AzTrials
AzTrials

Chronic Low Back PainTENBACKNCT02297685

Effectiveness of Electrotherapy Techniques to Treat Low Back Pain

A study testing Transcutaneous nerve stimulation and Interferential currents in people with Chronic Low Back Pain, run by Camilo Jose Cela University 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

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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Low Back Pain
What is being tested?
Transcutaneous nerve stimulation and Interferential currents
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteSpain
Study dates
1 Dec 2014to 1 Jul 2015
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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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."

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Health Center Almendrales

    Madrid, 28026

Other trials in Spain

About this study

Official title: Effectiveness of Two Electrotherapy Techniques to Treat Chronic Low Back Pain

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.

Read the 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.

Being tested
Sham Transcutaneous nerve stimulation, Transcutaneous nerve stimulation, Interferential currents
Keywords
Transcutaneous electrical nerve stimulation (TENS), Interferential currents therapy, Therapeutic exercises, Low back pain, 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.

  • Sham Transcutaneous nerve stimulationDevice

    Also called Sham TENS

    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.

  • Transcutaneous nerve stimulationDevice

    Also called TENS

    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.

  • Interferential currentsDevice

    Also called IC

    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.

Study groups in NCT02297685
Study groupRoleWhat they receive
Sham Transcutaneous nerve stimulationSham comparatorThe 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.
Receives: Device: Sham Transcutaneous nerve stimulation
Transcutaneous nerve stimulationExperimentalThe 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.
Receives: Device: Transcutaneous nerve stimulation
Interferential currentsExperimentalThe 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.
Receives: Device: Interferential currents

What is being measured

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

  1. 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)

    Measured: Change after 3 weeks of electrotherpy treatment

  2. 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)

    Measured: Change after 3 weeks of electrotherpy treatment

  3. 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.

    Measured: Change after 3 weeks of electrotherpy treatment

  4. 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.

    Measured: Change after 3 weeks of electrotherpy treatment

Timeline

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

  1. First posted21 Nov 2014 (estimated)
  2. Study start1 Dec 2014
  3. Primary completion1 Mar 2015
  4. Study completion1 Jul 2015

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02297685
Sponsor's protocol ID
UCJC-15
Acronym
TENBACK
Status last verified
Apr 2018
First submitted
17 Nov 2014
Last updated
5 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23537462

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous nerve stimulation and Interferential currents in people with Chronic Low Back Pain, run by Camilo Jose Cela University 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 3 inclusion and 1 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 5 Apr 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. 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?

Functional status (time frame: Change after 3 weeks of electrotherpy treatment). The study lists 4 primary outcomes in all. 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 NCT02297685, which also lists 1 linked publication.

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 5 Apr 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in