Effectiveness of Electrical Stimulation or Kinesio Taping on Recovery Disability in Low Back Pain (ELECBACK)
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|ClinicalTrials.gov Identifier: NCT02812459|
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Other: Kinesio taping Other: Electrical Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||April 2018|
Experimental: Kinesio taping plus exercise
Kinesio taping application for low back plus back exercises.This protocol will be administered three a week for 4 weeks.
Other: Kinesio taping
Kinesio taping is a new taping modality which act diminishing pain.
Active Comparator: Electrical stimulation plus exercise
Electrical stimulation for control pain applied in low back plus exercises.This protocol will be administered three a week for 4 weeks.
Other: Electrical Stimulation
Electrical stimulation therapy is a electrical current that allow patients diminish pain.
- 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
- Change from baseline Oswestry Disability Index (ODI) at one month. [ Time Frame: 4 weeks ]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%).
- Change from baseline Visual Analogue Scale (VAS) at one month [ Time Frame: 4 weeks ]The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain
- Change from baseline Tampa Scale for Kinesiophobia (TSK) at one month [ Time Frame: 4 weeks ]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".
- Change from baseline Pressure pain thresholds (PPT) at one month [ Time Frame: 4 weeks ]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.
- Change from baseline Mechanosensitive/the Seated Slump Test neurodynamic testing at one month [ Time Frame: 4 weeks ]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.
- Change from baseline Mechanosensitive/straight-leg raise neurodynamic testing at one month [ Time Frame: 4 weeks ]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.
- Change from baseline Anxiety and depression measures at one month [ Time Frame: 4 weeks ]Beck questionnaire
- Change from baseline Quality of Sleep at one month [ Time Frame: 4 weeks ]Pittsburgh questionnaire
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): NCT02812459
|Adelaida Mª Castro Sánchez|
|Almería, Spain, S/N|
|Principal Investigator:||María Encarnación Aguilar-Ferrándiz||Deparment of Physical Therapy. University of Granada|