NCT02848456

Brief Summary

This study investigated the effects of spinal manipulation on central nervous system activity. The presence of postactivation potentiation, an increase in muscular force production following prior muscular contractions, was measured with electromyography and the muscular force production during electrically-induced calf muscle reflexes. It was hypothesized that significantly greater potentiation would be stimulated by a calf muscle contraction with spinal manipulation delivered immediately beforehand than the potentiation arising from the contraction only.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

July 13, 2016

Last Update Submit

April 17, 2017

Conditions

Keywords

Manipulation, SpinalH-ReflexMuscle ContractionMuscle Strength Dynamometer

Outcome Measures

Primary Outcomes (2)

  • Changes in H-reflex amplitudes of the gastrocnemius and soleus muscles compared to baseline

    Peak-to-peak EMG amplitudes (mV) at Hmax of the gastrocnemius and soleus were recorded before and immediately following the three separate treatments

    Data were collected at 17 time points during a 20-minute tibial nerve electrical stimulation protocol post-treatment: 20 seconds, 40 seconds, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 14:00, 16:00, 18:00 and 20:00 minutes

  • Changes in isometric twitch torques of the gastrocnemius and soleus muscles compared to baseline

    Twitch torques (Nm) of the gastrocnemius and soleus at Mmax were recorded before and immediately following the three separate treatments

    Data were collected at 17 time points during a 20-minute tibial nerve electrical stimulation protocol post-treatment: 10 seconds, 30 seconds, 50 seconds, 1:30, 2:30, 3:30, 4:30, 5:30, 6:30, 7:30, 8:30, 9:30, 11:00, 13:00, 15:00, 17:00 and 19:00 minutes

Study Arms (3)

Spinal Manipulation SM

ACTIVE COMPARATOR

In a repeated measures, crossover design, all subjects received one of three randomized treatments during three separate sessions: SM; a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or the manipulation immediately preceding the contraction (SM+MVIC).

Procedure: Spinal Manipulation

Max Voluntary Isometric Contraction MVIC

ACTIVE COMPARATOR

In a repeated measures, crossover design, all subjects received one of three randomized treatments during three separate sessions: SM; a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or the manipulation immediately preceding the contraction (SM+MVIC).

Procedure: Max Voluntary Isometric Contraction

SM+MVIC

ACTIVE COMPARATOR

In a repeated measures, crossover design, all subjects received one of three randomized treatments during three separate sessions: SM; a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or the manipulation immediately preceding the contraction (SM+MVIC).

Procedure: SM+MVIC

Interventions

Manual, side-posture, high-velocity low-amplitude spinal manipulation targeting the lower lumbar spine and sacroiliac joints

Spinal Manipulation SM

A 10 second plantar flexion maximal voluntary isometric contraction

Max Voluntary Isometric Contraction MVIC
SM+MVICPROCEDURE

The spinal manipulation immediately preceding the maximal voluntary isometric contraction

SM+MVIC

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least one year of resistance training experience and current completion of at least three training sessions per week
  • Males needed to be able to back squat a minimum load of 1.5 x body weight
  • Females needed to be able to back squat 1 x body weight

You may not qualify if:

  • Any pain in the lower back, abdomen or legs and/or surgeries performed in these regions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Education, Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, KY

Lexington, Kentucky, 40506, United States

Location

Related Publications (48)

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MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Grant D Sanders, D.C., Ph.D.

    College of Education, Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, KY

    PRINCIPAL INVESTIGATOR
  • James W Yates, Ph.D.

    College of Education, Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, KY

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 28, 2016

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Shared data include the subjects' reflexive EMG amplitudes and peak torques of the gastrocnemius and soleus during the Hoffmann Reflex electrical stimulation protocol at the conclusion of each data collection session. These raw data are available in Appendix K of the PI's dissertation, which may be obtained at http://uknowledge.uky.edu/khp\_etds/27/

Locations