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

NCT ID: NCT04968535

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-08
• Study Completion Date: 2018-10-16

Brief Summary

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.

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.

Conditions

Chronic Low-back Pain; Chronic Pain; Back Pain Without Radiation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

StimaWELL

Intervention Type: DEVICE

mid frequent electrotherapy mat covering the whole spinal cord with different stimulation protocols installed

Control

Patients receiving device calibration without consequent electrotherapy.

Group Type: SHAM_COMPARATOR

StimaWELL

Intervention Type: DEVICE

mid frequent electrotherapy mat covering the whole spinal cord with different stimulation protocols installed

Control of control

Patients lay on the mat without receiving device calibration nor electrotherapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

StimaWELL

mid frequent electrotherapy mat covering the whole spinal cord with different stimulation protocols installed

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Asami Naka

Sponsor-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabine Sator-Katzenschlager, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Department of Special Anesthesia and Pain Medicine, Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 27745712 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31830313 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18843638 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

INS-621000-0687-002

Identifier Type: -

Identifier Source: org_study_id