Neuromuscular Electrical Stimulation in Chronic Low Back Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04119895|
Recruitment Status : Completed
First Posted : October 9, 2019
Last Update Posted : April 23, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Other: Neuromuscular electrical stimulation and core stabilization exercise Other: Sham neuromuscular electrical stimulation and core stabilization exercise||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind randomized controlled trial|
|Masking:||Double (Participant, Outcomes Assessor)|
|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?|
|Actual Study Start Date :||October 16, 2018|
|Actual Primary Completion Date :||October 16, 2019|
|Actual Study Completion Date :||October 16, 2019|
Experimental: NMES and exercise
Neuromuscular electrical stimulation and core stabilization exercise
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 Comparator: Sham NMES and exercise
Sham neuromuscular electrical stimulation and core stabilization exercise
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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 18 years or older,
- Pain intensity greater than 3 over 10,
- Pain duration more than 3 months,
- Consent to participate in the study
- Previous lumbar surgery,
- Non-mechanical back pain,
- Acute low back pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119895
|Koc University School of Medicine|
|Istanbul, Turkey, 34010|
|Principal Investigator:||Ozden Ozyemisci Taskiran, Prof||Koc University School of Medicine|
|Responsible Party:||Koç University|
|Other Study ID Numbers:||
|First Posted:||October 9, 2019 Key Record Dates|
|Last Update Posted:||April 23, 2021|
|Last Verified:||April 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||It was not planned to share individual participant data.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Low Back Pain