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Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chuna manual therapy
Conventional medication
Physical therapy
Sponsored by
Jaseng Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic neck pain patients (with pain duration of 3 months or longer)
  • Patients with numeric rating scale (NRS) of radicular pain ≤ neck pain in neck pain patients with or without radiculopathy
  • Patients with NRS of neck pain ≥5 during the 3 days
  • Patients who have agreed to trial participation and provided written informed consent

Exclusion Criteria:

  • Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
  • Patients with history of neck surgery
  • Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcomes (e.g. chronic renal failure, vertebral artery complications, rheumatoid arthritis, Down syndrome)
  • Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
  • Patients with severe mental illness
  • Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
  • Patients who have received Chuna manual therapy or physical therapy, medicine such as nonsteroidal anti-inflammatory drugs (NSAIDs), or treatment(s) that may influence pain within the past week
  • Pregnant patients or patients with plans of pregnancy
  • Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers

Sites / Locations

  • Bucheon Jaseng Hospital of Korean Medicine
  • Haeundae Jaseng Hospital of Korean Medicine
  • Daejeon Jaseng Hospital of Korean Medicine
  • Jaseng Hospital of Korean Medicine
  • Kyung Hee University Oriental Medicine Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chuna manual therapy

Usual care

Arm Description

The Chuna manual therapy group will receive Chuna manual therapy alone. Chuna manual therapy will employ a semi-standardized treatment plan of Chuna manual therapy through Chuna technique selection based on physician judgement of techniques from Chuna Medicine (Korean Society of Chuna Manual Medicine for Spine & Nerves: Chuna Medicine: Seoul: Korean Society of Chuna Manual Medicine for Spine & Nerves; 2017) and osteopathic manipulative medicine. The Chuna techniques employed in this study are divided into cervical, thoracic and rib cage, lumbar, pelvic, sacral, pubic, and hip joint area techniques. Chuna manual therapy sessions will be administered 2 sessions/week over a period of 5 weeks (total 10 sessions). The time duration of 1 Chuna manual therapy session will consist of approximately 10-20 minutes of diagnosis and approximately 10 minutes of treatment.

The usual care group will receive usual care alone. Usual care will be limited to physical therapy and conventional medication in this study. Usual care will be provided with reference to a list of most frequently used treatments in neck pain-related patients from Korean Health Insurance Review and Assessment (HIRA) 2014 statistics. Frequency and types of physical therapy used will be recorded in a separate electronic case report form for outcome assessor blinding purposes.

Outcomes

Primary Outcome Measures

Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline
VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.

Secondary Outcome Measures

Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively
In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively
The NDI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to neck pain.
Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively
The NPQ evaluates functional impairment for the past 3 days in this study and is a patient reported outcome of subjective neck pain and pain reduction. The NPQ is a 9-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 5 levels, each representing a score of 0-4. Higher scores indicate greater limitation relating to neck pain.
Patient Global Impression of Change (PGIC)
PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
Physical examination
Pain upon movement in cervical range of motion (ROM) will be assessed.
Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively
EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).
Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
EQ-VAS uses a vertical 10cm line labeled at each end with scale anchors. EQ-VAS is used to indicate the patient's health state and patients are asked to mark a point that represents their health state between the anchors of 'worst health state' and 'best health state imaginable'. Scores are recorded in millimeters with a total range of 0-100 millimeters.
Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively
SF-12 is a simplified version of SF-36. SF-12 assesses health-related quality of life (HRQoL) across 8 domains with 1-2 items per domain: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Higher scores indicate better HRQoL.
Economic evaluation (medical costs)
Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.
Economic evaluation (time-related costs)
Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.
Economic evaluation (lost productivity costs)
Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.
Credibility and Expectancy Questionnaire
The credibility and expectancy questionnaire will be used to assess treatment expectation on a 9-point Likert scale. Participants will be asked to select an answer to the following questions on their first visit of Week 1 (1='not at all'; and 5='somewhat'; to 9='very much'): "How much do you expect that treatment will alleviate your symptoms during the study period?"
Drug Consumption
Drug type and dose of prescription for medicine or rescue medicine (acetaminophen), and type and frequency of other treatments (e.g. physical therapy, injections) will be recorded.
Adverse events
Physicians will monitor and record any unexpected or unintended patient reaction to Chuna or usual care at each visit. Adverse events (AEs) associated with Chuna will include, but not be limited to, AEs anticipated from previous reports of manual therapy, and will stay open to all possibilities taking into consideration other potential, unknown AEs.

