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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020808
Receipt No. R000024022
Scientific Title Pilot study of spinal manipulation impact on sport-specific reaction time and core proprioception amongst participants with spine pain
Date of disclosure of the study information 2016/01/31
Last modified on 2016/02/04

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Basic information
Public title Pilot study of spinal manipulation impact on sport-specific reaction time and core proprioception amongst participants with spine pain
Acronym Spinal manipulation impact on reaction time and proprioception
Scientific Title Pilot study of spinal manipulation impact on sport-specific reaction time and core proprioception amongst participants with spine pain
Scientific Title:Acronym Spinal manipulation impact on reaction time and proprioception
Region
North America

Condition
Condition Exercise performance
Classification by specialty
Medicine in general Neurology Orthopedics
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1)Determine the impact of spinal manipulative therapy on reaction time and core proprioception.
Basic objectives2 Others
Basic objectives -Others 1)Measure reaction time during a basketball simulation task on a force plate, 2)measure angle change in relation to turning the core during a football player simulation turning task
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Basketball reaction time task
Prior to utilizing the force plate during each data collection it was zeroed. Participants stood in a crouched triple threat basketball position on top of the Bertec 4060 NC force plate. Two strips of duct tape were placed on top of the force plate to mark foot placement for all participants for standardization. The participants were instructed to place their feet just lateral to the two strips of duct tape and hold a basketball in their hands. A computer screen displayed a timed PowerPoint to the participants, which instructed them to cut to their immediate left off of the force plate as quickly as possible. The jump left command appeared after 5 seconds. The VICON software was synchronized to begin recording at the same time as the PowerPoint display began. Participants were all asked to perform one practice cutting maneuver prior to being recorded. A small gray box was taped to the left of the force plate as a target for participants to aim for with their lead outside foot. Researchers chose to have participants only cut left for standardization. The time to get both feet off the force plate was recorded. This was determined by the force plate reaching 0 Newtons of force relative to time. Force plate data was recorded at 1,000 Hz.

Key secondary outcomes Football hip proprioception task
Participants stood with their right upper extremity extended to the front at shoulder level simulating a blocking maneuver, while holding a football just above their left hip. The right lower limb was extended forward in line with the right shoulder while the left lower limb was extended to the back in line with the left shoulder. Participants were asked to place their heels at the base of tape marks on the ground before starting the activity. Silver 19mm MoCap reflective markers were placed on their right and left anterior superior iliac spine using surgical tape. The Vicon MX camera motion analysis system consisted of 8 infrared Bonita 0.3 megapixel cameras and was calibrated daily as suggested by the manufacturer. Kinematic data were recorded at 100 Hz using Nexus 1.7.1 software. After participants assumed the starting position the motion recording was begun. Within approximately two seconds participants were verbally commanded to turn their hips 90 degrees to the left along with the rest of their body and then freeze. At baseline, mathematically a line was formed between their ASIS. After turning to the left and freezing a second line was established between their ASIS at the new position and the angle between the two lines was calculated. The ability of the participant to accurately reach 90 degrees was used as a measure of participant core proprioception capability.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 25 participants were healthy controls.13 participants received spinal manipulation to treat spine pain. 16 participants had spine pain, but did not receive spine manipulation
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
50 years-old >=
Gender Male and Female
Key inclusion criteria 1) between 18-55 years of age
Key exclusion criteria 1) severe osteoporosis, multiple myeloma, osteomyelitis, bone tumor, Paget's disease, cauda equina syndrome, spinal cord tumor, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or unstable bleeding disorder
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rebekah Wilks, BS, BA
Organization Texas Chiropractic College
Division name Research
Zip code
Address 5912 Spencer Highway
TEL 2819985704
Email jward@txchiro.edu

Public contact
Name of contact person
1st name
Middle name
Last name John Ward, DC, MA, MS
Organization Texas Chiropractic College
Division name Research
Zip code
Address 5912 Spencer Highway
TEL 2819985704
Homepage URL
Email jward@txchiro.edu

Sponsor
Institute Texas Chiropractic College
Institute
Department

Funding Source
Organization Texas Chiropractic College
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
2016 Year 01 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: Participants with spine pain showed greater impairment in core proprioception at baseline than those with no pain. Participants who received SMT approximated 90 degrees more closely in relation to their peers on the post-test (p=0.005). There was no difference in reaction time between groups (p=0.219).
Conclusions: Spinal manipulation did not improve reaction time, but it did increase approximation to 90 degrees during the hip rotation task for participants with spine pain.

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
2015 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 01 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 31 Day
Last modified on
2016 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024022

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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