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Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain

Investigation of the Effectiveness of Electrotherapy Treatment for the Spine in Individuals with Chronic Low Back Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06638229
Enrollment
61
Registered
2024-10-15
Start date
2023-08-01
Completion date
2024-02-29
Last updated
2025-01-20

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

Conditions

Chronic Low Back Pain

Keywords

chronic low back pain, electrotherapy

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.

Interventions

DEVICEThe 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

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Catastrophizing ScaleBefore and after 4 weeks of treatmentParticipants' 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.

Secondary

MeasureTime frameDescription
Numeric Pain ScaleBefore and after 4 weeks of treatmentPain intensity during activity, at rest and at night was assessed with the Numeric Pain Scale. It was graded with 0 representing no pain and 10 representing the worst pain imaginable.
Oswestry Disability IndexBefore and after 4 weeks of treatmentDisability level was assessed with the Oswestry Disability Index. The scale consists of 10 items, each ranging from 0 to 5, with a total score of 100. Higher scores indicate higher levels of disability.
Nottingham Health ProfileBefore and after 4 weeks of treatmentThe Nottingham Health Profile was used to assess participants' health-related quality of life. The first part of the NHP contains 38 items covering six domains: pain, physical activity, emotional reactions, energy, social isolation and sleep. Each domain is scored from 0 to 100 and the total score is the sum of these domain scores. Only the first part of the NHP was used for this study

Countries

Turkey (Türkiye)

Outcome results

None listed

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