AzTrials
AzTrials

Low Back PainNCT02513173

Effects of Different Verbal Instructions in Healthy Adults and Patients With Low Back Pain

An observational study of Low Back Pain, run by Texas Woman's University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Low Back Pain
How many people
42 participants
Where
No sites listed yet
Study dates
Jan 2014to Jan 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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).

Who cannot join

  • 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).

About this study

Official title: Effects of Different Verbal Instructions on Lumbar Multifidus Muscle Activation in Healthy and Patients With Low Back Pain

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.

Read the detailed description

Participants:

Eligible participants were English-speaking adults 18 years of age or older. Additional criteria for asymptomatic healthy adults included no existing low back pain (LBP) and no LBP in the past year. Additional criteria for patient participants included 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).

Exclusion criteria for all participants included 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).

After participants were informed of the risks, benefits and procedures of the study, they were asked to sign a written consent form approved by the TWU Institutional Review Board - Dallas. Eligible participants were asked to complete an intake form, asking them about their age, gender, and past medical history. For participants with existing LBP, they were asked about their pain location, duration, intensity, and nature of their existing LBP and their LBP history. The height and body weight of each participant were taken to determine the body mass index (BMI). BMI has been shown to be a factor affecting muscle size.

Instrumentation:

  1. The Modified Oswestry Low Back Pain Index (OSW) questionnaire was used to determine an individual's perceived disability and function limitation due to his/her low back pain. The OSW questionnaire has been shown to be reliable and valid.
  2. A Sonosite M-Turbo ultrasound scanner (Sonosite, Inc., Bothell, WA) was used to measure muscle size of the lumbar multifidus. A curvilinear transducer (3-5 MHz) will be used to take transverse images of segmental lumbar multifidus at the L5-S1 segment. If the patient has multiple painful segments, the most painful segment will be imaged. The most common painful segments are L4-5 or L5-S1 in patients with LBP.
  3. The ImageJ software (free download from the NIH website) was used to determine muscle thickness off-line.

US Image Acquisition:

Participants was lying in prone on an examination table with their arms on the sides. A pillow was placed under the participant's abdomen to flatten the lumbar lordotic curve and an inclinometer was placed on the lumbosacral junction to ensure the lumbar curve ≤10.

The right side of asymptomatic healthy adults and the painful side of patients with low back pain were imaged. The spinous processes of the right L5-S1 or the painful segment were identified by palpation and marked with an erasable pen. Next, the spinous process was verified using US imaging. Transverse images of the segmental multifidus muscle were captured by placing the transducer horizontally on the spinous process of the target segment. The transverse image of segmental lumbar multifidus was taken 3 times "at rest" and 3 times during muscle activations of the lumbar multifidus. Activation of lumbar multifidus was achieved by asking participants to generate a slow gentle sustained (isometric) contraction of the lumbar multifidus using 3 different verbal instructions without moving their spine or pelvis. Participants held each contraction for 3-5 seconds. The order of 3 verbal instructions was given in a random order to minimize the learning and fatigue effects. Therefore, each participant performed a total of 9 lumbar multifidus muscle contractions during each testing session. Prior to taking ultrasound images, the anatomy and location of the lumbar multifidus muscle were explained and shown to participants using a model and pictures. Next, the following 3 verbal instructions were used to generate a multifidus contraction:

Breathe in and out and:

  1. Without moving your spine, try to "swell" the muscle underneath the transducer.
  2. Without moving your spine, draw your spinal column in toward your belly button.
  3. Attempt to elongate your spine by drawing the muscles in your back up toward your head.

All participants were asked to return one week later, the procedure was repeated. The order of verbal instructions also was randomized in the 2nd session.

Conditions
Low Back Pain
Keywords
low back pain, verbal instruction, lumbar multifidus, ultrasound imaging, Muscle thickness
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02513173
Study groupRoleWhat they receive
Low back pain groupNo intervention
ControlNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Participants were measured and then followed-up one week later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02513173
Sponsor's protocol ID
TWU17581
Status last verified
Jul 2015
First submitted
24 Jul 2015
Last updated
18 Oct 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by Texas Woman's University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasonographic muscle thickness measurement of lumbar multifidus (time frame: Participants were measured and then followed-up one week later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in