To find out the effectiveness of Piriformis stretch and muscle activation exercise among patients with Piriformis syndrome.
Design
The design of this study is Randomized, parallel clinical trial. Randomization is done by Lottery method. In this method the researcher gives each participant of the trial a number. Researchers draw numbers from the box randomly to allocate participants in two groups.
Settings and conduct
The study is conducted at Arif Memorial Teachning Hospital. in this trial participants are blinded through concealment to avoid baisness.
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering from Piriformis syndrome; both male and female; being at the age between 20 and 50 years. Non-inclusion criteria: The condition be a complication of hip surgery or fracture
Intervention groups
Intervention group: All the patients of this group will be treated by Piriformis stretch.
Control group: All the patients of this group will be treated by muscle activation exercise.
Main outcome variables
Pain intensity; Low back Disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210326050770N2
Registration date:2023-07-19, 1402/04/28
Registration timing:registered_while_recruiting
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Mohammad Abbas Jamil
Name of organization / entity
Rashid latif medical college
Country
Pakistan
Phone
+92 49 4510915
Email address
m.abbas@rlmc.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-30, 1402/04/09
Expected recruitment end date
2023-09-30, 1402/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of piriformis stretch and muscle activation exercises among patients with piriformis syndrome
Public title
Effect of piriformis stretch and muscle activation exercises on piriformis syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from Piriformis syndrome
Piriformis syndrome patients both male and female.
Age between 20 and 50 years.
Those patients who use steroids and non-steroids.
Exclusion criteria:
The condition be a complication of hip surgery or fracture
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated by lottery method into two groups. In this method the researcher gives each participant of the trial a number. Researchers draw numbers from the box randomly to allocate participants in two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding is achieved by concealment in which the treatment allocation for each patient is not revealed to the patient. This is done to avoid biasness
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review board of Rashid Latif Medical College
Street address
35- km Ferozepur road; Lahore
City
Lahore
Postal code
54000
Approval date
2022-09-02, 1401/06/11
Ethics committee reference number
IRB/2022/039
Health conditions studied
1
Description of health condition studied
Piriformis syndrome is one of the common causes of sciatic pain which negatively affects the activities of daily life of an individual and ultimately leads to poor quality of life.
ICD-10 code
G57.00
ICD-10 code description
Lesion of sciatic nerve, unspecified lower limb
Primary outcomes
1
Description
Pain
Timepoint
On 1st day pre-intervention measurement and post-intervention measurement after 4 weeks
Method of measurement
Numeric Pain Rating Scale
2
Description
Disability
Timepoint
On 1st day pre-intervention measurement and post-intervention measurement after 4 weeks
Method of measurement
Oswestry disability index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Piriformis stretch): All the patients of this group were treated by piriformis stretch. First baseline treatment was given. The subjects were made to bent two legs in a supine position and kept the leg of one side on the opposite side knee that would be measured. The subjects bent their knee over 90° until they felt tension in the direction toward the shoulder on the same side as the leg that was being stretched and then maintained the position for 30 seconds.This was repeated twice with a 30-second resting time in between.
Category
Treatment - Other
2
Description
Control group (Muscles Activation Exercises): All the patients of this group were treated by muscle activation exercise. First baseline treatment was given, Then for left hamstrings, adductor magnus, and gluteus medius). For Adductor Magnus Activation, Patient was asked to perform the close chain, weight-bearing task-sit to stand, to activate the Adductor Magnus. For Gluteus Medius Activation, Patient was asked to perform bridging on a stable surface, to activate the gluteus medius. For Hamstring Activation, The patient was asked to do a glute-hamstrings raise, to activate the Hamstrings.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif Memorial Teaching hospital
Full name of responsible person
Naseer Ahmad
Street address
35- km Feroze pur road lahore
City
Lahore
Postal code
54000
Phone
+92 303 7272342
Email
na992311@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Dr Abbas Jamil
Street address
35-km Ferozepur road; Lahore
City
Lahore
Postal code
54000
Phone
+92 336 4204167
Email
m.abbas@rlmc.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid Latif Medical College
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
Rashid Latif Medical College
Full name of responsible person
Naseer Ahmad
Position
physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-km Ferozepur road; Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 303 7272342
Email
na992311@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid latif medical college
Full name of responsible person
Dr Abbas Jamil
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-km Ferozepur road; Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 336 4204167
Email
m.abbas@rlmc.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif medical college
Full name of responsible person
Dr Abbas Jamil
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-km Ferozepur road; Lahore
City
lahore
Province
Punjab
Postal code
54000
Phone
+92 336 4204167
Email
m.abbas@rlmc.edu.pk
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