Back to resultsInvestigation on Efficacy Between TCM Treatment Using Acupuncture and Tui-na With Physiotherapy on Patellofemoral Pain Syndrome
Primary Purpose
Patellofemoral Pain Syndrome, Acupuncture, Physiotherapy
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
acupuncture and Tui-na manipulations
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 .
Sites / Locations
- Kevin Yue Kin ManRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
TCM group
PT group
Educational Group
Arm Description
As decided and performed by the registered Chinese Medicine Practitioners (CMP) on standardized treatment method
As decided and performed by physiotherapist of HKBH on standardized treatment method
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT06042465
First Posted
August 7, 2023
Last Updated
September 26, 2023
Sponsor
Hong Kong Baptist University
Collaborators
Hong Kong Baptist Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06042465
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
October 18, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hong Kong Baptist University
Collaborators
Hong Kong Baptist Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, Acupuncture, Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TCM group
Arm Type
Experimental
Arm Description
As decided and performed by the registered Chinese Medicine Practitioners (CMP) on standardized treatment method
Arm Title
PT group
Arm Type
Experimental
Arm Description
As decided and performed by physiotherapist of HKBH on standardized treatment method
Arm Title
Educational Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
acupuncture and Tui-na manipulations
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
i. Total 12 sessions of physiotherapy for 8 weeks training; ii. Treatment: Closed kinetic chain exercises program will be used when appropriate, which include:
Mini walk squat exercise
Forward step up
Lateral step up
Terminal knee extension
Knee taping
Unstable base training
Pain control
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.
Primary Outcome Measure Information:
Title
Effectiveness Measurement
Description
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).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Kin Man Yue
Phone
34112468
Email
kkmyue@hkbu.edu.hk
Facility Information:
Facility Name
Kevin Yue Kin Man
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Kin Man Yue
Phone
34112468
Email
kkmyue@hkbu.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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Investigation on Efficacy Between TCM Treatment Using Acupuncture and Tui-na With Physiotherapy on Patellofemoral Pain Syndrome
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