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| Name | Class |
|---|---|
| Saudi Arabian Cultural Mission | UNKNOWN |
| King Fahad Specialist Hospital Dammam | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stabilization exercises | Experimental | 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. |
|
| Stabilization exercises plus electrical stimulation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation exercises | Other |
| ||
| Electrical Stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants were followed from baseline to 6 weeks |
| 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. | Baseline to 6 weeks (post-treatment) to 10 weeks (follow up). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 6 weeks (post-treatment) to 10 weeks (follow-up) |
| Fear-avoidance Behavior Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Z Alrwaily, PhD | University of Pittsburgh | Principal Investigator |
| Anthony Delitto, PhD | University of Pittsburgh | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stabilization Exercises | 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. Rehabilitation exercises |
| FG001 | Stabilization Exercises Plus Electrical Stimulation | 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. Rehabilitation exercises Electrical Stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Chronic Low Back Pain Patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Stabilization Exercises | 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. Rehabilitation exercises |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This outcome measure was only used with the Stabilization plus Electrical Stimulation | Posted | Count of Participants | Participants | Participants were followed from baseline to 6 weeks |
6 weeks
Participants were monitored only for the following select adverse events: a. severe episode of low back pain or b. skin reaction due to use of adhesives.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stabilization Exercises | 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. Rehabilitation exercises |
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small sample size and no blinding
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Assistant | University of Pittsburgh | 412 4822283 | mza7@pitt.edu |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Device |
|
|
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. |
| Baseline to 6 weeks (post-treatment) |
| 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. | Baseline - 6 weeks (post-treatment) |
| 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 | only post-treatment at 6 weeks |
| BG001 | Stabilization Exercises Plus Electrical Stimulation | 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. Rehabilitation exercises Electrical Stimulation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Stabilization Exercises Plus Electrical Stimulation | 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. Rehabilitation exercises Electrical Stimulation |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of functional disability | Baseline to 6 weeks (post-treatment) to 10 weeks (follow up). |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 weeks (post-treatment) to 10 weeks (follow-up) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 weeks (post-treatment) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Nm | Baseline - 6 weeks (post-treatment) |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | only post-treatment at 6 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Stabilization Exercises Plus Electrical Stimulation | 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. Rehabilitation exercises Electrical Stimulation | 0 | 15 | 0 | 15 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
| 10 weeks |
|
| 10 weeks |
|
| FABQ-W Baseline |
|
| FABQ-W 6 weeks |
|
| Neutral |
|
| Unsatisfied |
|
| Very Unsatisfied |
|