Low Back PainNCT04119895
Neuromuscular Electrical Stimulation in Chronic Low Back Pain
A study testing Neuromuscular electrical stimulation and core stabilization exercise in people with Low Back Pain, run by Koç University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Neuromuscular electrical stimulation and core stabilization exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2018to 16 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older,
- Pain intensity greater than 3 over 10,
- Pain duration more than 3 months,
- Consent to participate in the study
Who cannot join
- Previous lumbar surgery,
- Radiculopathy,
- Non-mechanical back pain,
- Acute low back pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koc University School of Medicine
Istanbul, 34010
About this study
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?
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Neuromuscular electrical stimulation and core stabilization exercise, Sham neuromuscular electrical stimulation and core stabilization exercise
- Keywords
- Electric stimulation, Ultrasonography, Exercise Therapy, Rehabilitation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation and core stabilization exerciseOther
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 exerciseOther
In sham NMES group, the amplitude of the electrical current will be set at a minimum level which does not stimulate any contraction.
| Study group | Role | What they receive |
|---|---|---|
| NMES and exercise | Experimental | Neuromuscular electrical stimulation and core stabilization exercise Receives: Other: Neuromuscular electrical stimulation and core stabilization exercise |
| Sham NMES and exercise | Sham comparator | Sham neuromuscular electrical stimulation and core stabilization exercise Receives: Other: Sham neuromuscular electrical stimulation and core stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks (change from baseline to 4 weeks after)
Secondary outcomes (3)
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.
Measured: 4 weeks (change from baseline to 4 weeks after)
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.
Measured: 4 weeks (change from baseline to 4 weeks after)
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.
Measured: 4 weeks (change from baseline to 4 weeks after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start16 Oct 2018
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Sponsor
- Investigators
- Ozden Ozyemisci Taskiran, Prof, Principal investigator, Koc University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119895
- Sponsor's protocol ID
- 2018.174.IRB1.022
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2019
- Last updated
- 23 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It was not planned to share individual participant data.
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.
PubMed 20227638Kim 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.
PubMed 27064323Coghlan 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.
PubMed 19163276Coghlan 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.
PubMed 22256103Fairbank 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.
PubMed 24266676Ohnhaus 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.
PubMed 800639Yakut 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.
PubMed 15129077Fairbank 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.
PubMed 11074683Hunt 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.
PubMed 6973203Kucukdeveci 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.
PubMed 10826123Liddle 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.
PubMed 14715404Akhtar 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.
PubMed 29067082
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT04119895
- Acronym / sponsor ID
- 2018.174.IRB1.022
- Conditions
- Low Back Pain
- Keywords
- Electric stimulation, Ultrasonography, Exercise Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| NMES and exercise | Experimental | Other: Neuromuscular electrical stimulation and core stabilization exerciseNeuromuscular electrical stimulation and core stabilization exercise |
| Sham NMES and exercise | Sham comparator | Other: Sham neuromuscular electrical stimulation and core stabilization exerciseSham neuromuscular electrical stimulation and core stabilization exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older,
- Pain intensity greater than 3 over 10,
- Pain duration more than 3 months,
- Consent to participate in the study
Key exclusion criteria (4 listed)
- Previous lumbar surgery,
- Radiculopathy,
- Non-mechanical back pain,
- Acute low back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulation and core stabilization exerciseIn 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 | NMES and exercise |
| Sham neuromuscular electrical stimulation and core stabilization exerciseIn sham NMES group, the amplitude of the electrical current will be set at a minimum level which does not stimulate any contraction. | Other | Sham NMES and exercise |
Primary outcome
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.
3 secondary outcomes
Change in Visual Analog Scale
Time frame: 4 weeks (change from baseline to 4 weeks after)
Change in Nottingham Health Profile
Time frame: 4 weeks (change from baseline to 4 weeks after)
Change in Ultrasonographic thickness of multifidus and abdominal muscles
Time frame: 4 weeks (change from baseline to 4 weeks after)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Results publication: PubMed 20227638Hoy 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.
- Results publication: PubMed 27064323Kim 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 publication: PubMed 19163276Coghlan 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 publication: PubMed 22256103Coghlan 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 publication: PubMed 24266676Fairbank 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.
- Results publication: PubMed 800639Ohnhaus 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.
- Results publication: PubMed 15129077Yakut 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.
- Results publication: PubMed 11074683Fairbank 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.
- Results publication: PubMed 6973203Hunt 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.
- Results publication: PubMed 10826123Kucukdeveci 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.
- Results publication: PubMed 14715404Liddle 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.
- Results publication: PubMed 29067082Akhtar 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.
- Individual participant dataSharing planned: No. It was not planned to share individual participant data.
Related trials for Low Back Pain
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
The Hidden Burden of Cerebral Palsy: Exploring the Relationship Between Gross Motor Function of Children, Maternal Low Back Pain, and Quality of Life
Gross Motor
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Myofascial Techniques on Chronic Low Back Pain
Chronic Low-back Pain (cLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozden Ozyemisci Taskiran, Prof principal investigator
Koc University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation and core stabilization exercise in people with Low Back Pain, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (time frame: 4 weeks (change from baseline to 4 weeks after)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04119895, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.