Chronic Low Back PainELECBACKNCT02812459

Effectiveness of Electrical Stimulation or Kinesio Taping on Recovery Disability in Low Back Pain

A study testing Kinesio taping and Electrical Stimulation in people with Chronic Low Back Pain, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to analyze the effectiveness of electrical stimulation and kinesio taping in combination with exercise in People with Chronic Low Back Pain Read more about this study

Who is it for?: Ages 25 to 65 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: Kinesio taping and Electrical Stimulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteSpain
Study dates: Jun 2016to Apr 2018
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 25 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

LBP for three months or more;
age between 25 and 65 years;
a score of four points or more on the Roland Morris Disability Questionnaire;
not currently receiving physical therapy.

Who cannot join

the presence of lumbar stenosis;
any clinical signs of radiculopathy;
a diagnosis of spondylolisthesis;
a diagnosis of fibromyalgia;
treatment with corticosteroid or oral medication within the past two weeks;
a history of spinal surgery;
disease of the central or peripheral nervous system.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Adelaida Mª Castro Sánchez
Almería, S/N

Other trials in Spain

About this study

Official title: Short-term Effectiveness of Additional Electrical Stimulation to Exercise Versus Kinesio Taping in Patients With Chronic Low Back Pain: A Randomized Controlled Trial

The purpose of this study is to analyze the effectiveness of electrical stimulation and kinesio taping in combination with exercise in People with Chronic Low Back Pain

Conditions: Chronic Low Back Pain
Being tested: Kinesio taping, Electrical Stimulation
Keywords: Electrical Stimulation Therapy, Kinesio taping, Exercise
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Kinesio tapingOther
Kinesio taping is a new taping modality which act diminishing pain.
Electrical StimulationOther
Electrical stimulation therapy is a electrical current that allow patients diminish pain.

Study groups in NCT02812459
Study group	Role	What they receive
Kinesio taping plus exercise	Experimental	Kinesio taping application for low back plus back exercises.This protocol will be administered three a week for 4 weeks. Receives: Other: Kinesio taping
Electrical stimulation plus exercise	Active comparator	Electrical stimulation for control pain applied in low back plus exercises.This protocol will be administered three a week for 4 weeks. Receives: Other: Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Roland Morris Disability Questionnaire (RMDQ) at one month.
The Roland Morris disability questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability
Measured: 4 weeks

Secondary outcomes (8)

Change from baseline Oswestry Disability Index (ODI) at one month.
The Oswestry disability index evaluates daily life activity limitations in 10 dimensions, each scored on a 6-point scale (0-5 points); the total points scored are expressed as a percentage, used to classify individuals as minimally disabled (0-10%), moderately disabled (20-40%), severely disabled (40-60%), crippled (60-80%), or bedbound (80-100%).
Measured: 4 weeks
Change from baseline Visual Analogue Scale (VAS) at one month
The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain
Measured: 4 weeks
Change from baseline Tampa Scale for Kinesiophobia (TSK) at one month
The Tampa Scale for Kinesiophobia comprises 17 items on the fear of movement or recurrent lesion, each scored on a 4-point Likert scale from "completely disagree" to "completely agree".
Measured: 4 weeks
Change from baseline Pressure pain thresholds (PPT) at one month
Examination of PPT will be performed with the use of an Algometer. According to International Association for the Study of Pain, PPT is the smallest stimulus causing the feeling of pain (International Association for the Study of Pain, Subcommittee on Taxonomy, 1986). The examination will carried out twice in the same places, on the left and right sides following the protocol described by Sipko et al.2013: musculus erector spinae - at the level of L2, 3 cm away from the interspinous line; musculus gluteus medius - between the greater trochanter and iliac crest sideways; musculus triceps surae - the transition of the belly of the muscle into the tendon; and musculus tibialis anterior - one-third of the upper shank, at the front.
Measured: 4 weeks
Change from baseline Mechanosensitive/the Seated Slump Test neurodynamic testing at one month
The subject will be positioned in an erect sitting position on an examination plinth with the popliteal creases just off the edge of the plinth. The subject will be asked to sit in a slouched position. After, the subject will be asked to actively flex the cervical spine as far as comfortably possible. After, the subject's ankle will be then passively dorsiflexed to slight resistance, while the knee is slowly passively extended.The knee will be extended until the subject reports onset of neural-mediated symptoms.The degree of knee extension will be measured with a large universal goniometer.
Measured: 4 weeks
Change from baseline Mechanosensitive/straight-leg raise neurodynamic testing at one month
The subject will be positioned in supine with standardized head support. After the test will be performed with the ankle in neutral position and with 30º of ankle flexion. The hip will be flexed with the knee extended until the subject reports onset of neural-mediated symptoms. The degree of hip flexion will be measured with a large universal goniometer.
Measured: 4 weeks
Change from baseline Anxiety and depression measures at one month
Beck questionnaire
Measured: 4 weeks
Change from baseline Quality of Sleep at one month
Pittsburgh questionnaire
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Apr 2018

