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Completed

NCT Number: NCT06638229

Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Pain Catastrophizing Scale

    Time frame: Before and after 4 weeks of treatment

    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.

Secondary outcomes

  1. Numeric Pain Scale

    Time frame: Before and after 4 weeks of treatment

    Pain 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".

  2. Oswestry Disability Index

    Time frame: Before and after 4 weeks of treatment

    Disability 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.

  3. Nottingham Health Profile

    Time frame: Before and after 4 weeks of treatment

    The 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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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