Effectiveness of Electrotherapy Techniques to Treat Low Back Pain

NCT02297685 | Completed

• 1 other identifier: UCJC-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Transcutaneous electrical nerve stimulation (TENS); Interferential currents therapy; Therapeutic exercises; Low back pain; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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)

  Change after 3 weeks of electrotherpy treatment

• 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)

  Change after 3 weeks of electrotherpy treatment

• 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.

  Change after 3 weeks of electrotherpy treatment

• 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.

  Change after 3 weeks of electrotherpy treatment

Study Arms (3)

Sham Transcutaneous nerve stimulation

SHAM COMPARATOR

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

Transcutaneous nerve stimulation

EXPERIMENTAL

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

Interferential currents

EXPERIMENTAL

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

Interventions

Sham Transcutaneous nerve stimulation DEVICE

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.

Also known as: Sham TENS

Sham Transcutaneous nerve stimulation

Transcutaneous nerve stimulation DEVICE

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.

Also known as: TENS

Transcutaneous nerve stimulation

Interferential currents DEVICE

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.

Also known as: IC

Interferential currents

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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."

You may not qualify if:

• 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.

Sponsors & Collaborators

• Camilo Jose Cela University: lead
• Public Health Service of Madrid: collaborator

Study Sites (1)

Health Center Almendrales

Madrid, 28026, Spain

Location

Related Publications (1)

• 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.

  PMID: 23537462 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Juan Del Coso, PhD

  Camilo Jose Cela University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 21, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

ES (1)