UMIN-CTR Clinical Trial

Public title

Spine Buddy LT2 H/C ergonomic chair support short-term impact on spine pain and flexion-relaxation phenomenon

Acronym

Ergonomic chair pad impact

Scientific Title

Spine Buddy LT2 H/C ergonomic chair support short-term impact on spine pain and flexion-relaxation phenomenon

Scientific Title:Acronym

Ergonomic chair pad impact

Region

North America

Australia

Condition

Participants sat against an ice-pack cooled ergonomic chair support pad.

Classification by specialty

Orthopedics	Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The impact of an ergonomic chair support pad was measured with the Nordic Musculoskeletal Questionnaire (NMQ) and the surface EMG Flexion-Relaxation Phenomenon test. The intent of the study was to determine if the Spine Buddy LT2 H/C ergonomic chair support impacted these variables for participants.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Nordic Musculoskeletal Questionnaire form, and lower back motor unit action potential pattern during the surface EMG Flexion-Relaxation Phenomenon (FRP) test. The FRP test measures lower erector spinae muscle activity during a functional toe-touch task and is a common tool to measure back muscle coordination.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The Spine Buddy LT 2 H/C ergonomic chair support pad was connected to an office chair. Participants sat in the chair for 12 minutes at the end of their college student day (after approximately 6 hours of sitting in classrooms). The impact of the ergonomic pad on a musculoskeletal pain survey and a functional surface EMG test was monitored.

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

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

college student 18-65 years of age, provide written informed consent, and between 5'5" and 5'10"

Key exclusion criteria

Diagnosis of any blood vessel or neurological disorder that would result in a decreased ability to perceive pain, sweaty or damp clothing worn by participants, or wearing a sports bra or similar minimalist clothing that would put most of their back directly in contact with the cooled Spine Buddy product

Target sample size

32

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

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, Pasadena TX

TEL

2819985704

Homepage URL

Email

jward@txchiro.edu

Institute

Texas Chiropractic College

Institute

Department

Personal name

Organization

na

Organization

Division

Category of Funding Organization

Self funding

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

02

Month

19

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 demonstrated a statistically significant decrease in neck (p=0.005) and low back (p=0.000) pain/discomfort using the product. The extension and flexion phases of the FRP test showed that participants were approaching a more pain-free profile.
Conclusions: In this study, the addition of an ice-pack cooled chair support product to an office chair demonstrated an ability to lower neck and low back pain or discomfort and normalize FRP test results short-term.

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

10

Month

01

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2016

Year

02

Month

17

Day

Other related information

Registered date

2016

Year

02

Month

19

Day

Last modified on

2016

Year

02

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024335