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 |
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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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Low back pain, Buttock pain, |
|
Intervention / Comparator Agent
|
|
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.
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