- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03359603
Electro-acupuncture in Knee Osteoarthritis
Electro-acupuncture of Different Treatment Frequency in Knee Osteoarthritis: a Pilot Randomized Clinical Trial
Study Overview
Detailed Description
Patients will be randomly allocated to one of two groups. In the 24-session treatments group (group A), patients will receive EA 3 sessions per week for 8 weeks. The EA stimulation lasted for 30 minutes with a dilatational wave of 2/100 Hz and a current intensity depending on the participant's comfort level (preferably with skin around the acupoints shivering mildly without pain). It involves having needles inserted into acupoints which are stimulated manually for 10 seconds to create "De Qi" sensation and paired alligator clips will be attached to the needle holders at LR8-GB33 and two other customized acupoints. Disposable needles (Huatuo) and the HANS-200A acupoint nerve stimulator (Nanjing Jisheng Medical Co., Ltd. production) will be used.
Patients in the 8-session treatments group (group B) will receive EA once per week for 8 weeks. Other interventions are the same as group A. Assessments will be conducted at baseline and 4, 6, 8, 12 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, acupuncture can make people feel nauseous or experience a temporary increase in pain either during or after treatment. Rare side effects during acupuncture treatment include fainting, infection and subcutaneous hematoma (pooling of blood under the skin). Participants will be warned of these potential side-effects before consenting to have acupuncture.
Patients will be allowed, or required, to back out of the trial based on the following:
- A major protocol violation;
- Development of a serious disease;
- Adverse events related to electro-acupuncture;
- Request to be back out of the trial. The purpose of the study is to accumulate clinical data, obtain the outcome data of the intervention method and prove the feasibility of the study protocol.
Sixty patients will be selected as the sample size according to clinical experience.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cun-Zhi Liu, MD
- Phone Number: 010-52176043
- Email: lcz623780@126.com
Study Contact Backup
- Name: Lu-Lu Lin, Postgraduate Student
- Phone Number: 15628933890
- Email: linlulu365@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Recruiting
- Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
-
Contact:
- Cun-Zhi Liu, MD
- Phone Number: 010-52176043
- Email: lcz623780@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 45-75 years old, male or female;
- Single / bilateral knee pain, duration of more than 6 months;
- KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 6 months;
- NRS ≥ 40mm;
- Signed informed consent
Exclusion Criteria:
- 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.);
- History of arthroscopy within 1 year or intra-articular injection within 4 months;
- History of receiving acupuncture treatment within 3 months;
- Severe acute/chronic organic or mental diseases;
- Pregnant women, pregnant and lactating women;
- Coagulation disorders (such as hemophilia, etc.);
- Participation in another clinical study in the past 3 months;
- With a cardiac pacemaker, metal allergy or needle phobia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group A
After recruiting, patients are assigned to the group by randomization,and then receive electro-acupuncture treatment.
Patients in the group will receive EA 3 sessions per week for 8 weeks.
The EA stimulation lasted for 30 minutes with a dilatational wave of 2/100 Hz and a current intensity depending on the patient's comfort level (preferably with skin around the acupoints shivering mildly without pain).
|
Patients will be treated by use of 5 obligatory and 3 customized acupoints.
Obligatory points (ST35, EX-LE5, LR8, GB33 and Ashi) will be used in all patients.
Other 3 customized acupoints should be chosen by the physicians on the basis of traditional Chinese medicine diagnosis for acupuncture channels related to the individual pain area, with the intent of optimizing efficacy.
ST34, ST36, ST32, ST40 and EX-LE2 will be used for pain at stomach meridian.
GB31, GB36, GB34, GB39 and GB41 will be used for pain at gallbladder meridian.
BL39, BL40, BL57 and BL60 will be used for pain at bladder meridian.
LR7, SP9, SP10, KI10, SP4, SP6, LR3 and KI3 will be used for pain at three yin meridians of foot.
Needles will be stimulated manually for 10 seconds to achieve"De Qi".
Paired alligator clips will be attached transversely to the needle holders at LR8-GB33 and two other customized acupoints.
Other needles will be manipulated for 10 seconds during the treatments.
|
EXPERIMENTAL: Group B
After recruiting, patients are assigned to the group by randomization,and then receive electro-acupuncture treatment.
Patients in the group will receive EA once per week for 8 weeks.
The EA stimulation lasted for 30 minutes with a dilatational wave of 2/100 Hz and a current intensity depending on the patient's comfort level (preferably with skin around the acupoints shivering mildly without pain).
|
Patients will be treated by use of 5 obligatory and 3 customized acupoints.
Obligatory points (ST35, EX-LE5, LR8, GB33 and Ashi) will be used in all patients.
Other 3 customized acupoints should be chosen by the physicians on the basis of traditional Chinese medicine diagnosis for acupuncture channels related to the individual pain area, with the intent of optimizing efficacy.
ST34, ST36, ST32, ST40 and EX-LE2 will be used for pain at stomach meridian.
GB31, GB36, GB34, GB39 and GB41 will be used for pain at gallbladder meridian.
BL39, BL40, BL57 and BL60 will be used for pain at bladder meridian.
LR7, SP9, SP10, KI10, SP4, SP6, LR3 and KI3 will be used for pain at three yin meridians of foot.
Needles will be stimulated manually for 10 seconds to achieve"De Qi".
Paired alligator clips will be attached transversely to the needle holders at LR8-GB33 and two other customized acupoints.
Other needles will be manipulated for 10 seconds during the treatments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: baseline and 8 weeks
|
the percentage of patients with improvement in average pain (numerical rating scale, NRS) at least 2 units and in Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) function subscale score at least 6 units at 8 weeks.
Pain NRS was a self-administered instrument, a number selected from 0-10 by participant.
Intensity of pain range (over past week): 0 =no pain to 10 =worst possible pain.
Higher score indicating severe pain.
The WOMAC function subscale referred to the participant's ability to move around and perform usual activities of daily living.
The WOMAC function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee.
The WOMAC function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function.
An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.
|
baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Credibility score
Time Frame: 1 week(after the first treatment)
|
using Credibility/expectancy questionnaire
|
1 week(after the first treatment)
|
Expectancy score
Time Frame: 1 week(after the first treatment)
|
using Credibility/expectancy questionnaire
|
1 week(after the first treatment)
|
Adverse events
Time Frame: up to 16 weeks
|
using Adverse Event Form
|
up to 16 weeks
|
Pain
Time Frame: baseline, 8 weeks and 16 weeks
|
using numerical rating scale (NRS) and WOMAC pain subscale.
Pain NRS was a self-administered instrument, a number selected from 0-10 by participant.
Intensity of pain range (over past week): 0 =no pain to 10 =worst possible pain.
Higher score indicating severe pain.
The WOMAC pain subscale referred to the patient's pain.
It was comprised of 5 items, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst pain condition.
An overall score range of 0 (minimum) to 20 (maximum), with higher scores indicating worse physical function.
|
baseline, 8 weeks and 16 weeks
|
Knee-joint function
Time Frame: baseline, 8 weeks and 16 weeks
|
using WOMAC function subscale.
The WOMAC function subscale referred to the participant's ability to move around and perform usual activities of daily living.
The WOMAC function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee.
The WOMAC function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function.
An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.
|
baseline, 8 weeks and 16 weeks
|
Stiffness
Time Frame: baseline, 8 weeks and 16 weeks
|
using WOMAC stiffness subscale.
The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee.
The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness.
An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.
|
baseline, 8 weeks and 16 weeks
|
Overall effect
Time Frame: baseline, 8 weeks and 16 weeks
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using the Overall Treatment Effect (OTE)
|
baseline, 8 weeks and 16 weeks
|
Quality of life
Time Frame: baseline, 8 weeks and 16 weeks
|
using the 12-Item Short Form Health Survey (SF-12)
|
baseline, 8 weeks and 16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cun-Zhi Liu, MD, Beijing Hospital of Traditional Chinese Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017BL-076-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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