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

Browse trials for

• Back Pain 2,373
• Low Back Pain 2,818

Keywords

• Low back pain
• stabilization exercises
• neuromuscular electrical stimulation

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Study arms

• Experimental
  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.

  Other: Rehabilitation exercises

• Experimental
  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.

  Other: Rehabilitation exercises · Device: Electrical Stimulation

Interventions

• OtherRehabilitation exercises
• DeviceElectrical Stimulation

  Also known as: Neuromuscular Electrical Stimulation (NMES)

Primary outcomes

1. 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

2. 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).

Secondary outcomes

1. 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)

2. 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)

3. 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)

4. 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

Baseline characteristics

Individual participant data

Plan to share: No