First posted24 Jun 2016 (estimated)
Study startJun 2016
Primary completionApr 2018
Study completionApr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Chronic 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02812459
Sponsor's protocol ID: ELECBACK_KT
Acronym: ELECBACK
Status last verified: Oct 2018
First submitted: 16 Jun 2016
Last updated: 9 Oct 2018
Results posted: No
Data monitoring committee: No

Publications

Boyd BS, Wanek L, Gray AT, Topp KS. Mechanosensitivity of the lower extremity nervous system during straight-leg raise neurodynamic testing in healthy individuals. J Orthop Sports Phys Ther. 2009 Nov;39(11):780-90. doi: 10.2519/jospt.2009.3002.
PubMed 19881004
Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther. 2001 Feb;81(2):776-88. doi: 10.1093/ptj/81.2.776.
PubMed 11175676
Sipko T, Kuczynski M. Intensity of chronic pain modifies postural control in low back patients. Eur J Pain. 2013 Apr;17(4):612-20. doi: 10.1002/j.1532-2149.2012.00226.x.
PubMed 23065907
Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
PubMed 11172169
Ekman M, Johnell O, Lidgren L. The economic cost of low back pain in Sweden in 2001. Acta Orthop. 2005 Apr;76(2):275-84. doi: 10.1080/00016470510030698.
PubMed 16097556
Melloh M, Elfering A, Stanton TR, Kaser A, Salathe CR, Barz T, Roder C, Theis JC. Who is likely to develop persistent low back pain? A longitudinal analysis of prognostic occupational factors. Work. 2013 Jan 1;46(3):297-311. doi: 10.3233/WOR-131672.
PubMed 24004738
Hallegraeff JM, Krijnen WP, van der Schans CP, de Greef MH. Expectations about recovery from acute non-specific low back pain predict absence from usual work due to chronic low back pain: a systematic review. J Physiother. 2012;58(3):165-72. doi: 10.1016/S1836-9553(12)70107-8.
PubMed 22884183
Costa Lda C, Maher CG, McAuley JH, Hancock MJ, Herbert RD, Refshauge KM, Henschke N. Prognosis for patients with chronic low back pain: inception cohort study. BMJ. 2009 Oct 6;339:b3829. doi: 10.1136/bmj.b3829.
PubMed 19808766
Added MA, Costa LO, de Freitas DG, Fukuda TY, Monteiro RL, Salomao EC, de Medeiros FC, Costa Lda C. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Jul;46(7):506-13. doi: 10.2519/jospt.2016.6590. Epub 2016 Jun 6.
PubMed 27266883
Forozeshfard M, Bakhtiary AH, Aminianfar A, Sheikhian S, Akbarzadeh Z. Short term effects of kinesio taping on pain and functional disability in young females with menstrual low back pain: A randomised control trial study. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):709-715. doi: 10.3233/BMR-160673.
PubMed 26966819
Luz Junior MA, Sousa MV, Neves LA, Cezar AA, Costa LO. Kinesio Taping(R) is not better than placebo in reducing pain and disability in patients with chronic non-specific low back pain: a randomized controlled trial. Braz J Phys Ther. 2015 Nov-Dec;19(6):482-90. doi: 10.1590/bjpt-rbf.2014.0128. Epub 2015 Oct 9.
PubMed 26647750
Kelle B, Guzel R, Sakalli H. The effect of Kinesio taping application for acute non-specific low back pain: a randomized controlled clinical trial. Clin Rehabil. 2016 Oct;30(10):997-1003. doi: 10.1177/0269215515603218. Epub 2015 Aug 27.
PubMed 26316553
Hagen L, Hebert JJ, Dekanich J, Koppenhaver S. The effect of elastic therapeutic taping on back extensor muscle endurance in patients with low back pain: a randomized, controlled, crossover trial. J Orthop Sports Phys Ther. 2015 Mar;45(3):215-9. doi: 10.2519/jospt.2015.5177. Epub 2015 Feb 13.
PubMed 25679343
Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
PubMed 25202177
Alvarez-Alvarez S, Jose FG, Rodriguez-Fernandez AL, Gueita-Rodriguez J, Waller BJ. Effects of Kinesio(R) Tape in low back muscle fatigue: randomized, controlled, doubled-blinded clinical trial on healthy subjects. J Back Musculoskelet Rehabil. 2014;27(2):203-12. doi: 10.3233/BMR-130437.
PubMed 24284272

