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CTRI Number  CTRI/2017/10/009957 [Registered on: 03/10/2017] Trial Registered Retrospectively
Last Modified On: 27/09/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [therapeutic]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare effectiveness of x-rays versus ultrasound for giving iliopsoas injection 
Scientific Title of Study   COMPARITIVE EVALUATION OF EFFICACY OF FLUOROSCOPY AND ULTRASOUND FOR ILIO-PSOAS BLOCK  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SGPGI ethics committee code no. IEC code 2012-188-ip-66  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil Agarwal 
Designation  Professor  
Affiliation  Sanjay Gandhi Post Graduate Institute Of Medical Sciences 
Address  Deptt of Anesthesiology Sanjay Gandhi Post Graduate Institute Of Medical Sciences, Lucknow. 226014

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904589  
Fax  0522-2668544  
Email  anil_sgpgi@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Agarwal 
Designation  Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute Of Medical Sciences 
Address  Deptt of Anesthesiology Sanjay Gandhi Post Graduate Institute Of Medical Sciences, Lucknow.

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904589  
Fax  0522-2668544  
Email  anil_sgpgi@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chetna Shamshery 
Designation  Senior resident 
Affiliation  Sanjay Gandhi Post Graduate Institute Of Medical Sciences 
Address  Deptt of Anesthesiology Sanjay Gandhi Post Graduate Institute Of Medical Sciences, Lucknow.

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904611  
Fax  0522-2668544  
Email  drchetna@rediffmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Post Graduate Institute Of Medical Sciences, Lucknow 
 
Primary Sponsor  
Name  Sanjay Gandhi Post Graduate Institute Of Medical Sciences 
Address  Deptt of Anesthesiology Sanjay Gandhi Post Graduate Institute Of Medical Sciences, Lucknow. Mob. No. 8004904589 Fax No Funding source: none  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anil Agarwal  Sanjay Gandhi Post Graduate Institute Of Medical Sciences  Deptt of Anesthesiology Sanjay Gandhi Post Graduate Institute Of Medical Sciences, Lucknow.
Lucknow
UTTAR PRADESH 
8004904589
0522-2668544
anil_sgpgi@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGPGIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Myofacial pain syndrome of the ilio-psoas muscle. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Trigger point injection  ilio-psoas block by USG 
Comparator Agent  Trigger point injection  ilio-psoas injection using fluoroscopy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients complaining of back pain unilateral , radiating to buttocks or ant side of hip joint, with a triggering zone. 
 
ExclusionCriteria 
Details  1) pregnant females
2) age < 18yrs / > 60yrs
3) patient with other comorbidities.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients would be assessed for
1) pain using visual analog scale (VAS3)
2) disability using Oswestry disability index (ODI)
3) for ease of application using either fluoroscope or USG (operators subjectivity),
4) depression anxiety stress scale (DASS) for psychological state of the person.
 
preproedure, day 1, 1wk, 4 wks, 12 wks 
 
Secondary Outcome  
Outcome  TimePoints 
none  -- 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   21/01/2013 
Date of Study Completion (India) 10/01/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet. Waiting for the CTRI no. to publish the findings. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION:

Myofascial pain is caused due to strain in the muscles and has particular sensory or motor characteristics. The trigger points are 2-5mm nodules of hypersensitive areas located within the taut band of the muscle. There is a particular area of reference zone (RZ) related to a muscle. The pain could run up or down along a RZ. Pain could range from dull ache to severe excruciating pain. 

Iliacus muscle helps in the extension of hip and psoas muscle is active during sitting, standing and maintaining postures. Patients with ilio-psoas myofascial pain often complain of pain in the region of back radiating to upper buttocks or in front of the hip joint. Psoas muscle originates from the transverse process of T12, L1-L5 vertebrae and inserted on the lesser trochanter of the femur.

The most definite sign of trigger point would be a point of hypersensitivity, and on pressing the trigger, arousal of the pain similar to the pain complained by the patient. Sometimes the pain would also be associated with autonomic feature eg. vasovagal response, flushing, lacrimation etc. On inserting a needle in the trigger area, a twitch could be elicited. The trigger points could be active or latent. Active trigger points are points complined by the patient and latent points are the areas which the patient does not complain of, but a pressure would initiate pain in those areas. Active trigger ponts need treatment whereas latent points do not. Out of the several modalities of treatment available, we in our study have chosen injecting lignocaine 0.25% in the trigger points because this reduces the soreness at the point of needle insertion. Trigger point injections of ilio-psoas could be given using either fluoroscopy or ultrasound, and in the study we would compare these for the ease and efficacy of the block.

 

AIMS AND OBJECTIVES:

1) To compare efficacy of the block given by the two methods by VAS scoring

2) Ease of application of the block by the operator

3) Change in DASS (Depression anxiety stress scale) scoring by two methods during follow up

4) Change in quality of life studied by Oswestry Disability Index (ODI) during follow up

 

MATERIALS AND METHODS: After taking the patient’s consent, an i/v line would be secured and for fluoroscopy standard monitoring would be done using ECG, pulse owimeter (SPO2), non- invasive blood pressure (NIBP). Patients would be made prone, and the part would be painted using betadine and draped.

