Low Back PainNCT02836860
Effects of Tactile Stimuli for Lumbar Multifidus Muscle Activation in Healthy Adults and Patients With Low Back Pain
A study testing Tactile stimuli in people with Low Back Pain, run by Texas Woman's University at 1 site in United States.
Trial 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. 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
- What is being tested?
- Tactile stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2017
- Phase
- Interventional
- 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
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 in the past 24 hours (numeric pain rating scale of 0-10, 0 being no pain, 10 being unbearable pain).
Who cannot join
- Exclusion criteria for all participants include 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Woman's University
Dallas, Texas, 75235
Sharon Wang-Price, PhD, 214-689-7715, swang@twu.edu
About this study
Official title: Effects of Adding Tactile Stimuli to Verbal Instructions for Lumbar Multifidus Muscle Activation in Healthy Adults and Patients With Low Back Pain
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.
Read the detailed description
Reduced lumbar multifidus muscle contraction has been observed in patients with low back pain (LBP). Currently, considerable evidence supports spinal stabilization exercises for treating LBP, including lumbar multifidus muscle activation exercises. Clinicians often apply a tactile stimulation on the muscle in addition to verbal instructions to ensure muscle activation. However, whether or not the addition of tactile stimulation would increase muscle activation has not been studied. Therefore, the investigators plan to use electromyography (EMG) to examine if addition of tactile stimulation to verbal instructions would increase lumbar multifidus muscle activation in healthy adults and patients with LBP.
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. The research hypothesis is that the lumbar multifidus muscle activation will be increased when the participants are given combined tactile stimulation and verbal instruction as compared to when the participants are given verbal instruction only.
Participants:
Eligible participants are English-speaking adults 18 years of age or older. 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). Exclusion criteria for all participants include 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).
The investigators plan to enroll 20 asymptomatic healthy adults, and 20 patients with LBP. Potential participants will be recruited from the local community (including but not limited to Texas Woman's University - Dallas) via flyers. The flyers will be posted at the TWU - Dallas campus and other community centers with approval. Participants who are interested in taking part in the study will be asked to call investigators to schedule an appointment time for testing. The consent form will be presented at the beginning of the appointment.
Procedures:
After participants are informed of the risks, benefits and procedures of the study, they will be asked to sign a written consent form approved by the TWU Institutional Review Board - Dallas. Eligible participants will be asked to complete an intake form, asking them about their age, gender, and past medical history. For participants with existing low back pain, they will be asked about their pain location, duration, intensity, and nature, medicine use of their existing LBP and their LBP history.
Instrumentation
- The Modified Oswestry Low Back Pain Index (OSW) questionnaire will be 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 Delsys EMG system with 2 wireless surface electrodes (Delsys Inc., Boston, MA) will be used to obtain muscle activities. The bandwidth of the EMG system will be set at 20 to 450 Hz with a gain of 1,000. The EMG signal will be recorded at a sampling rate of 1,000 Hz. Each surface electrode has a built-in reference electrode.
EMG Recording Prior to EMG recording, the anatomy and location of the lumbar multifidus muscle will be explained and shown to participants using a model and pictures. Next, participants will lie in prone on an examination table with their arms on the sides. A pillow will be placed under the participant's abdomen to flatten the lumbar lordotic curve and an inclinometer will be placed on the lumbosacral junction to ensure the lumbar curve ≤10 degrees. The spinous processes of the L4-S2 and sacral sulcus will be identified by palpation and marked with an erasable pen.
Next, one investigator will prepare the participant's skin in the areas of the 2 electrode placements. The skin will be cleaned with isopropyl alcohol. If there is excessive hair, a new disposable razor will be used to shave the hair to improve the quality of the EMG recording. If shaving is required, the investigator will wear gloves to perform shaving following universal precautions. Once the skin is prepared for EMG recording, 2 electrodes will be placed on the skin over the right and left lumbar multifidus at two at the L4-5 level.
