Osteoarthritis, KneeNCT03966248
Chinese Tuina Therapy for Treatment of Knee Osteoarthritis
A study testing Chinese Tuina therapy and Physical Manual therapy in people with Osteoarthritis, Knee, run by Beijing University of Chinese Medicine at 1 site in China.
Trial summary
Knee osteoarthritis (KOA) is one of the most common musculoskeletal diseases in clinic. It usually occurs in middle-aged people, especially women. An estimated lifetime risk for KOA is approximately 40% in men and 47% in women. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Chinese Tuina therapy and Physical Manual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2019to 7 Oct 2021
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of KOA;
- Age 40-75 years;
- KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
- NRS score of pain at least more than 4 points;
- Single/bilateral knee pain, duration of more than 6 month; If the patient has KOA on both legs, the heavier leg is selected for study.
Who cannot join
- Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
- Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
- Oral administration of hormones within 3 month, intra-articular injection within 6 months, knee injuries or open injuries within 6 months, or knee arthroscopy within 1 year.
- Severe acute/chronic organic or mental diseases;
- Pregnant women, pregnant and lactating women;
- Coagulation disorders (such as hemophilia, etc.), or the skin diseases at the site of operation;
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- Device support treatment after knee osteoarthritis disability;
- Participation in another clinical study in the past 3 months;
- History of receiving acupuncture, massage, manipulation, or any medical plaster treatment within 3 months
- Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Dongzhimen hospital affiliated to Bejing University of Chinese Medicine
Beijing, Beijing Municipality
About this study
Official title: Chinese Tuina (Chinese Massage and Manipulation Therapy) for KOA: A Randomized, Parallel, Physical Therapies Active Controlled Study
Knee osteoarthritis (KOA) is one of the most common musculoskeletal diseases in clinic. It usually occurs in middle-aged people, especially women. An estimated lifetime risk for KOA is approximately 40% in men and 47% in women. KOA is a chronic disease which can lead to obvious pain, joint stiffness, limitation of activity and even disability, with significant associated costs and effects on society, health systems, and individuals. Tuina therapy has been used and showed effectiveness and safety for pain relief and disability for the patients with musculoskeletal disorders for years in China. Though it is regarded that the Traditional Chinese medicine (TCM) Tuina therapy is similar to the modern manual therapies, the modalities of TCM tuina therapy are different and effect maybe equal to or more better than the modern manual therapy in clinic. However, little evidence exists that Tuina benefits the KOA. The investigators will do this in a randomized, parallel, active controlled study to observe whether TCM Tuina is more beneficial to KOA than the physical manual therapy, which has been considered an effective and standard care for KOA.
Read the detailed description
Patients will be randomly allocated to one of two groups. In the Chinese Tuina group (group CTG), patients will receive the traditional Chinese Tuina therapy (including rolling, grasping, scratching, pressing, acupressure or pushing) on the basis of KOA health education and home-exercise. Patients in the Physical Manual group (group PMG) will receive the modern physical manual therapy (including joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching, range of motion and strength training) on the basis of KOA health education and home-exercise. Assessments will be conducted at baseline and 4 and 16 weeks after randomization.
It is expected that the interventions will alleviate the sufferings of the patient. The risks of participation are minimal. Occasionally, tuina can make people feel nauseous or experience a temporary increase in pain either during or after treatment. Rare side effects happen during and after Tuina or manual treatment.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Chinese Tuina therapy, Physical Manual therapy
- Keywords
- Arthritis, Massage, Tuina, Traditional Chinese medicine, Physical therapy, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, manual therapy
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Tuina therapyOther
- The doctor presses the affected lower limb from the anterior superior iliac spine to the ankle;
- The doctor gives the pressure on the Biguan(ST31), Futu(ST32), Heding(EX-LE2), Neixiyan(EX-LE4), Waixiyan(Dubi, ST35), Zusanli(ST36) and Sanyinjiao(SP6) of the affected lower limb;
- Massage the spleen and stomach meridians of the affected lower extremes;
- Roll the soft tissues around the affected knee;
- Relax the gastrocnalis muscle
- The doctor gives the pressure on the Xuehai(SP10), Liangqiu(ST34), Neixifeng(medial patellofemoral ligament), Waixifeng(lateral patellofemoral ligament), Neixiyan(EX-LE4) and Waixiyan(Dubi, ST35) at the same time;
- Push the patella and do the passive movement of the affected knee;
- Strength training of the affected knee.
