NCT02513173

Brief Summary

Segmental stabilization exercise has been shown to be effective in the rehabilitation of low back pain (LBP). Due to the isometric nature of segmental stabilization exercise, manual therapists use various verbal instructions to elicit lumbar multifidus muscle contraction. The purpose of this study was to assess whether or not three verbal instructions would alter muscle thickness of the lumbar multifidus differently in asymptomatic individuals and patients with LBP. Three verbal instructions were selected for this study: (1) swell the muscle underneath the transducer, (2) draw your belly button in towards your spinal column, and (3) think about tilting your pelvis but without really doing it. Lumbar multifidus muscle thickness was determined using parasagittal ultrasound imaging. Measurements of muscle thickness were collected at rest and during verbal instructions from 21 asymptomatic adults and 21 patients with LBP. Percent changes of muscle thickness during contraction and at rest were compared between groups and across verbal instructions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
Last Updated

October 18, 2021

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

July 24, 2015

Last Update Submit

October 15, 2021

Conditions

Keywords

low back painverbal instructionlumbar multifidusultrasound imagingMuscle thickness

Outcome Measures

Primary Outcomes (1)

  • Ultrasonographic muscle thickness measurement of lumbar multifidus

    Muscle thickness of lumbar multifidus was measured at rest and during contraction under each of 3 verbal instructions on two visits with an average of one week apart.

    Participants were measured and then followed-up one week later

Study Arms (2)

Low back pain group

No intervention

Control

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible participants are English-speaking adults 18 years of age or older, with or without low back pain.

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 (numeric pain rating scale of 0-10, 0 being no pain, 10 being unbearable pain).

You may not qualify if:

  • previous low back surgery,
  • systemic joint disease (e.g. rheumatoid arthritis),
  • cancer of the lower quadrant,
  • neurological disorders,
  • allergic reaction to ultrasound gel, or
  • inability to obtain testing positions (prone lying).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 31, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 18, 2021

Record last verified: 2015-07