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Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation exercises
Electrical Stimulation
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain focused on measuring Low back pain, stabilization exercises, neuromuscular electrical stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 18 years of age and 60.
  • Body Mass Index (BMI) of less than 34.
  • Low Back Pain duration of 3 months or greater (chronic).
  • Minimum pain level on Numeric Pain Rating Scale (NPRS) is 3 or greater.
  • Minimum score of Modified Oswestry Disability Questionnaire (MODQ) is 20 or greater.
  • Understands English

Exclusion Criteria:

  • Positive nerve root tension signs
  • Progressive neurological deficit
  • Positive Babinski sign.
  • Sensory loss that is not in correspondence with dermatomal distribution or peripheral nerves.
  • History of spinal surgery
  • History of inflammatory joint disease
  • Contraindications to physical exercise including history of cardiac disease or being told by a physician not to engage in physical exercise.
  • Contraindications to NMES including cardiac pacemaker or skin allergy to adhesives
  • History of metastatic cancer in previous 5 years or present treatment for cancer
  • Women who indicate that they are pregnant or plan to become pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Stabilization exercises

    Stabilization exercises plus electrical stimulation

    Arm Description

    The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.

    The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.

    Outcomes

    Primary Outcome Measures

    Tolerability of Electrical Stimulation (NMES)
    NMES tolerability was performed by asking each subject in the stab + NMES group to describe their subjective perception of both the intensity and discomfort of the NMES current using the descriptors listed in a table. The descriptors represent two distinct domains of adjectives: the sensory aspect of the perceived intensity of stimulation and the affective aspect of the perceived discomfort. Each aspect has 15 adjectives. Each subject was asked to describe the current using the descriptors listed for each aspect at baseline and at 6 weeks. To analyze the the subjects description of the current, the 15 descriptors of each aspect were divided into 3 zones (high, medium, low). The top 5 descriptors in each aspect were considered high, the middle 5 descriptors were considered medium, and the bottom descriptors were considered low. Descriptive statistics were used to compare the subjects description of each aspect at baseline and at 6 weeks follow-up.
    Modified Oswestry Disability Questionnaire (MODQ)
    The MODQ is a self-reported measure of disability consisting of 10 domains of functional activities related to low back pain. The domains include pain intensity, personal care, lifting, walking, standing, sitting, traveling, social life, employment/homemaking, and sleeping. Each domain is rated from 0 - 5. The total of all the domains range from 0 - 50. The scores can be multiplied by 2 to get a percentage of functional disability. The higher the percentage the higher the disability.

    Secondary Outcome Measures

    Numeric Pain Rating Scale (NPRS)
    The NPRS measures pain intensity on an 11-point scale from 0 (no pain) to 10 (maximum pain). The higher the score the worst the pain intensity
    Fear-avoidance Behavior Questionnaire
    The Fear-avoidance Behavior Questionnaire (FABQ) measure avoidant behavior to physical activity or work due to fear of pain. The has two sub scales: physical activity and work. This FABQ consists of 16 items; 5 items for the physical activity sub scale and 11 items for the work subscale. Each item is scored from 0-6. Higher scores on the FABQ are indicative of greater fear and avoidance beliefs. The total score on the FABQ is 66, however, this score is considered separately. The FABQ-physical activity sub scale ranges from 0 - 24 points and the FABQ-work activity ranges from 0 - 42 points.
    Paraspinal Muscle Strength
    The paraspinal muscle strength was assessed using the Biodex 3 Pro dynamometer (20 Ramsey Rd, Shirley, NY 11967). Active extension of the trunk was performed with the subject in a semi-standing position; the subject's hips were flexed at 60 degrees with the feet resting on an adjustable footrest. The thighs were secured to the seat with two Velcro straps. The scapulae rested against a roll that is attached to the chair arms. The trunk was secured with two Velcro straps that crossed the front trunk forming the shape of an X. The subject was asked to extend the trunk by exerting maximal isometric contraction for 5 seconds against the scapular roll. The average of three 5-second trials was recorded. All subjects received the same verbal instruction: "Push your trunk against the scapular roll as strong as you can". The higher the score the stronger the muscles. The range starts from 0 without a limit to the amount of force that could be exerted.
    Patient Satisfaction Survey
    Satisfaction level with the interventions. Subjects were asked rate their satisfaction with the treatment by choosing one of the following statements: Very satisfied Satisfied Neutral Unsatisfied Very unsatisfied

    Full Information

    First Posted
    August 4, 2016
    Last Updated
    August 21, 2023
    Sponsor
    University of Pittsburgh
    Collaborators
    Saudi Arabian Cultural Mission, King Fahad Specialist Hospital Dammam
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02864732
    Brief Title
    Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain
    Official Title
    A Comparison Between Stabilization Exercises and Stabilization Exercises Supplemented With Neuromuscular Electrical Stimulation: A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pittsburgh
    Collaborators
    Saudi Arabian Cultural Mission, King Fahad Specialist Hospital Dammam

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the feasibility of applying neuromuscular electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and whether the electrical stimulation improve pain, function and muscle strength.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    Low back pain, stabilization exercises, neuromuscular electrical stimulation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stabilization exercises
    Arm Type
    Experimental
    Arm Description
    The stabilization exercises program will consist of exercises for the lower back and abdomen. These exercises include various types of abdominal bracing and bridging and side bridging. The exercises will be performed in supine, sidelying, and quadruped. It involves activation of muscles, dissociation of lumbar spine movement from extremities movement and endurance.
    Arm Title
    Stabilization exercises plus electrical stimulation
    Arm Type
    Experimental
    Arm Description
    The neuromuscular electrical stimulation is a hand-size unit that has four plastic adhesive electrical conductors known as electrodes. These electrodes are going to be placed on the skin covering the lower back muscles. They will deliver an electric current that will generate muscle contraction that resembles normal muscle contraction. This treatment will be given in addition to the stabilization exercise program.
    Intervention Type
    Other
    Intervention Name(s)
    Rehabilitation exercises
    Intervention Type
    Device
    Intervention Name(s)
    Electrical Stimulation
    Other Intervention Name(s)
    Neuromuscular Electrical Stimulation (NMES)
    Primary Outcome Measure Information:
    Title
    Tolerability of Electrical Stimulation (NMES)
    Description
    NMES tolerability was performed by asking each subject in the stab + NMES group to describe their subjective perception of both the intensity and discomfort of the NMES current using the descriptors listed in a table. The descriptors represent two distinct domains of adjectives: the sensory aspect of the perceived intensity of stimulation and the affective aspect of the perceived discomfort. Each aspect has 15 adjectives. Each subject was asked to describe the current using the descriptors listed for each aspect at baseline and at 6 weeks. To analyze the the subjects description of the current, the 15 descriptors of each aspect were divided into 3 zones (high, medium, low). The top 5 descriptors in each aspect were considered high, the middle 5 descriptors were considered medium, and the bottom descriptors were considered low. Descriptive statistics were used to compare the subjects description of each aspect at baseline and at 6 weeks follow-up.
    Time Frame
    Participants were followed from baseline to 6 weeks
    Title
    Modified Oswestry Disability Questionnaire (MODQ)
    Description
    The MODQ is a self-reported measure of disability consisting of 10 domains of functional activities related to low back pain. The domains include pain intensity, personal care, lifting, walking, standing, sitting, traveling, social life, employment/homemaking, and sleeping. Each domain is rated from 0 - 5. The total of all the domains range from 0 - 50. The scores can be multiplied by 2 to get a percentage of functional disability. The higher the percentage the higher the disability.
    Time Frame
    Baseline to 6 weeks (post-treatment) to 10 weeks (follow up).
    Secondary Outcome Measure Information:
    Title
    Numeric Pain Rating Scale (NPRS)
    Description
    The NPRS measures pain intensity on an 11-point scale from 0 (no pain) to 10 (maximum pain). The higher the score the worst the pain intensity
    Time Frame
    Baseline to 6 weeks (post-treatment) to 10 weeks (follow-up)
    Title
    Fear-avoidance Behavior Questionnaire
    Description
    The Fear-avoidance Behavior Questionnaire (FABQ) measure avoidant behavior to physical activity or work due to fear of pain. The has two sub scales: physical activity and work. This FABQ consists of 16 items; 5 items for the physical activity sub scale and 11 items for the work subscale. Each item is scored from 0-6. Higher scores on the FABQ are indicative of greater fear and avoidance beliefs. The total score on the FABQ is 66, however, this score is considered separately. The FABQ-physical activity sub scale ranges from 0 - 24 points and the FABQ-work activity ranges from 0 - 42 points.
    Time Frame
    Baseline to 6 weeks (post-treatment)
    Title
    Paraspinal Muscle Strength
    Description
    The paraspinal muscle strength was assessed using the Biodex 3 Pro dynamometer (20 Ramsey Rd, Shirley, NY 11967). Active extension of the trunk was performed with the subject in a semi-standing position; the subject's hips were flexed at 60 degrees with the feet resting on an adjustable footrest. The thighs were secured to the seat with two Velcro straps. The scapulae rested against a roll that is attached to the chair arms. The trunk was secured with two Velcro straps that crossed the front trunk forming the shape of an X. The subject was asked to extend the trunk by exerting maximal isometric contraction for 5 seconds against the scapular roll. The average of three 5-second trials was recorded. All subjects received the same verbal instruction: "Push your trunk against the scapular roll as strong as you can". The higher the score the stronger the muscles. The range starts from 0 without a limit to the amount of force that could be exerted.
    Time Frame
    Baseline - 6 weeks (post-treatment)
    Title
    Patient Satisfaction Survey
    Description
    Satisfaction level with the interventions. Subjects were asked rate their satisfaction with the treatment by choosing one of the following statements: Very satisfied Satisfied Neutral Unsatisfied Very unsatisfied
    Time Frame
    only post-treatment at 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Between 18 years of age and 60. Body Mass Index (BMI) of less than 34. Low Back Pain duration of 3 months or greater (chronic). Minimum pain level on Numeric Pain Rating Scale (NPRS) is 3 or greater. Minimum score of Modified Oswestry Disability Questionnaire (MODQ) is 20 or greater. Understands English Exclusion Criteria: Positive nerve root tension signs Progressive neurological deficit Positive Babinski sign. Sensory loss that is not in correspondence with dermatomal distribution or peripheral nerves. History of spinal surgery History of inflammatory joint disease Contraindications to physical exercise including history of cardiac disease or being told by a physician not to engage in physical exercise. Contraindications to NMES including cardiac pacemaker or skin allergy to adhesives History of metastatic cancer in previous 5 years or present treatment for cancer Women who indicate that they are pregnant or plan to become pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Muhammad Z Alrwaily, PhD
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Anthony Delitto, PhD
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain

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