NCT02836860

Brief Summary

The purpose of this study is to compare combined tactile stimulation and verbal instruction to verbal instruction only on lumbar multifidus muscle activation in asymptomatic healthy adults and in patients with LBP.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

July 14, 2016

Last Update Submit

July 18, 2016

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Electromyographic (EMG) amplitude

    Surface EMG activity of the right and left lumbar multifidus at L4-5 level

    8 seconds, 5 repetitions during one visit

Study Arms (2)

Healthy Controls

OTHER

Effects of tactile stimulation on lumbar multifidus activation in healthy adults without LBP.

Other: Tactile stimuli

Low Back Pain

OTHER

Effects of tactile stimulation on lumbar multifidus activation in adults with LBP.

Other: Tactile stimuli

Interventions

Tactile stimuliOTHER

Both groups will receive tactile stimuli: hand touch on the right and left lumbar multifidus muscles at L4-5

Healthy ControlsLow Back Pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Additional criteria for asymptomatic healthy adults include no existing LBP and no LBP in the past year. Additional criteria for patient participants include existing LBP near the L5-S1 level with an average pain intensity score ≥ 2/10 in the past 24 hours (numeric pain rating scale of 0-10, 0 being no pain, 10 being unbearable pain).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sharon Wang-Price, PhD

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Wang-Price, PhD

CONTACT

214-689-7715swang@twu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 19, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 20, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)