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Trial registered on ANZCTR


Registration number
ACTRN12614000941662
Ethics application status
Approved
Date submitted
2/08/2014
Date registered
3/09/2014
Date last updated
28/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound guided intercostal nerve block using pulsed radiofrequency in management of thoracic postherpetic neuralgia
Scientific title
Ultrasound guided intercostal nerve block using pulsed radiofrequency in management of thoracic postherpetic neuralgia (PHN) in adult patients who had chest wall PHN at T2-T11 of more than 6 months duration, who had moderate and severe pain (VAS more than 30 mm).
Secondary ID [1] 284951 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-herpetic neuralgia 292433 0
Condition category
Condition code
Anaesthesiology 293068 293068 0 0
Pain management
Neurological 293139 293139 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The affected thoracic dermatome first will be determined. In addition to the affected dermatome, one dermatome above and below will be the therapeutic targets of this study. Ultrasound guided localization of targets Intercostal nerve (ICN) at the angulus costae then sensory stimulation of the nerve roots with paresthesia response in the dermatome distribution of the affected nerve root using (Neurotherm Rediofrequancy machine 1100 at 50 HZ using a 22-gauge 10 cm radiofrequency needle with 5 mm active tip) . In the active group after sensory stimulation patients will receive 1 ml xylocaine 2% locally infilterated for each nerve root and wait for one minute. Then the patients will receive 2 cycles pulsed radiofrequency (PRF) 42 C for 120 second for ICN at the angulus costae for the affected thoracic nerves. These therapeutic modalities will be applied to the affected dermatome and to adjacent upper and lower one The total duration of the procedure will take about thirty minutes and will be undertaken on a single occasion only. patients will receive pregabalin in a dose of 150 mg twice daily orally. Their pain score will be evaluated in each visit. Once patients reported mild pain (VAS less than 30), the pregabalin dose will be reduced by 75 mg every 3 days provided that pain score remained less than 30 with each reduction. If the VAS value will increase to more than 30, the patient will be returned to the last controllable pregabalin dose and the result will be recorded in the patient diary. Acetaminophen will be available as rescue analgesia in a dose of 1,000 mg orally on request. For those with persistent pain more than 30, a maximum daily dose of 4,000 mg will be allowed.
Intervention code [1] 290034 0
Treatment: Devices
Comparator / control treatment
The intervention consists of two parts the first part is localization of the nerve by ultra sound then sensory stimulation for confirmation of its place,the second part is active lesion by pulsed radiofrequency. the control Group will undergo only localization of the targets intercostal nerves at the angulus costae by ultrasound then sensory stimulation of the nerve roots with paresthesia response in the dermatome distribution of the affected nerve root using (Neurotherm Rediofrequancy machine 1100 at 50 HZ using a 22-gauge 10 cm radiofrequency needle with 5 mm active tip) without any lesioning . After sensory stimulation the control patients will receive 1 ml xylocaine 2% locally infilterated for each nerve root and for the patient to be blind we will put the needle for the same time as in the active procedure but without any lesion cycle of pulsed radiofrequency ,so the patient cannot suggest to which group he pelongs These therapeutic modalities will be applied to the affected dermatome and to adjacent upper and lower one. Control patients then will receive pregabalin in a dose of 150 mg twice daily orally. Their pain score will be evaluated in each visit. Once patients reported mild pain (VAS less than 30), the pregabalin dose will be reduced by 75 mg every 3 days provided that pain score remained less than 30 with each reduction. If the VAS value will increase to more than 30, the patient will be returned to the last controllable pregabalin dose and the result will be recorded in the patient diary. Acetaminophen will be available as rescue analgesia in a dose of 1,000 mg orally on request. For those with persistent pain more than 30, a maximum daily dose of 4,000 mg will be allowed.
Control group
Placebo

Outcomes
Primary outcome [1] 292594 0
Patients will be evaluated for pain severity using Visual Analogue Scale (VAS), (100 mm unmarked line in which 0 equal no pain and 100 mm means worst pain imaginable)
Timepoint [1] 292594 0
before the block (basal), , every 2 weeks after the procedure for 6 months and every 1 month for another 6 months.
Primary outcome [2] 292935 0
Quality of life
Timepoint [2] 292935 0
Quality of life will be evaluated using self-evaluation questionnaires (SF-36) at 1, 3, 6 and 12 months
Secondary outcome [1] 309288 0
Analgesic consumption was assessed on a patient daily diary
Timepoint [1] 309288 0
before the block (basal), , every 2 weeks after the procedure for 6 months and every 1 month for another 6 months.

