Neuromuscular Electrical Stimulation in Chronic Low Back Pain

• ClinicalTrials.gov Identifier: NCT04119895
• Recruitment Status: Completed
• First Posted: October 9, 2019
• Last Update Posted: April 23, 2021
• Sponsor: Koç University
• Collaborator: Bahçeşehir University
• Information provided by (Responsible Party): Koç University

Tracking Information

• First Submitted Date: April 12, 2019
• First Posted Date: October 9, 2019
• Last Update Posted Date: April 23, 2021
• Actual Study Start Date: October 16, 2018
• Actual Primary Completion Date: October 16, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 7, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 7, 2019)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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?
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Double blind randomized controlled trial

Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: 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

• Other: 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.

Study Arms

• Experimental: NMES and exercise
  Neuromuscular electrical stimulation and core stabilization exercise
  Intervention: Other: Neuromuscular electrical stimulation and core stabilization exercise
• Sham Comparator: Sham NMES and exercise
  Sham neuromuscular electrical stimulation and core stabilization exercise
  Intervention: Other: Sham neuromuscular electrical stimulation and core stabilization exercise

Publications *

• 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.
• 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):399-406. doi: 10.1589/jpts.28.399. Epub 2016 Feb 29.
• 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.
• 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 Biol Soc. 2011;2011:7622-5. doi: 10.1109/IEMBS.2011.6091878.
• Fairbank JC. Oswestry disability index. J Neurosurg Spine. 2014 Feb;20(2):239-41. doi: 10.3171/2013.7.SPINE13288. Epub 2013 Nov 22. No abstract available.
• 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.
• Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler 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; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.
• Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
• 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. doi: 10.1016/0271-7123(81)90005-5. No abstract available.
• Kucukdeveci AA, McKenna SP, Kutlay S, Gursel 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. doi: 10.1097/00004356-200023010-00004.
• Liddle SD, Baxter GD, Gracey JH. Exercise and chronic low back pain: what works? Pain. 2004 Jan;107(1-2):176-90. doi: 10.1016/j.pain.2003.10.017. Erratum In: Pain. 2004 May;109(1-2):200-1.
• 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. doi: 10.12669/pjms.334.12664.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 7, 2019): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 16, 2019
• Actual Primary Completion Date: October 16, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04119895
• Other Study ID Numbers: 2018.174.IRB1.022
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: It was not planned to share individual participant data.

• Current Responsible Party: Koç University
• Original Responsible Party: Same as current
• Current Study Sponsor: Koç University
• Original Study Sponsor: Same as current
• Collaborators: Bahçeşehir University

Investigators

• Principal Investigator: Ozden Ozyemisci Taskiran, Prof; Koc University School of Medicine

• PRS Account: Koç University
• Verification Date: April 2021