This group receives 8 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email.
Physical Manual therapyOther
- Manual therapy: Stretching the knee joint, stretching the knee joint with valgus or abduction, stretching the knee joint with varus or adduction is suitable for patients with knee flexion and extension difficulty.Patellar manipulation by bending the knee 5-10 degrees downward is suitable for patients with patellar sliding difficulty.The lower end of the muscle length manipulation is suitable for patients with muscle tension and soft tissue tension.Soft tissue loosening is performed in the suprapatellar and peripatellar regions, medial and lateral capsule joints, and popliteal fossa.
- Activity training: Mainly about the knee joint flexion and extension movement training.
- Strength training: Mainly about quadriceps muscle resistance exercises
This group receives 8 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Tuina group (CTG) | Experimental | The participants in CT group will receive the traditional Chinese Tuina therapy on the basis of KOA health education and home-exercise. Receives: Other: Chinese Tuina therapy |
| Physical Manual group (PMG) | Active comparator | The participants in PM group will receive the modern physical manual therapy on the basis of KOA health education and home-exercise. Receives: Other: Physical Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
Measured: Change from baseline at 4 weeks
Secondary outcomes (12)
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
Measured: Change from baseline at 8 weeks and 16 weeks
Change in Numeric Knee Pain Rating Scale
Subjects will rate their worst knee pain in the last 24 hours using an 11 point numeric pain rating scale with 0 representing "no pain" and 10 representing " the worst pain imaginable".
Measured: Change from baseline at 4 weeks, 8 weeks and 16 weeks
Change in Patient Global Assessment (PGA)
The Patient global assessment rating is a 11 point Numeric Rating Scale in which subjects will rate the degree to which their knee condition has changed from the time treatment was initiated to the present. The subject responds to the following query: "Please rate your overall knee's condition from the time you began treatment until now." using an 11 point numeric rating scale with 0 representing "A very great deal better" and 10 representing "A very great deal worse".
Measured: Change from baseline at 4 weeks, 8 weeks and 16 weeks
Change in 12-item Short Form Health Survey (SF-12)
The SF-12 is a generic health-related quality of life measure.
Measured: Change from baseline at 4 weeks, 8 weeks and 16 weeks
Change in 30 second time chair rise test
Subjects will be seated with their arms crossed in front of their chest. On the command "go" subjects will stand up and sit down for as many trials as they can in a 30 second period.
Measured: Change from baseline at 4 weeks
Change in Timed Up and Go Test Time
On the command "go" subjects will stand up from a chair, walk 3 meters, turn around, return to the chair and sit down. The time it takes to complete this task will be recorded.
Measured: Change from baseline at 4 weeks
Change in One Leg Standing Test
One single-leg standing was assessed balance. Test required the subject to stand with arms by his/her side.Timing was started when the subject raised one foot off the ground. Timing was stopped if the subject displaced the weight-bearing foot, touched the suspended foot to the ground, used the suspended limb to support the weight-bearing limb, or reached the maximum balance time of 30 seconds.
Measured: Change from baseline at 4 weeks
OARSI Responder Criteria
Responder criteria included 1) greater than or equal to 50% improvement in WOMAC pain or WOMAC function and an absolute improvement of greater than or equal to 20, or 2) improvement in at least 2 of the following 3 scores: 20% improvement in pain and absolute change ≥ 10 on WOMAC pain score, 20% improvement in pain and absolute change ≥ 10 on WOMAC function score, or moderate or greater improvement (≤ 4) on a 15 point global rating of change scale
Measured: At weeks 4 after randomisation.
Blinding assessment
To test whether the participants are blinded successfully, all participants will be asked to guess which kind of treatment they received.
