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Comparative Effects Of Post Isometric Relaxation Technique And Strain-Counterstrain In Patients With Piriformis Syndrome

Protocol summary

Study aim
To evaluate comparative effects of post isometric relaxation technique and straincounterstrain in patients with piriformis syndrome.
Design
In the randomized clinical trial, participants were randomly assigned to either the Post-Isometric Relaxation or Strain Counter-Strain therapy groups, ensuring unbiased distribution. Both groups received standard conventional treatments, with each group getting its assigned therapy. This design improved the reliability and validity of the results.
Settings and conduct
Participants were selected from Outdoor Patient Department of Allied hospital, National hospital Faisalabad
Participants/Inclusion and exclusion criteria
Participants were eligible if they were aged 30-50 years, of either sex, with unilateral piriformis muscle involvement and positive FAIR and Beatty tests. Exclusion criteria included pregnancy, SIJ pain, lumbar radiculopathy, malignancy, previous hip, knee, or ankle surgery, pre-existing musculoskeletal abnormalities in the lumbar spine.
Intervention groups
Both groups received 15 minutes of hot packs, 30-second piriformis stretches, and hip abductor strengthening. Group A received Post-Isometric Relaxation therapy with resisted piriformis contractions, while Group B had Strain Counter-Strain therapy with gentle pressure on the piriformis trigger point. Each additional therapy was given three times per session, three times a week, for four weeks.
Main outcome variables
OUTCOME MEASURES A primary outcome measure was pain which was assessed by Numeric Pain Rating Scale (NPRS). Secondary outcome measures were hip abduction and internal rotation range of motion that was measured through universal goniometer and Lower Extremity Functional Status was assessed by Lower Extremity Functional Scale (LEFS).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240718062453N1
Registration date: 2024-08-27, 1403/06/06
Registration timing: retrospective

Last update: 2024-08-27, 1403/06/06
Update count: 0
Registration date
2024-08-27, 1403/06/06
Registrant information
Name
Umaira Ijaz
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 87509715
Email address
uiimaejaz457@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-18, 1402/11/29
Expected recruitment end date
2024-06-08, 1403/03/19
Actual recruitment start date
2024-02-18, 1402/11/29
Actual recruitment end date
2024-06-08, 1403/03/19
Trial completion date
2024-06-18, 1403/03/29
Scientific title
Comparative Effects Of Post Isometric Relaxation Technique And Strain-Counterstrain In Patients With Piriformis Syndrome
Public title
Comparative Effects Of PIR Technique And SCS In Patients With Piriformis Syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pain in buttocks not more than 2 weeks Numeric Pain Rating Scale (3-9 on scale) Complain of Pain while sitting, standing, or lying longer than 15 to 20 minutes Positive FAIR test Positive Beatty test
Exclusion criteria:
pregnancy SIJ pain Lumbar radiculopathy malignancy rheumatoid disease
Age
From 30 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 66
Actual sample size reached: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomly allocated into two groups through lottery method. Participants were randomly allocated into two groups using the lottery method to ensure unbiased group assignment. Each participant was assigned a unique identifier, which was written on a slip of paper. These slips were placed into a container, mixed thoroughly, and drawn one by one. The first slip was assigned to Group A, the second to Group B, and this alternation continued until all participants were allocated. This method ensured equal chances of being assigned to either group, maintaining the integrity of the randomization process.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
research and ethics technical commette
Street address
Faisal Town, West Canal Road, Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
TUF/Addl Reg/SB/796

Health conditions studied

1

Description of health condition studied
piriformis syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
A primary outcome measure was pain which was assessed by Numeric Pain Rating Scale (NPRS).
Timepoint
This brief assessment ensured minimal disruption to the therapy sessions and provided a quick and effective way to monitor pain changes over time. measurement was taken before intervention, at 2nd week , 4rth week.
Method of measurement
Pain, the primary outcome measure, was assessed using the Numeric Pain Rating Scale (NPRS). Participants rated their pain on a scale from 0 (no pain) to 10 (worst possible pain). Measurements were taken at four time points: baseline (before the start of the intervention), at the end of the 2nd week, at the end of the 4th week (after the intervention period), and at the 8th week follow-up. This method ensured a comprehensive evaluation of pain reduction over time.

Secondary outcomes

1

Description
Secondary outcome measures were hip abduction and internal rotation range of motion that was measured through universal goniometer and Lower Extremity Functional Status was assessed by Lower Extremity Functional Scale (LEFS).
Timepoint
1.Hip Abduction and Internal Rotation Range of Motion: Measured using a universal goniometer. Each measurement typically took about 5-10 minutes per hip, including positioning the participant, taking measurements, and recording results. outcome measurement was taken before treatment , at 2nd week and at 4th week. Lower Extremity Functional Status: Assessed using the Lower Extremity Functional Scale (LEFS). Completing the LEFS questionnaire generally took about 5 minutes per participant.In total, assessing both range of motion and functional status would take approximately 10-15 minutes per participant per assessment session.outcome measurement was taken before treatment , at 2nd week and at 4th week.
Method of measurement
For secondary outcome measures, hip abduction and internal rotation range of motion were assessed using a universal goniometer. Lower Extremity Functional Status was assessed using the Lower Extremity Functional Scale (LEFS). Participants completed a 20-item questionnaire evaluating their ability to perform daily activities, with responses scored from 0 (extreme difficulty or unable to perform) to 4 (no difficulty).

Intervention groups

1

Description
Intervention group 1=will receive Positional Release Therapy
Category
Rehabilitation

2

Description
Intervention group:2= Group B will receive Post isometric relaxation
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Allied Hospital Faislabad
Full name of responsible person
Umaira Ijaz
Street address
Dr. Tusi Rd, Faisalabad, Punjab
City
Faislabad
Postal code
3800
Phone
+92 41 9210095
Fax
Email
help@ahfsd.pk
Web page address
https://ahfsd.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faislabad
Full name of responsible person
Umaira Ijaz
Street address
The university of faislabad, amin campus, faisal town, canal road, faislabad
City
Faislabad
Postal code
37300
Phone
+92 41 8750971
Email
2022-ms-pt-054@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faislabad
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
The University of Faislabad
Full name of responsible person
Umaira ijaz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
samunadri
City
Faislabad
Province
Punjab
Postal code
37300
Phone
+92 305 3275533
Email
2022-ms-pt-054@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University Of Faislabad
Full name of responsible person
Umaira Ijaz
Position
Punjab
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
samundari
City
Faislabad
Province
Punjab
Postal code
37300
Phone
+92 305 3275533
Email
2022-ms-pt-054@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University Of Faislabad
Full name of responsible person
umaira ijaz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Samundari
City
Faislabad
Province
Punjab
Postal code
37300
Phone
+92 41 34753453
Email
2022-ms-pt-054@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
there is no further information
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not 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
N/A
When the data will become available and for how long
N/A
To whom data/document is available
N/A
Under which criteria data/document could be used
N/A
From where data/document is obtainable
N/A
What processes are involved for a request to access data/document
N/A
Comments
provided all the information above
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