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CTRI Number  CTRI/2018/09/015600 [Registered on: 05/09/2018] Trial Registered Prospectively
Last Modified On: 31/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of frozen shoulder by platelet rich plasma versus suprascapular nerve block. 
Scientific Title of Study   Comparative study between Suprascapular nerve block versus Platelet Rich Plasma injection in the treatment of Adhesive Capsultis of shoulder joint 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Buddhadeb Nayak 
Designation  PG- jr in Orthopaedics doing M S Orthopaedics 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR 
Address  ROOM NO-10, FACULTY CHAMBER, DEPARTMENT OF ORTHOPAEDICS, BLOCK-A1, GROUND FLOOR, AIIMS HOSPITAL BUILDING, GATE NO-4, TATIBANDH, RAIPUR.
ROOM NO-B107, RESIDENT HOSTEL, AIIMS CAMPUS, TATIBANDH, RAIPUR- 492099
Raipur
CHHATTISGARH
492099
India 
Phone  8826981727  
Fax    
Email  buddhadeb9188@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alok Chandra Agrawal 
Designation  Professor and HOD 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR 
Address  Department of Orthopaedics AIIMS CAMPUS, TATIBANDH, RAIPUR-492099
H2 sector 2 Agrasen Nagar Agroha Colony Raipur CG
Raipur
CHHATTISGARH
492099
India 
Phone  9425151634  
Fax    
Email  dralokcagrawal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Alok C Agrawal 
Designation  Prof and HOD 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR 
Address  Dept of Orthopaedics AIIMS CAMPUS, TATIBANDH, RAIPUR-492099
H2 sector 2 Agrasen Nagar Agroha Colony Raipur CG
Raipur
CHHATTISGARH
492099
India 
Phone  07712577242  
Fax    
Email  dralokcagrawal@yahoo.co.in  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences,G E Road, Tatibandh Raipur CG 492099 
 
Primary Sponsor  
Name  Institutional PG Thesis 
Address  AIIMS, Raipur Tatibandh, C.G-492099 
Type of Sponsor  Government medical college 
 
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 
Buddhadeb Nayak  All India Institute of Medical Sciences Raipur CG  Room No 16, Hospital Block 2, AIIMS, Raipur. Tatibandh, C.G-492099
Raipur
CHHATTISGARH 		 8826981727

buddhadeb9188@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIIMSRPR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Platelet Rich Plasma  single injection of 4 ml Platelet Rich Plasma (derived from patients own blood) which contains approximately 7.5 lakhs platelets/ml will be injected in shoulder joint and patient will be followed up for 6 months. 
Comparator Agent  Suprascapular Nerve Block  single injection of 9ml 2% lignocaine + 1 ml(40 mg) methyleprednisolone acetate will be injected in suprascapular fossa. patient will be followed up for 6 months. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Pain and stiffness in one or both the shoulders for at least 4 weeks.
2.Restricted active and passive range of motion at the glenohumeral joint.
3. Patients giving voluntary consent for participation in the study.
 
 
ExclusionCriteria 
Details  1. Patients with chronic shoulder pain due to other causes like nerve damage or neurologic disorders.
2. Patient having any skin infection over the affected shoulder.
3. Having abrasion/lacerations over the affected shoulder.
4. History of trauma to shoulder joint.
5. Patient following shoulder surgery.
6. Allergy to Methyl prednisolone
7. Contraindications to methylprednisolone-like bleeding problems, osteoporosis etc.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Is PRP better than SSNB  assessment will be done on day 0, 3rd day, 1 month and at 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
Complications will be recorded- e.g Infections, Fall in BP, Bleeding.  1 year 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/09/2018 
Date of Study Completion (India) 12/05/2019 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

"COMPARATIVE STUDY BETWEEN SUPRA-SCAPULAR NERVE BLOCK VERSUS PLATELET RICH PLASMA INJECTION IN THE TREATMENT OF ADHESIVE CAPSULITIS OF SHOULDER JOINT”

 

Candidate:

Dr. Buddhadeb Nayak

P.G. Resident , Department of Orthopaedics

AIIMS, Raipur (C.G.)