Measured: At weeks 4 after randomisation.
Credibility/Expectancy Questionnaire
The credibility and expectancy of participants will be measured using the Credibility/Expectancy Questionnaire
Measured: About 5 min after the first treatment
Rescue medicine
Any use of pain-killers will be ascertained.
Measured: At weeks 4, 8 and 16 after randomisation.
Adverse events
Adverse Event Form
Measured: At weeks 4 after randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start19 Oct 2019
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Model description
- Two arms recruit and evaluate the participants at the same time, and the included participants have the equal opportunity to either the Chinese Tuina or physical manual therapy groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changhe Yu, Beijing University of Chinese Medicine
- Investigators
- Xiyou Wang, Principal investigator, Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966248
- Sponsor's protocol ID
- DZM-KY201906
- Status last verified
- Feb 2023
- First submitted
- 26 May 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma P, Liu L, Li S, Cai M, Han S, Weng Z, Chen Q, Gao Y, Zhang L, Wu G, Yang X, Zhang Y, Li D, Liu C, Sun Y, Yan S, Wang X, Yu C. Comparative effectiveness of Tuina therapy versus manual physical therapy for knee osteoarthritis: a randomized controlled trial. BMC Complement Med Ther. 2025 Apr 8;25(1):128. doi: 10.1186/s12906-025-04850-w.
PubMed 40200237
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Tuina (Chinese Massage and Manipulation Therapy) for KOA: A Randomized, Parallel, Physical Therapies Active Controlled Study
- ClinicalTrials.gov ID
- NCT03966248
- Acronym / sponsor ID
- DZM-KY201906
- Conditions
- Osteoarthritis, Knee
- Keywords
- Arthritis, Massage, Tuina, Traditional Chinese medicine, Physical therapy, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 19 Oct 2019 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 29 May 2019 (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 osteoarthritis (KOA) is one of the most common musculoskeletal diseases in clinic. It usually occurs in middle-aged people, especially women. An estimated lifetime risk for KOA is approximately 40% in men and 47% in women. KOA is a chronic disease which can lead to obvious pain, joint stiffness, limitation of activity and even disability, with significant associated costs and effects on society, health systems, and individuals. Tuina therapy has been used and showed effectiveness and safety for pain relief and disability for the patients with musculoskeletal disorders for years in China. Though it is regarded that the Traditional Chinese medicine (TCM) Tuina therapy is similar to the modern manual therapies, the modalities of TCM tuina therapy are different and effect maybe equal to or more better than the modern manual therapy in clinic. However, little evidence exists that Tuina benefits the KOA. The investigators will do this in a randomized, parallel, active controlled study to observe whether TCM Tuina is more beneficial to KOA than the physical manual therapy, which has been considered an effective and standard care for KOA.
Detailed description
Patients will be randomly allocated to one of two groups. In the Chinese Tuina group (group CTG), patients will receive the traditional Chinese Tuina therapy (including rolling, grasping, scratching, pressing, acupressure or pushing) on the basis of KOA health education and home-exercise. Patients in the Physical Manual group (group PMG) will receive the modern physical manual therapy (including joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching, range of motion and strength training) on the basis of KOA health education and home-exercise. Assessments will be conducted at baseline and 4 and 16 weeks after randomization.
It is expected that the interventions will alleviate the sufferings of the patient. The risks of participation are minimal. Occasionally, tuina can make people feel nauseous or experience a temporary increase in pain either during or after treatment. Rare side effects happen during and after Tuina or manual treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms recruit and evaluate the participants at the same time, and the included participants have the equal opportunity to either the Chinese Tuina or physical manual therapy groups.
| Arm | Type | Receives |
|---|---|---|
| Chinese Tuina group (CTG) | Experimental | Other: Chinese Tuina therapyThe participants in CT group will receive the traditional Chinese Tuina therapy on the basis of KOA health education and home-exercise. |
| Physical Manual group (PMG) | Active comparator | Other: Physical Manual therapyThe participants in PM group will receive the modern physical manual therapy on the basis of KOA health education and home-exercise. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of KOA;
- Age 40-75 years;
- KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
- NRS score of pain at least more than 4 points;
- Single/bilateral knee pain, duration of more than 6 month; If the patient has KOA on both legs, the heavier leg is selected for study.
Key exclusion criteria (10 listed)
- Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
- Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
- Oral administration of hormones within 3 month, intra-articular injection within 6 months, knee injuries or open injuries within 6 months, or knee arthroscopy within 1 year.
- Severe acute/chronic organic or mental diseases;
- Pregnant women, pregnant and lactating women;
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 |
|---|---|---|
| Chinese Tuina therapy1. The doctor presses the affected lower limb from the anterior superior iliac spine to the ankle; 2. The doctor gives the pressure on the Biguan(ST31), Futu(ST32), Heding(EX-LE2), Neixiyan(EX-LE4), Waixiyan(Dubi, ST35), Zusanli(ST36) and Sanyinjiao(SP6) of the affected lower limb; 3. Massage the spleen and stomach meridians of the affected lower extremes; 4. Roll the soft tissues around the affected knee; 5. Relax the gastrocnalis muscle 6. The doctor gives the pressure on the Xuehai(SP10), Liangqiu(ST34), Neixifeng(medial patellofemoral ligament), Waixifeng(lateral patellofemoral ligament), Neixiyan(EX-LE4) and Waixiyan(Dubi, ST35) at the same time; 7. Push the patella and do the passive movement of the affected knee; 8. Strength training of the affected knee. This group receives 8 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email. | Other | Chinese Tuina group (CTG) |
| Physical Manual therapy1. Manual therapy: Stretching the knee joint, stretching the knee joint with valgus or abduction, stretching the knee joint with varus or adduction is suitable for patients with knee flexion and extension difficulty.Patellar manipulation by bending the knee 5-10 degrees downward is suitable for patients with patellar sliding difficulty.The lower end of the muscle length manipulation is suitable for patients with muscle tension and soft tissue tension.Soft tissue loosening is performed in the suprapatellar and peripatellar regions, medial and lateral capsule joints, and popliteal fossa. 2. Activity training: Mainly about the knee joint flexion and extension movement training. 3. Strength training: Mainly about quadriceps muscle resistance exercises This group receives 8 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email. | Other | Physical Manual group (PMG) |
Primary outcome
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Change from baseline at 4 weeks
Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
12 secondary outcomes
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Change from baseline at 8 weeks and 16 weeks
Change in Numeric Knee Pain Rating Scale
Time frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks
Change in Patient Global Assessment (PGA)
Time frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks
Change in 12-item Short Form Health Survey (SF-12)
Time frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks
Change in 30 second time chair rise test
Time frame: Change from baseline at 4 weeks
Change in Timed Up and Go Test Time
Time frame: Change from baseline at 4 weeks
Change in One Leg Standing Test
Time frame: Change from baseline at 4 weeks
OARSI Responder Criteria
Time frame: At weeks 4 after randomisation.
Blinding assessment
Time frame: At weeks 4 after randomisation.
Credibility/Expectancy Questionnaire
Time frame: About 5 min after the first treatment
Rescue medicine
Time frame: At weeks 4, 8 and 16 after randomisation.
Adverse events
Time frame: At weeks 4 after randomisation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 40200237Ma P, Liu L, Li S, Cai M, Han S, Weng Z, Chen Q, Gao Y, Zhang L, Wu G, Yang X, Zhang Y, Li D, Liu C, Sun Y, Yan S, Wang X, Yu C. Comparative effectiveness of Tuina therapy versus manual physical therapy for knee osteoarthritis: a randomized controlled trial. BMC Complement Med Ther. 2025 Apr 8;25(1):128. doi: 10.1186/s12906-025-04850-w.
- 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.
Xiyou Wang principal investigator
Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese Tuina therapy and Physical Manual therapy in people with Osteoarthritis, Knee, run by Beijing University of Chinese Medicine at 1 site in China.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 8 Feb 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (time frame: Change from baseline at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03966248, which also lists 1 linked publication.
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 8 Feb 2023.