Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT06638229
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Catastrophizing Scale	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 Outcome Measures

Name	Time	Method
Numeric Pain Scale	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".
Oswestry Disability Index	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.
Nottingham Health Profile	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

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey