4. Patients with non-specific inflammation at knee joint and rheumatoid disease;
5. Patients with ostomy or other tumor related;
6. Patients with knee pain but not anterior knee pain, e.g. meniscal or other intra articular pathologic condition, cruciate or collateral ligament cases, patella subluxation or dislocation, previous surgery in the knee and hip joints, knee and hip joint osteoarthritis, any conditions affect muscle strength like diabetes mellitus or rheumatoid arthritis；
7. Patients with patellar tendon inflammation or Osgood-Schlatter Disease;
8. Any psychiatric disorder;
9. Pregnancy;
10. Patients with severe disease such as immune disease, genetic disease and severe coronary vascular disease;
11. Patients receive any other treatment such as physiotherapy or acupuncture after washout period.
12. If participants are incompetent in giving consent .

Primary outcomes:
measure: Effectiveness Measurement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kevin Yue Kin Man
Study officials:
References: