4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Chinese Tuina Therapy for Treatment of Knee Osteoarthritis

Chinese Tuina Therapy for Treatment of Knee Osteoarthritis

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: Chinese Tuina therapy Other: Physical Manual therapy Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: Participants are randomly divided into Chinese Tuina group and Physical Manual group at a ratio of 1:1, only knowing that they will receive the manual therapies. The assessor, data manager and statistician will not participate in the randomized process and the treatment and share any information with each other.
Primary Purpose: Treatment
Official Title: Chinese Tuina (Chinese Massage and Manipulation Therapy) for KOA: A Randomized, Parallel, Physical Therapies Active Controlled Study
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Chinese Tuina group (CTG)
The participants in CT group will receive the traditional Chinese Tuina therapy on the basis of KOA health education and home-exercise.
Other: Chinese Tuina therapy
  1. 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.


Active Comparator: Physical Manual group (PMG)
The participants in PM group will receive the modern physical manual therapy on the basis of KOA health education and home-exercise.
Other: Physical Manual therapy
  1. 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.


Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: Change from baseline at 8 weeks and 16 weeks ]
    Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.

  2. Change in Numeric Knee Pain Rating Scale [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    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".

  3. Change in Patient Global Assessment (PGA) [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    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".

  4. Change in 12-item Short Form Health Survey (SF-12) [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    The SF-12 is a generic health-related quality of life measure.

  5. Change in 30 second time chair rise test [ Time Frame: Change from baseline at 4 weeks ]
    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.

  6. Change in Timed Up and Go Test Time [ Time Frame: Change from baseline at 4 weeks ]
    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.

  7. Change in One Leg Standing Test [ Time Frame: Change from baseline at 4 weeks ]
    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.

  8. OARSI Responder Criteria [ Time Frame: At weeks 4 after randomisation. ]
    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

  9. Blinding assessment [ Time Frame: At weeks 4 after randomisation. ]
    To test whether the participants are blinded successfully, all participants will be asked to guess which kind of treatment they received.

  10. Credibility/Expectancy Questionnaire [ Time Frame: About 5 min after the first treatment ]
    The credibility and expectancy of participants will be measured using the Credibility/Expectancy Questionnaire

  11. Rescue medicine [ Time Frame: At weeks 4, 8 and 16 after randomisation. ]
    Any use of pain-killers will be ascertained.

  12. Adverse events [ Time Frame: At weeks 4 after randomisation. ]
    Adverse Event Form


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of KOA;
  2. Age 40-75 years;
  3. KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
  4. NRS score of pain at least more than 4 points;
  5. 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.

Exclusion Criteria:

  1. Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
  2. Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
  3. 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.
  4. Severe acute/chronic organic or mental diseases;
  5. Pregnant women, pregnant and lactating women;
  6. Coagulation disorders (such as hemophilia, etc.), or the skin diseases at the site of operation;
  7. Device support treatment after knee osteoarthritis disability;
  8. Participation in another clinical study in the past 3 months;
  9. History of receiving acupuncture, massage, manipulation, or any medical plaster treatment within 3 months
  10. Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Changhe Yu 18601159559 yakno2@163.com
Contact: Xiyou Wang 8610111889 dwxy658@163.com

Locations
Layout table for location information
China, Beijing
Dongzhimen hospital affiliated to Bejing University of Chinese Medicine Recruiting
Beijing, Beijing, China
Contact: Changhe Yu    8618601159559    yakno2@163.com   
Contact: Xiyou Wang    8613810111889    dwxy658@163.com   
Sponsors and Collaborators
Beijing University of Chinese Medicine
Investigators
Layout table for investigator information
Principal Investigator: Xiyou Wang Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
Tracking Information
First Submitted Date  ICMJE May 26, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date November 7, 2019
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: Change from baseline at 8 weeks and 16 weeks ]
    Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
  • Change in Numeric Knee Pain Rating Scale [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    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".
  • Change in Patient Global Assessment (PGA) [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    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".
  • Change in 12-item Short Form Health Survey (SF-12) [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    The SF-12 is a generic health-related quality of life measure.
  • Change in 30 second time chair rise test [ Time Frame: Change from baseline at 4 weeks ]
    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.
  • Change in Timed Up and Go Test Time [ Time Frame: Change from baseline at 4 weeks ]
    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.
  • Change in One Leg Standing Test [ Time Frame: Change from baseline at 4 weeks ]
    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.
  • OARSI Responder Criteria [ Time Frame: At weeks 4 after randomisation. ]
    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
  • Blinding assessment [ Time Frame: At weeks 4 after randomisation. ]
    To test whether the participants are blinded successfully, all participants will be asked to guess which kind of treatment they received.
  • Credibility/Expectancy Questionnaire [ Time Frame: About 5 min after the first treatment ]
    The credibility and expectancy of participants will be measured using the Credibility/Expectancy Questionnaire
  • Rescue medicine [ Time Frame: At weeks 4, 8 and 16 after randomisation. ]
    Any use of pain-killers will be ascertained.
  • Adverse events [ Time Frame: At weeks 4 after randomisation. ]
    Adverse Event Form
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2019)
  • Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: Change from baseline at 8 weeks and 16 weeks ]
    Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
  • Change in Numeric Knee Pain Rating Scale [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    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".
  • Change in Patient Global Assessment (PGA) [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    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".
  • Change in 12-item Short Form Health Survey (SF-12) [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    The SF-12 is a generic health-related quality of life measure.
  • Change in 30 second time chair rise test [ Time Frame: Change from baseline at 4 weeks ]
    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.
  • Change in Timed Up and Go Test Time [ Time Frame: Change from baseline at 4 weeks ]
    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.
  • Change in One Leg Standing Test [ Time Frame: Change from baseline at 4 weeks ]
    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.
  • OARSI Responder Criteria [ Time Frame: At weeks 4 after randomisation. ]
    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
  • Blinding assessment [ Time Frame: At weeks 4 after randomisation. ]
    To test whether the participants are blinded successfully, all participants will be asked to guess which kind of acupuncture they received.
  • Credibility/Expectancy Questionnaire [ Time Frame: About 5 min after the first treatment ]
    The credibility and expectancy of participants will be measured using the Credibility/Expectancy Questionnaire
  • Rescue medicine [ Time Frame: At weeks 4, 8 and 16 after randomisation. ]
    Any use of pain-killers will be ascertained.
  • Adverse events [ Time Frame: At weeks 4 after randomisation. ]
    Adverse Event Form
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chinese Tuina Therapy for Treatment of Knee Osteoarthritis
Official Title  ICMJE Chinese Tuina (Chinese Massage and Manipulation Therapy) for KOA: A Randomized, Parallel, Physical Therapies Active Controlled Study
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description:
Participants are randomly divided into Chinese Tuina group and Physical Manual group at a ratio of 1:1, only knowing that they will receive the manual therapies. The assessor, data manager and statistician will not participate in the randomized process and the treatment and share any information with each other.
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Other: Chinese Tuina therapy
    1. 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: Physical Manual therapy
    1. 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.

Study Arms  ICMJE
  • Experimental: Chinese Tuina group (CTG)
    The participants in CT group will receive the traditional Chinese Tuina therapy on the basis of KOA health education and home-exercise.
    Intervention: Other: Chinese Tuina therapy
  • Active Comparator: Physical Manual group (PMG)
    The participants in PM group will receive the modern physical manual therapy on the basis of KOA health education and home-exercise.
    Intervention: Other: Physical Manual therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 26, 2019)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of KOA;
  2. Age 40-75 years;
  3. KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
  4. NRS score of pain at least more than 4 points;
  5. 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.

Exclusion Criteria:

  1. Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
  2. Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
  3. 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.
  4. Severe acute/chronic organic or mental diseases;
  5. Pregnant women, pregnant and lactating women;
  6. Coagulation disorders (such as hemophilia, etc.), or the skin diseases at the site of operation;
  7. Device support treatment after knee osteoarthritis disability;
  8. Participation in another clinical study in the past 3 months;
  9. History of receiving acupuncture, massage, manipulation, or any medical plaster treatment within 3 months
  10. Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Changhe Yu 18601159559 yakno2@163.com
Contact: Xiyou Wang 8610111889 dwxy658@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966248
Other Study ID Numbers  ICMJE DZM-KY201906
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Changhe Yu, Beijing University of Chinese Medicine
Study Sponsor  ICMJE Beijing University of Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiyou Wang Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
PRS Account Beijing University of Chinese Medicine
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP