Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07335718
Low back pain is a very common health problem in societies, regardless of the underlying cause. Its lifetime prevalence has been reported to be as high as 75-80%. Low back pain negatively affects the quality of life of affected individuals. In addition to diagnostic and treatment costs, it can lead to serious physical disability, resulting in loss of workforce and placing a substantial economic burden on countries. Many different factors play a role in the etiology of low back pain. According to etiology, it can be classified as idiopathic, mechanical, rheumatologic, metabolic, endocrine, infectious, neoplastic, neurologic/psychiatric disorders, and pain of visceral origin. The treatment of low back pain can be classified into medical treatment, physical therapy, percutaneous invasive interventions, and surgical intervention. TECAR therapy is also one of the treatment modalities routinely used in clinical practice. Our aim is to develop more effective physical therapy programs.
Interested in participating?
Request Info20 year–60 year
All sexes
Observational
Ankara, Turkey (Türkiye)
Location status: Recruiting
The study is planned as a prospective, randomized, double-blind trial. According to power analysis, 54 patients will be included to achieve 95% power. Eligible participants will be women or men aged 20-60 years who are diagnosed with lumbar disc herniation, have low back pain lasting longer than 12 weeks, present to the Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital as outpatients, and consent to participate in the study.
According to the study criteria, initial evaluations will be performed by a single Physical Medicine and Rehabilitation physician. Demographic data of eligible patients, including age, sex, height, weight, occupation, and systemic diseases, will be recorded.
Patients will be evaluated before treatment, immediately after treatment, and one month after the end of treatment using the following scales: Visual Analog Scale (VAS) for pain, Numeric Rating Scale (NRS), Quality of Life Scale (SF-36), Roland-Morris Disability Questionnaire, Oswestry Disability Index, Finger-to-Floor Distance Measurement, Beck Depression Inventory, and Lumbar Schober Test.
Patients will be divided into two groups. The first group will receive a home exercise program including lumbar active range of motion exercises and lumbar isometric strengthening exercises, performed five times per week for three weeks according to the level of movement restriction and pain severity, along with TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions.
The second group will receive the same home exercise program-including lumbar active range of motion exercises and lumbar isometric strengthening exercises-performed five times per week for three weeks according to the level of movement restriction and pain severity, along with sham TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Having a diagnosis of lumbar disc herniation (bulging, protruded, or extruded)
Being able to comply with the exercise program
Willingness to participate in the study Being between 20 and 60 years of age
Exclusion criteria
Being younger than 20 years or older than 60 years
Having a known and/or newly diagnosed malignancy
Presence of cardiac implants such as a pacemaker
Having inflammatory low back pain
Having absolute spinal stenosis (anteroposterior diameter of the spinal canal < 10 mm and anteroposterior diameter of the lateral recess < 3 mm)
History of surgery due to lumbar disc herniation, lumbar spinal stenosis, vertebral fracture, or similar conditions
Presence of lumbar spondylolisthesis
Patients with sequestered disc herniation
Patients with polyneuropathy
Patients with central pain following stroke
Patients with neurological deficits
Having a diagnosed neurodegenerative disease
Having a systemic musculoskeletal disease
Patients with acute deep vein thrombosis
Pregnancy
Presence of infection at the skin surface where treatment will be applied
Unexplained weight loss
Bladder and/or bowel incontinence
Having received physical therapy modalities or injections for low back pain within the last 1 month
Having cognitive impairment
Refusal to participate in the study
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TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions
Time frame: Up to 1 month after the end of treatment
Zero indicates no pain at all, whereas ten represents the most severe pain imaginable.
Time frame: Up to 1 month after the end of treatment
The Oswestry Disability Index (ODI) is a standardized questionnaire designed to assess the degree of disability and functional impairment in individuals with lower back pain
Contact information is provided by the study sponsor or research team.
Ankara City Hospital Bilkent
Other
Acronym: TECAR THERAPY
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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