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Effects of mobilization with movement at Sacroiliac joint with and without Postero-Anterior Glide at L5-S1 in patients with Sacroiliac joint dysfunction

Protocol summary

Study aim
To evaluate the Effects of mobilization with movement at Sacroiliac joint with and without Postero-Anterior Glide at L5-S1 in patients with Sacroiliac joint dysfunction.
Design
Randomized, parallel-group trial with blinded patient and assessor in 26 patients randomly assigned by computerised method with concealed randomisation sequence carried out at an external site
Settings and conduct
Ghurki trust and teaching hospital National hospital defence max rehabitilation centre patient and assesor will be blinded, them without knowing to which group they belong and whom they are assesing, researcher will allocate and therapist will be treating.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA: Patients who had an acute unilateral or bilateral SIJ syndrome during the past 6 weeks, level of pain over the previous 24 h increased, no manipulative treatment within the past month, Pain and tenderness at SIJ, FABER, compression, distraction, and Gaenslen's. provocation tests POSITIVE EXCLUSION CRITERIA: Previous spinal manipulative treatment, Having pain and discomfort in the lumbar spine, Destructive lesions of the spine, ribs and pelvis, Cauda equina syndrome, gross instability or active infection, Pregnancy, Spondylolysthesis, and previous back surgery.
Intervention groups
Intervention group: After taking consent from both groups, interventional group will be treated with postero-anterior glide at L5-S1 with mobilization with movement at sacroiliac joint CONTROL GROUP will be treated with mobilization with movement at sacroiliac joint only
Main outcome variables
Numeric pain rating scale (NPRS) Oswestry Disability Questionnaire (ODQ)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200527047582N1
Registration date: 2020-07-21, 1399/04/31
Registration timing: registered_while_recruiting

Last update: 2020-07-21, 1399/04/31
Update count: 0
Registration date
2020-07-21, 1399/04/31
Registrant information
Name
Hufsa Tariq
Name of organization / entity
Riphah international university
Country
Pakistan
Phone
+92 42 36603199
Email address
hufsa.tariq5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-05, 1398/08/14
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of mobilization with movement at Sacroiliac joint with and without Postero-Anterior Glide at L5-S1 in patients with Sacroiliac joint dysfunction
Public title
Comparison of effects of mobilization with movement at Sacroiliac joint with and without Postero-Anterior Glide at L5-S1 in patients with Sacroiliac joint dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who had an acute unilateral or bilateral SIJ syndrome during the past 6 weeks. Those in whom the level of pain over the previous 24 h increased Patients having no manipulative treatment within the past month. Pain and tenderness at SIJ FABER, compression, distraction, and Gaenslen's. provocation tests POSITIVE
Exclusion criteria:
Previous spinal manipulative treatment Having pain and discomfort in the lumbar spine Destructive lesions of the spine, ribs and pelvis cauda equina syndrome Patients having gross instability or active infection Pregnancy, Spondylolysthesis, and previous back surgery.
Age
From 25 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
The basic strategy used for randomization will be the development of an ordered list with group assignments made in advance using simple random sampling by random number generator. As participants enter the study, they will be given consecutive numbers and assigned to the group indicated for each number
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient will be blinded fo their group allocation. They will receive their allocated treatment without the knowledge of whether they belong to the control group or interventional group. The duration of the treatment session will be the same for both groups. The assessor will be a physical therapist who will have no role in the treatment of the patients. The collected data will be analyzed by a biostatistician who will be unaware of the group specification of data.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
riphah college of rehabilitation sciences
Street address
near hajj complex, 1-14, islamabad capital territory
City
islamabad
Postal code
46000
Approval date
2019-11-30, 1398/09/09
Ethics committee reference number
REC/RCRS/20/1026

Health conditions studied

1

Description of health condition studied
sacroiliac joint dysfunction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain
Timepoint
before intervention, after intervention , after 2 weeks and after one month.
Method of measurement
Numeric pain rating scale (NPRS): NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. “no pain”) to '10' representing the other pain extreme (e.g. “pain as bad as you can imagine” or “worst pain imaginable”).

Secondary outcomes

1

Description
disability
Timepoint
Subjects will be reassessed by researcher immediately after treatment, after 2 weeks and after one month. Treatment sessions (3 session a week) will be given to the subjects.
Method of measurement
Oswestry Disability Questionnaire (ODQ):It is a functional index designed to determine the symptoms and limitations that patient experiences while performing daily activities. This scale consists of 10 items in the form of activities of daily living with each item scoring from 0 to 5 where 0 is no difficulty in performing that activity and 5 is inability to do that activity. This will used for assessment of the associated disability

Intervention groups

1

Description
Intervention group 1: Mobilisation with movement at Sacroiliac joint dysfunction with Poster-anterior glide at L5-S1. After taking consent 3 sessions per week will be given to the patient. each session will be of 30-45 mins. The total treatment will be of 2 weeks. sustained glide with 10 repetitions and patient advised to actively move the body in mobilization with movement whereas in posteroanterior glide 30 oscillations in each set at the spinous process of L5-S1. 3 sets of both interventions will be applied and prior to treatment hot pack for 20 minutes.
Category
Rehabilitation

2

Description
Intervention group 2: hot pack will be applied prior to treatment for 20 minute. this group will only receive mobilization with movement at sacroiliac joint for 2 weeks. 3 sets and 3 sessions per week. In each set 10 repetitions of sustained glide and patient actively doing push-ups.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
national hospital
Full name of responsible person
Dr. Shehzad Ahmed
Street address
132\3, L-Block, phase 1, Near Sports Stadium، Sector L Dha Phase 1, Lahore, Punjab
City
lahore
Postal code
34000
Phone
+92 42 36603199
Email
shahzad.ahmad@lmdc.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghurki trust and teaching hospital, Lahore
Full name of responsible person
Hassan bin Ikram
Street address
GT RD-BURKI ROAD LINK, BAND ROAD, JALLO MORE
City
lahore
Postal code
53401
Phone
+92 42 37392201
Email
marketing.ghurkihospital@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ghurki trust and teaching hospital
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Hufsa Tariq
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
279 E state life housing society lahore
City
Lahore
Province
Punjab
Postal code
53101
Phone
+92 42 36603199
Fax
Email
hufsa.tariq5@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Hufsa Tariq
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
279 E state life housing society lahore
City
Lahore
Province
Punjab
Postal code
53101
Phone
+92 42 36603199
Fax
Email
hufsa.tariq5@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Hufsa Tariq
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
279 E state life housing society lahore
City
Lahore
Province
Punjab
Postal code
53101
Phone
+92 42 36603199
Fax
Email
hufsa.tariq5@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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