Patellofemoral Pain SyndromeNCT06042465
Investigation on Efficacy Between TCM Treatment Using Acupuncture and Tui-na With Physiotherapy on Patellofemoral Pain Syndrome
A study testing acupuncture and Tui-na manipulations and Physiotherapy in people with Patellofemoral Pain Syndrome and Acupuncture, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome, Acupuncture, Physiotherapy
- What is being tested?
- acupuncture and Tui-na manipulations and Physiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Oct 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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；
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- 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 .
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Kevin Yue Kin Man
Hong Kong
Kevin Kin Man Yue, 34112468, kkmyue@hkbu.edu.hk
About this study
Official title: Investigation on the Efficacy Between TCM Treatment Using Acupuncture and Tui-na Manipulation With Physiotherapy on Patellofemoral Pain Syndrome
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.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome, Acupuncture, Physiotherapy
- Being tested
- acupuncture and Tui-na manipulations, Physiotherapy
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture and Tui-na manipulationsOther
- 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.
- 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
PhysiotherapyOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| TCM group | Experimental | As decided and performed by the registered Chinese Medicine Practitioners (CMP) on standardized treatment method Receives: Other: acupuncture and Tui-na manipulations |
| PT group | Experimental | As decided and performed by physiotherapist of HKBH on standardized treatment method Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start18 Oct 2021
- Primary completion18 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042465
- Sponsor's protocol ID
- ACAO/L53/AY/2018
- Status last verified
- Mar 2023
- First submitted
- 7 Aug 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Efficacy Between TCM Treatment Using Acupuncture and Tui-na Manipulation With Physiotherapy on Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT06042465
- Acronym / sponsor ID
- ACAO/L53/AY/2018
- Conditions
- Patellofemoral Pain Syndrome, Acupuncture, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 18 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TCM group | Experimental | Other: acupuncture and Tui-na manipulationsAs decided and performed by the registered Chinese Medicine Practitioners (CMP) on standardized treatment method |
| PT group | Experimental | Other: PhysiotherapyAs decided and performed by physiotherapist of HKBH on standardized treatment method |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture and Tui-na manipulationsi. 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 | Other | TCM group |
| Physiotherapyi. 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. | Other | PT group |
Primary outcome
Effectiveness Measurement
Time frame: 3 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and Tui-na manipulations and Physiotherapy in people with Patellofemoral Pain Syndrome and Acupuncture, run by Hong Kong Baptist University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Kin Man Yue (34112468, kkmyue@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness Measurement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.