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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030640
Receipt No. 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

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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
Email 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
Email jward@txchiro.edu

Sponsor
Institute Texas Chiropractic College and NCMIC.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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