NCT04772950

Brief Summary

The first propose of the study is to understand the contraction of deep and superficial multifidus in patients with non-specific low back pain and the elderly. The second purpose of the study is to understand the relationship between the multifidus and the functional performance in patients with non-specific low back pain and the elderly. The hypothesis is that the patients with non-specific low back pain and the elderly have less ability to contract the deep multifidus then asymptomatic adults and younger adults. Besides, the multifidus is correlated to the functional performance.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

May 25, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 23, 2021

Last Update Submit

May 20, 2021

Conditions

Outcome Measures

Primary Outcomes (8)

  • Change of superficial multifidus

    change of superficial multifidus during contraction by using ultrasound image

    10 minutes

  • Change of deep multifidus

    change of deep multifidus during contraction by using ultrasound image

    10 minutes

  • Disability index

    use Oswestry Disability Index

    5 minutes

  • Timed up and go test

    Examiner will record the seconds the subjects spend in the test including standing up, walking, turn around and sit down.

    3 minutes

  • Sit to stand test

    Subjects will repeat 5 times sit to stand and the seconds subjects spend will be recorded.

    3 minutes

  • Countermovement jump test

    The subjects start from an upright standing position, makes a preliminary downward movement by flexing at the knees and hips, then immediately extends the knees and hips again to jump vertically up off the ground. The distance which the subjects jump for will be recorded.

    3 minutes

  • Sahrmann five-level core stability test

    Examiner will use stabilizer pressure biofeedback unit to detect whether there is lumbar motion during different levels of lower extremities movement.

    5 minutes

  • Rotatory stability test

    Rotatory stability test is one of the test from functional movement screen. Subjects will start in quadruped position and move the extremities to maintain the spine in neutral position.

    3 minutes

Study Arms (2)

Healthy adults

Patients with non-specific low back pain

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with non-specific low back pain

You may qualify if:

  • age 20-90
  • have lumbar region discomfort in the past three months, and the discomfort is more than one day
  • have diagnosis of non-specific low back pain

You may not qualify if:

  • have received surgery of lumbar or lower extremities
  • neurological symptom (eg. numbness of lower extremities)
  • have no ability to stand and walking independently
  • cancer
  • systemic disease (eg. ankylosing spondylitis, rheumatoid arthritis, Systemic lupus erythematosus)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shing-Tian, Chiang

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Shing-Tian Chiang

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 26, 2021

Study Start

March 8, 2021

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

May 25, 2021

Record last verified: 2021-02

Locations