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Effects of Tactile Stimuli for Lumbar Multifidus Muscle Activation in Healthy Adults and Patients With Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tactile stimuli
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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:

  • 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).

Sites / Locations

  • Texas Woman's UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy Controls

Low Back Pain

Arm Description

Effects of tactile stimulation on lumbar multifidus activation in healthy adults without LBP.

Effects of tactile stimulation on lumbar multifidus activation in adults with LBP.

Outcomes

Primary Outcome Measures

Electromyographic (EMG) amplitude
Surface EMG activity of the right and left lumbar multifidus at L4-5 level

Secondary Outcome Measures

Full Information

First Posted
July 14, 2016
Last Updated
July 18, 2016
Sponsor
Texas Woman's University
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1. Study Identification

Unique Protocol Identification Number
NCT02836860
Brief Title
Effects of Tactile Stimuli for Lumbar Multifidus Muscle Activation in Healthy Adults and Patients With Low Back Pain
Official Title
Effects of Adding Tactile Stimuli to Verbal Instructions for Lumbar Multifidus Muscle Activation in Healthy Adults and Patients With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls
Arm Type
Other
Arm Description
Effects of tactile stimulation on lumbar multifidus activation in healthy adults without LBP.
Arm Title
Low Back Pain
Arm Type
Other
Arm Description
Effects of tactile stimulation on lumbar multifidus activation in adults with LBP.
Intervention Type
Other
Intervention Name(s)
Tactile stimuli
Intervention Description
Both groups will receive tactile stimuli: hand touch on the right and left lumbar multifidus muscles at L4-5
Primary Outcome Measure Information:
Title
Electromyographic (EMG) amplitude
Description
Surface EMG activity of the right and left lumbar multifidus at L4-5 level
Time Frame
8 seconds, 5 repetitions during one visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Wang-Price, PhD
Phone
214-689-7715
Email
swang@twu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Wang-Price, PhD
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Woman's University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Wang-Price, PhD
Phone
214-689-7715
Email
swang@twu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Tactile Stimuli for Lumbar Multifidus Muscle Activation in Healthy Adults and Patients With Low Back Pain

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