Investigation on Efficacy Between TCM Treatment Using Acupuncture and Tui-na With Physiotherapy on Patellofemoral Pain Syndrome

NCT06042465 | Unknown

• 1 other identifier: ACAO/L53/AY/2018
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain Syndrome; Acupuncture; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Effectiveness Measurement

  The expected outcomes are both interventions have effectiveness on curing the PFPS. Traditional Chinese Medicine group and Physiotherapy group have better effectiveness than control group in treating PFPS. By according to the Visual Analogue Scale score and the before and after evaluation form, it indicates whether the pain condition has improved. (Visual Analogue Scale will be indicated from 0 to 10. Which 0 stand for no pain at all and 10 marks stand for the worst pain).

  3 months

Study Arms (3)

TCM group

EXPERIMENTAL

As decided and performed by the registered Chinese Medicine Practitioners (CMP) on standardized treatment method

Other: acupuncture and Tui-na manipulations

PT group

EXPERIMENTAL

As decided and performed by physiotherapist of HKBH on standardized treatment method

Other: Physiotherapy

Educational Group

NO INTERVENTION

Included patients in this group are provided with educational talk on knee health protection. Patients are advised with daily-life protection on their PFPS. Questionnaire assessments are performed to assess the healthy situation of their PFPS.

Interventions

acupuncture and Tui-na manipulations OTHER

i. Patients in supine position with knee elevated 20-30 degrees bending using a pillow below. ii. Acupuncture needle using 0.25 mm diameter and 1.5-inch length. iii. Choose 'A shi point' to inject the acupuncture needles. iv. Inject 4 acupuncture needles respectively at the upper, lower, lateral and medial edge of the patella, along the medial and lateral edge at the posterior surface of patella. v. Connect the needles with electro-therapy, selecting high frequency and strength that the patients have sensation and acceptable. Time duration is 30 minutes each time. Infra-radiation is provided and warm above the treatment region. vi. Tui-na manipulations using the method of 'Tui-na'. Time duration is 2-5 minutes. Patella is pushed up and elevated during treatment. vii. No external herbal medicine for TCM group , other medication such as painkiller is required to record

TCM group

Physiotherapy OTHER

i. Total 12 sessions of physiotherapy for 8 weeks training; ii. Treatment: Closed kinetic chain exercises program will be used when appropriate, which include: 1. Mini walk squat exercise 2. Forward step up 3. Lateral step up 4. Terminal knee extension 5. Knee taping 6. Unstable base training 7. Pain control 8. Manual Therapy Each session will approximately cost each patient 1 hours' time. There is no Chinese medicine is allowed for PT group , other medication such as painkiller is required to record.

PT group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70, male and female, knee pain as main complaint;
• Diagnosed as PFPS using our diagnostic standard;
• Knee pain for more than 1 month;
• Patients could be able to finish all questionnaires, treatment;
• Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6 weeks;
• Able to cooperate with questionnaires, examination and treatment and follow-up cycles;
• Agree to receive regular Chinese medicine diagnosis and assist in the designated examinations in the study.
• Agree to record physical condition indicators and report the situation at each follow-up consultation.
• 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.

You may not qualify if:

• Age below 18 and above 70; Patients with Body Mass Index (BMI)≧30;
• Patients with acute traumatic bone fracture, dislocation or acute soft tissue injury at knee joint;
• Patients with infections at knee joint;
• Patients with non-specific inflammation at knee joint and rheumatoid disease;
• Patients with ostomy or other tumor related;
• 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；
• Patients with patellar tendon inflammation or Osgood-Schlatter Disease;
• Any psychiatric disorder;
• Pregnancy;
• Patients with severe disease such as immune disease, genetic disease and severe coronary vascular disease;
• Patients receive any other treatment such as physiotherapy or acupuncture after washout period.
• If participants are incompetent in giving consent .

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Kevin Yue Kin Man

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Acupuncture Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation

Central Study Contacts

Kevin Kin Man Yue

CONTACT

34112468; kkmyue@hkbu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: September 18, 2023
• Study Start: October 18, 2021
• Primary Completion: October 18, 2023
• Study Completion: December 31, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)