Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    84
  • sponsor
    Jaseng Medical Foundation
Updated on 4 June 2022
Accepts healthy volunteers

Summary

This is pilot study for a 3-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy, acupunture therapy and physical therapy, medication(prn) for cervical disc herniation.

Description

This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture, the type and number of acupuncture and the type and time of physical therapy according to participants' conditions, respectively.

Details
Condition Cervical Disc Herniation
Treatment acupuncture therapy, pharmacopuncture therapy, physical therapy, medication(prn)
Clinical Study IdentifierNCT05240586
SponsorJaseng Medical Foundation
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Symptoms of cervical disc herniation for less than 12 months
Numeric Rating Scale (NRS) of neck pain is more than 5
Symptoms of neuromuscular disease in one or both upper limbs (pain, pull, numbness, sensory abnormalities, motor abnormalities)
Discrimination findings above protusion, which can explain clinical symptoms on Cervical spine MRI or CT
19-69 years old
participants who agreed and wrote informed consents

Exclusion Criteria

Case of being diagnosed with a specific serious disease that may cause neck pain(Migration of cancer reaching to spine, acute fracture of spine, spine dislocation)
Progressive neurologic deficits or severe neurologic deficits
Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.)
Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
Pregnant, planning to get pregnant or lactating women
Participants who had undergone cervical surgery within 3 months
Participants who had participated in other clinical trial within 1 month, had participated in other study within 6 months from the date of selection, or have plan for participation in other trial during follow up period of this trial
Participants who can not write informed consent
Participants who is difficult to participate in the trial according to investigator's decision
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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