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Completed

NCT Number: NCT04833309

Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial

This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain.

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Key information

Conditions

Chronic Low-back Pain

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jaseng Hospital of Korean Medicine, Seoul, Gangnam-Gu, South Korea

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About this study

This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (50:50) for pharmacopuncture therapy group and physical therapy group. Participants of each group will receive total 5 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific type and volume of pharmacopuncture and physical therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • low back pain for more than 6 months
  • Numeric rating scale (NRS) score for low back pain 5 or more
  • 19-70 years old
  • participants who agreed and signed informed consent form

Exclusion criteria

  • Spine metastasis of cancer, acute fracture of spine, or spine dislocation
  • Progressive neurologic deficits or severe neurologic deficits
  • Soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc)
  • Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
  • Concurrent use of steroids, immunosuppressants, or psychotropic medications
  • Hemorrhagic disease, severe diabetes or taking anticoagulant drug
  • Participants who took NSAIDs or pharmacopuncture within 1 week
  • Pregnant or lactating women
  • Participants who had undergone lumbar surgery within 3 months
  • Participants who had participated in other clinical trial within 1 month, 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

The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and dosage will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively.

physical therapy

Procedure

The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and body part will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively.

Primary outcomes

  1. Numeric rating scale (NRS) of low-back pain

    Time frame: week 6

    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 low-back pain

    Time frame: week 1, 2, 3, 4, 5, 6, 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. Numeric rating scale (NRS) of radiating pain in lower extremities

    Time frame: week 1, 2, 3, 4, 5, 6, 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'.

  3. Visual analogue scale (VAS) of leg radiating pain

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

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

  4. Visual analogue scale (VAS) of low-back pain

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

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

  5. Oswestry Disability Index (ODI)

    Time frame: week 1, 6, 13, 25

    ODI 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).

  6. Korean version of the Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: week 1, 6, 13, 25

    The Roland Morris Disability Questionnaire consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). There is no weighting applied to the statements, therefore the score can range from 0 (no disability) to 24 (maximal disability).

  7. Patient Global Impression of Change (PGIC)

    Time frame: week 6, 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.)

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

    Time frame: week 1, 6, 13, 25

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

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

    Time frame: week 1, 6, 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

Collaborators

  • Korea Institute of Oriental Medicine

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2021
Registry last updated
Dec 18, 2024

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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