The EMG of lumbar multifidus will be recorded 3 times "at rest" first prior to each of muscle activation conditions: (1) verbal instruction only, and (2) combined tactile stimulation and verbal instruction. For both the muscle activation conditions, the participant will be asked to assume a starting position: abduct the contralateral shoulder and flex the contralateral elbow to approximately 90°. The contralateral side will be opposite to the painful side of patients with LBP or the left side of the asymptomatic participants. If the patient has bilateral LBP, the contralateral side will be the less painful side.
During verbal instruction, one investigator will give a verbal instruction and then ask the participant to perform a contralateral-arm task, in which the participant will lift the contralateral arm approximately 5 cm above the table and hold for 5 seconds. The verbal instruction was selected based on our published pilot study which showed that this instruction seemed to activate lumbar multifidus muscle the most: "Breathe normally, without moving the pelvis or spine, think about tilting the pelvis forward without actually moving it, and lift the left (right) arm".
During tactile stimulation, the investigator will place his/her middle 2 or 3 fingers on the lumbar multifidus at L5-S1 between the 2 electrodes before the verbal instruction is given. The investigator will then give the same verbal instruction and ask the participant to perform the contralateral-arm-lift task while maintaining finger contact on the multifidus muscle during muscle activation. EMG testing will start after the verbal instruction is completed.
For each muscle activation condition, participants will hold each contraction for 5-8 seconds, and a 10-minute rest will be given between the 2 contraction conditions.
- Conditions
- Low Back Pain
- Being tested
- Tactile stimuli
- 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.
Tactile stimuliOther
Both groups will receive tactile stimuli: hand touch on the right and left lumbar multifidus muscles at L4-5
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Other | Effects of tactile stimulation on lumbar multifidus activation in healthy adults without LBP. Receives: Other: Tactile stimuli |
| Low Back Pain | Other | Effects of tactile stimulation on lumbar multifidus activation in adults with LBP. Receives: Other: Tactile stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic (EMG) amplitude
Surface EMG activity of the right and left lumbar multifidus at L4-5 level
Measured: 8 seconds, 5 repetitions during one visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Wang-Price, Texas Woman's University
- Investigators
- Sharon Wang-Price, PhD, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836860
- Sponsor's protocol ID
- 17920
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Tactile Stimuli to Verbal Instructions for Lumbar Multifidus Muscle Activation in Healthy Adults and Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT02836860
- Acronym / sponsor ID
- 17920
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Jul 2016 (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.
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.
Detailed description
Reduced lumbar multifidus muscle contraction has been observed in patients with low back pain (LBP). Currently, considerable evidence supports spinal stabilization exercises for treating LBP, including lumbar multifidus muscle activation exercises. Clinicians often apply a tactile stimulation on the muscle in addition to verbal instructions to ensure muscle activation. However, whether or not the addition of tactile stimulation would increase muscle activation has not been studied. Therefore, the investigators plan to use electromyography (EMG) to examine if addition of tactile stimulation to verbal instructions would increase lumbar multifidus muscle activation in healthy adults and patients with LBP.
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. The research hypothesis is that the lumbar multifidus muscle activation will be increased when the participants are given combined tactile stimulation and verbal instruction as compared to when the participants are given verbal instruction only.
Participants:
Eligible participants are English-speaking adults 18 years of age or older. 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). Exclusion criteria for all participants include 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).
The investigators plan to enroll 20 asymptomatic healthy adults, and 20 patients with LBP. Potential participants will be recruited from the local community (including but not limited to Texas Woman's University - Dallas) via flyers. The flyers will be posted at the TWU - Dallas campus and other community centers with approval. Participants who are interested in taking part in the study will be asked to call investigators to schedule an appointment time for testing. The consent form will be presented at the beginning of the appointment.
Procedures:
After participants are informed of the risks, benefits and procedures of the study, they will be asked to sign a written consent form approved by the TWU Institutional Review Board - Dallas. Eligible participants will be asked to complete an intake form, asking them about their age, gender, and past medical history. For participants with existing low back pain, they will be asked about their pain location, duration, intensity, and nature, medicine use of their existing LBP and their LBP history.
