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CTRI Number  CTRI/2011/12/002205 [Registered on: 05/12/2011] Trial Registered Retrospectively
Last Modified On: 11/05/2011
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   Role of sacroiliac joint problem in low back pain. 
Scientific Title of Study   Association between sacroiliac joint pain and dysfunction - a case control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1120-9653  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S Raja sekar 
Designation  Assisstant Professor 
Affiliation   
Address  Department of Physiotherapy, centre for basic sciences, KMC, Mangalore.
Department of Physiotherapy , centre for basic sciences, KMC, Mangalore.
Dakshina Kannada
KARNATAKA
575001
India 
Phone  998601241  
Fax    
Email  rs.rajasheker@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Sivaraman S 
Designation  Post graduate student 
Affiliation   
Address  Department of Physiotherapy , KMC, Mangalore.
Department of Physiotherapy , KMC, Mangalore.
Dakshina Kannada
KARNATAKA
575001
India 
Phone  9738312824  
Fax    
Email  siva_physio@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Sivaraman S 
Designation  Post graduate student 
Affiliation   
Address  Department of Physiotherapy , KMC, Mangalore.
Department of Physiotherapy , KMC, Mangalore.
Dakshina Kannada
KARNATAKA
575001
India 
Phone  9738312824  
Fax    
Email  siva_physio@hotmail.com  
 
Source of Monetary or Material Support  
Manipal University Research Grant 
 
Primary Sponsor  
Name  Manipal University  
Address  Department of Physiotherapy , KMC, Mangalore. 
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 
Sivaraman S  KMC hospitals - Attavara and Ambedkar circle  Department of physiotherapy , KMC, Mangalore
Dakshina Kannada
KARNATAKA 
9738312824

siva_physio@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Time bound research ethics committee, Kasturba Medical College.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Low back pain, Buttock pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Inclusion criteria for case group:
• Age 21-50 years
• Pain below L5 level
• Pain around posterior superior iliac spine and buttock with or without leg pain.
• Positive pain provocation tests

Inclusion criteria for control group:
Subjects with 21-50 years of age with no history of LBP for past one year, fractures of lower limb and no spinal deformities.
 
 
ExclusionCriteria 
Details  • Midline or symmetrical pain above the level of L5
• Radicular pain with neurological deficit
• History of spinal surgery
• Fracture of spine, pelvis, and lower extremities
• Limb length discrepancy
• Pregnancy or postpartum duration of six months
• Hip, knee and ankle pain and dysfunctions
• Any systemic infections
• Seronegative spondyloarthropathies.
• Crystalline arthropathy.
• Rheumatoid arthritis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Sacroiliac joint Dysfunction, Pain (VAS)   pain (VAS) was measuresd during initial general orthopaedic assessment and dysunction was measured after clearing inclusion and exclusion criteria. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/05/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="4" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NO 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

                                                                                    PROCEDURE

 

The study was approved by the scientific research committee and Time bound Ethics Committee of K.M.C Mangalore.The subjects diagnosed to have low back pain, by the physician referred to physiotherapy department were given informed consent and purpose of the study was explained. Once informed consent was obtained, the subject was screened by the investigator for inclusion and exclusion criteria. The subjects who fulfilled the inclusion criteria were taken as case group. Similarly asymptomatic individuals who fulfilled their inclusion criteria were taken as control group. General musculoskeletal examination was performed for the case group and both the case and control group subjects were assessed for pelvic asymmetry. The total duration taken for the procedure was 20-30 min.

 

Measurement of pelvic asymmetry:

The PALM instrument, (Performance Attainment Associates, St. Paul, MN) which combines the features of a calliper and an inclinometer, was used to measure the pelvic asymmetry.

 

Levelness of the floor was established with a carpenter’s level and 2 pieces of tape spaced 15 cm apart were placed on the floor. The tape strips marked the location on the floor where subjects would position their feet and standing in a fully erect posture with no bending of the ankles, knees, hips, or spine, with folding their arms across the chest.

 

To measure the differences in Posterior Superior Iliac Spines (PSIS) level the examiner palpated the most prominent aspect of PSIS from behind and placed the PALM calipers.The inclinometer ball was designed to move towards the shorter side. The extent of deflection was recorded in the record sheet.

 

Then, the examiner placed the PALM at prominent point of Anterior Superior Iliac Spines (ASIS) from front for measuring ASIS differences and standing laterally for measuring one side innominate tilt by placing PALM calipers between ASIS and PSIS of the same side and deflection was recorded as before . During the procedure subjects were instructed to take a deep breath in, exhale, and to wait to inhale again until after the measurement was taken.

The subjects with pelvic asymmetry were not taken for further motion palpation tests.

 

Motion palpation tests:

Four motion palpation tests were performed in diagnosing SIJ aberrant motion. Reliability for cluster of two or three out of four tests was found to be substantial. The presence of asymmetry or positive motion palpation tests indicated SIJ dysfunction, which was tested on both case and control groups. The results were recorded in a record sheet .

 

DATA ANALYSIS

Chi square test and odds ratio was used to analyze the data. Data was evaluated with the Statistical program for Social Science (SPSS) 16.0 version. The level of significance of < 0.05 was considered to be statistically significant with 95% confidence interval.

  • Chi square test was used for the comparison of age, gender, SIJ dysfunction, between the case and control group.
  • The strength of association between SIJ pain, age and gender on SIJ dysfunction was calculated using estimated Odds Ratio.

                                                                                                       CONCLUSION

Our study concluded there was significant association between pelvic asymmetry and SIJ pain of less than 1 year of duration. All the subjects with SIJ symptoms have to be checked for SIJ dysfunction. But, all the subjects with SIJ dysfunction need not be symptomatic. This information may be important in identifying the SI joint pain with and without pelvic asymmetry and restoring pelvic asymmetry as the part of treatment program. Our study also found that there was no association with age, gender and SIJ dysfunction.

 
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