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A clinical trial to study efficacy and safety of pulsed radiofrequency as treatment of oral cancer pain.

Completed
Conditions
Cancer pain involving glossopharyngeal nerve in a case of oropharyngeal carcinoma with no curative intervention planned
Registration Number
CTRI/2016/08/007179
Lead Sponsor
Post Graduate Institute of Medical Education Research
Brief Summary

The Pulsed Radiofrequency (PRF)  treatment has been used previously for the treatment of various pain conditions and found to be safe & effective.In this trial we will study whether PRF treatment of glossopharyngeal nerve is effective & safe in the pain management of oropharyngeal cancer patient suffering from intractable pain which can not be controlled by traditional analgesic therapy at base of tongue, tonsillar fossa, oropharynx( area supplied by glossopharyngeal nerve). PRF of glossopharyngeal nerve will be done at Operation theatre under full aseptic precaution with standard monitoring for vital signs & as day care basis. Post procedure patient will be monitored at PACU for 2 hrs and subsequently patient will be assessed at 1 week, 2week. 1 month, 2 month, 3 month post PRF at pain clinic. During their visit pain score will be noted according to numerical rating scale ( NRS). Treatment will be considered effective if there is 50% reduction in NRS at 2 week post PRF from the base line.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
Inclusion Criteria

Adult population (18-65 years)suffering from oropharyngeal carcinoma with no curative intervention planned( not fit for surgery) undergoing treatment by WHO step ladder II method still complaining of severe pain ( NRS>5) in the base of tongue, tonsillar fossa, pharynx- area mainly supplied by glossopharyngeal nerve.

Exclusion Criteria

unstable cardio-respiratory disorder coagulation & hematological disorder psychological disorder & history drug abuse non compliant for 3 months follow up injection site not suitable due to presence of infection , lymph node enlaegement bilateral involvement of glossopharyngeal nerve.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Efficacy of PRF ablation of glossopharyngeal nerve for the treatment of cancer pain by pain score by numerical rating scalePost intervention - 1week, 2 week, 1 month, 2 month, 3 month
Secondary Outcome Measures
NameTimeMethod
Safety profile of PRF of glossopharyngeal nerve in cancer painduring & post intervention (120 mins ) & post intervention 1 week, 2 week, 1 month, 2 month,3 month

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education & Research

🇮🇳

Chandigarh, CHANDIGARH, India

Post Graduate Institute of Medical Education & Research
🇮🇳Chandigarh, CHANDIGARH, India
DR Suryabrata Chattopadhyay
Principal investigator
08727083344
drsurya24@gmail.com

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