| CTRI Number |
CTRI/2025/10/096120 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess changes in walking, balance, and muscle stiffness before and after a nerve block procedure in patients with hip adductor spasticity |
|
Scientific Title of Study
|
Clinical, gait and balance parameters after diagnostic obturator nerve block in patients with spasticity - a pre-post interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaydeep Nandi |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Physical Medicine & Rehabilitation,
AIIMS Raipur,
Tatibandh,
G E Road,
Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9760456198 |
| Fax |
|
| Email |
jaydeepnandidgp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaydeep Nandi |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Physical Medicine & Rehabilitation,
AIIMS Raipur,
Tatibandh,
G E Road,
Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9760456198 |
| Fax |
|
| Email |
jaydeepnandidgp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaydeep Nandi |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Physical Medicine & Rehabilitation,
AIIMS Raipur,
Tatibandh,
G E Road,
Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9760456198 |
| Fax |
|
| Email |
jaydeepnandidgp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Jaydeep Nandi,
Principal Investigator,
Department of Physical Medicine & Rehabilitation,
AIIMS Raipur,
Tatibandh,
G E Road,
Raipur
PIN 492099 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Jaydeep Nandi |
AIIMS Raipur |
Department of Physical Medicine & Rehabilitation, Unit 1, Room No: 3
Raipur
CHHATTISGARH |
9760456198
jaydeepnandidgp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, (2) ICD-10 Condition: G809||Cerebral palsy, unspecified, (3) ICD-10 Condition: G35||Multiple sclerosis, (4) ICD-10 Condition: S141||Other and unspecified injuries ofcervical spinal cord, (5) ICD-10 Condition: S241||Other and unspecified injuries ofthoracic spinal cord, (6) ICD-10 Condition: S341||Other and unspecified injury of lumbar and sacral spinal cord, (7) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
USG guided diagnostic Obturator nerve block |
Patient monitor will be connected to the patient for assessment of heart rate, SpO2, respiratory rate,
blood pressure and temperature throughout the procedure. SONOSITE EDGE II Ultrasound
system with High Frequency 13-6 Mhz Linear Transducer (HFL 38xi) will be used in this
procedure. Ultrasonography will be performed to identify the obturator nerve, located in between the pectineus, adductor longus, and short adductor brevis muscles. A 22-gauge needle will be advanced
via an in-plane approach laterally to medially to position the needle tip between the adductor
longus and adductor brevis muscles (to block the anterior division of obturator nerve) . After negative aspiration, 5 mL of lidocaine 1% will be injected. The needle will then be advanced and positioned between the adductor brevis and adductor magnus muscles (to block the posterior division of obturator nerve), and another volume of 5 mL of lidocaine 1% will be injected. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged greater than or equal to 18 years
2. Patients affected by hip adductor spasticity (unilateral or bilateral) because of
underlying generalised or focal cerebral and spinal pathologies like cerebrovascular
accident, spinal cord injury, traumatic brain injury, cerebral palsy or multiple sclerosis.
3. Hip adductor spasticity severity 1, 1 plus, 2 or 3 on the Modified Ashworth Scale (MAS)
4. Use of any anti-spasticity medications at stable doses for at least 1 month prior to
enrolment, and the participant must agree to maintain same dose throughout the study |
|
| ExclusionCriteria |
| Details |
1. Patients who do not wish to be included in the study
2. Patients who have an allergy to lidocaine
3. Hip adductor spasticity severity 4 on the Modified Ashworth Scale (MAS)
4. Established severe contracture of the hip adductors.
5. Received recent treatment with botulinum toxin (within 6 months), phenol injection
(within 24 months).
6. Unstable medical conditions such as peripheral vascular disease, hepatic disease,
renal disease, coronary artery disease, malignant hyperthermia and an estimated
survival of less than 6 months.
7. Patients with a history of dystonic posture or deep vein thrombosis in the lower
limbs
8. Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Modified Ashworth Scale (MAS)
b) Spasm Frequency Scale
c) R1 of Modified Tardieu Scale (both in knee flexed and extended condition). |
Baseline, 30 minutes after procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Gait parameters:
1. Step length, Swing time (SwT), Stance time (StT), Single-leg support time (SLST),
Double-leg support time (DLST) and Step Length Symmetry Ratio
2. Walking velocity |
Baseline, 30 minutes after procedure |
b) Balance parameters:
1. Postural stability test
2. Fall risk test
3. Limits of stability test |
Baseline, 30 minutes after procedure |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/10/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jaydeepnandipmr@aiimsraipur.edu.in].
- For how long will this data be available start date provided 03-07-2026 and end date provided 03-07-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study expects to find out the functional improvement in hip adductor spasticity and the
change in gait and balance parameters after obturator nerve block. Patients above 18 years of age will be enrolled
for the study as per inclusion and exclusion criteria. All the patients will
receive anti spasticity medications at stable doses throughout the study duration. Modified
Ashworth Scale (MAS), Spasm Frequency Scale, R1 of Modified Tardieu Scale (knee flexed
and extended) , Gait parameters and Balance parameters will be assessed immediately before
the procedure. Clinical
data for primary evaluation will be obtained by examination for Modified Ashworth Scale
(MAS) of adductor group of muscles, Spasm Frequency Scale and R1 of Modified Tardieu
Scale (both in knee flexed and extended condition).
Spatiotemporal gait parameters will be collected by using the inertial motion sensor G-WALK
(G-SENSOR II) of BTS gait analysis system which uses G-STUDIO software.
Balance data will be collected by using the platform BALANCE SD which uses Balance
System SD Software Update v4.0.18. USG guided Obturator nerve block will be done on the affected side using 1%
lidocaine. 30 minutes after the procedure, the outcome variables will be assessed again. |