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

NCT04968535 | Completed

• 1 other identifier: INS-621000-0687-002
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

electrotherapy; chronic back pain; range of motion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• change in cervical range of motion at 8 weeks compared to baseline

  8 weeks

• change in lumbar range of motion at 8 weeks compared to baseline

  8 weeks

• Change in activity in daily living influenced by neck pain at 8 weeks compared to baseline

  8 weeks

• Change in activity in daily living influenced by low back pain at 8 weeks compared to baseline

  8 weeks

Study Arms (3)

Therapy

EXPERIMENTAL

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

Control

SHAM COMPARATOR

Patients receiving device calibration without consequent electrotherapy.

Device: StimaWELL

Control of control

NO INTERVENTION

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

Interventions

StimaWELL DEVICE

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

Control; Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (3)

• 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.

  PMID: 27745712 BACKGROUND

• 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.

  PMID: 31830313 BACKGROUND

• 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.

  PMID: 18843638 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Sabine Sator-Katzenschlager, Prof., MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization was performed using a Computer based randomization program. The physician regulating the electrotherapy device was the only one who was unmasked. The others (physician recruiting the patients, physician investigating the patients at the beginning and in the end of the enrollment, nurses) as well as the patients were blinded. The team was instructed to keep conversations to a minimum required.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: randomized controlled double blinded pilot study

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: July 20, 2021
• Study Start: January 8, 2015
• Primary Completion: October 16, 2018
• Study Completion: October 16, 2018
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)