| CTRI Number |
CTRI/2024/06/068996 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Static Stretching versus Stretching with assistance of Instrument on the backside of the thigh in patients with Neck pain. |
|
Scientific Title of Study
|
Immediate effect of Static stretching versus Instrument-assisted soft tissue
mobilisation over hamstring area in mechanical neck pain- An Experimental
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 |
Dr Rhea Deshpande |
| Designation |
Masters of Musculoskeletal physiotherapy Student |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
K J Somaiya College of Physiotherapy,
Musculoskeletal Physiotherapy OPD number 4 and 5
Ayurvihar, Eastern Express Highway, Sion
Mumbai
MAHARASHTRA
400022
India
-
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8452850604 |
| Fax |
- |
| Email |
rhea.d@somaiya.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Ganu |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
K J Somaiya College of Physiotherapy,
Musculoskeletal Physiotherapy OPD number 4 and 5
Ayurvihar, Eastern Express Highway, Sion
Mumbai
MAHARASHTRA
400022
India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9820790250 |
| Fax |
|
| Email |
s.ganu@somaiya.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rhea Deshpande |
| Designation |
Masters of Musculoskeletal physiotherapy Student |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
K J Somaiya College of Physiotherapy,
Musculoskeletal Physiotherapy OPD number 4 and 5
Ayurvihar, Eastern Express Highway, Sion
Mumbai
MAHARASHTRA
400022
India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8452850604 |
| Fax |
|
| Email |
rhea.d@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| K J Somaiya College of Physiotherapy,
Ayurvihar, Eastern Express Highway, Sion
Mumbai
MAHARASHTRA
400022
India
|
|
|
Primary Sponsor
|
| Name |
KJ Somaiya College of Physiotherapy |
| Address |
K J Somaiya College of Physiotherapy,
Musculoskeletal Physiotherapy OPD number 4 and 5
Ayurvihar, Eastern Express Highway, Sion
Mumbai
MAHARASHTRA
400022
India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rhea Deshpande |
K J Somaiya College of Physiotherapy |
K J Somaiya College of Physiotherapy,
Musculoskeletal Physiotherapy OPD number 4 and 5
Ayurvihar, Eastern Express Highway, Sion
Mumbai
MAHARASHTRA
400022
India
Mumbai
MAHARASHTRA |
8452850604
rhea.d@somaiya.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KJ Somaiya College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Instrument- assisted soft tissue mobilisation |
The bevelled edge of the Instrument-assisted soft tissue mobilisation tool will be held in an angle of 45 degrees to the patient’s posterior thigh and the pressure applied will just be the tool’s weight.
There are 2 positions: In neutral spine and in the stretch position. In a neutral
spine that is the relaxed position for SBL: prone with 45 degrees angulation the
blade with no pressure moves from proximal to distal.
(a)In the stretch position, a repetition of the above activity but in a stretch position of Superficial backline with patient in side lying position. A slow stretch should be maintained throughout.
(b)The aim will be to manipulate the fascia in both relaxed and stretched for decreasing fascial restrictions treatment will last for 3-5mins. |
| Intervention |
Static Stretching |
Patients dominant leg will be taken in the straight leg raise position until the point of resistance and will be held in that position for 30 seconds.
3 Repetitions of 30 seconds hold with each repetition having end 10 seconds
relaxation period with 3 reps.
Precautions to be taken are that opposite limb pelvis and leg is not lifted from the
surface of contact.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants with Subacute and Chronic Mechanical neck pain.
2.Participants with pain intensity on
NPRS between 3 to 7.
3.Participants unable to achieve Active knee extension less than 20 degrees from full extension and who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Participants who have history of Cervical disc herniation or spinal stenosis.
2. Participants who have musculoskeletal disorders, neurological disorders
and Vascular disorders, vestibular disorders.
3. Injury or surgery in the lower extremity in last six months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Cervical Pain
2. Cervical Flexion Range of motion.
3. Cervical Proprioception. |
Pre- intervention: Baseline assessment.
Post- intervention: Immediately after 5-7 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Approval is Obtained from the Institutional Ethics Committee. Participants will be screened according to the inclusion and exclusion criteria and a written informed consent will be obtained in the language best understood by them. The subjects will be randomly allocated to Group A or Group b using the
computer allocation method using GraphPad. The dominant leg will be assessed using the ball kicking test which involves
placing the ball in front of the participant and asking him to kick the ball. The leg
used to kick the ball is considered as dominant leg on which the intervention will
be administered. The pre-test assessment of Hamstring length using Active knee extension
test. This test will be used as a screening test for recruiting participants along with
other inclusion criteria.
Pre-test assessment of Cervical pain will be done using NPRS, Cervical flexion
range using universal goniometer and Cervical proprioception using the Cervical
joint position error test will be done and values will be noted. Group A will receive static stretching and Group B will receive
Instrument-assisted soft tissue release over hamstring area. Immediate post test assessment of Hamstring length using Active knee extension
test, Cervical pain will be done using NPRS, Cervical flexion range using
universal goniometer and Cervical proprioception using the Cervical joint
position error test will be done and values will be noted. The values obtained will be statistically analyzed and the results will be
generated.Normality of numerical data will be checked using Kolmogorov test.
Depending on the normality of data, statistical tests will be determined.Intra group comparisons for a numerical continuous data following a normal
distribution will be done using paired t test, else a non-parametric test Wilcoxan
signed rank test will be used. For inter group analysis unpaired t test for parametric data and Mann Whitney
U Test for non-parametric data will be used. Keeping alpha error at 5% and Beta
error at 20%, power at 80%, p<0.05 will be considered statistically significant.Statistical Analysis will be done and results will be obtained |