To compare the effects of dry needling and conventional physical therapy patients with piriformis syndrome
Design
Two arm parallel group randomized trails with blinded outcome assesor and with sample size of 86 enrolled
Settings and conduct
Participants were referred by the orthopedic physician of Nishtar hospital to the Physical Therapy Department
Participants/Inclusion and exclusion criteria
Inclusion criteria was as follows:
• Aged between 30-50 years
• Both Male and females
• Patients with positive FAIR & Lasegue test
• Having atleast 4 score of Numeric Pain Rating Scale
Exclusion Criteria:
• Patients with any abnormality in spine column
• Patients with any systemic inflammatory disease (rheumatologic Conditions)
• Recent fracture/dislocation in and around the Hip Joint
• Patient with psychological impairment (Parkinson's disease)
• Pregnancy
Intervention groups
All the screened and willing participants were randomly allocated to two groups (Group A: Experimental group / Dry needling group, Group B: Comparative Group / Conventional therapy group) by lottery method.
Main outcome variables
1. Pain (Numeric Pain Rating Scale)
2. Lower extremity Functional Scale (LEFS)
3. Range of Motion (Goniometry)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241125063847N1
Registration date:2025-02-19, 1403/12/01
Registration timing:retrospective
Last update:2025-02-19, 1403/12/01
Update count:0
Registration date
2025-02-19, 1403/12/01
Registrant information
Name
Ghanwa Noor
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 332 1877045
Email address
drghanwa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-10, 1403/07/19
Expected recruitment end date
2025-02-15, 1403/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dry Needling in Addition to conventional Physical Therapy in Patients with Piriformis Syndrome
Public title
Dry Needling in Addition to conventional Physical Therapy in Patients with Piriformis Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 30-50 years
• Both Male and females
• Patients with positive FAIR & Lasegue test
• Having atleast 4 score of Numeric Pain Rating Scale
Exclusion criteria:
• Patients with any abnormality in spine column
• Patients with any systemic inflammatory disease (rheumatologic Conditions)
• Recent fracture/dislocation in and around the Hip Joint
• Patient with psychological impairment (Parkinson's disease)
• Pregnancy
Age
From 30 years old to 50 years old
Gender
Both
Phase
0
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method will be used for randomization by an independent statistician. Randomization will be done by one of the research team members who will not involve in patient recruitment or assessment or data analysis. In this method Group names will be mentioned on separate slips of paper of same size, shape and color. They are folded and mixed up in a container. A blind fold selection will be made and each member of the population will be assigned a number. Randomization assignments will be kept in opaque, sealed envelopes and unsealed by a researcher after baseline testing. Outcome assessors will be unaware of group assignment.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is single blinded study in which accessor will be kept blind who will not involve in patient recruitment or assessment or data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of University of Lahore
Street address
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
City
Lahore
Postal code
55150
Approval date
2024-12-05, 1403/09/15
Ethics committee reference number
REC_UOL_/481/08/24
Health conditions studied
1
Description of health condition studied
Piriformis syndrome is a neuromuscular condition that occurs when the piriformis muscle , located in the buttock region , compresses the sciatic nerve. This can cause pain, numbness , and down the leg , often mimicking symptoms of sciatica
ICD-10 code
M62.838
ICD-10 code description
Other muscle spasm
Primary outcomes
1
Description
The Numeric pain rating scale in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. The NPRS takes <1 minute to complete Scores range from 0-10 points, with higher scores indicating greater pain intensity. The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion
Timepoint
2nd week
Method of measurement
The Numeric pain rating scale in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. The NPRS takes <1 minute to complete Scores range from 0-10 points, with higher scores indicating greater pain intensity.
2
Description
The Lower Extremity Functional Scale (LEFS) is a valid patient-rated outcome measure (PROM) used to assess lower extremity function. It was initially developed by Binkley et al. (1999) for patients with various musculoskeletal conditions.
Timepoint
2nd week
Method of measurement
This self-report questionnaire asks patients about their ability to perform twenty everyday activities, with five response options ranging from “Extreme Difficulty or Unable to Perform Activity” to “No Difficulty.” Patients’ scores are totaled, with a maximum score of 80 points indicating high function and a minimum score of 0 points indicating low function
3
Description
The term 'goniometry' is derived from the Greek words 'gonia' meaning angle and 'metron' meaning measure, therefore goniometry refers to the measurement of angles, which in rehabilitation settings refers to the measurement of angles in each plane at the joints of the body. T
Timepoint
2nd week
Method of measurement
he neutral zero method (0 to 180- degree system) is the most widely used method. The range of motion of each joint should be measured in isolation, to avoid trick movement (simultaneous movement of another joint) and muscle insufficiency which may alter the reading.
