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Completed

NCT Number: NCT05240586

Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study

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.

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Key information

Conditions

Cervical Disc Herniation

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyung Hee University Korean Medicine Hospital, Seoul, Dongdaemun-gu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pharmacopuncture therapy

Procedure

This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.

acupuncture therapy

Procedure

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

physical therapy, medication(prn)

Procedure

This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions. According to clinical judgment, clinicians can prescribe analgesics and muscle relaxants if necessary.

Primary outcomes

  1. Numeric rating scale (NRS) of neck pain

    Time frame: Week 1, 2, 3, 4, 5, 6, 7, 13, 25

    NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

Secondary outcomes

  1. Numeric rating scale (NRS) of radiating arm pain

    Time frame: Week 1, 2, 3, 4, 5, 6, 7, 13, 25

    NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

  2. Visual analogue scale (VAS) of neck pain and radiating arm pain

    Time frame: Week 1, 2, 3, 4, 5, 6, 7, 13, 25

    Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.

  3. Neck Disability Index (NDI)

    Time frame: Week 1, 7, 13, 25

    NDI is a functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome).

  4. Northwick Park Questionnaire (NPQ)

    Time frame: Week 1, 7, 13, 25

    NPQ measures the neck pain and the consequent patient disabilities. The questionnaire is divided in nine five-part sections. Each parameter is divided in five answer possibilities with points from 0 till 4. 0 is significant for no pain and 4 is significant for worst pain. The maximum score is 36 if all nine questions were answered and 32 if only the first eight questions were answered. The percentage ranges from 0% to 100%. The higher the percentage, the greater the disability and the pain.

  5. Patient Global Impression of Change (PGIC)

    Time frame: Week 7, 13, 25

    Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)

  6. Short Form-12 Health Survey version 2 (SF-12 v2)

    Time frame: Week 1, 7, 13, 25

    The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.

  7. EuroQol-5 Dimension (EQ-5D-5L)

    Time frame: Week 1, 7, 13, 25

    The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2022
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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