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

A Comparison Between Stabilization Exercises and Stabilization Exercises Supplemented With Neuromuscular Electrical Stimulation: A Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02864732
Enrollment
30
Registered
2016-08-12
Start date
2014-01-31
Completion date
2015-02-28
Last updated
2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low back pain, stabilization exercises, neuromuscular electrical stimulation

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.

Interventions

DEVICEElectrical Stimulation

Sponsors

Saudi Arabian Cultural Mission
CollaboratorUNKNOWN
King Fahad Specialist Hospital Dammam
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tolerability of Electrical Stimulation (NMES)Participants were followed from baseline to 6 weeksNMES 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)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.

Secondary

MeasureTime frameDescription
Numeric Pain Rating Scale (NPRS)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
Fear-avoidance Behavior QuestionnaireBaseline 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.
Paraspinal Muscle StrengthBaseline - 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.
Patient Satisfaction Surveyonly post-treatment at 6 weeksSatisfaction 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

Participant flow

Participants by arm

ArmCount
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
15
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
15
Total30

Baseline characteristics

CharacteristicStabilization ExercisesStabilization Exercises Plus Electrical StimulationTotal
Age, Continuous38.33 years
STANDARD_DEVIATION 11.3
33.40 years
STANDARD_DEVIATION 9
35.87 years
STANDARD_DEVIATION 10.15
BMI25.89 kg/m^2
STANDARD_DEVIATION 3.9
26.47 kg/m^2
STANDARD_DEVIATION 2.9
26.18 kg/m^2
STANDARD_DEVIATION 3.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
4 Participants1 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
9 Participants13 Participants22 Participants
Sex: Female, Male
Female
11 Participants8 Participants19 Participants
Sex: Female, Male
Male
4 Participants7 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 15

Outcome results

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Stabilization Exercises Plus Electrical StimulationModified Oswestry Disability Questionnaire (MODQ)Baseline30.80 percentage of functional disabilityStandard Deviation 10.2
Stabilization Exercises Plus Electrical StimulationModified Oswestry Disability Questionnaire (MODQ)6 weeks12.81 percentage of functional disabilityStandard Deviation 5.2
Stabilization Exercises Plus Electrical StimulationModified Oswestry Disability Questionnaire (MODQ)10 weeks10.00 percentage of functional disabilityStandard Deviation 5.6
Stabilization Exercises Plus Electrical StimulationModified Oswestry Disability Questionnaire (MODQ)6 weeks14.49 percentage of functional disabilityStandard Deviation 10.2
Stabilization Exercises Plus Electrical StimulationModified Oswestry Disability Questionnaire (MODQ)Baseline30.52 percentage of functional disabilityStandard Deviation 7.8
Stabilization Exercises Plus Electrical StimulationModified Oswestry Disability Questionnaire (MODQ)10 weeks13.24 percentage of functional disabilityStandard Deviation 8
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.

Time frame: Participants were followed from baseline to 6 weeks

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)6 week discomfort medium0 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)6 week sensory high10 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)Baseline discomfort low13 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)Baseline discomfort medium0 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)Baseline discomfort high0 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)6 week discomfort low13 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)6 week discomfort high0 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)Baseline sensory low0 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)Baseline sensory medium5 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)Baseline sensory high8 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)6 week sensory low0 Participants
Stabilization Exercises Plus Electrical StimulationTolerability of Electrical Stimulation (NMES)6 week sensory medium3 Participants
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.

