Effectiveness of Pharmacopuncture for Chronic Neck Pain

A Study on the Effectiveness of Pharmacopuncture for Chronic Neck Pain: A Protocol for a Pragmatic Randomized Controlled Trial

In this study, the investigators will evaluate the efficacy and safety of pharmacopuncture therapy for chronic neck pain compared to physical therapy.

Study Overview

• Status: Completed
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Procedure: Physical therapy; Procedure: pharmacopuncture therapy

Detailed Description

This study is prgmatic RCT of pharmacopuncture therapy for chronic neck pain compared to physical therapy.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 48102
    • Haeundae Jaseng Hospital of Korean Medicine
  • Daejeon, Korea, Republic of, 35262
    • Daejeon Jaseng Hospital of Korean Medicine
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
      • Jaseng Hospital of Korean Medicine
  • Gyeonggi Province
    • Bucheon, Gyeonggi Province, Korea, Republic of, 14598
      • Bucheon Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Neck pain more than 6 months
• VAS of neck pain more than 5
• Age between 17 and 70 years old
• Participants who wrote informed consent

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: pharmacopuncture therapy; The physicians will select one or more pharmacopuncture therapy for each participants. The physicians will also decide dosage and frequency of treatment according to the participant's status.	Procedure: pharmacopuncture therapy; The participants in the treatment group will be receive one or more pharmacopuncture therapy according to the physician's decision.
ACTIVE_COMPARATOR: physical therapy; The physicians will select one or more physical therapy for each participants. The physicians will also decide intensity and frequency of treatment according to the participant's status.	Procedure: Physical therapy; The participants in the control group will be receive one or more physical therapy according to the physician's decision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale of neck pain	Minimum 0, Maximum 100. Higher values represent a worse outcome	week 6

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation

Publications and helpful links

General Publications

• Park KS, Kim S, Kim C, Seo JY, Cho H, Kim SD, Lee YJ, Lee J, Ha IH. A Comparative Study of the Effectiveness of Pharmacopuncture Therapy for Chronic Neck Pain: A Pragmatic, Randomized, Controlled Trial. J Clin Med. 2021 Dec 21;11(1):12. doi: 10.3390/jcm11010012.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2019
• Primary Completion (ACTUAL): June 25, 2020
• Study Completion (ACTUAL): June 25, 2020

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (ACTUAL): July 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: JS-CT-2019-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No