 

Guide:

Prof. Dr. Alok C. Agrawal (M.S. D.N.B, PhD Orthopaedics, MAMS)

H.O.D

Department of Orthopaedics

AIIMS, Raipur

 

Co-Guide:

 

Dr. Harshal Sakale –M.S Orthopaedics (Assistant professor, Orthopaedics)

Dr. Sankalp Sharma-M.D Pathology (Associate professor, Transfusion Medicine)

Dr. Mayank Kumar- M.D Anaesthesiology (Assistant professor, Anaesthesiology)

 

                 DEPARTMENT OF ORTHOPAEDICS 

ALL INDIA INSTITUTE OF MEDICAL SCIENCES , RAIPUR (C.G)

 

 

Thesis For

 M.S (ORTHOPAEDICS )

 AIIMS, RAIPUR (C.G.)

2018-2019

•Adhesive capsulitis(Frozen shoulder) is a benign condition of unknown etiology characterised by painful and ≥ 25% limitation of active and passive glenohumeral range of motion in atleast two directions most notably shoulder abduction and external rotation[1].
•First reported by Duplay in 1872 – “periarthritis scapulohumeral”

1.Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ 2005; 331:1453-6. (LoE: 3a)
2.Duplay E. De la periarthrite scapulo-humérale et des raideurs de l`épaule qui en sont la conséquence. Arch Gen Med. 1872;20:513–542.

Suprascapular nerve block:

It is found that in the group receiving Suprascapular nerve block has significant improvement than the control group.[5]

The group who  underwent ultrasound guided nerve block had more significant pain relief and the effect was more longer than the blind technique.[6]

 A study from Anaesthetic pain medicine journal reported that few complications are seen with suprascapular nerve block(SSNB) like intra vascular injection, residual motor block, and very rare pneumothorax.[7]


5.Shanahan.Ahern,Smith et al. Suprascapular nerve block,BMJ.Ann Rheum Dis 2003;62.

             6.  Venkat Gorthi, young lae Moon, Jeong-hoon kang, the effectiveness of ultrasonography-guided suprascapular nerve block, orthopaedics.2010;33(4).

             7.  Chin –wern Chan, FANZCA and Philip W.H peng, Suprascapular nerve block,anesth pain med2011;36:358-373


Platelet Rich Plasma:
Platelet-rich plasma is a fraction of whole blood.

Aslani et al have reported after treatment with platelet rich plasma(PRP) have-[8]

• 60% improvement of pain and 70% improvement in functional outcome,
•ROM (range of motion): flexion from 70 degree to 150 degree,
•Abduction from 75 degree to 135 and
•External rotation from 25 degree to 50 degree with 70% satisfaction score.
•All above complications of SSNB are not seen with PRP.

8.  Hamidreza Aslani, Sayed Taghi Nourbakhsh, Shahin Salehi, Platelet rich plasma for frozen shouder: -: ABJS.Jan 2016.

 AIMS AND OBJECTIVES:-

1. To evaluate & compare the outcome of frozen shoulder after either injection of Platelet Rich Plasma or Supra-

scapular nerve block.

 

MATERIALS & METHODS:-

STUDY DESIGN: Prospective Study (randomized, parallel group, active control trial)

SOURCE OF DATA: All consecutive patients with adhesive capsulitis who present to  the Department of 

Orthopaedics, All India Institute Of Medical Sciences, Raipur, during study period of May 2018 to April 2019, and 

those who fulfil the criteria and give consent to participate in the study.

INCLUSION CRITERIA: 

•Pain and stiffness in one or both the shoulders for at least 4 weeks.
•Restricted Active and passive range of motion at the glenohumeral joint.
•Age of  ≥ 40 and ≤60 years.

•Patients giving consent for undergoing in the study. 
EXCLUSION CRITERIA:
•patients with chronic shoulder pain due to other causes like nerve damage or neurologic disorders.
•Patient having any skin infection over the affected shoulder.
•Having abrasion/lacerations over the affected shoulder.
•H/o trauma to shoulder joint.
•Patient following shoulder surgery.
•Allergy to Depomedrol.

•Contraindications to methylprednisolone-like bleeding problems, osteoporosis etc.

SAMPLE SIZE: The study will be done on 45 patients each of adhesive capsulitis by SSNB and PRP. Total 

patients will be 90.