 

FOR FLUOROSCOPY: After draping, under fluoroscope adequate positioning would be done focusing the L3 vertebrae. Taking an oblique view a 22g 5 inch needle would be inserted app. 5cms lateral to the spinous process. A gun barrel view would be obtained and the needle tip would be proceeded till about ant 1/3rd of the vertebral body in lateral view. Then dye would be injected in the muscle and confirmed by its spread along the psoas muscle belly. Patient would be given lignocaine 0.25% 10ml at the site. Then patient would be kept for 1/2 hour to monitor hemodynamic vitals. Stretching would be advised afterwards which would be done by the patient twice in a day. Tab. etoricoxib 90mg once daily would be given for five days.

 

FOR ULTRASONOGRAPHY: Patient would be made lateral, opposite to the side where the pain is. The area would be painted and draped and using ultrasound slightly lateral from the L3 vertebrae transverse process of the L3 vertebrae would be identified. Then using a 22g 5 inch needle lignocaine 0.25% 10ml would be injected. Patients would be observed for 1/2 hr and then stretching exercises would be advised which would be done by the patient twice in a day. Tab. etoricoxib 90mg once daily would be given for five days.

OBSERVATIONS:

Patients would be assessed for pain using visual analog scale (VAS), for disability using Oswestry disability index (ODI), for ease of application using either fluoroscope or USG (operators subjectivity), and depression anxiety stress scale (DASS) for psychological state of the person. These observations would be done during pre-procedure, after 1st day, 1st week, 4th week, and 12th week.


STATISTICAL ANALYSIS: Assuming that patients with iliopsoas myofascial have VAS pain score of 80/100 and post triggerpoint injection by either fluoroscopy or USG would decrease pain by 40%, keeping the minimum confidence interval 95% and power of study 80% we enrolled 18 patients in either groups.

REVIEW OF LITERATURE:

Studies have been done comparing the efficacy and safety of ultrasound over fluoroscopy for selectve nerve root block and transforaminal block1 proving that ultrasound also helps to identify and avoid vascular trauma. Stellate ganglion block2 or intercostal steroid injections3 has also been given with the help of ultrasound, and it has been seen that similar reduction in the vas score could be achieved as the fluoroscopy.Pudendal nerve block under USG and fluoroscopy4 proves that ultrasound is as accurate as fluoroscopically performed injections provided they are given by experienced clinicians. USG guidance for psoas compartment block has been given in the cadavers and confirmed by CT scan5. Lumbar facet joint injections6 and caudal neuroplasty7 given by ultrasound has been also confirmed by CT scan, and demonstrated significant correlation between the two. For caudal placement of injection 100% correct position was confirmed in a study done on 70 patients.

On the similar grounds we would compare ilio-psoas block using ultrasound and fluoroscopy as USG could give us several benefits, such as:

1) cost effectivity

2) do the procedures on the OPD basis

3) avoid radiation exposure.

4) patient compliance is improved.

5) procedure is not delayed

6) radio-contrast dye induced side effects could be avoided.

 

REFERENCES

1) Jee H, Lee JH, Kim J, Park KD, Lee WY, Park Y. Ultrasound-guided selective nerve root block versus fluoroscopy-guided transforaminal 

1)      block for the treatment of radicular pain in the lower cervical spine: A randomized, blinded, controlled study. Skeletal Radiol. 2012 May 20. [Epub ahead of print]

2)     2)  Cornelia Kean. Experts advocate ultrasound to guide stellate ganglion block anaesthesiology news march 2009 volm 35:3

3)    

1     3)  Shankar H, Eastwood D. Retrospective comparison of ultrasound and fluoroscopic image guidance for intercostal steroid injections. Pain Pract. 2010 Jul-Aug;10(4):312-7. Epub 2010 Mar 3.

1)   4)  Bellingham GA, Bhatia A, Chan CW, Peng PW. Randomized controlled trial comparing pudendal nerve block under ultrasound and fluoroscopic guidance. Reg Anesth Pain Med. 2012 May-Jun;37(3):262-6.

5)   5)    Lukas Kirchmair, Tanja Entner, Stephan Kapral, Gottfried Mitterschiffthaler. Ultrasound Guidance for the Psoas Compartment Block: An Imaging Study. Anesth Analg 2002;94:706 –10

6)     6) Greher M, Kirchmair L, Enna B, Kovacs P, Gustorff B, Kapral S, Moriggl B. Ultrasound-guided lumbar facet nerve block: accuracy of a new technique confirmed by computed tomography. Anesthesiology. 2004 Nov;101(5):1195-200.

7)     7)  Chen CP, Tang SF, Hsu TC, Tsai WC, Liu HP, Chen MJ, Date E, Lew HL.Ultrasound guidance in caudal epidural needle placement. Anesthesiology. 2004 Jul;101(1):181-4.


 

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