UMIN-CTR Clinical Trial

Public title

Immediate effects of cervical spine manipulation on upper extremity ergometer performance to muscle failure amongst asymptomatic participants

Acronym

upper limb endurance and manipulation

Scientific Title

Immediate effects of cervical spine manipulation on upper extremity ergometer performance to muscle failure amongst asymptomatic participants

Scientific Title:Acronym

upper limb endurance and manipulation

Region

North America

Condition

Cervical spine manipulation

Classification by specialty

Medicine in general	Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Researchers measured how cervical spine manipulation impacted upper extremity exercise performance.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Exercise time to exhaustion, exercise heart rate, blood lactate, post 1-min Rating of Perceived Exertion (RPE), and post 5-min RPE were recorded during each session.

Key secondary outcomes

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Cervical 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

20

years-old

<=

Age-upper limit

55

years-old

>=

Gender

Male and Female

Key inclusion criteria

no contraindication to cervical SMT,
between the ages of 20-55 years of age,
answer no to all sections of the Physical
Activity Readiness Questionnaire,
they provided their informed written consent

Key exclusion criteria

unstable fractures, neck surgery, multiple myeloma, osteopenia, primary bone tumor
, Paget's disease
, spinal cord tumor
, rheumatoid arthritis
, psoriatic arthritis
, ankylosing spondylitis
, Reiter's syndrome
, unstable bleeding disorders
, receiving cervical SMT in the past 2 days
, report shoulder, elbow, wrist, or
hand injury
, body pain rated greater than a 3 on
a 1-10 Numeric Rating Scale

Target sample size

46

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

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

Institute

Texas Chiropractic College

Institute

Department

Personal name

Organization

None

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

2015

Year

05

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Objective: The purpose of the study was to determine if cervical spinal manipulative therapy (SMT) impacted upper extremity ergometer performance to muscle failure amongst asymptomatic participants.
Methods: Forty-six healthy chiropractic college students were randomized into three study groups using an AB:BA crossover study design with an additional control arm (BB). Each week, of the two-week protocol, participants engaged in a Monark; upper extremity ergometer test at 50 W resistance for females and 100 W for males while maintaining 50 rpm until muscle failure. Group 1(AB) received cervical SMT prior to testing during week one and no SMT prior to testing during week two. Similarly, Group 2(BA) received no SMT week one and SMT week two. Group 3(BB) did not receive SMT either week. Exercise time to exhaustion, exercise heart rate, blood lactate, post 1-min Rating of Perceived Exertion (RPE), and post 5-min RPE were recorded during each session. A paired samples t-test was used to make comparisons between A and B conditions, and to track test acclimation in the BB group.
Results: There was no statistically significant difference between SMT and no-SMT conditions for time to exhaustion (p=0.712), heart rate (p=0.220), blood lactate (p=0.462), post 1-min RPE (0.804) and post 5-min RPE (0.561); however, the week that participants received cervical SMT their heart rate was 8.5 beats higher than the week they did not at test completion.
Conclusions: Preliminarily, this research demonstrates that cervical SMT does not impact upper extremity ergometer performance amongst asymptomatic participants to a statistically significant level.

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

2014

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2014

Year

05

Month

02

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2015

Year

02

Month

28

Day

Other related information

Registered date

2015

Year

05

Month

08

Day

Last modified on

2015

Year

05

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020236