•Sample size was calculated using the formula,  n= zα2pq/L2 .
•Where, n= sample size
•Zα = 1.96 (A point on normal distribution with 95% confidence level)
•p = prevalence of frozen shoulder i.e. 5% (0.05) (refer article)
•q = 1-p= 100%-5%= 95% (0.95)
•L= Allowable error which is equal to 10% of p = 0.5% (0.005)
•The significance level α (type I error) was fixed at 5%
•n (Sample size) = (1.96)2 * 0.05*0.95/ (0.005) 2  = 75
•Considering 20 % dropouts, total sample size is 90
•45 will be given Platelet Rich Plasma injection, and 45 suprascapular nerve block.
METHOD:

Those patient attending OPD, Dept. of Orthopedics, AIIMS, Raipur with pain and restricted shoulder joint

 mobility in any plane of less than 25% specially abduction and external rotation for more than a month

 duration and a normal X-ray will be the material of the study. Recruited patients will undergo simple random

 sampling by lottery method and divided into 2 groups.

Group-1 : Will receive Suprascapular nerve block.    

Group-2 : Will receive Plate Rich Plasma injection.

STATISTICAL CALCULATION :

•Statistical analysis will be carried out using statistical packages for SPSS 16.0 for Windows (SPSS Inc., 
Chicago, IL, USA).
•Students t-test will be applied to compare between the two groups.
•RM-ANOVA will be used to compare between post- procedure(day-0), 1 day, 1 month and 6 month.

•Two sided p values will be considered as statistically significant at p<0.05.

     DEPERTMENT OF ORTHOPAEDICS


ALL INDIA INSTITUTE OF MEDICAL SCIENCES , RAIPUR

 

Case Record Form

 

"COMPARATIVE STUDY BETWEEN SUPRA-SCAPULAR NERVE BLOCK VERSUS PLATELET RICH PLASMA INJECTION IN THE TREATMENT OF ADHESIVE CAPSULITIS OF SHOULDER JOINT.”

 

Name-

Age/sex-


UHID No-


Address-


Contact No-


Complaints with duration-


     1.


     2.


     3.


Clinical examination-


      1.Inspection-



      2. Palpation-



     3. movments-



Investigations-


     A)blood tests-


                   1. CBC


                   2. ESR


                   3. CRP


                  6. Sr uric Acid-


                  7. FBS/PPBS-


                  8. Hb1Ac(in uncontrolled diabetes)-


      B) Imaging-


                   X-ray shoulder joint AP view.


      c) Others-

 

Date of procedure-


Procedure done-

 

Post procedure observations-


CONSTANT AND MURLEY SHOULDER SCORE

 

DAY-0

3RD DAY

1 MONTH

6 MONTH

1.Pain-

      .none-           15

       .mild-            10

       .moderate-     5

       .severe-          0

 

 

 

 

2.Activity-

       .ability to work:                          0-4

       .ability to recreational activity:  0-4

       .ability to sleep:                          0-4

 

 

 

 

3.Arm position-

    .up to waist-          2

    .up to xiphoid-      4

    .up to neck-           6

    .up to top of head-8

    .above head-         10

        

 

 

 

 

4.Strength of abduction(pounds) -25 points(1/lb*)  [1 lb=0.454 kg]

 

 

 

 

5.Forward flexion-

     >150      -10

     121-150  -8

     91-120    -6

     61-90      -4

    31-60       -2

    0-30         -0

 

 

 

 

6.Abduction-

     >150      -10

     121-150  -8

     91-120    -6

     61-90      -4

    31-60       -2

    0-30         -0

 

 

 

 

7.External rotation-

Head behind head-elbow forward-    2

Head behind head-elbow back     -    2

Head on top of head- elbow forward-2

Head on top of head- elbow back-     2

Full elevation-                                2

 

 

 

 

8.Internal rotation-

Inter scapular region-        10

Inferior tip of scapula-       8

12th rib-                              6

Lumbo sacral junction-      4

Buttock-                             2

Lateral thigh-                     0

 

 

 

 

 

 

 

 

 

•       Followups-

 

            Day 0-

 

            Day 3-

 

            1st Month-

 

            6th Months-

 

 

•       Complications-

1. Infection-


2. Fall in BP-


3. Bleeding-


4. Others-

 

•       Result-


 
Close