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short-term Effectiveness of Additional Electrical Stimulation to Exercise Versus Kinesio Taping in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02812459
Acronym / sponsor ID: ELECBACK / ELECBACK_KT
Conditions: Chronic Low Back Pain
Keywords: Electrical Stimulation Therapy, Kinesio taping, Exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Universidad de GranadaUniversity, hospital or other
Study start: Jun 2016
Primary completion: Apr 2018 (actual)
Study completion: Apr 2018 (actual)
First posted: 24 Jun 2016 (estimated)
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.

The purpose of this study is to analyze the effectiveness of electrical stimulation and kinesio taping in combination with exercise in People with Chronic Low Back Pain

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Kinesio taping plus exercise	Experimental	Other: Kinesio tapingKinesio taping application for low back plus back exercises.This protocol will be administered three a week for 4 weeks.
Electrical stimulation plus exercise	Active comparator	Other: Electrical StimulationElectrical stimulation for control pain applied in low back plus exercises.This protocol will be administered three a week for 4 weeks.

Who may qualify

Ages: 25 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

LBP for three months or more;
age between 25 and 65 years;
a score of four points or more on the Roland Morris Disability Questionnaire;
not currently receiving physical therapy.

Key exclusion criteria (7 listed)

the presence of lumbar stenosis;
any clinical signs of radiculopathy;
a diagnosis of spondylolisthesis;
a diagnosis of fibromyalgia;
treatment with corticosteroid or oral medication within the past two weeks;

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
Kinesio tapingKinesio taping is a new taping modality which act diminishing pain.	Other	Kinesio taping plus exercise
Electrical StimulationElectrical stimulation therapy is a electrical current that allow patients diminish pain.	Other	Electrical stimulation plus exercise

Primary outcome

Change from baseline in Roland Morris Disability Questionnaire (RMDQ) at one month.
Time frame: 4 weeks
The Roland Morris disability questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability

8 secondary outcomes

Change from baseline Oswestry Disability Index (ODI) at one month.
Time frame: 4 weeks
Change from baseline Visual Analogue Scale (VAS) at one month
Time frame: 4 weeks
Change from baseline Tampa Scale for Kinesiophobia (TSK) at one month
Time frame: 4 weeks
Change from baseline Pressure pain thresholds (PPT) at one month
Time frame: 4 weeks
Change from baseline Mechanosensitive/the Seated Slump Test neurodynamic testing at one month
Time frame: 4 weeks
Change from baseline Mechanosensitive/straight-leg raise neurodynamic testing at one month
Time frame: 4 weeks
Change from baseline Anxiety and depression measures at one month
Time frame: 4 weeks
Change from baseline Quality of Sleep at one month
Time frame: 4 weeks

