Ultrasound-Guided Thoracolumbar Fascia Injection for Chronic Low Back Pain in Patients With Type 2 Diabetes
Chronic Low Back Pain · Type 2 Diabetes Mellitus (DM)
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 65 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 60 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This prospective, randomized, controlled clinical trial aims to evaluate the efficacy of ultrasound-guided thoracolumbar fascia (TLF) injection as an adjunct to standard conservative treatment in patients with type 2 diabetes mellitus and chronic nonspecific low back pain.
A total of 60 patients aged 18-65 years, diagnosed with type 2 diabetes mellitus for at least one year and experiencing chronic nonspecific low back pain for at least three months, will be enrolled. Eligible participants will be randomly assigned to two groups. The intervention group will receive ultrasound-guided thoracolumbar fascia injection in addition to standard conservative treatment, while the control group will receive standard conservative treatment alone, consisting of patient education and a structured exercise program.
Clinical assessments will be performed at baseline and at 1 and 3 months after treatment. Treatment outcomes will include pain intensity measured using the Numeric Rating Scale (NRS), functional disability assessed using the Oswestry Disability Index (ODI), pressure pain threshold (PPT) measured by algometry, and analgesic consumption.
Thoracolumbar fascia thickness will be measured using ultrasonography at baseline to investigate its potential association with treatment response. Diabetes-related characteristics, including HbA1c levels, diabetes duration, and peripheral neuropathy status, will also be recorded.
The primary objective is to determine whether adding ultrasound-guided thoracolumbar fascia injection to standard conservative treatment provides greater improvement in pain intensity and functional disability compared with standard conservative treatment alone. The study will also explore whether baseline thoracolumbar fascia thickness and diabetes-related characteristics are associated with clinical outcomes.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
\*\*Inclusion Criteria:\*\*
- Age between 18 and 65 years.
- Diagnosis of type 2 diabetes mellitus for at least 1 year.
- Chronic low back pain lasting at least 3 months.
- Nonspecific or mechanical low back pain.
- Baseline pain intensity of ≥4 on the Numeric Rating Scale (NRS).
- Pain or tenderness on palpation over the thoracolumbar fascia region.
- Willingness to participate in the study.
- Provision of written informed consent.
\*\*Exclusion Criteria:\*\*
- Radiculopathy or significant neurological deficits.
- Neurogenic claudication due to spinal stenosis.
- Spinal tumor or infection.
- History or presence of vertebral fracture.
- Inflammatory rheumatic disease.
- Spinal surgery within the previous 6 months.
- Injection in the lumbar region within the previous 3 months.
- Anticoagulant therapy or conditions contraindicating injection.
- Active infection at the injection site.
- Severe systemic disease, including advanced renal failure.
- Uncontrolled diabetic metabolic condition.
- Pregnancy.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
Thoracolumbar Fascia Injection Group
No informado en este registro.
Procedure: Ultrasound-Guided Thoracolumbar Fascia Injection · Behavioral: Standard Conservative Treatment
Standard Conservative Treatment Group
No informado en este registro.
Behavioral: Standard Conservative Treatment
Ultrasound-Guided Thoracolumbar Fascia Injection PROCEDURE
A single ultrasound-guided thoracolumbar fascia injection will be performed with the patient in the prone position under aseptic conditions. Using an in-plane technique, a 22-gauge needle will be advanced into the middle layer of the thoracolumbar fascia between the quadratus lumborum and erector spinae muscles at the L4 level. Correct needle placement will be confirmed by hydrodissection using approximately 2 mL of local anesthetic. Subsequently, 10 mL of 0.25% bupivacaine and 40 mg of methylprednisolone acetate will be administered into the interfascial plane.
Standard Conservative Treatment BEHAVIORAL
Standard conservative treatment will consist of structured patient education and a home-based exercise program. The exercise program will include lumbopelvic and core stabilization exercises, abdominal and paraspinal muscle strengthening, hip muscle strengthening, lower extremity stretching, and aerobic activity as tolerated. Participants will receive instructions on correct exercise techniques, maintaining daily activities, and avoiding prolonged bed rest. The program will be recommended for regular home practice throughout the study period.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in Low Back Pain Intensity Measured by the Numeric Rating Scale (NRS)
Plazo: Baseline, Month 1, and Month 3
No informado en este registro.
Medidas secundarias
Change in Functional Disability Measured by the Oswestry Disability Index (ODI)
Plazo: Baseline, Month 1, and Month 3
No informado en este registro.
Change in Pressure Pain Threshold (PPT) Measured by Algometry
Plazo: Baseline, Month 1, and Month 3
No informado en este registro.
Change in Analgesic Consumption During Follow-up
Plazo: Baseline to Month 3
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
Kanuni Sultan Suleyman Training and Research HospitalKüçükçekmece, Istanbul, Turkey (Türkiye)Reclutando
Equipo y fechas
- Patrocinador principal
- Hatice Zehra FERHATLAR
- Inicio del estudio
- 23 oct 2026 Real
- Finalización primaria
- 30 abr 2027 Estimado
- Finalización del estudio
- 30 abr 2027 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Efficacy of Ultrasound-Guided Thoracolumbar Fascia Injection in the Treatment of Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026