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

NCT ID: NCT02864732

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Rehabilitation exercises

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Rehabilitation exercises

Intervention Type: OTHER

Electrical Stimulation

Intervention Type: DEVICE

Interventions

Rehabilitation exercises

Intervention Type: OTHER

Electrical Stimulation

Intervention Type: DEVICE

Other Intervention Names

Neuromuscular Electrical Stimulation (NMES)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saudi Arabian Cultural Mission

UNKNOWN

Sponsor Role: collaborator

King Fahad Specialist Hospital Dammam

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Z Alrwaily, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Anthony Delitto, PhD

Role: STUDY_DIRECTOR

University of Pittsburgh

Other Identifiers

PRO12100651

Identifier Type: -

Identifier Source: org_study_id