Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain

Hacettepe University

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Device: The StimaWELL 120MTRS system

Study type: Interventional

Funder types: Other

Identifiers

NCT06638229

HUSpine017

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

StimaWell

Experimental group

Description:

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.

Treatment:

Device: The StimaWELL 120MTRS system

Waitlist

No Intervention group

Description:

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