UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017159 |
|---|---|
| Receipt number | R000019905 |
| Scientific Title | Immediate influence of lumbar spine manipulation on pain, functional reach, static balance, and walking gait kinematics of individuals with acute low back pain |
| Date of disclosure of the study information | 2015/04/18 |
| Last modified on | 2015/04/17 14:09:10 |
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Basic information
Public title
Immediate influence of lumbar spine manipulation on pain, functional reach, static balance, and walking gait kinematics of individuals with acute low back pain
Acronym
Manipulation impact on low back pain
Scientific Title
Immediate influence of lumbar spine manipulation on pain, functional reach, static balance, and walking gait kinematics of individuals with acute low back pain
Scientific Title:Acronym
Manipulation impact on low back pain
Region
| North America |
Condition
Condition
Manipulation
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measure how pain, functional reach, static balance, and walking gait are impacted by manipulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
baseline numeric rating scale (NRS) pain score assessment, functional reach test (FRT), static one-legged balance test of both lower limbs, and 1.5 mph walking gait evaluation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Spinal manipulation to L3, bilaterally.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Possess acute LBP, 18-90 years of age, provide informed written consent, report no contraindication to manipulation, answer no to PAR-Q questions, and participant does not report engaging in strenuous exercise.
Key exclusion criteria
surgery in the past year, broken bones in the past year, reported neurologic condition, diagnosis of lower limb pathology that would impair walking, pregnancy, history of alcohol abuse, hypertonia, use of a cane or similar device, visual impairment, vertigo, taking medication that impairs balance, cannot be a student or faculty member.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | John Ward, DC, MA, MS |
Organization
Texas Chiropractic College
Division name
Research
Zip code
Address
5912 Spencer Highway, Pasadena, TX 77505
TEL
2819985704
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 77505
TEL
2819985704
Homepage URL
jward@txchiro.edu
Sponsor or person
Institute
TCC
Institute
Department
Personal name
Funding Source
Organization
TCC
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2015 | Year | 04 | Month | 18 | 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: Participants in the Manip group decreased their pain by 1.4 points (p=0.000), and increased their FRT by 41.5 mm (p=0.012), step length by 13.5 mm (p=0.019), and stride length by 40.0 mm (p=0.030). Participants in the No-Manip group only increased their FRT by 10.5 mm (p=0.011).
Conclusions: Short-term, spinal manipulation of acute LBP patients resulted in a decrease in pain, and small improvements in functional reach, step length, and stride length.
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
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 17 | Day |
Last modified on
| 2015 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019905
