| CTRI Number |
CTRI/2024/03/063913 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Physiotherapy Intervention on Pain and Quality of Life in Cervical Radiculopathy |
|
Scientific Title of Study
|
Effect of Physiotherapy Intervention on Pain and Quality of Life in Cervical Radiculopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mehak Harjai |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no.4, General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be-University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
08708993931 |
| Fax |
|
| Email |
mehakharjai00737@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Simranjeet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no.4, General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be-University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9877144498 |
| Fax |
|
| Email |
dr.simranjeet.kaur@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Mehak Harjai |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no.4, General OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be-University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
08708993931 |
| Fax |
|
| Email |
mehakharjai00737@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation, Mullana Ambalab Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Mehak Harjai |
| Address |
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation, 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 Simranjeet Kaur |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be-University), Mullana-Ambala, Haryana
Ambala
HARYANA |
09877144498
dr.simranjeet.kaur@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MMIMSR, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myokinetic Stretching Technique, Neurodynamics |
Myokinetic Stretching Technique: Myokinetic stretching technique (MST)4 is a form of myofascial release, (The term Myofascial Release5was popularized in the 1950s and is defined as a hyperirritable spot in skeletal muscle that is associated with a hypersensitive palpable nodule in a taut band.
DURATION: 4 set of 15 Stretches with 3 minutes of rest.
Neurodynamics: Neurodynamic techniques refer to therapeutic methods which is to facilitate movement between the nervous system and its interfacing tissues or to reduce the mechanical loading on the nervous system.
DURATION: 3-4 Repetition with 60 seconds hold. |
| Comparator Agent |
Not Applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-40 years
Both male and female individuals
Subjects having neck pain and tingling
numbness unilaterally in upper limb for more than one week.
Patients with evident symptoms of cervical
spine radiculopathy
Patients with Spurling Test, Distraction
Test and Upper Limb Neurodynamic Test 1
Positive
|
|
| ExclusionCriteria |
| Details |
History of fracture cervical vertebrae
Cervical hypermobility
Bone diseases
Diabetic neuropathy
Osteoporosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck Disability Index (NDI)
SF-12
|
Pre and Post
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NPRS ( Numeric Pain Rating Scale) |
PRE & POST |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
17/03/2024 |
| 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="6"
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
|
All the participants were selected according to the
inclusion and exclusion criteria, and
patients will be assessed for the outcome measures inclusive of SF12, CRIS and NDI at the baseline. And
then a treatment for 5 days a week for
2 weeks. Participants receive Moist Hot Pack for 15 minutes, Myokinetic Stretching Technique 4 sets of stretch
with 3 minutes rest, Neurodynamics, Stretching Exercises
(Trapezius stretch, Levator
scapulae stretch, Sternocleidomastoid stretch, cervical deep
extensor stretch, 10 repetitions with 15
seconds hold), TENS for 15 minutes. |