Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain

NCT06638229 | Completed

• 1 other identifier: HUSpine017
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effectiveness of a specific electrotherapy treatment for individuals with chronic non-specific low back pain. The participants, who had low back pain for more than three months, were divided into two groups: a treatment group and a waitlist control group. The treatment group received electrotherapy using the StimaWELL 120MTRS system, which provided electrical stimulation and heat therapy to the entire spine over four weeks. The study assessed various outcomes, including pain levels, disability, and quality of life, before and after the intervention.

Conditions

Chronic Low Back Pain

Keywords

chronic low back pain; electrotherapy

Outcome Measures

Primary Outcomes (1)

• Pain Catastrophizing Scale

  Participants' pain catastrophizing levels were measured using the Pain Catastrophizing Scale (PCS). The total score of the PCS is 52, with higher scores indicating higher levels of catastrophizing behavior.

  Before and after 4 weeks of treatment

Secondary Outcomes (3)

• Numeric Pain Scale

  Before and after 4 weeks of treatment

• Oswestry Disability Index

  Before and after 4 weeks of treatment

• Nottingham Health Profile

  Before and after 4 weeks of treatment

Study Arms (2)

StimaWell

EXPERIMENTAL

Participants in the StimaWELL group had previously received electrotherapy treatment for the entire spine for 4 weeks, 2 days a week. Before the treatment, participants were informed about their medical condition and the planned treatment. The StimaWELL 120MTRS system (StimaWELL® 120MTRS; Schwa-medico, Wetzlarer Straße 41-43, 35630 Ehringshausen, Germany) was used for the treatment and a stimulation mat was used to apply electrical stimulation along the entire back. The 12 channels of the mat provided different current intensities to different areas and the system offered programs tailored to various therapeutic goals.

Device: The StimaWELL 120MTRS system

Waitlist

NO INTERVENTION

Patients presenting to the clinic for treatment and waiting without intervention in the waitlist group after routine evaluation.

Interventions

The StimaWELL 120MTRS system DEVICE

A standardized current (dynamic deep wave stimulation) was applied to all patients. Additionally, the mat, which reached a temperature of 40°C, provided heat therapy with electrical stimulation

StimaWell

Eligibility Criteria

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

You may qualify if:

• years old,
• LBP for more than three months,
• Pain of 3 or more according to the Numeric Pain Scale
• being literate

You may not qualify if:

• having a pacemaker,
• body mass index greater than 30,
• pathologies of the cervical or lumbar region,
• cervical radiculopathy, thoracic outlet syndrome, malignant conditions,
• systemic diseases, such as neurological, psychological, cardiovascular or rheumatologic conditions, loss of function due to these diseases,
• history of surgery on the spine or upper extremities,
• acute infection

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

Location

Study Officials

• Özlem Ülger, professor

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Spine Health Unit, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: August 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: January 20, 2025

Record last verified: 2024-10

Locations

TU (1)