Eligibility
Key inclusion criteria
Adult patients who had chest wall PHN at T2-T11 of more than 6 months duration, who had moderate and severe pain (VAS more than 30 mm).
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patient refusal, patients with mild pain,Presence of psychiatric illness. and infection at site of injection. Patients with history of renal, hepatic diseases, coagulopathy, diabetes, steroid therapy, malignancies and patients taking chemo and/or radiotherapy will be excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A blinded pain physician will determine if a subject was eligible for inclusion in the trial.
Patients will be randomly assigned using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly assigned using a computer-generated random number assignment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This randomized blind clinical trial will be carried out at Mansoura University Hospital. Sample size calculation will be based on the previous studies which reported the mean VAS for PHN patients was 65 and the assumed standard deviation (SD) was 20 and reduction of VAS by 20 will be a clinically significant improvement with a power of study 90% (alpha equal 0.05, beta equal 0.1). The calculated sample size of 21 patients in each group.The total number of the calculated sample size will be 42 patients. The number will increase by 20% to compensate for possible dropouts. Therefore, the total sample size will be 50 patients (25 patient in each group). The collected data will be coded, processed and analyzed using SPSS version 16 (SPSS Inc., Chicago, IL, USA). The appropriate statistical testes will be carried out based on the intention to treat. The level of statistical significance will be considered at 5% (P equal 0.05). 1.Dworkin RH, Corbin AE, Young JP, Jr, Sharma U, LaMoreaux L, Bockbrader H, Garofalo EA, Poole RM. Pregabalin for the treatment of postherpetic neuralgia: a randomized,placebo-controlled trial. Neurology, 2003; 60(8):1274-83. 2.Ke M, Yinghui F, Yi J, Xeuhua H, Xiaoming L, Zhijun C, Chao H, Yingwei W.Efficacy of pulsed radiofrequency in the treatment of thoracic postherpetic neuralgia from the angulus costae: a randomized, double-blinded, controlled trial. Pain Physician. 2013 Jan;16(1):15-25. 3.Sabatowski R, Galvez R, Cherry DA, Jacquot F, Vincent E, Maisonobe P, Versavel M. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomized, placebo-controlled clinical trial. Pain 2004; 109(1-2):26-35.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6207 0
Egypt
State/province [1] 6207 0

Funding & Sponsors
Funding source category [1] 289791 0
Self funded/Unfunded
Name [1] 289791 0
Address [1] 289791 0
Country [1] 289791 0
Primary sponsor type
Individual
Name
Mohamed Y. Makharita
Address
Faculty Of Medicine - El Mansoura University - 60 El Gomhoureya St. El Mansoura, El Dakahleya Post code 35516
Country
Egypt
Secondary sponsor category [1] 288255 0
Individual
Name [1] 288255 0
Hanaa Mahmoud Elbendary
Address [1] 288255 0
Faculty Of Medicine - El Mansoura University - 60 El Gomhoureya St. El Mansoura, El Dakahleya Post code 35516
Country [1] 288255 0
Egypt
Secondary sponsor category [2] 288256 0
Individual
Name [2] 288256 0
Mahmoud Abdel Latif Mohamed
Address [2] 288256 0
Faculty Of Medicine - El Mansoura University - 60 El Gomhoureya St. El Mansoura, El Dakahleya Post code 35516
Country [2] 288256 0
Egypt
Secondary sponsor category [3] 288652 0
Individual
Name [3] 288652 0
Zainab Mahmoud Sonbul
Address [3] 288652 0
Faculty Of Medicine - El Mansoura University - 60 El Gomhoureya St. El
Mansoura, El Dakahleya Post code 35516
Country [3] 288652 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291310 0
medical research ethical committe- Mansoura university
Ethics committee address [1] 291310 0
Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El
Mansoura
, El Dakahleya
Post code 35516
Ethics committee country [1] 291310 0
Egypt
Date submitted for ethics approval [1] 291310 0
09/06/2014
Approval date [1] 291310 0
25/06/2014
Ethics approval number [1] 291310 0
MD/88

Summary
Brief summary
This randomized blind clinical trial will be carried out at Mansoura University Hospital. Sample size calculation will be based on the previous studies which reported the mean VAS for PHN patients was 65 and the assumed standard deviation (SD) was 20 and reduction of VAS by 20 will be a clinically significant improvement with a power of study 90% (alpha equal 0.05, Beta equal 0.1). The calculated sample size of 21 patients in each group.The total number of the calculated sample size will be 42 patients. The number will increase by 20% to compensate for possible dropouts. Therefore, the total sample size will be 50 patients (25 patient in each group).

