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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864732
• Other study ID #: PRO12100651
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Rehabilitation exercises

Device:
• Electrical Stimulation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	King Fahad Specialist Hospital Dammam, Saudi Arabian Cultural Mission

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Participants were followed from baseline to 6 weeks
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.	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	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.	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.	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	only post-treatment at 6 weeks