Trial Outcomes & Findings for Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain (NCT NCT02864732)

Last Updated: 2023-08-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Participants were followed from baseline to 6 weeks

Results posted on

2023-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	15	15
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stabilization Exercises n=15 Participants 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	Stabilization Exercises Plus Electrical Stimulation n=15 Participants 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	Total n=30 Participants Total of all reporting groups
Age, Continuous	38.33 years STANDARD_DEVIATION 11.3 • n=5 Participants	33.40 years STANDARD_DEVIATION 9.0 • n=7 Participants	35.87 years STANDARD_DEVIATION 10.15 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
BMI	25.89 kg/m^2 STANDARD_DEVIATION 3.9 • n=5 Participants	26.47 kg/m^2 STANDARD_DEVIATION 2.9 • n=7 Participants	26.18 kg/m^2 STANDARD_DEVIATION 3.4 • n=5 Participants

PRIMARY outcome

Timeframe: Participants were followed from baseline to 6 weeks

Population: This outcome measure was only used with the Stabilization plus Electrical Stimulation

Outcome measures

Outcome measures
Measure	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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	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
Tolerability of Electrical Stimulation (NMES) Baseline sensory medium	5 Participants	—
Tolerability of Electrical Stimulation (NMES) 6 week sensory medium	3 Participants	—
Tolerability of Electrical Stimulation (NMES) 6 week sensory high	10 Participants	—
Tolerability of Electrical Stimulation (NMES) Baseline discomfort medium	0 Participants	—
Tolerability of Electrical Stimulation (NMES) Baseline discomfort high	0 Participants	—
Tolerability of Electrical Stimulation (NMES) 6 week discomfort high	0 Participants	—
Tolerability of Electrical Stimulation (NMES) Baseline discomfort low	13 Participants	—
Tolerability of Electrical Stimulation (NMES) 6 week discomfort low	13 Participants	—
Tolerability of Electrical Stimulation (NMES) Baseline sensory low	0 Participants	—
Tolerability of Electrical Stimulation (NMES) Baseline sensory high	8 Participants	—
Tolerability of Electrical Stimulation (NMES) 6 week sensory low	0 Participants	—
Tolerability of Electrical Stimulation (NMES) 6 week discomfort medium	0 Participants	—

PRIMARY outcome

Timeframe: Baseline to 6 weeks (post-treatment) to 10 weeks (follow up).

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.

Outcome measures

Outcome measures
Measure	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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
Modified Oswestry Disability Questionnaire (MODQ) Baseline	30.80 percentage of functional disability Standard Deviation 10.2	30.52 percentage of functional disability Standard Deviation 7.8
Modified Oswestry Disability Questionnaire (MODQ) 6 weeks	12.81 percentage of functional disability Standard Deviation 5.2	14.49 percentage of functional disability Standard Deviation 10.2
Modified Oswestry Disability Questionnaire (MODQ) 10 weeks	10.00 percentage of functional disability Standard Deviation 5.6	13.24 percentage of functional disability Standard Deviation 8.0

SECONDARY outcome

Timeframe: Baseline to 6 weeks (post-treatment) to 10 weeks (follow-up)

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

Outcome measures

Outcome measures
Measure	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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
Numeric Pain Rating Scale (NPRS) Baseline	4.44 units on a scale Standard Deviation 1.8	4.20 units on a scale Standard Deviation 1.9
Numeric Pain Rating Scale (NPRS) 6 weeks	2.07 units on a scale Standard Deviation 1.1	2.34 units on a scale Standard Deviation 1.5
Numeric Pain Rating Scale (NPRS) 10 weeks	1.63 units on a scale Standard Deviation 1.0	2.34 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline to 6 weeks (post-treatment)

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.

Outcome measures

Outcome measures
Measure	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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
Fear-avoidance Behavior Questionnaire FABQ-PA Baseline	12.33 units on a scale Standard Deviation 5.5	14.27 units on a scale Standard Deviation 6.5
Fear-avoidance Behavior Questionnaire FABQ-PA 6 weeks	8.41 units on a scale Standard Deviation 6.0	10.75 units on a scale Standard Deviation 4.7
Fear-avoidance Behavior Questionnaire FABQ-W Baseline	12.20 units on a scale Standard Deviation 10.9	11.67 units on a scale Standard Deviation 10.5
Fear-avoidance Behavior Questionnaire FABQ-W 6 weeks	8.87 units on a scale Standard Deviation 9.6	10.75 units on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: Baseline - 6 weeks (post-treatment)

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.

Outcome measures

Outcome measures
Measure	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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
Paraspinal Muscle Strength Baseline	117.29 Nm Standard Deviation 57.7	154.49 Nm Standard Deviation 59.1
Paraspinal Muscle Strength 6 weeks	162.30 Nm Standard Deviation 55.2	175.80 Nm Standard Deviation 58.4

SECONDARY outcome

Timeframe: only post-treatment at 6 weeks

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

Outcome measures

Outcome measures
Measure	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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	Stabilization Exercises Plus Electrical Stimulation n=13 Participants 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
Patient Satisfaction Survey Very satisfied	10 Participants	8 Participants
Patient Satisfaction Survey Satisfied	3 Participants	5 Participants
Patient Satisfaction Survey Neutral	0 Participants	0 Participants
Patient Satisfaction Survey Unsatisfied	0 Participants	0 Participants
Patient Satisfaction Survey Very Unsatisfied	0 Participants	0 Participants

Adverse Events

Stabilization Exercises

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stabilization Exercises Plus Electrical Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Assistant

University of Pittsburgh

Phone: 412 4822283

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place