Full Information

First Posted
September 23, 2017
Last Updated
July 31, 2019
Sponsor
Jaseng Medical Foundation
Collaborators
Kyung Hee University Hospital at Gangdong, Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT03294785
Brief Title
Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain
Official Title
Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain: A Multi-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation
Collaborators
Kyung Hee University Hospital at Gangdong, Michigan State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of Chuna manual therapy for chronic neck pain
Detailed Description
A multi-center randomized controlled, parallel, assessor-blinded trial will be conducted to evaluate the comparative clinical effectiveness and cost-effectiveness of Chuna manual therapy for chronic neck pain patients compared to usual care as assessed using pain, functional disability, health-related quality of life, economic evaluation, and safety measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chuna manual therapy
Arm Type
Experimental
Arm Description
The Chuna manual therapy group will receive Chuna manual therapy alone. Chuna manual therapy will employ a semi-standardized treatment plan of Chuna manual therapy through Chuna technique selection based on physician judgement of techniques from Chuna Medicine (Korean Society of Chuna Manual Medicine for Spine & Nerves: Chuna Medicine: Seoul: Korean Society of Chuna Manual Medicine for Spine & Nerves; 2017) and osteopathic manipulative medicine. The Chuna techniques employed in this study are divided into cervical, thoracic and rib cage, lumbar, pelvic, sacral, pubic, and hip joint area techniques. Chuna manual therapy sessions will be administered 2 sessions/week over a period of 5 weeks (total 10 sessions). The time duration of 1 Chuna manual therapy session will consist of approximately 10-20 minutes of diagnosis and approximately 10 minutes of treatment.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
The usual care group will receive usual care alone. Usual care will be limited to physical therapy and conventional medication in this study. Usual care will be provided with reference to a list of most frequently used treatments in neck pain-related patients from Korean Health Insurance Review and Assessment (HIRA) 2014 statistics. Frequency and types of physical therapy used will be recorded in a separate electronic case report form for outcome assessor blinding purposes.
Intervention Type
Procedure
Intervention Name(s)
Chuna manual therapy
Other Intervention Name(s)
Chuna manipulation
Intervention Description
Chuna is a Korean manual therapy that has absorbed and incorporated aspects of osteopathic manipulative medicine. Chuna manual therapy utilizes spinal manipulation techniques for joint mobilization including high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement, muscle energy, and fascial techniques.
Intervention Type
Drug
Intervention Name(s)
Conventional medication
Other Intervention Name(s)
Conventional medicine, Conventional drugs
Intervention Description
Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.
Intervention Type
Procedure
Intervention Name(s)
Physical therapy
Other Intervention Name(s)
Physiotherapy
Intervention Description
Physical therapy will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.
Primary Outcome Measure Information:
Title
Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline
Description
VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
Time Frame
Week 5 post-baseline (screening)
Secondary Outcome Measure Information:
Title
Difference between visual analogue scale (VAS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
Description
VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
Time Frame
Week 1, 2, 3, 4, 5, 6 post-baseline (screening)
Title
Difference between numeric rating scale (NRS) of neck pain for the past 3 days at each timepoint and baseline, respectively
Description
In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Difference between numeric rating scale (NRS) of radiating arm pain for the past 3 days at each timepoint and baseline, respectively
Description
In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Difference between Neck Disability Index (NDI) at each timepoint and baseline, respectively
Description
The NDI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to neck pain.
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Difference between Northwick Park Neck Pain Questionnaire (NPQ) at each timepoint and baseline, respectively
Description
The NPQ evaluates functional impairment for the past 3 days in this study and is a patient reported outcome of subjective neck pain and pain reduction. The NPQ is a 9-item questionnaire developed to assess the level of disability due to neck pain. Each item is graded into 5 levels, each representing a score of 0-4. Higher scores indicate greater limitation relating to neck pain.
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Patient Global Impression of Change (PGIC)
Description
PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
Time Frame
Week 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Physical examination
