CompletedNot Applicable

Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for Metastatic Pain in Thoracic Vertebral Body

Egypt69 participantsStarted 2017-02-14

Plain-language summary

AIM OF THE WORK To evaluate the effectiveness and safety of Pulsed and Thermal Radiofrequency lesion of the dorsal root ganglion (RF-DRG) on a consecutive group of patients presenting with chronic thoracic pain due to vertebral bone metastasis.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A greater than 6-month history of segmental pain of thoracic vertebral body metastasis origin.
✓. Unsatisfactory pain control with oral pharmacotherapy including strong opioid with VAS \>5 .
✓. Absence of a chronic or progressive motor deficit.
✓. Absence of significant sensory deficit.
✓. No indication for percutaneous or open surgical intervention.
✓. Magnetic resonance imaging and Computed Tomogrophy evidence of thoracic involvement.
✓. ASA status of II to III .
✓. Age \> 18 .

Exclusion criteria

✕. Known sensitivity or contraindication to injected materials: local anesthetics.
✕. History of psychological disorders.
✕. Evidence of significant neurological deficit.
✕. Inability to lie prone.
✕. Local contraindication to procedure e.g. local sepsis at the site of intervention, coagulopathy.
✕. Patient refusal.

What they're measuring

The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30

Timeframe: Assessment done at 3 months after the procedure.

EORTC QLQ-BM22

Timeframe: Assessment done at 3 months after the procedure.

Visual Analog Scale (VAS), to Evaluate Pain

Timeframe: Assessment of pain done at 3 months after the procedure.

Oswestry Low Back Pain Disability Questionnaire (ODI),

Timeframe: Assessment of pain done at 3 months after the procedure.

Trial details

NCT IDNCT03204942

SponsorNational Cancer Institute, Egypt

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-30

Results submitted2019-09-27

View on ClinicalTrials.gov More Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A greater than 6-month history of segmental pain of thoracic vertebral body metastasis origin.
✓. Unsatisfactory pain control with oral pharmacotherapy including strong opioid with VAS \>5 .
✓. Absence of a chronic or progressive motor deficit.
✓. Absence of significant sensory deficit.
✓. No indication for percutaneous or open surgical intervention.
✓. Magnetic resonance imaging and Computed Tomogrophy evidence of thoracic involvement.
✓. ASA status of II to III .
✓. Age \> 18 .

Exclusion criteria

✕. Known sensitivity or contraindication to injected materials: local anesthetics.
✕. History of psychological disorders.
✕. Evidence of significant neurological deficit.
✕. Inability to lie prone.
✕. Local contraindication to procedure e.g. local sepsis at the site of intervention, coagulopathy.
✕. Patient refusal.

What they're measuring

The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30

Timeframe: Assessment done at 3 months after the procedure.

EORTC QLQ-BM22

Timeframe: Assessment done at 3 months after the procedure.

Visual Analog Scale (VAS), to Evaluate Pain

Timeframe: Assessment of pain done at 3 months after the procedure.

Oswestry Low Back Pain Disability Questionnaire (ODI),

Timeframe: Assessment of pain done at 3 months after the procedure.