UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030640 |
|---|---|
| Receipt number | R000034985 |
| Scientific Title | Case series of the week-by-week changes in pain, function, and presenteeism amongst chiropractic patients with chronic LBP treated over 4 weeks. |
| Date of disclosure of the study information | 2017/12/31 |
| Last modified on | 2017/12/30 09:54:24 |
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Basic information
Public title
Case series of the week-by-week changes in pain, function, and presenteeism amongst chiropractic patients with chronic LBP treated over 4 weeks.
Acronym
Chiropractic low back pain patient outcomes
Scientific Title
Case series of the week-by-week changes in pain, function, and presenteeism amongst chiropractic patients with chronic LBP treated over 4 weeks.
Scientific Title:Acronym
Chiropractic low back pain patient outcomes
Region
| North America |
Condition
Condition
Participants received 2 treatment sessions per week for the first 3 weeks and 1 treatment in the 4th week. Chiropractic care included spinal manipulation and passive care for the first 2 weeks, followed by spinal manipulation and primarily active care for the remaining 2 weeks of the study.
Classification by specialty
| Medicine in general | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Participants completed a 0-10 pt numeric rating scale for pain (NRS), 0-24 pt Roland-Morris LBP and Disability Questionnaire (RDQ), and 1-5 pt Stanford Presenteeism Survey (a measure of impaired work performance) on day 0, 7, 14, 21, and 28 of care as patient outcomes were measured due to chiropractic care for low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numeric rating scale for pain, Roland Morris Questionnaire, and Stanford Presenteeism Scale.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic non-specific LBP, between 18-75 years of age, possessing a job, and providing informed consent.
Key exclusion criteria
unstable fractures, severe osteoporosis, multiple myeloma, osteomyelitis, primary bone tumor, Paget disease, cauda equina, rheumatoid arthritis, ankylosing spondylitis, Reiter syndrome, abdominal aortic aneurysm, and spondylolisthesis.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | John Ward |
Organization
Texas Chiropractic College
Division name
Research
Zip code
Address
5912 Spencer Highway, Pasadena TX 77504
TEL
281-236-4908
jward@txchiro.edu
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | John Ward |
Organization
Texas Chiropractic College
Division name
Research
Zip code
Address
5912 Spencer Highway, Pasadena TX 77504
TEL
281-236-4908
Homepage URL
jward@txchiro.edu
Sponsor or person
Institute
Texas Chiropractic College and NCMIC.
Institute
Department
Personal name
Funding Source
Organization
NCMIC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Results: In this study, NRS pain and RDQ improved as follows at the conclusion of 4 weeks: NRS 6.1 to 2.9, RDQ 9.1 to 4.9. Pain improved to statistically significant levels by day 14 (p=0.000), and the RDQ by day 21 (p=0.026). It took until day 28 for responses to most questions on the SPS-6 to reach statistical significance. The 2 attributes of the SPS-6 that improved the most were: ability to cope with work stress (improved from 3.3 to 2.3) and feeling of hopelessness to finish work tasks (improved from 3.1 to 2.1).
Management information
Registered date
| 2017 | Year | 12 | Month | 30 | Day |
Last modified on
| 2017 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034985
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
