Neuromuscular Electrical Stimulation in Chronic Low Back Pain

NCT04119895 | Completed

• 1 other identifier: 2018.174.IRB1.022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Electric stimulation; Ultrasonography; Exercise Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Visual Analog Scale

  4 weeks (change from baseline to 4 weeks after)

• Change in Nottingham Health Profile

  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 Arms (2)

NMES and exercise

EXPERIMENTAL

Neuromuscular electrical stimulation and core stabilization exercise

Other: Neuromuscular electrical stimulation and core stabilization exercise

Sham NMES and exercise

SHAM COMPARATOR

Sham neuromuscular electrical stimulation and core stabilization exercise

Other: Sham neuromuscular electrical stimulation and core stabilization exercise

Interventions

Neuromuscular electrical stimulation and core stabilization exercise OTHER

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

NMES and exercise

Sham neuromuscular electrical stimulation and core stabilization exercise OTHER

In sham NMES group, the amplitude of the electrical current will be set at a minimum level which does not stimulate any contraction.

Sham NMES and exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Koç University: lead
• Bahçeşehir University: collaborator

Study Sites (1)

Koc University School of Medicine

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 20227638 RESULT

• 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.

  PMID: 27064323 RESULT

• 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.

  PMID: 19163276 RESULT

• 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.

  PMID: 22256103 RESULT

• 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.

  PMID: 24266676 RESULT

• 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.

  PMID: 800639 RESULT

• 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.

  PMID: 15129077 RESULT

• 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.

  PMID: 11074683 RESULT

• 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.

  PMID: 6973203 RESULT

• 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.

  PMID: 10826123 RESULT

• 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.

  PMID: 14715404 RESULT

• 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.

  PMID: 29067082 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ozden Ozyemisci Taskiran, Prof

  Koc University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomized controlled trial

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: October 9, 2019
• Study Start: October 16, 2018
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)