| CTRI Number |
CTRI/2025/10/096380 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Foot MET And Neural Mobilization In Patients With Lumbosacral Radiculopathy |
|
Scientific Title of Study
|
Effect of Foot Muscle Energy Technique (MET) and Neural
Mobilization in Patients with Lumbosacral Radiculopathy |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sameer Singh |
| Designation |
MPT Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology,Hisar |
| Address |
Department of Physiotherapy,
Guru Jambheshwar University of Science and Technology,
Hisar (Haryana).
NA
Hisar
HARYANA
125001
India |
| Phone |
9599399634 |
| Fax |
|
| Email |
drsameer2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Rani |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology,Hisar |
| Address |
Department of Physiotherapy,
Guru Jambheshwar University of Science and Technology,
Hisar (Haryana).
NA
Hisar
HARYANA
125001
India |
| Phone |
8708711667 |
| Fax |
|
| Email |
dr.vandanaravi7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Rani |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology,Hisar |
| Address |
Department of Physiotherapy,
Guru Jambheshwar University of Science and Technology,
Hisar (Haryana).
NA
Hisar
HARYANA
125001
India |
| Phone |
8708711667 |
| Fax |
|
| Email |
dr.vandanaravi7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sameer Singh |
| Address |
Department of Physiotherapy
Guru Jambheshwar University of Science and Technology, Hisar, Haryana, India. PIN-125001.
Hisar (Haryana)
NA |
| 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 Vandana Rani |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
Department of Physiotherapy Room No. 04 and 08 and 10 Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA |
08708711667
dr.vandanaravi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Department of Physiotherapy, GJUS&T,Hisar. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (3) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (4) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group.
Standard isometrics exercises protocol. |
Patients will receive standard isometrics excercises treatment for 4 weeks.
3 days per week
Session of 30-45 minutes. |
| Intervention |
Foot Muscle Energy Technique(MET) |
Foot Muscle Energy Technique Each participant will receive 30-45 min of session, conducting 3 times/ week for 4 consecutive weeks. The intervention includes both the MET Techniques: 1.Autogenic Inhibition MET Post Isometric Relaxation (PIR) Post Facilitation Stretching (PFS) 2.Reciprocal Inhibition MET Muscle energy technique (MET) for foot muscles involves using the patients own muscle energy to improve flexibility, reduce pain, and correct muscle imbalances. This technique utilizes controlled, gentle contractions against a counterforce to achieve therapeutic effects |
| Intervention |
Neural Mobilization. |
Nerve mobilization (NM) is a physiotherapy technique performed by a specialist physiotherapist that involves moving, pulling, or vibrating nerve tissue to improve the function of the nervous system. This technique is primarily used to treat neuropathy, nerve pain, muscle tension, and other neurological problems (Talebi et al.,2020, Ahmed et al., 2022). Each participant received 30-45 minutes of session, conducting 3 times/ week for 4 consecutive weeks. The intervention includes both the neural sliders and tensioners for Tibial and Common Peroneal nerves. In the remote sequences, the hip joint will be kept in fixed position, and the remote joints i.e. knee and ankle will be moved. As the pain subsided, we will proceed to standard sequence. In standard sequence the hip and ankle joint were moved keeping the knee in fixed position. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Lumbar disc herniation.
Both male and female patients are in the age group 25- 45 years.
Patients with lumbar radiculopathy(more than 3 months).
Patients with positive SLR with induced symptoms.
|
|
| ExclusionCriteria |
| Details |
Patients with cerebral concussion.
Patients with vestibular and ortho disorders.
Patients with neurological deficit(s); viz., balance.
Spine surgical intervention.
Patients with visual acuity impairment(s).
Alcoholic abuse.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Foot pressure
Balance
Foot functional index(FFI) |
Foot pressure evaluate and measured pressure distribution with Harris Mat in conjunction with Podia Scan.
Balance measured with Sensamove.
Foot functional index(FFI) Questionnaire (23 items):
a) Pain subscale
b) Disability subscale
c)Activity subscale
Assessment at baseline ,in the 3rd week and 4th week(follow up) after interventions, i.e. Foot MET and Neural Mobilization. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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 |
|
Date of First Enrollment (India)
|
02/11/2025 |
| 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="0"
Months="0"
Days="30" |
|
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?
- What additional supporting information will be shared?
- Who will be able to view these files?
- For what types of analyses will this data be available?
- By what mechanism will data be made available?
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information -
|
|
Brief Summary
|
Low back pain is a common condition that causes low back discomfort and gradual loss of functionality and mobility. Lumbo-Sacral radiculopathy is a manifestation of LBP with radicular symptoms. LBP patients have balance deficits in quiet standing and in perturbed standing; not a universal finding. Proposed mechanisms behind the balance deficits in LBP patients include reduced lower back proprioception, hip control mechanisms alterations, and decreased lumbar motion. In healthy young adults, there is elevation of centre of pressure (COP), deviation in quiet standing after induced plantar cutaneous somatosensory loss at the feet. Chronic impairment of proprioceptors in the lumbar spine, trunk, or lower extremities has reduced postural balance, thereby reduce the precision in the sensory integration process. Herniated disc is a common cause of lumbar radiculopathy (LR) with entrapment or compression, or irritation of nerve root. In nerve root impingement, sensory deficits, reflex changes, and/or muscle weakness are components of neurological findings.. Radicular pain for more than 3 months manifests disability, lowers the quality of life (QoL), and impaired ambulatory mechanisms on functional ground. Efficacy of Foot MET in conjunction with Neural Mobilization has better implications on foot pressure biomechanics, enhances ambulation, postural balance control, and improves pain and disability. Adjunct module of treatment protocol gives recovery with good prognosis. There is a paucity of literature that showed the efficacy of Foot MET and Neural Mobilization in lumbo-sacral radiculopathy as a treatment protocol. So, the need arises to explore the efficacy of Foot MET and Neural Mobilization in lumbo-sacral radiculopathy. However, there is no study that has adjunct application of Foot MET and Neural Mobilization in lumbo-sacral radiculopathy. |