Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain

NCT ID: NCT06638229

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-02-29

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

StimaWell

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.

Group Type: EXPERIMENTAL

The StimaWELL 120MTRS system

Intervention Type: 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

Waitlist

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The StimaWELL 120MTRS system

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18-65 years old,
• LBP for more than three months,
• Pain of 3 or more according to the Numeric Pain Scale
• being literate

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Ozlem Ulger

Head of Spine Health Unit, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Özlem Ülger, professor

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HUSpine017

Identifier Type: -

Identifier Source: org_study_id