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Completed

NCT Number: NCT04576520

PCT of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study

This is pilot study for a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy and 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 pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture 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

  • low back pain for more than 6 months
  • Visual Analogue Scale (VAS) of low back pain is more than 5
  • 19-70 years old
  • participants who agreed and wrote informed consents

Exclusion criteria

  • Migration of cancer reaching to spine, fracture of spine
  • Progressive neurologic deficits or severe neurologic deficits
  • Cancer, fibromyalgia, RA, or goat
  • Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy
  • Participants taking steroid, immunosuppressant, or psychotropic medication
  • 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 cervical 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

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

physical therapy

Procedure

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

Primary outcomes

  1. Visual analogue scale (VAS) of low back pain

    Time frame: Change from baseline VAS at week 6

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

Secondary outcomes

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

    Time frame: Week 1, 2, 3, 4, 5, 6, 10, 16

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

  2. Numeric rating scale (NRS) of low back pain and leg radiating pain

    Time frame: Week 1, 2, 3, 4, 5, 6, 10, 16

    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. Oswestry Disability Index (ODI)

    Time frame: Week 1, 6, 10, 16

    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).

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

    Time frame: Week 1, 6, 10, 16

    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).

  5. Patient Global Impression of Change (PGIC)

    Time frame: Week 6, 10, 16

    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, 6, 10, 16

    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, 6, 10, 16

    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 Chronic Low Back Pain : A Pilot Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2020
Registry last updated
Aug 30, 2021

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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