NCT04035018

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 18, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

July 24, 2019

Last Update Submit

July 7, 2020

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale of neck pain

    Minimum 0, Maximum 100. Higher values represent a worse outcome

    week 6

Study Arms (2)

pharmacopuncture therapy

EXPERIMENTAL

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

physical therapy

ACTIVE COMPARATOR

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

Interventions

pharmacopuncture therapyPROCEDURE

The participants in the treatment group will be receive one or more pharmacopuncture therapy according to the physician's decision.

pharmacopuncture therapy
Physical therapyPROCEDURE

The participants in the control group will be receive one or more physical therapy according to the physician's decision.

physical therapy

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, 48102, South Korea

Location

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, 35262, South Korea

Location

Related Publications (3)

  • Lee SM, Kim SJ, Nam D, Park YC, Kim EJ, Ha IH, Lee YJ. Comparison of preference-based health-related quality of life measures for chronic neck pain: a pooled analysis of data from three RCTs. BMJ Open. 2024 Dec 26;14(12):e086104. doi: 10.1136/bmjopen-2024-086104.

    PMID: 39725423DERIVED

  • Kim D, Kim ES, Song HJ, Park SY, Park KS, Lee YJ, Ha IH. An economic evaluation of pharmacopuncture versus usual care for chronic neck pain: a pragmatic randomized controlled trial. BMC Health Serv Res. 2023 Nov 23;23(1):1286. doi: 10.1186/s12913-023-10325-w.

    PMID: 37993844DERIVED

  • 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.

    PMID: 35011752DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • In-Hyuk Ha

    Jaseng Hospital of Korean Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 29, 2019

Study Start

September 18, 2019

Primary Completion

June 25, 2020

Study Completion

June 25, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(4)