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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017159
Receipt No. 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

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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
Last 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
Email jward@txchiro.edu

Public contact
1st 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
Email jward@txchiro.edu

Sponsor
Institute TCC
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019905

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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