Description
Pain upon movement in cervical range of motion (ROM) will be assessed.
Time Frame
Week 1, 6 post-baseline (screening)
Title
Difference between the 5 level version of EuroQol-5 Dimension (EQ-5D-5L) at each timepoint and baseline, respectively
Description
EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
Description
EQ-VAS uses a vertical 10cm line labeled at each end with scale anchors. EQ-VAS is used to indicate the patient's health state and patients are asked to mark a point that represents their health state between the anchors of 'worst health state' and 'best health state imaginable'. Scores are recorded in millimeters with a total range of 0-100 millimeters.
Time Frame
Week 1, 6 post-baseline (screening)
Title
Difference between the Short Form Health Survey 12 (SF-12) at each timepoint and baseline, respectively
Description
SF-12 is a simplified version of SF-36. SF-12 assesses health-related quality of life (HRQoL) across 8 domains with 1-2 items per domain: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Higher scores indicate better HRQoL.
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Economic evaluation (medical costs)
Description
Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.
Time Frame
Week 1, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Economic evaluation (time-related costs)
Description
Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.
Time Frame
Week 2 post-baseline (screening)
Title
Economic evaluation (lost productivity costs)
Description
Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Credibility and Expectancy Questionnaire
Description
The credibility and expectancy questionnaire will be used to assess treatment expectation on a 9-point Likert scale. Participants will be asked to select an answer to the following questions on their first visit of Week 1 (1='not at all'; and 5='somewhat'; to 9='very much'): "How much do you expect that treatment will alleviate your symptoms during the study period?"
Time Frame
Week 1 post-baseline (screening)
Title
Drug Consumption
Description
Drug type and dose of prescription for medicine or rescue medicine (acetaminophen), and type and frequency of other treatments (e.g. physical therapy, injections) will be recorded.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening)
Title
Adverse events
Description
Physicians will monitor and record any unexpected or unintended patient reaction to Chuna or usual care at each visit. Adverse events (AEs) associated with Chuna will include, but not be limited to, AEs anticipated from previous reports of manual therapy, and will stay open to all possibilities taking into consideration other potential, unknown AEs.
Time Frame
Week 1, 2, 3, 4, 5, 6, Month 3, 6, 9, 12 post-baseline (screening) (every visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic neck pain patients (with pain duration of 3 months or longer) Patients with numeric rating scale (NRS) of radicular pain ≤ neck pain in neck pain patients with or without radiculopathy Patients with NRS of neck pain ≥5 during the 3 days Patients who have agreed to trial participation and provided written informed consent Exclusion Criteria: Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation) Patients with history of neck surgery Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcomes (e.g. chronic renal failure, vertebral artery complications, rheumatoid arthritis, Down syndrome) Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury Patients with severe mental illness Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results Patients who have received Chuna manual therapy or physical therapy, medicine such as nonsteroidal anti-inflammatory drugs (NSAIDs), or treatment(s) that may influence pain within the past week Pregnant patients or patients with plans of pregnancy Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, KMD, MPH
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bucheon Jaseng Hospital of Korean Medicine
City
Bucheon
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Haeundae Jaseng Hospital of Korean Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Daejeon Jaseng Hospital of Korean Medicine
City
Daejeon
Country
Korea, Republic of
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
ZIP/Postal Code
06110
Country
Korea, Republic of
Facility Name
Kyung Hee University Oriental Medicine Hospital at Gangdong
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34259850
Citation
Lee J, Cho JH, Kim KW, Lee JH, Kim MR, Kim J, Kim MY, Cho HW, Lee YJ, Lee SH, Shin JS, Prokop LL, Shin BC, Ha IH. Chuna Manual Therapy vs Usual Care for Patients With Nonspecific Chronic Neck Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2113757. doi: 10.1001/jamanetworkopen.2021.13757.
Results Reference
derived
PubMed Identifier
30497483
Citation
Do HJ, Shin JS, Lee J, Lee YJ, Kim MR, Cho JH, Kim KW, Ha IH. Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial. Trials. 2018 Nov 29;19(1):663. doi: 10.1186/s13063-018-3016-6.
Results Reference
derived

Learn more about this trial

Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain

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