Effect of Regular Electrotherapy in Patients With Chronic Non-specific Neck Pain and Low-back Pain

Effect of Regular Electrotherapy in Patients With Chronic Non-specific Neck Pain and Low-back Pain: a Randomized Controlled Double-blinded Pilot Trial

This randomized controlled double-blinded pilot trial was performed in the Medical University of Vienna, Department of Special Anesthesia and Pain Medicine between 2015 and 2018. Aim of the study was to assess the effect of regular electrotherapy applied on the spinal cord of patients with chronic non-specific neck pain and/or low-back pain. The hypothesis was that subjective feeling of pain, range of motion of the cervical and lumbar region, as well as the activity in daily living improved after weekly electrotherapy sessions for 30 min each.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Chronic Low-back Pain; Back Pain Without Radiation
• Intervention / Treatment: Device: StimaWELL

Detailed Description

Chronic neck pain and low-back pain are common causes for the decrease in quality of life. Unfortunately, efficacy of medical therapy is limited (Maher et al, 2017), and evidence for the efficacy of transcutaneous electrical nerve stimulation (TENS) therapy for both chronic neck pain (Martimbianco et al, 2019), as well as for chronic low-back pain (Khadilkar et al, 2008) is scarce .

With the aim to assess the effectiveness of regular electrotherapy in chronic pain patients applied via a mat covering the whole spinal cord, and thus allowing deeper current penetration into the tissue compared to conventional TENS, male and female patients with chronic neck pain or low back pain aged 18 years or over were enrolled in this study.

After informed consent, patients were randomly divided in three groups: Group 1 (verum) received right after device calibration suprathreshold electrotherapy on the whole back for 30 min weekly, Group 2 (Control) received device calibration without consequent electrotherapy, Group 3 (Control of Control) just lay on the mat without receiving device calibration nor electrotherapy.

Electrotherapy was applied using a mat covering the whole spinal cord called "StimaWELL". Therefore, all the patients were asked to put off the clothes and lay supine on the mat for 30 min in each session.

Primary outcome was the subjective pain sensation measured with the numeric pain rating scale (NRS). Secondary outcomes were cervical and lumbar range of motion and activities in daily living.

Data recorded before and after the sessions (i.e. NRS at rest, NRS under activity, average NRS in the last four weeks, maximum and minimum NRS, and Short-form Mc Gill Pain Questionnaire for pain sensation, measurement of the lumbar range of motion using Modified Schober and measurement of cervical range of motion using the Cervical range of Motion Device (CROM), assessment of activities in daily living using the Neck Disability Index and Rolland Morris Questionnaire) was compared in each group,respectively.

Inclusion criteria were a numeric pain rating scale (NRS) equal or more than 5 prior to study enrollment, and chronic pain in the cervical or lumbar Region longer than three month.

Exclusion criteria were pregnancy, prior experience in TENS, epilepsy, cardiac arrythmia, cardiac operation prior to study enrollment including implanted pacemaker or defibrillator, operation in the spinal cord, malignancies or infectious diseases affecting the spinal cord, severe radicular pain with acute paralysis in the extremities or an ongoing pension application.

Oral pain medication had to be unchanged at least four weeks before the study enrollment. Additional pain therapies like acupuncture, physical therapy, intravenous pain therapy or intramuscular or subcutaneous injection of pain medication were not accepted.

All patients, as well as the recruiting investigator and the physician performing the physical measurements and questionnaires were blinded.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic neck pain and/or low back pain longer than 3 month
• Minimum numeric pain rating scale equal or > 5

Exclusion Criteria:

• Change in pain medication within 4 weeks prior or during the enrollment (except intake of rescue medication)
• Additional pain therapies within 4 weeks prior or during the enrollment
• Epilepsy
• Pregnancy
• Previous experience in TENS
• Cardiac arrythmia/previous cardiac operation/implanted cardiac devices
• Infection or malignancies affecting the spinal cord/previous spine operation
• Severe radicular pain with acute paralysis in the extremities
• Ongoing pension application

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapy; Patients receiving suprathreshold electrotherapy in weekly intervals for a Duration of 30 min each. Device calibration with determination of the individual threshold was performed prior to the application of electrical current.	Device: StimaWELL; mid frequent electrotherapy mat covering the whole spinal cord with different stimulation protocols installed
Sham Comparator: Control; Patients receiving device calibration without consequent electrotherapy.	Device: StimaWELL; mid frequent electrotherapy mat covering the whole spinal cord with different stimulation protocols installed
No Intervention: Control of control; Patients lay on the mat without receiving device calibration nor electrotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in numeric pain rating scale at 8 weeks compared to baseline	Change from baseline subjective pain sensation from 0 (no pain) to 10 (maximum pain) at 8 weeks	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in cervical range of motion at 8 weeks compared to baseline	Cervical range of motion measured in degree using CROM (cervical range of motion device; the higher the number, the better the mobility).	8 weeks
change in lumbar range of motion at 8 weeks compared to baseline	Lumbar range of motion measured in cm using the Modified Schober Method (measurement of the skin distance 10 cm above and 5 cm below the posterior superior iliac spine during anteflexion and retroflexion, respectively. The higher the value in anteflexion, the better the mobility; the smaller the measured skin distance in retroflexion, the better the mobility).	8 weeks
Change in activity in daily living influenced by neck pain at 8 weeks compared to baseline	Change in the activity in daily living after 8 weeks compared to baseline using a questionnaire called "Neck Disability Index" for cervicalgia: Minimum 0 points (no disability), maximum 50 Points (severe disability); score calculation: Points examined divided 50 times 100; the higher, the more disabled in daily living due to chronic neck pain.	8 weeks
Change in activity in daily living influenced by low back pain at 8 weeks compared to baseline	Change in the activity in daily living after 8 weeks compared to baseline using "Rolland Morris Disability Questionnaire" for low back pain: Minimum 0 points (no disability), Maximum 24 points. The higher the score, the more disabled due to low back pain.	8 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Sabine Sator-Katzenschlager, Prof., MD, Department of Special Anesthesia and Pain Medicine, Medical University of Vienna

Publications and helpful links

General Publications

• Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
• Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003008. doi: 10.1002/14651858.CD003008.pub3.
• Martimbianco ALC, Porfirio GJ, Pacheco RL, Torloni MR, Riera R. Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain. Cochrane Database Syst Rev. 2019 Dec 12;12(12):CD011927. doi: 10.1002/14651858.CD011927.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2015
• Primary Completion (Actual): October 16, 2018
• Study Completion (Actual): October 16, 2018

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: range of motion; electrotherapy; chronic back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain; Neck Pain
• Other Study ID Numbers: INS-621000-0687-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No