Time frame: Baseline to 6 weeks (post-treatment)

ArmMeasureGroupValue (MEAN)Dispersion
Stabilization Exercises Plus Electrical StimulationFear-avoidance Behavior QuestionnaireFABQ-PA Baseline12.33 units on a scaleStandard Deviation 5.5
Stabilization Exercises Plus Electrical StimulationFear-avoidance Behavior QuestionnaireFABQ-W Baseline12.20 units on a scaleStandard Deviation 10.9
Stabilization Exercises Plus Electrical StimulationFear-avoidance Behavior QuestionnaireFABQ-W 6 weeks8.87 units on a scaleStandard Deviation 9.6
Stabilization Exercises Plus Electrical StimulationFear-avoidance Behavior QuestionnaireFABQ-PA 6 weeks8.41 units on a scaleStandard Deviation 6
Stabilization Exercises Plus Electrical StimulationFear-avoidance Behavior QuestionnaireFABQ-W 6 weeks10.75 units on a scaleStandard Deviation 7.6
Stabilization Exercises Plus Electrical StimulationFear-avoidance Behavior QuestionnaireFABQ-PA Baseline14.27 units on a scaleStandard Deviation 6.5
Stabilization Exercises Plus Electrical StimulationFear-avoidance Behavior QuestionnaireFABQ-PA 6 weeks10.75 units on a scaleStandard Deviation 4.7
Stabilization Exercises Plus Electrical StimulationFear-avoidance Behavior QuestionnaireFABQ-W Baseline11.67 units on a scaleStandard Deviation 10.5
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

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

ArmMeasureGroupValue (MEAN)Dispersion
Stabilization Exercises Plus Electrical StimulationNumeric Pain Rating Scale (NPRS)Baseline4.44 units on a scaleStandard Deviation 1.8
Stabilization Exercises Plus Electrical StimulationNumeric Pain Rating Scale (NPRS)6 weeks2.07 units on a scaleStandard Deviation 1.1
Stabilization Exercises Plus Electrical StimulationNumeric Pain Rating Scale (NPRS)10 weeks1.63 units on a scaleStandard Deviation 1
Stabilization Exercises Plus Electrical StimulationNumeric Pain Rating Scale (NPRS)Baseline4.20 units on a scaleStandard Deviation 1.9
Stabilization Exercises Plus Electrical StimulationNumeric Pain Rating Scale (NPRS)6 weeks2.34 units on a scaleStandard Deviation 1.5
Stabilization Exercises Plus Electrical StimulationNumeric Pain Rating Scale (NPRS)10 weeks2.34 units on a scaleStandard Deviation 1.5
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.

Time frame: Baseline - 6 weeks (post-treatment)

ArmMeasureGroupValue (MEAN)Dispersion
Stabilization Exercises Plus Electrical StimulationParaspinal Muscle StrengthBaseline117.29 NmStandard Deviation 57.7
Stabilization Exercises Plus Electrical StimulationParaspinal Muscle Strength6 weeks162.30 NmStandard Deviation 55.2
Stabilization Exercises Plus Electrical StimulationParaspinal Muscle StrengthBaseline154.49 NmStandard Deviation 59.1
Stabilization Exercises Plus Electrical StimulationParaspinal Muscle Strength6 weeks175.80 NmStandard Deviation 58.4
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

Time frame: only post-treatment at 6 weeks

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Stabilization Exercises Plus Electrical StimulationPatient Satisfaction SurveySatisfied3 Participants
Stabilization Exercises Plus Electrical StimulationPatient Satisfaction SurveyUnsatisfied0 Participants
Stabilization Exercises Plus Electrical StimulationPatient Satisfaction SurveyNeutral0 Participants
Stabilization Exercises Plus Electrical StimulationPatient Satisfaction SurveyVery Unsatisfied0 Participants
Stabilization Exercises Plus Electrical StimulationPatient Satisfaction SurveyVery satisfied10 Participants
Stabilization Exercises Plus Electrical StimulationPatient Satisfaction SurveyVery Unsatisfied0 Participants
Stabilization Exercises Plus Electrical StimulationPatient Satisfaction SurveyVery satisfied8 Participants
Stabilization Exercises Plus Electrical StimulationPatient Satisfaction SurveySatisfied5 Participants
Stabilization Exercises Plus Electrical StimulationPatient Satisfaction SurveyNeutral0 Participants
Stabilization Exercises Plus Electrical StimulationPatient Satisfaction SurveyUnsatisfied0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026