In the first visit to pain clinic, after taking medical history and thorough clinical examination, the severity of pain will be evaluated using VAS. Patient quality of life will be assessed using self-evaluation questionnaires (SF-36)
Inclusion criteria:
Adult patients who had chest wall PHN at T2-T11 of more than 6 months duration, who had moderate and severe pain (VAS more than 30 mm).
Exclusion Criteria: patient refusal, patients with mild pain,Presence of psychiatric illness. and infection at site of injection. Patients with history of renal, hepatic diseases, coagulopathy, diabetes, steroid therapy, malignancies and patients taking chemo and/or radiotherapy will be excluded


Randomization will be performed using sealed envelopes indicating the group to which patients will be assigned. A blinded chief nurse who will not be involved in the study or in the data collection will read the number contained in the envelope and make group assignment.
The affected thoracic dermatome first will be determined. In addition to the affected dermatome, one dermatome above and below will be the therapeutic targets of this study. Ultrasound guided localization of targets (ICN at the angulus costae) then sensory stimulation of the nerve roots with paraasthesia response in the dermatome distribution of the affected nerve root using (Neurotherm Rediofrequancy machine 1100 at 50 HZ using a 22-gauge 10 cm radiofrequency needle with 5 mm active tip) for both group.

Group 1(25 patients): after sensory stimulation patients will receive 1 ml xylocaine 2%locally for each nerve root and wait for one minute. Then the patients will receive 2 cycles PRF 42 C for 120 second for ICN at the angulus costae for the affected thoracic nerves.

Group 2(25 patients): after sensory stimulation patients will receive 1 ml xylocaine 2%locally for each nerve root and we will spend same time taken for pulsed radiofrequency cycles to occure at the angulus costae for each affected thoracic nerves.

These therapeutic modalities will be applied to the affected dermatome and to adjacent upper and lower one in all patients in both groups.

All patients will receive pregabalin in a dose of 150 mg twice daily. Their pain score will be evaluated in each visit. Once patients reported mild pain (VAS less than 30), the pregabalin dose will be reduced by 75 mg every 3 days provided that pain score remained less than 30 with each reduction. If the VAS value will increase to more than 30, the patient will be returned to the last controllable pregabalin dose and the result will be recorded in the patient diary. Acetaminophen will be available as rescue analgesia in a dose of 1,000 mg on request. For those with persistent pain more than 30, a maximum daily dose of 4,000 mg will be allowed.

Blinding (masking)
Patients preparation for interventional procedures and ensure fulfillment of inclusion and exclusion criteria will be performed by Dr. Salma El Sayed. The same investigator (Dr. Salma El Sayed under supervision of Dr. Mohamed Makharita and Dr. Mahmoud Abdel Latif) will perform all interventional procedures for all patients. Follow ups and reporting of the data will be performed by an investigator from the pain clinic who will be unaware of the randomization procedure and the type of intervention to which the patients was subjected. Data collection from the patient files will be by Dr. Salma El Sayed.


Evaluation Parameters:
Patients will be evaluated for pain severity using Visual Analogue Scale (VAS), (100 mm unmarked line in which 0 equal no pain and 100 mm means worst pain imaginable) before the block (basal), , every 2 weeks after the procedure for 6 months and every 1 month for another 6 months. If VAS less than 30 mm gradual reduction of medication will be allowed.

Follow up
At each assessment visit, VAS, duration of pain relief and the total analgesic consumption will be recorded. Quality of life will be evaluated using self-evaluation questionnaires (SF-36) at 1, 3, 6 and 12 months. Adverse effects include vasovagal attack, pneumothorax, neuritis and any sensory or motor deficits will be also reported. Telephone consultations were allowed if any increase in pain occurred during follow up.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49810 0
Dr Salma El Sayed Abd Elsalam Ahmed
Address 49810 0
Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El
Mansoura , El Dakahleya postal code: 35516
Country 49810 0
Egypt
Phone 49810 0
+201002990553
Fax 49810 0
Email 49810 0
salmaaa_ahmed@yahoo.com
Contact person for public queries
Name 49811 0
Dr Salma El Sayed Abd Elsalam Ahmed
Address 49811 0
Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El
Mansoura , El Dakahleya postal code: 35516
Country 49811 0
Egypt
Phone 49811 0
+201002990553
Fax 49811 0
Email 49811 0
salmaaa_ahmed@yahoo.com
Contact person for scientific queries
Name 49812 0
Dr Salma El Sayed Abd Elsalam Ahmed
Address 49812 0
Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El
Mansoura , El Dakahleya postal code: 35516
Country 49812 0
Egypt
Phone 49812 0
+201002990553
Fax 49812 0
Email 49812 0
salmaaa_ahmed@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary