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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sham Transcutaneous nerve stimulation
Transcutaneous nerve stimulation
Interferential currents
Sponsored by
Camilo Jose Cela University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Transcutaneous electrical nerve stimulation (TENS), Interferential currents therapy, Therapeutic exercises, Low back pain, Rehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Health Center Almendrales

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Sham Transcutaneous nerve stimulation

Transcutaneous nerve stimulation

Interferential currents

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Functional status
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)
Perceptual evaluation of low back pain
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)
The straight leg raise (SLR)
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.
Pressure pain threshold (PPT)
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.

Secondary Outcome Measures

Full Information

First Posted
November 17, 2014
Last Updated
April 4, 2018
Sponsor
Camilo Jose Cela University
Collaborators
Public Health Service of Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02297685
Brief Title
Effectiveness of Electrotherapy Techniques to Treat Low Back Pain
Acronym
TENBACK
Official Title
Effectiveness of Two Electrotherapy Techniques to Treat Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
March 1, 2015 (Actual)
Study Completion Date
July 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Camilo Jose Cela University
Collaborators
Public Health Service of Madrid

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Subjects The subjects for this study were recruited from a waiting list at the Almendrales Physiotherapy Center (Madrid, Spain). Potential participants had to be older than 18 years and present continuous low back pain for more than 12 weeks. Potential participants were then examined by an independent specialist and the diagnosis of LBP was made according the medical diagnosis, the Roland Morris Disability Questionnaire (RMQD)24 and an X-ray. With these inclusion criteria, a total of 96 patients were contacted to participate in the experiment. Twenty-one participants were excluded because they fulfilled one or several of the following exclusion criteria: 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 declined to participate. Treatment groups The experimental design was a randomized, double-blind sham-controlled clinical trial. After the preliminary examination, 48 patients were randomly assigned to three groups: control (sham electrotherapy), transcutaneous electrical nerve stimulation (TENS) and interferential currents (IC). A set of sealed and sequentially numbered opaque envelopes was used for group assignment. The study was double-blind because the examiner had no contact with the patient during the duration of the treatment and patients were not informed about the electrotherapy technique they received during the investigation. Intervention Each treatment was applied 3 times per week on alternate days (excluding weekends) over a period of 4 weeks, including a total of 12 sessions. All the treatments were administered by an experienced physiotherapist. 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 current intensity was set 3 times during each session according to each patient's sensitivity. The patients were informed that they may or may not feel any sensation at the application site of the electrodes. 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 group with TENS received current at a frequency of 80 Hz and with a pulse width of 150 μs with two channels (P-82 TENS med Enraf-nonius, Netherlands). Participants in the control group received the same procedures (e.g., electrode placement) but the current was always equal to 0. In each session, the electrical stimulation technique was administered for 30 minutes while the subjects were comfortable seated in an adjustable chair. After the electrostimulation procedures, all participants performed a 30-min session of therapeutic exercises. The session included lumbar stabilization (5 different exercises) and conventional stretching (5 different exercises). Each exercise was performed for 10 repetitions and with 60 s of rest between exercises. These exercise routines were added to the all the electrotherapy techniques investigated at the request of the Ethics Committee in order to provide treatment to all participants. Outcome measurements The day before the onset of the treatment (pre-treatment) and the day after the end of the treatment (post-treatment), the intensity of low back pain was evaluated by using a 100-mm visual analogue pain scale (VAS). The functional status of each individual was measured using the Rolland Morris Disability Questionnaire(RMDQ) at these same time-points. 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). The use of disability scales, such as RMDQ, has been shown to correlate with physical incapacity better than the scales that measure the intensity of pain, X Rays, magnetic resonance imaging scans (MRIs), and computerized tomography scans. 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. 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. Three months after the end of the treatments, the RMDQ was applied to all participants to evaluate the LBP disability and the maintenance of the improvements obtained by the treatments. The follow-up was performed by the same independent experimenter and in the same experimental conditions. Statistical analysis All the data were analyzed using the SPSS v.20 statistical package. Descriptive statistics were calculated for each group (mean and standard deviation). Normality was tested with the Shapiro-Wilk test. All the variables presented a normal distribution in this test (P > 0.05). Baseline characteristics were compared using the analysis of variance (ANOVA) for measuring independent data. Pre-to-post treatment changes and the comparison between groups were performed by using a two-way ANOVA (group x time). After a significant F test, differences between means were identified using Tukey's HSD post hoc procedure. The level of significance was established at P < 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Transcutaneous electrical nerve stimulation (TENS), Interferential currents therapy, Therapeutic exercises, Low back pain, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Transcutaneous nerve stimulation
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Transcutaneous nerve stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Interferential currents
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcutaneous nerve stimulation
Other Intervention Name(s)
Sham TENS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous nerve stimulation
Other Intervention Name(s)
TENS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Interferential currents
Other Intervention Name(s)
IC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional status
Description
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)
Time Frame
Change after 3 weeks of electrotherpy treatment
Title
Perceptual evaluation of low back pain
Description
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)
Time Frame
Change after 3 weeks of electrotherpy treatment
Title
The straight leg raise (SLR)
Description
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.
Time Frame
Change after 3 weeks of electrotherpy treatment
Title
Pressure pain threshold (PPT)
Description
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.
Time Frame
Change after 3 weeks of electrotherpy treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Del Coso, PhD
Organizational Affiliation
Camilo Jose Cela University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Center Almendrales
City
Madrid
ZIP/Postal Code
28026
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23537462
Citation
Thiese MS, Hughes M, Biggs J. Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial. BMC Musculoskelet Disord. 2013 Mar 28;14:117. doi: 10.1186/1471-2474-14-117.
Results Reference
background

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Effectiveness of Electrotherapy Techniques to Treat Low Back Pain

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