Protocol summary

Summary
The sacroiliac joint (SIJ) has been found to be a significant source of back pain. Several treatments for SIJ syndrome have been advocated by clinicians. Spinal manipulation is an intervention commonly used in the treatment of individual with SIJ pain.The aim of present study was to investigate the effect of two manipulative therapy and outcome in patient with SIJ pain.Thirty two women aged between18-30 years with SIJ pain with a history of unilateral or bilateral SIJ pain; Duration of pain between 2 weeks to one year at the time of initial consultation were included in the study.The exclusion criteria were Gross instability; Pregnancy; Spondylolysis; Osteoporesis and previous back surgery.The patients were randomly divided into two groups of 16 subjects. One group received the high-velocity low-amplitude (HVLA) SIJ manipulation and the other group received the HVLA SIJ and lumbar manipulation in only one session. The outcome were assessed with Oswestry disability index (ODI) questionnaire and visual analogue scale (VAS)at before, immediately,48 hours and one month after treatmnt.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138806102398N1
Registration date: 2011-06-04, 1390/03/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-04, 1390/03/14
Registrant information
Name
Esmaeil Shokri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1731 9618
Email address
shokries@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Sciences
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2009-07-21, 1388/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two manipulative therapy techniques and outcome in patients with sacroiliac joint pain
Public title
Comparison of two manipulative therapy techniques and outcome in patients with sacroiliac joint pain
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were: 18-30 years old; Female patients with a history of unilateral or bilateral SIJ pain; Duration of pain between 2 weeks to one year at the time of initial consultation. The exclusion criteria were: destructive lesions of the spine, ribs and pelvis; Cauda equina syndrome; Gross instability; Infection; Pregnancy; Spondylolysis; Osteoporesis and previous back surgery.
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University Of Medical Sciences
Street address
Shiraz, Chamran Ave, Abiverdi 1, School Of Rehabilitation, Shiraz University of Medical Sciences
City
shiraz
Postal code
Approval date
2008-09-05, 1387/06/15
Ethics committee reference number
88-4614

Health conditions studied

1

Description of health condition studied
sacroiliac joint pain
ICD-10 code
s33.2
ICD-10 code description
Dislocation of sacroiliac and sacrococcygeal joint

Primary outcomes

1

Description
visual analogue scale (VAS).
Timepoint
before, immediately, 48 hours and one month after treatment
Method of measurement
Pain intensity was recorded by using a 100mm visual analogue scale (VAS), 0 indicating no pain and 100, the worst pain ever.

Secondary outcomes

1

Description
Oswestry disability index (ODI) Questionnaire
Timepoint
before treatment, 48 hours and one month after treatment
Method of measurement
Functional disability was recorded by using the Oswestry low back pain disability questionnaire (ODI). Each item was scored on a 0-5 scale, and the maximum score was 50.In this study the maximum score was 45 because one item was omitted (sex life). Relative values are reported (total score/total possible score ×100%).

Intervention groups

1

Description
1.SIJ manipulation: The patient was supine; the therapist stood on opposite side to be manipulated. The patient was passively moved into side bending to be manipulated. The patient interlocked the fingers behind his or her hand. The therapist passively rotated the patient, and then delivered a quick thrust to the ASIS in the posterior and inferior direction.
Category
Rehabilitation

2

Description
2. Lumbar manipulation: The patient lied with the more painful side up (e.g. right). The therapist stood in front of the patient. The therapist then flexed the top leg until the lumbar spine was flexed and placed the patient’s foot in the popliteal fossa of the lower leg. Next the therapist grasped the patients lower shoulder and arm, introduced left trunk side bending and right rotation until motion felt at the lumbar spine. The patient’s arms were positioned around the therapist right arm. Set up is maintained while the patient is rolled toward the therapist. Finally the therapists left arm was used to apply a high-velocity low-amplitude thrust of the pelvis in the anterior direction.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Rehabilitation School of Shiraz University of medical science
Full name of responsible person
Dr.fahimeh kamali
Street address
Shiraz, Chamran Ave, Abiverdi 1, School Of Rehabilitation, Shiraz University of Medical Sciences
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
shiraz university of medical science
Full name of responsible person
Vice-chancellery for Research Office
Street address
Vice-chancellery for Research Office, The central building of Shiraz University of Medical Sciences, Zand Ave, Shiraz, Iran
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shiraz university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School Of Rehabilitation, Shiraz University Of Medical Science
Full name of responsible person
Dr.Fahimeh Kamali
Position
Assistant professor
Other areas of specialty/work
Street address
Shiraz, Chamran Ave, Abiverdi 1, School Of Rehabilitation, Shiraz University of Medical Sciences
City
shiraz
Postal code
Phone
+98 71 1627 1551
Fax
Email
fahimehkamali@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School Of Rehabilitation, Shiraz University Of Medical Science
Full name of responsible person
Dr.fahimeh kamali
Position
Assistant professor,PT. PHD
Other areas of specialty/work
Street address
Shiraz, Chamran Ave, Abiverdi 1, School Of Rehabilitation, Shiraz University of Medical Sciences
City
shiraz
Postal code
Phone
+98 71 1627 1551
Fax
Email
fahimehkamali@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School Of Rehabilitation, Shiraz University of Medical Science
Full name of responsible person
Esmaeil Shokri
Position
Student
Other areas of specialty/work
Street address
Shiraz, Chamran Ave, Abiverdi 1, School Of Rehabilitation, Shiraz University of Medical Sciences
City
shiraz
Postal code
Phone
+98 71 1627 1551
Fax
Email
shokries@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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