| CTRI Number |
CTRI/2025/07/091382 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Targeted Neural Mobilization on Hamstring length and Pain in Subjects with Lumbar PIVD |
|
Scientific Title of Study
|
Effect of Neural Tissue Mobilization on Hamstring length and pain in patients with prolapsed intervertebral disc |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Saxena |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar (Deemed to be) University, MMIPR Mullana, Ambala, Haryana |
| Address |
Maharishi Markandeshwar (Deemed to be) University, MMIPR Mullana, Ambala, Haryana
Maharishi Markandeshwar (Deemed to be) University, MMIPR Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
07906989678 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Sayani Das |
| Designation |
post graduate student |
| Affiliation |
Maharishi Markandeshwar (Deemed to be) University, MMIPR Mullana, Ambala, Haryana |
| Address |
Maharishi Markandeshwar (Deemed to be) University, MMIPR Mullana, Ambala, Haryana
Maharishi Markandeshwar (Deemed to be) University, MMIPR Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9038684205 |
| Fax |
|
| Email |
das96sayani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sayani Das |
| Designation |
post graduate student |
| Affiliation |
Maharishi Markandeshwar (Deemed to be) University, MMIPR Mullana, Ambala, Haryana |
| Address |
Maharishi Markandeshwar (Deemed to be) University, MMIPR Mullana, Ambala, Haryana
Maharishi Markandeshwar (Deemed to be) University, MMIPR Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9038684205 |
| Fax |
|
| Email |
das96sayani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar (Deemed to be) University, MMIPR Mullana, Ambala, Haryana 133207 |
|
|
Primary Sponsor
|
| Name |
Sayani Das |
| Address |
Maharishi Markandeshwar (Deemed to be) University, MMIPR 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 Sayani Das |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Maharishi Markandeshwar (Deemed to be university), MMIPR, mullana, Ambala, Haryana-133207
Ambala
HARYANA |
9038684205
das96sayani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee, M.M. Institute of Medical Sciences and Research, Mullana (Ambala) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M241||Other articular cartilage disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional treatment |
conventional treatment like
hot pack, static and dynamic stretching.
the procedure will take 10 minutes per session. |
| Intervention |
Neural tissue mobilization |
The subject was placed in a supine position with support for their neck and thoracic spine. In addition to concurrent hip flexion, knee flexion, and ankle dorsiflexion, the therapist actively alternated hip extension, knee extension, and ankle plantar flexion.
The procedure was used passively for 180 seconds, or three minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Prolapsed Intervertebral Disc (PIVD): Confirmed by clinical assessment and imaging (e.g. MRI).
2.Age Range: Typically, 18-60 years old (adults, to capture a general population while excluding extreme age-related factors).
3.Presence of Hamstring Tightness: Active knee extension angle of less than 20° (indicating hamstring tightness or restriction).
4.Pain Intensity: Moderate pain severity, typically between 3-7 on the Visual Analog Scale (VAS).
5.Consent: Able to provide informed consent and willingness to participate in the study.
6.No previous surgical intervention: No history of surgery related to the lumbar spine or hamstring muscles (unless stable post-surgery for a certain period).
|
|
| ExclusionCriteria |
| Details |
1.Severe Neurological Deficits: Patients with significant motor weakness, sensory loss, or reflex abnormalities unrelated to PIVD.
2.Severe Pain: Individuals with VAS score more than 8 or extreme pain that restricts participation in movement or exercise.
3.Other Spinal Pathologies: Patients with conditions like spinal stenosis, spondylolisthesis, or vertebral fractures.
4.Inflammatory Conditions: History of inflammatory diseases (e.g., rheumatoid arthritis or ankylosing spondylitis) that could affect mobility or pain perception.
5.Pregnancy: Pregnant individuals, due to potential risks associated with certain manual therapy techniques.
6.Recent Acute Injury: Hamstring injury or another acute injury within the past 6 weeks.
7.Uncontrolled Systemic Conditions: Such as uncontrolled diabetes, cardiovascular conditions, or other conditions that contraindicate exercise or manual therapy.
8.Psychiatric or Cognitive Issues: Individuals unable to follow study instructions or with cognitive impairments (e.g., severe dementia).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
active knee extension test
visual analogue scale |
5 days a week, 5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| finger to toe touch test |
5 days a week , 5 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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: A common spinal disorder
that most commonly occurs in the lumbar region, prolapsed intervertebral disc
disease (PIVD) is characterized by displacement of disc tissue beyond the
intervertebral space. Compression or irritation
of adjacent nerve roots, most often the sciatic nerve, may cause low back pain,
sciatica (pain traveling down the leg), and reduced lower limb flexibility,
particularly of the hamstring muscles.
Individuals with lumbar disc disease tend to be tight
in their hamstrings. Both neural stress,
which restricts the movement of the nerve itself, and defensive muscle guarding
may be the reason. Electrotherapy, core
strengthening, traction, and flexibility training are typical elements of
conventional PIVD rehabilitation; however, these interventions could not
effectively deal with the mechanosensitivity of brain structures.
The objective of neural tissue mobilization, which is
also referred to as neurodynamics or nerve gliding, is to restore peripheral
nerves’ normal range of movement and flexibility. Mobilizing the nerve through controlled joint
and muscle movements along its course may reduce pain, improve range of motion,
and reduce nerve irritation. Neural mobilization has been demonstrated in
research to reduce symptoms in conditions like sciatica and carpal tunnel
syndrome, but its application in the treatment of hamstring pain and stiffness
related to PIVD is in its early stages.
Investigating the effectiveness of neural tissue
mobilization in patients with PIVD may offer valuable information and lead to
improved rehabilitation methods due to the relationship between neural
structures, muscle flexibility, and pain..
Purpose: The
purpose of this study is to evaluate the effectiveness of neural tissue
mobilization in helping patients with prolapsed intervertebral disc disease
(PIVD) extend their hamstring muscles and reduce their discomfort.
Methods: : A
sample of PIVD with hamstring tightness will be recruited. Active knee
extension test, finger to toe touch test for hamstring tightness and visual
analogue scale for pain will be recorded at baseline. They will be divided into
2 groups: experimental group which receive the neural tissue mobilization and
control group which receive conventional treatment . The treatment will be
given for 5 days a week for 1 week and further assessments will be done at the
end of 4 weeks.
Data Analysis:. : Data will be analyzed by using SPSS software version
24. |