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.
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:
- 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.
- 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.
- 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:
- Without moving your spine, try to "swell" the muscle underneath the transducer.
- Without moving your spine, draw your spinal column in toward your belly button.
- 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 group | Role | What they receive |
|---|---|---|
| Low back pain group | No intervention | |
| Control | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted31 Jul 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Verbal Instructions on Lumbar Multifidus Muscle Activation in Healthy and Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT02513173
- Acronym / sponsor ID
- TWU17581
- Conditions
- Low Back Pain
- Keywords
- low back pain, verbal instruction, lumbar multifidus, ultrasound imaging, Muscle thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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:
- Without moving your spine, try to "swell" the muscle underneath the transducer.
- Without moving your spine, draw your spinal column in toward your belly button.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low back pain group | – | –No intervention |
| Control | – | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants are English-speaking adults 18 years of age or older, with or without low back pain.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- previous low back surgery,
- systemic joint disease (e.g. rheumatoid arthritis),
- cancer of the lower quadrant,
- neurological disorders,
- allergic reaction to ultrasound gel, or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ultrasonographic muscle thickness measurement of lumbar multifidus
Time frame: Participants were measured and then followed-up one week later
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.