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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04968535
Enrollment
162
Registered
2021-07-20
Start date
2015-01-08
Completion date
2018-10-16
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

electrotherapy, chronic back pain, range of motion

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.

Interventions

DEVICEStimaWELL

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

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Intervention model description

randomized controlled double blinded pilot study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in numeric pain rating scale at 8 weeks compared to baseline8 weeksChange from baseline subjective pain sensation from 0 (no pain) to 10 (maximum pain) at 8 weeks

Secondary

MeasureTime frameDescription
change in cervical range of motion at 8 weeks compared to baseline8 weeksCervical range of motion measured in degree using CROM (cervical range of motion device; the higher the number, the better the mobility).
change in lumbar range of motion at 8 weeks compared to baseline8 weeksLumbar 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).
Change in activity in daily living influenced by neck pain at 8 weeks compared to baseline8 weeksChange 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.
Change in activity in daily living influenced by low back pain at 8 weeks compared to baseline8 weeksChange 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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026