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Neuromuscular Electrical Stimulation in Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation and core stabilization exercise
Sham neuromuscular electrical stimulation and core stabilization exercise
Sponsored by
Koç University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Electric stimulation, Ultrasonography, Exercise Therapy, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Koc University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

NMES and exercise

Sham NMES and exercise

Arm Description

Neuromuscular electrical stimulation and core stabilization exercise

Sham neuromuscular electrical stimulation and core stabilization exercise

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 12, 2019
Last Updated
April 22, 2021
Sponsor
Koç University
Collaborators
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT04119895
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?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koç University
Collaborators
Bahçeşehir University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Electric stimulation, Ultrasonography, Exercise Therapy, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NMES and exercise
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation and core stabilization exercise
Arm Title
Sham NMES and exercise
Arm Type
Sham Comparator
Arm Description
Sham neuromuscular electrical stimulation and core stabilization exercise
Intervention Type
Other
Intervention Name(s)
Neuromuscular electrical stimulation and core stabilization exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sham neuromuscular electrical stimulation and core stabilization exercise
Intervention Description
In sham NMES group, the amplitude of the electrical current will be set at a minimum level which does not stimulate any contraction.
Primary Outcome Measure Information:
Title
Change in Oswestry Disability Index
Description
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.
Time Frame
4 weeks (change from baseline to 4 weeks after)
Secondary Outcome Measure Information:
Title
Change in Visual Analog Scale
Description
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.
Time Frame
4 weeks (change from baseline to 4 weeks after)
Title
Change in Nottingham Health Profile
Description
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.
Time Frame
4 weeks (change from baseline to 4 weeks after)
Title
Change in Ultrasonographic thickness of multifidus and abdominal muscles
Description
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.
Time Frame
4 weeks (change from baseline to 4 weeks after)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozden Ozyemisci Taskiran, Prof
Organizational Affiliation
Koc University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koc University School of Medicine
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It was not planned to share individual participant data.
Citations:
PubMed Identifier
20227638
Citation
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Results Reference
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27064323
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):399-406. doi: 10.1589/jpts.28.399. Epub 2016 Feb 29.
Results Reference
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PubMed Identifier
19163276
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.
Results Reference
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PubMed Identifier
22256103
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 Biol Soc. 2011;2011:7622-5. doi: 10.1109/IEMBS.2011.6091878.
Results Reference
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Neuromuscular Electrical Stimulation in Chronic Low Back Pain

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