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Effectiveness of Electrotherapy Techniques to Treat Low Back Pain (TENBACK)

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ClinicalTrials.gov Identifier: NCT02297685
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Public Health Service of Madrid
Information provided by (Responsible Party):
Camilo Jose Cela University

Brief Summary:
Objective: The aim of this investigation was compare the effectiveness of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IC) on chronic low back pain. Forty-eight patients diagnosed as having chronic low back pain were randomly assigned to three groups: control (sham electrotherapy; age 47 ± 8 years), interferential currents (IC; age 48 ± 8 years) and transcutaneous electrical nerve stimulation (TENS; age 48 ± 8 years). Patients in all groups received 12 × 30-min sessions of the assigned treatment for a period of 4 weeks plus therapeutic exercises. Before and after the treatment, low back pain was measured using a 100-mm visual analogue scale and functional disability level was measured using the Rolland Morris Disability Questionnaire. Participants status was followed up 3 months after the end of the treatment.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Sham Transcutaneous nerve stimulation Device: Transcutaneous nerve stimulation Device: Interferential currents Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Two Electrotherapy Techniques to Treat Chronic Low Back Pain
Actual Study Start Date : December 1, 2014
Actual Primary Completion Date : March 1, 2015
Actual Study Completion Date : July 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Sham Comparator: Sham Transcutaneous nerve stimulation
The group with sham TENS did not receive any current. Four surface electrodes (5×5 cm Prim-Trode®, Spain) were symmetrically placed over the L1 and L5 transverse processes with respect to the spine. The patients were informed that they may or may not feel any sensation at the application site of the electrodes.
Device: Sham Transcutaneous nerve stimulation
The group with sham transcutaneous nerve stimulation (TENS) did not receive any electrical treatment. We placed 4 surface electrodes (5x5 cm Prim-Trode, Spain) over the L1 and L5 transverse processes with respect to the spine but we did not delivery any current. The patients were informed that they may or may not feel any sensation at the application site of the electrodes.
Other Name: Sham TENS

Experimental: Transcutaneous nerve stimulation
The group with TENS received current at a frequency of 80 Hz and with a pulse width of 150 μs with two channels, for 30 minutes over a period of 4 weeks, including a total of 12 sessions.
Device: Transcutaneous nerve stimulation
The group with transcutaneous nerve stimulation (TENS) received electrical stimulation for 12 sessions at a frequency of 80 Hz and with a pulse width of 150 ns. The TENS was delivered by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) placed over the L1 and L5 transverse processes with respect to the spine. The current intensity was set 3 times during each session according to each patient's sensitivity.
Other Name: TENS

Experimental: Interferential currents
The group with IC received a base frequency of 4000 Hz with AMF = 65 Hz, sweep = 95 Hz and slope of 1/1 in tetrapolar mode, for 30 minutes over a period of 4 weeks, including a total of 12 sessions.
Device: Interferential currents
The group with IC received a base frequency of 4000 Hz with AMF = 65 Hz, sweep = 95 Hz and slope of 1/1 in tetrapolar mode (Endomed 492 Enraf-nonius, Netherlands). The current was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: were symmetrically placed over the L1 and L5 transverse processes with respect to the spine; the current intensity was set 3 times during each session according to each patient's sensitivity.
Other Name: IC




Primary Outcome Measures :
  1. Functional status [ Time Frame: Change after 3 weeks of electrotherpy treatment ]
    The functional status of each individual was measured using the Rolland Morris Disability Questionnaire (RMDQ) before and after 3 weeks of eletrotherapy treatment. The RMDQ is a simple, fast and valid questionnaire to assess the LBP disability. It consists of 24 items that reflect limitation in different activities of daily living attributed by the patient to low back pain. Each item receives a score of 1 point, so the RMDQ score ranges between 0 (no disability) and 24 points (the maximum possible disability)

  2. Perceptual evaluation of low back pain [ Time Frame: Change after 3 weeks of electrotherpy treatment ]
    The intensity of low back pain was evaluated before and after 3 weeks of electrotherpy treatment by using a 100-mm visual analogue pain scale (VAS)

  3. The straight leg raise (SLR) [ Time Frame: Change after 3 weeks of electrotherpy treatment ]
    The straight leg raise (SLR) in both legs was also used to measure the range of motion of the leg. For this measurement, an inclinometer (Baseline, Enterprises Inc., USA) was applied to the anterior tibial tuberosity with the patient lying on a treatment stretcher. To prevent the external rotation of the hip, the contralateral leg was fixed with a strap to the stretcher. The examiner passively flexed the participant's hip with the knee fully extended until the subject felt tightness in the hamstring area or until the lower back was destabilized. The SLR (in degrees) was calculated separately for each leg by using one repetition.

  4. Pressure pain threshold (PPT) [ Time Frame: Change after 3 weeks of electrotherpy treatment ]
    Pressure pain threshold (PPT) was measured at the lumbosacral joint and at the right and left sacroiliac joints with the application of a pressure algometer (FPK 20, Wagner Instruments, USA) with a rubber tip of 1 cm2. The PPT recorded the maximal pressure (kg/cm2) applied until the participant perceived it as painful. The PPT measured at each location was repeated three times with 1 min of rest between repetitions. The average value of these 3 measurements was used for further analysis.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subjects for this study were recruited from a waiting list from patients with acute low back pain.
  • To be included in the list they had to be older than 18 years and have had unilateral shoulder pain for more than 12 weeks.
  • Potential participants were then examined by an independent specialist and the diagnosis of LBP was made according to the Roland Morris Disability Questionnaire."

Exclusion Criteria:

  • The following participants were excluded from the investigation: individuals presenting trauma, disc disease or lumbosciaticas; individuals who were receiving pain-relieving treatments with another physiotherapy method at the same time; patients with previous surgery or intra-articular injections; individuals with contraindications against electrotherapy and those who declined to participate.

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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): NCT02297685


Locations
Spain
Health Center Almendrales
Madrid, Spain, 28026
Sponsors and Collaborators
Camilo Jose Cela University
Public Health Service of Madrid
Investigators
Principal Investigator: Juan Del Coso, PhD Camilo Jose Cela University

Publications:
Responsible Party: Camilo Jose Cela University
ClinicalTrials.gov Identifier: NCT02297685     History of Changes
Other Study ID Numbers: UCJC-15
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Camilo Jose Cela University:
Transcutaneous electrical nerve stimulation (TENS)
Interferential currents therapy
Therapeutic exercises
Low back pain
Rehabilitation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms