Neuromuscular Electrical Stimulation in Chronic Low Back Pain

Low Back Pain Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119895
• Other study ID #: 2018.174.IRB1.022
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: October 16, 2019

Study information

• Verified date: April 2021
• Source: Koç University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Neuromuscular electrical stimulation and core stabilization exercise
In NMES group, the amplitude of the electrical current will be set at the highest level subject can tolerate. The lumbar stabilization mode of the device will be used. This mode consists of three phases; warming, contraction and recovery phases. The duration will be set to 35 minutes. In the first 2 minutes (warming phase), frequency is 6 Hz. Contraction phase includes consecutive cycles of contractile frequency of 40 Hz for 6 seconds and the rest frequency of 4 Hz for 12 seconds, lasting a total of 30 minutes. The last 3 minutes (recovery phase) frequency is 3 Hz. The ramp up time is 2 seconds and the ramp down time is 1 second
• Sham neuromuscular electrical stimulation and core stabilization exercise
In sham NMES group, the amplitude of the electrical current will be set at a minimum level which does not stimulate any contraction.

Locations

Country	Name	City	State
Turkey	Koc University School of Medicine	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Koç University	Bahçesehir University

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. do — View Citation

Coghlan S, Crowe L, McCarthyPersson U, Minogue C, Caulfield B. Electrical muscle stimulation for deep stabilizing muscles in abdominal wall. Annu Int Conf IEEE Eng Med Biol Soc. 2008;2008:2756-9. doi: 10.1109/IEMBS.2008.4649773. — View Citation

Coghlan S, Crowe L, McCarthypersson U, Minogue C, Caulfield B. Neuromuscular electrical stimulation training results in enhanced activation of spinal stabilizing muscles during spinal loading and improvements in pain ratings. Annu Int Conf IEEE Eng Med Bi — View Citation

Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review. — View Citation

Fairbank JC. Oswestry disability index. J Neurosurg Spine. 2014 Feb;20(2):239-41. doi: 10.3171/2013.7.SPINE13288. Epub 2013 Nov 22. — View Citation

Hoy D, March L, Brooks P, Woolf A, Blyth F, Vos T, Buchbinder R. Measuring the global burden of low back pain. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):155-65. doi: 10.1016/j.berh.2009.11.002. Review. — View Citation

Hunt SM, McKenna SP, McEwen J, Williams J, Papp E. The Nottingham Health Profile: subjective health status and medical consultations. Soc Sci Med A. 1981 May;15(3 Pt 1):221-9. — View Citation

Kim SY, Kim JH, Jung GS, Baek SO, Jones R, Ahn SH. The effects of transcutaneous neuromuscular electrical stimulation on the activation of deep lumbar stabilizing muscles of patients with lumbar degenerative kyphosis. J Phys Ther Sci. 2016 Jan;28(2):399-4 — View Citation

Kücükdeveci AA, McKenna SP, Kutlay S, Gürsel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. — View Citation

Liddle SD, Baxter GD, Gracey JH. Exercise and chronic low back pain: what works? Pain. 2004 Jan;107(1-2):176-90. Review. Erratum in: Pain. 2004 May;109(1-2):200-1. — View Citation

Ohnhaus EE, Adler R. Methodological problems in the measurement of pain: a comparison between the verbal rating scale and the visual analogue scale. Pain. 1975 Dec;1(4):379-384. doi: 10.1016/0304-3959(75)90075-5. — View Citation

Yakut E, Düger T, Oksüz C, Yörükan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Güler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oswestry Disability Index	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.	4 weeks (change from baseline to 4 weeks after)
Secondary	Change in Visual Analog Scale	It is a scale consisting of a 10-centimeter line that evaluates the intensity of pain. Starting point of scale, 0 = no pain, end point 10 = expressed as the most severe pain encountered in life. Patients are asked to mark the severity of pain on the line. When calculating, the distance between the marked point and the starting point is measured in centimeters. Increasing the score means that the pain intensity increases.	4 weeks (change from baseline to 4 weeks after)
Secondary	Change in Nottingham Health Profile	Nottingham health profile is a general quality-of-life questionnaire that measures health problems that a person perceives and how these problems affect normal and daily activities. The questionnaire consists of 38 items and evaluates 6 dimensions related to health: energy, pain, emotional reactions, sleep, social isolation and physical activity. Questions are answered as yes or no. Scoring is done in every section between 0-100. 0 indicates the best health status, 100 worst health status. The total Nottingham Health Profile score is obtained from the sum of the sub-scores. Turkish validity and reliability were shown in 2000.	4 weeks (change from baseline to 4 weeks after)
Secondary	Change in Ultrasonographic thickness of multifidus and abdominal muscles	Participants will be asked to lie in supine position with feet flat, knees flexed 90 degree and hips flexed about 45 degrees. Probe is placed transversely at the intersection point of two lines, one horizontal line passing through umbilicus and second vertical line passing through anterior superior iliac spine to visualize the transversus abdominis, oblique internus and oblique externus. No pressure applied. The image is taken at the end of expiration.; Participants will be asked to lie in prone position with a pillow placed under the abdomen to minimize the lumbar lordosis. Probe will be placed longitudinally over L3, L4, L5 spinous processes with reference to the sacrum and moved to both sides to view the multifidus muscles at these levels in a single screen to measure muscle thickness. Then probe will be placed transversely and moved laterally until the facet joints are seen in the screen to visualize the multifidus muscles and to measure its area at each level.	4 weeks (change from baseline to 4 weeks after)