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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

post-herpetic neuralgia

Condition category

Condition code

Anaesthesiology

Pain management

Neurological

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]

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]

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]

before the block (basal), , every 2 weeks after the procedure for 6 months and every 1 month for another 6 months.

Primary outcome [2]

Quality of life

Timepoint [2]

Quality of life will be evaluated using self-evaluation questionnaires (SF-36) at 1, 3, 6 and 12 months

Secondary outcome [1]

Analgesic consumption was assessed on a patient daily diary

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

25/09/2014

Actual

25/09/2014

Date of last participant enrolment

Anticipated

Actual

22/07/2015

Date of last data collection

Anticipated

Actual

1/08/2016

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

Individual

Name [1]

Hanaa Mahmoud Elbendary

Address [1]

Faculty Of Medicine - El Mansoura University - 60 El Gomhoureya St. El Mansoura, El Dakahleya Post code 35516

Country [1]

Egypt

Secondary sponsor category [2]

Individual

Name [2]

Mahmoud Abdel Latif Mohamed

Address [2]

Faculty Of Medicine - El Mansoura University - 60 El Gomhoureya St. El Mansoura, El Dakahleya Post code 35516

Country [2]

Egypt

Secondary sponsor category [3]

Individual

Name [3]

Zainab Mahmoud Sonbul

Address [3]

Faculty Of Medicine - El Mansoura University - 60 El Gomhoureya St. El
Mansoura, El Dakahleya Post code 35516

Country [3]

Egypt

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

medical research ethical committe- Mansoura university

Ethics committee address [1]

Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El
Mansoura
, El Dakahleya
Post code 35516

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

09/06/2014

Approval date [1]

25/06/2014

Ethics approval number [1]

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

Dr Salma El Sayed Abd Elsalam Ahmed

Address

Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El
Mansoura , El Dakahleya postal code: 35516

Country

Egypt

Phone

+201002990553

Fax

salmaaa_ahmed@yahoo.com

Contact person for public queries

Name

Salma El Sayed Abd Elsalam Ahmed

Address

Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El
Mansoura , El Dakahleya postal code: 35516

Country

Egypt

Phone

+201002990553

Fax

salmaaa_ahmed@yahoo.com

Contact person for scientific queries

Name

Salma El Sayed Abd Elsalam Ahmed

Address

Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El
Mansoura , El Dakahleya postal code: 35516

Country

Egypt

Phone

+201002990553

Fax

salmaaa_ahmed@yahoo.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Ultrasound-guided Pulsed Radiofrequency in the Management of Thoracic Postherpetic Neuralgia.	2018	https://dx.doi.org/10.1097/AJP.0000000000000629

N.B. These documents automatically identified may not have been verified by the study sponsor.

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