UMIN-CTR Clinical Trial

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

Exercise performance

Classification by specialty

Medicine in general	Neurology	Orthopedics
Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Texas Chiropractic College

Institute

Department

Personal name

Organization

Texas Chiropractic College

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

01

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

01

Month

31

Day

Last modified on

2016

Year

02

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024022