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Clinical Trials/NCT04119895
NCT04119895
Completed
N/A

Does Neuromuscular Electrical Stimulation Have an Additive Effect to Core Stabilization Exercises on Pain, Disability and Ultrasonographic Thickness of Abdominal and Lumbar Muscles in Chronic Low Back Pain?

Koç University1 site in 1 country30 target enrollmentOctober 16, 2018
ConditionsLow Back Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Koç University
Enrollment
30
Locations
1
Primary Endpoint
Change in Oswestry Disability Index
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study evaluates whether there is additive effect of neuromuscular electrical stimulation applied to lower lumbar region to core stabilization exercises in the management of chronic low back pain. Participants will randomly divide into two groups; half will receive core stabilization exercises and neuromuscular electrical stimulation (NMES) in combination, while the other half will receive core stabilization exercises and sham NMES.

Detailed Description

Patients with low back pain cannot activate enough the deep lumbar stabilization muscles necessary for spinal stability, such as transversus abdominis, lumbar multifidus. Core stabilization exercises are valuable in motor relearning of coactivation of deep lumbar and abdominal muscles and in stabilization of the spine. Hence, they are important in the management of chronic low back pain. Neuromuscular electrical stimulation (NMES) has been used in the training and strengthening of skeletal muscles for many years. It is shown that NMES can contract deep lumbar stabilization muscles and changes in muscle activation are significantly associated with pain reduction in patients with low back pain.

Registry
clinicaltrials.gov
Start Date
October 16, 2018
End Date
October 16, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Koç University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years or older,
  • Pain intensity greater than 3 over 10,
  • Pain duration more than 3 months,
  • Consent to participate in the study

Exclusion Criteria

  • Previous lumbar surgery,
  • Radiculopathy,
  • Non-mechanical back pain,
  • Acute low back pain

Outcomes

Primary Outcomes

Change in Oswestry Disability Index

Time Frame: 4 weeks (change from baseline to 4 weeks after)

Oswestry Disability Index (ODI), measures the level of disability. It consists of 10 items questioning the severity of pain, self-care, lifting and carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. Its Turkish version is validated in 2004. Items are scored between 0 and 5, and the total score is multiplied by two. The maximum score is "100". As the total score increases, the level of disability increases.

Secondary Outcomes

  • Change in Nottingham Health Profile(4 weeks (change from baseline to 4 weeks after))
  • Change in Visual Analog Scale(4 weeks (change from baseline to 4 weeks after))
  • Change in Ultrasonographic thickness of multifidus and abdominal muscles(4 weeks (change from baseline to 4 weeks after))

Study Sites (1)

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