Secondary outcomes
empty
Intervention groups
1
Description
Dry Needling: Participants of Group A was received dry needling (DN). Acupuncture was applied to the trigger points, as described in previous studies by Itoh et al. Tight points or taut band was identified by palpation. The patient was laying on the abdomen. The examiner found the landmarks of greater trochanter and sacrum in S2, S3 and S4. He was inserted the needle vertically to the surface of trochanter, from the sciatic notch toward the pubis symphysis, directly to the stiffness points. Dry needling was performed deeply by a needle with the. 30mm in diameter and 65mm in length. Duration of needling in piriformis muscle was one minute. After the application of DN, mild stretching of piriformis was performed. This group was received dry needling at the end of 1st, 3rd and 5th sessions. Hip Abductor Strengthening: Subject’s position was in side- lying with the affected side upward. Lower leg flexed at hip & knee. Pelvis was stabilized by therapist and upper leg kept out of couch at the level of ankle. One end of the elastic band was tied to the distal part of the affected leg while the other end tied around. The leg of that couch, keeping the elastic band perpendicular to the floor. Subjects were instructed to lift the upper leg towards the ceiling against the force of the resistance band. This strengthening exercise was performed 3 sets; 10 times per set. Sciatic Nerve Mobilization (Tensioning Technique): Sciatic nerve mobilization was given for 12-15 sessions including 30 sec hold and 1 min rest. The subjects were in supine lying position and straight leg raise was done for inducing longitudinal tension as the sciatic nerve runs posterior to hip and knee Joints while maintaining extension at the Knee. In order to induce Dural motion through the sciatic nerve; the leg was raised. At least past 35 degrees in order to take up Slack in the nerve. To introduce additional Traction (i.e., sensitization) into the proximal aspect of the sciatic nerve, hip adduction was added to the straight leg raise. The nerve sliding technique was applied for 20-30 repetitions in 2-3 sets per day, and the nerve tensioning technique was implemented in addition for 15-25 seconds in 5-7 repetitions.Piriformis Stretching: In supine lying position subject’s tested leg was placed into flexion at the hip and knee so that the foot rests on the table lateral to the contra-lateral knee (the tested leg is crossed over the straight non-tested Leg). The non-tested side pelvis was stabilized during the test and the knee of the tested side was pushed into adduction, to place a stretch on piriformis. Holding time was 20seconds, with 5 seconds rest period and repeated for 5 times.
Category
Other
2
Description
Intervention group: In Group B all allocated participants received conventional therapy. Conventional therapy includes 15 minutes of heat therapy. All the patients of this group was treated by hip abductor muscle strengthening along with sciatic Nerve mobilization & piriformis stretching. Three sets of hip abductor muscle strengthening exercises with 10 sec hold for 10 repetitions were done 3 days per week for 2 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Lahore teaching hospital
Full name of responsible person
Dr.Asim Arif
Street address
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
City
Lahore
Postal code
55150
Phone
+92 335 1450137
Email
asim.arif@uipt.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Ghanwa Noor
Street address
1 km Defence Road , near Bhuptian Chowk , Lahore , Punjab
City
Lahore
Postal code
55150
Phone
+92 332 1877045
Email
Drnoor045@gmail.com
Grant name
None
Grant code / Reference number
None
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None
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 Lahore
Full name of responsible person
Ghanwa Noor
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 km Defence Road , near Bhuptian Chowk , Lahore , Punjab
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 332 1877045
Email
Drnoor045@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Lahore
Full name of responsible person
Ghanwa Noor
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 km Defence Road , near Bhuptian Chowk , Lahore , Punjab
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 332 1877045
Email
Drnoor045@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The university of Lahore
Full name of responsible person
Ghanwa Noor
Position
Concultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 km Defence Road , near Bhuptian Chowk , Lahore , Punjab
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 332 1877045
Email
Drnoor045@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographics data and data related to final outcome will be shared by maintaining the confidentially
When the data will become available and for how long
Data will be available after the publication of findings till six months
To whom data/document is available
Ghanwa Noor
Under which criteria data/document could be used
For research purpose
From where data/document is obtainable
To the corresponding author of the study, Ghanwa Noor and cane contact on +92 332 1877045 and Drnoo045@gmail.com
What processes are involved for a request to access data/document
Open access and there is the traditional public data release where anyone can get access to the data