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 9 Oct 2018.
Background: PubMed 19881004Boyd BS, Wanek L, Gray AT, Topp KS. Mechanosensitivity of the lower extremity nervous system during straight-leg raise neurodynamic testing in healthy individuals. J Orthop Sports Phys Ther. 2009 Nov;39(11):780-90. doi: 10.2519/jospt.2009.3002.
Background: PubMed 11175676Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther. 2001 Feb;81(2):776-88. doi: 10.1093/ptj/81.2.776.
Background: PubMed 23065907Sipko T, Kuczynski M. Intensity of chronic pain modifies postural control in low back patients. Eur J Pain. 2013 Apr;17(4):612-20. doi: 10.1002/j.1532-2149.2012.00226.x.
Results publication: PubMed 11172169Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
Results publication: PubMed 16097556Ekman M, Johnell O, Lidgren L. The economic cost of low back pain in Sweden in 2001. Acta Orthop. 2005 Apr;76(2):275-84. doi: 10.1080/00016470510030698.
Results publication: PubMed 24004738Melloh M, Elfering A, Stanton TR, Kaser A, Salathe CR, Barz T, Roder C, Theis JC. Who is likely to develop persistent low back pain? A longitudinal analysis of prognostic occupational factors. Work. 2013 Jan 1;46(3):297-311. doi: 10.3233/WOR-131672.
Results publication: PubMed 22884183Hallegraeff JM, Krijnen WP, van der Schans CP, de Greef MH. Expectations about recovery from acute non-specific low back pain predict absence from usual work due to chronic low back pain: a systematic review. J Physiother. 2012;58(3):165-72. doi: 10.1016/S1836-9553(12)70107-8.
Results publication: PubMed 19808766Costa Lda C, Maher CG, McAuley JH, Hancock MJ, Herbert RD, Refshauge KM, Henschke N. Prognosis for patients with chronic low back pain: inception cohort study. BMJ. 2009 Oct 6;339:b3829. doi: 10.1136/bmj.b3829.
Results publication: PubMed 27266883Added MA, Costa LO, de Freitas DG, Fukuda TY, Monteiro RL, Salomao EC, de Medeiros FC, Costa Lda C. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Jul;46(7):506-13. doi: 10.2519/jospt.2016.6590. Epub 2016 Jun 6.
Results publication: PubMed 26966819Forozeshfard M, Bakhtiary AH, Aminianfar A, Sheikhian S, Akbarzadeh Z. Short term effects of kinesio taping on pain and functional disability in young females with menstrual low back pain: A randomised control trial study. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):709-715. doi: 10.3233/BMR-160673.
Results publication: PubMed 26647750Luz Junior MA, Sousa MV, Neves LA, Cezar AA, Costa LO. Kinesio Taping(R) is not better than placebo in reducing pain and disability in patients with chronic non-specific low back pain: a randomized controlled trial. Braz J Phys Ther. 2015 Nov-Dec;19(6):482-90. doi: 10.1590/bjpt-rbf.2014.0128. Epub 2015 Oct 9.
Results publication: PubMed 26316553Kelle B, Guzel R, Sakalli H. The effect of Kinesio taping application for acute non-specific low back pain: a randomized controlled clinical trial. Clin Rehabil. 2016 Oct;30(10):997-1003. doi: 10.1177/0269215515603218. Epub 2015 Aug 27.

Related trials for Chronic Low Back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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.

María Encarnación Aguilar-Ferrándiz principal investigator

Deparment of Physical Therapy. University of Granada

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Kinesio taping and Electrical Stimulation in people with Chronic Low Back Pain, run by Universidad de Granada at 1 site in Spain.

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 7 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 9 Oct 2018. 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 Spain. 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. 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 from baseline in Roland Morris Disability Questionnaire (RMDQ) at one month. (time frame: 4 weeks). 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 NCT02812459, which also lists 22 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 9 Oct 2018.