| CTRI Number |
CTRI/2025/04/085369 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Addition of opening positions to nerve mobilization on pain, range of motion and leg functions in participants having piriformis syndrome. |
|
Scientific Title of Study
|
Additive effect of static openers to sciatic nerve mobilization on pain, range of motion and lower extremity functions in individuals with piriformis syndrome. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Saxena |
| Designation |
Associate Professor |
| Affiliation |
MMIPR Mullana |
| Address |
Department of Neurophysiotherapy,Maharishi Markandeshwar Deemed to be University, Mullana , Ambala ,Haryana.
Ambala
HARYANA
133207
India |
| Phone |
7906989678 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Apoorva saini |
| Designation |
post graduate student |
| Affiliation |
MMIPR Mullana |
| Address |
Department of Neurophysiotherapy, Maharishi Markandeshwar Deemed to be University, Mullana , Ambala ,Haryana.
Ambala
HARYANA
133207
India |
| Phone |
8077131964 |
| Fax |
|
| Email |
apoorvasaini273@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Apoorva saini |
| Designation |
post graduate student |
| Affiliation |
MMIPR Mullana |
| Address |
Department of Neurophysiotherapy, Maharishi Markandeshwar Deemed to be University, Mullana , Ambala ,Haryana.
Ambala
HARYANA
133207
India |
| Phone |
8077131964 |
| Fax |
|
| Email |
apoorvasaini273@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Apoorva Saini |
| Address |
Department of Neurophysiotherapy,Maharishi Markandeshwar Deemed to be University, Mullana , Ambala ,Haryana-133207 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr APOORVA SAINI PT |
MMIPR |
Department of Neurophysiotherapy, Maharishi Markandeshwar Deemed to be University, Mullana , Ambala ,Haryana-133207
Ambala
HARYANA |
8077131964
apoorvasaini273@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Maharishi Markandeshwar Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neurodynamic mobilization |
Patient was positioned in supine lying while the therapist stood beside the treatment couch.
The therapist held the symptomatic lower extremity the therapist raised the leg straight with ankle dorsiflexion .
Upon reaching the point of maximum pain for the patient ,the therapist adjusted the hip flexion by reducing it to 10 degree before commencing the procedure.
With the hip held in a stable position, the therapist then performed the movements involving the knee and ankle joints .
These movement included flexion of knee with plantarflexion of the ankle and extension of the knee with dorsiflexion of ankle.
The procedure was structured to last 2 minutes per set, with 30-40 repetitions per set, total 3 sets . A rest period of 1 minutes was provided between each set. Intervention is given for 5days/week for 1 week.
|
| Intervention |
Neurodynamic mobilization And Static openers for sciatic nerve. |
Static openers
Position –painful side uppermost with a bolster under the lower side & towel between ilium and trochanter.
One leg over a side place in open position -painful side up, legs flexed to 90 degree , one foot placed over the side of couch .If this increases symptoms return foot to couch and place a bolster under waist instead. Do not mobilise.
Duration- 30-60 seconds at first , if better repeat several times
Both legs over the side .position as above ,two feet placed over the side of the couch .Dosage same as above . Dosage up to several minutes at a time, hourly.
Neurodynamic mobilization
Patient was positioned in supine lying while the therapist stood beside the treatment couch. The therapist held the symptomatic lower extremity the therapist raised the leg straight with ankle dorsiflexion . Upon reaching the point of maximum pain for the patient ,the therapist adjusted the hip flexion by reducing it to 10 degree before commencing the procedure. With the hip held in a stable position, the therapist then performed the movements involving the knee and ankle joints . These movement included flexion of knee with plantarflexion of the ankle and extension of the knee with dorsiflexion of ankle. The procedure was structured to last 2 minutes per set, with 30-40 repetitions per set, total 3 sets . A rest period of 1 minutes was provided between each set. Intervention is given for 5days/week for 1 week.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals suffering from piriformis syndrome.
Patients expressing a readiness to take part in the study.
Both males and females.
19-45 years of age.
Individuals having positive special test Beatty maneuver , Fair test ,SLR sensitivity test.1
|
|
| ExclusionCriteria |
| Details |
Individuals suffering from any other neurological conditions.
Individuals having any history of trauma or surgery in previous six months.
Spondylolisthesis.
Degeneration of both spine and hip joint .
Unwilling to actively participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS).
Pain Pressure Threshold (PPT) Of piriformis muscle.
Lower Extremity Functional Scale (LEFS)
Hip rotation ROM
|
Outcome measured at baseline 1st day and at 5th/last day of intervention.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS).
Pain Pressure Threshold (PPT) Of piriformis muscle.
Lower Extremity Functional Scale (LEFS)
Hip rotation ROM
|
Outcome measured at baseline 1st day & at 5th/last day of intervention.
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background:
Piriformis syndrome is a disorder which is a
combination of neural and muscular symptoms caused by sciatic nerve compression
leading to pain and compromised hip functions. Sciatic nerve mobilization is
very beneficial in treating neural symptoms in piriformis syndrome and Openers
are beneficial in canal opening and creating space for the compressed nerves.
Addition of openers to sciatic nerve mobilization may be beneficial in treating
individuals with Piriformis syndrome. The study need is to identify the additive effect of openers to sciatic
nerve mobilization to improve the quality of life
Purpose:
To find out the
effectiveness of static openers to sciatic nerve mobilization on pain, range of
motion and lower extremity functions in individuals with piriformis syndrome.
Methods: Patients will be recruited based on selection
criteria. Subjects will be randomly allocated into group 1 and group 2 through
computer based random allocation techniques. Group 1 will receive Openers, Sciatic
nerve Mobilization and Conventional treatment for 4 days a week and Group 2 will receive sciatic nerve
mobilization and Conventional treatment only for 4 days a week. Pre-test and
post-test assessment will be done by using Visual Analogue scale(VAS), Lower
Extremity Functional Scale(LEFS), Pressure Algometer and Universal Goniometer.
Data Analysis: Data will be analyzed using the Statistical Package
for Social Sciences (SPSS) software. Shapiro - Wilk test will be used
to establish the normality of the data. If data is found to be normally distributed it
will be presented as mean±SD and paired t-test
will be used for within the group analysis and unpaired t-test will be
used for between the group analysis. If data is found to be not normally
distributed it will be presented as Median (Interquartile range) and Wilcoxon
Signed rank test will be used for within the group analysis and Mann Whitney U
test will be used for between the group analysis. |