Clinical trial NCT04119895: Neuromuscular Electrical Stimulation in Chronic Low Back Pain
Official title: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Electric stimulation
Ultrasonography
Exercise Therapy
Rehabilitation
Lead sponsor: Koç University
Sponsor class: OTHER
Collaborators: name: Bahçeşehir University
First posted: 2019-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Oswestry Disability Index
timeFrame: 4 weeks (change from baseline to 4 weeks after)
Secondary outcomes:
measure: Change in Visual Analog Scale
timeFrame: 4 weeks (change from baseline to 4 weeks after)
measure: Change in Nottingham Health Profile
timeFrame: 4 weeks (change from baseline to 4 weeks after)
measure: Change in Ultrasonographic thickness of multifidus and abdominal muscles
timeFrame: 4 weeks (change from baseline to 4 weeks after)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University School of Medicine
Study officials:
affiliation: Koc University School of Medicine
name: Ozden Ozyemisci Taskiran, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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