Instrumentation
- The Modified Oswestry Low Back Pain Index (OSW) questionnaire will be 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 Delsys EMG system with 2 wireless surface electrodes (Delsys Inc., Boston, MA) will be used to obtain muscle activities. The bandwidth of the EMG system will be set at 20 to 450 Hz with a gain of 1,000. The EMG signal will be recorded at a sampling rate of 1,000 Hz. Each surface electrode has a built-in reference electrode.
EMG Recording Prior to EMG recording, the anatomy and location of the lumbar multifidus muscle will be explained and shown to participants using a model and pictures. Next, participants will lie in prone on an examination table with their arms on the sides. A pillow will be placed under the participant's abdomen to flatten the lumbar lordotic curve and an inclinometer will be placed on the lumbosacral junction to ensure the lumbar curve ≤10 degrees. The spinous processes of the L4-S2 and sacral sulcus will be identified by palpation and marked with an erasable pen.
Next, one investigator will prepare the participant's skin in the areas of the 2 electrode placements. The skin will be cleaned with isopropyl alcohol. If there is excessive hair, a new disposable razor will be used to shave the hair to improve the quality of the EMG recording. If shaving is required, the investigator will wear gloves to perform shaving following universal precautions. Once the skin is prepared for EMG recording, 2 electrodes will be placed on the skin over the right and left lumbar multifidus at two at the L4-5 level.
The EMG of lumbar multifidus will be recorded 3 times "at rest" first prior to each of muscle activation conditions: (1) verbal instruction only, and (2) combined tactile stimulation and verbal instruction. For both the muscle activation conditions, the participant will be asked to assume a starting position: abduct the contralateral shoulder and flex the contralateral elbow to approximately 90°. The contralateral side will be opposite to the painful side of patients with LBP or the left side of the asymptomatic participants. If the patient has bilateral LBP, the contralateral side will be the less painful side.
During verbal instruction, one investigator will give a verbal instruction and then ask the participant to perform a contralateral-arm task, in which the participant will lift the contralateral arm approximately 5 cm above the table and hold for 5 seconds. The verbal instruction was selected based on our published pilot study which showed that this instruction seemed to activate lumbar multifidus muscle the most: "Breathe normally, without moving the pelvis or spine, think about tilting the pelvis forward without actually moving it, and lift the left (right) arm".
During tactile stimulation, the investigator will place his/her middle 2 or 3 fingers on the lumbar multifidus at L5-S1 between the 2 electrodes before the verbal instruction is given. The investigator will then give the same verbal instruction and ask the participant to perform the contralateral-arm-lift task while maintaining finger contact on the multifidus muscle during muscle activation. EMG testing will start after the verbal instruction is completed.
For each muscle activation condition, participants will hold each contraction for 5-8 seconds, and a 10-minute rest will be given between the 2 contraction conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Other | Other: Tactile stimuliEffects of tactile stimulation on lumbar multifidus activation in healthy adults without LBP. |
| Low Back Pain | Other | Other: Tactile stimuliEffects of tactile stimulation on lumbar multifidus activation in adults with LBP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 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 in the past 24 hours (numeric pain rating scale of 0-10, 0 being no pain, 10 being unbearable pain).
Key exclusion criteria (1 listed)
- Exclusion criteria for all participants include 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactile stimuliBoth groups will receive tactile stimuli: hand touch on the right and left lumbar multifidus muscles at L4-5 | Other | Healthy Controls, Low Back Pain |
Primary outcome
Electromyographic (EMG) amplitude
Time frame: 8 seconds, 5 repetitions during one visit
Surface EMG activity of the right and left lumbar multifidus at L4-5 level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Sharon Wang-Price, PhD principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile stimuli in people with Low Back Pain, run by Texas Woman's University at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Wang-Price, PhD (214-689-7715, swang@twu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyographic (EMG) amplitude (time frame: 8 seconds, 5 repetitions during one visit). 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 20 Jul 2016.