Protocol summary

Study aim
To determine the effects of strain counter-strain technique with and without dry needling on pain, range of motion, functional disability and quality of life in patients with sacroiliac joint dysfunction.
Design
Randomized clinical trial, single blinded study, two parallel groups with 32 patients from Al syed Touqeer Altaf surgical Hospital Lahore
Settings and conduct
The trial will be conducted at Al syed Touqeer Altaf surgical Hospital Lahore.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient of age 25-50 years, Both Male and female patients, patient having pain in lower back and buttocks from last 3 months, NPRS score greater than 4. Inclusion criteria: Acute injury or fracture of the lower limb and spine, previous major lumbar or hip surgery, Infection, pregnancy, Congenital spinal deformity, Malignancy
Intervention groups
Group A:Strain counterstrain technique with dry needling will be given to group A along with conventional therapy Group B: Strain counterstrain technique will be given to group B along with conventional therapy
Main outcome variables
Pain, Range of motion, functional disability, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190717044238N15
Registration date: 2024-05-18, 1403/02/29
Registration timing: registered_while_recruiting

Last update: 2024-05-18, 1403/02/29
Update count: 0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-07-08, 1403/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Strain counterstrain technique with and without dry needling on pain, range of motion, functional disability and quality of life in patients with sacroiliac joint dysfunction
Public title
Effects of Strain counterstrain technique with and without dry needling on pain, range of motion, functional disability and quality of life in patients with sacroiliac joint dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient of age 25-50 years Both Male and female patients Pain in lower back and buttocks from last 3 months NPRS score greater than 4
Exclusion criteria:
Acute injury or fracture of the lower limb and spine previous major lumbar or hip surgery Infection Congenital spinal deformity Malignancy
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be done by using computer generated randomizer.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be a single blinded study. Assessor will be kept blind about the group allocation and previous readings.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and ethics Commitee Riphah College of Rehabilitation and Allied Health Sciences
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Postal code
54000
Approval date
2024-04-03, 1403/01/15
Ethics committee reference number
REC/RCR & AHS/23/0191

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, 4 week
Method of measurement
Numerical pain rating scale

2

Description
Range of motion
Timepoint
Before intervention, 4 week
Method of measurement
Inclinometer

3

Description
Functional disability
Timepoint
Before intervention, 4 week
Method of measurement
Oswestry disability index

4

Description
Quality of life
Timepoint
Before intervention, 4 week
Method of measurement
SF-36

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A:Initially group will receive conventional physical therapy treatment. Strain counterstrain technique will be performed on four muscles including quadratus lumborum, piriformis, illiacus and erector spinae. In this technique, therapist will place the patient in a comfortable position for each of the corresponding muscle for 90 seconds to achieve relaxation and then he will return passively to the starting position. The technique will be repeated 3 times in each session. Also dry needling will be performed on the same four muscles by using the injection technique (described by Travel and Simons8).The frequency of treatment will be 3 sessions per week for 4 weeks.
Category
Rehabilitation

2

Description
Intervention group: Group B:Initially group will receive conventional physical therapy treatment .Strain counterstrain technique will performed with same procedure as in group A for same 4 muscles including quadratus lumborum, piriformis, illiacus and erector spinae.The frequency of treatment will be 3 sessions per week for 4 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Al Syed Touqeer Altaf surgical Hospital
Full name of responsible person
Aneeqa mubarik
Street address
Sher shah road shadbagh
City
Lahore
Postal code
54000
Phone
+92 316 4562591
Email
aneeqamubarik123456@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Fareeha Amjad
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University Lahore
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Aneeqa Mubarik
Position
MS student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Hanif Park Badami bagh lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 316 4562591
Email
aneeqamubarik123456@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Fareeha Amjad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International university Lahore
Full name of responsible person
Aneeqa Mubarik
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 316 4562591
Email
aneeqamubarik123456@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
confidentiality of participants
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Consent form in its original format with no information about any participant study protocol -how the intervention was given to both groups
When the data will become available and for how long
Data would be available after the completion of the research
To whom data/document is available
People working in an academic and clinical setting can have access to the above mentioned information/documents
Under which criteria data/document could be used
Data can be used for Research Purpose
From where data/document is obtainable
Data can be asked for at the following email address: aneeqamubarik123456@gmail.com@gmail.com
What processes are involved for a request to access data/document
One can ask for data at the given email address and it would be provided after knowing the general implications of sharing that particular data
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