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

NCT02864732 | Completed Results DMC

• 1 other identifier: PRO12100651
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Keywords

Low back pain; stabilization exercises; neuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (2)

• 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).

Secondary Outcomes (4)

• Numeric Pain Rating Scale (NPRS)

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

• Fear-avoidance Behavior Questionnaire

  Baseline to 6 weeks (post-treatment)

• Paraspinal Muscle Strength

  Baseline - 6 weeks (post-treatment)

• Patient Satisfaction Survey

  only post-treatment at 6 weeks

Study Arms (2)

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.

Other: Rehabilitation exercises

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.

Other: Rehabilitation exercises; Device: Electrical Stimulation

Interventions

Rehabilitation exercises OTHER

Stabilization exercises; Stabilization exercises plus electrical stimulation

Electrical Stimulation DEVICE

Also known as: Neuromuscular Electrical Stimulation (NMES)

Stabilization exercises plus electrical stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Saudi Arabian Cultural Mission: collaborator
• King Fahad Specialist Hospital Dammam: collaborator

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Therapy; Electric Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Stimulation; Investigative Techniques

Limitations and Caveats

small sample size and no blinding

Results Point of Contact

• Title: Research Assistant
• Organization: University of Pittsburgh

mza7@pitt.edu

412 4822283

Study Officials

• Muhammad Z Alrwaily, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Anthony Delitto, PhD

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 12, 2016
• Study Start: January 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 22, 2023
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share