| CTRI Number |
CTRI/2024/08/072472 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Cervical muscle release and Neuromuscular Stretching to improve Hamstring muscle flexibility in Young Females |
|
Scientific Title of Study
|
Effectiveness of Suboccipital Muscle Inhibition Technique and Proprioceptive Neuromuscular Facilitation Stretching to improve Hamstring Muscle Flexibility among Young Females |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritika Chandel |
| Designation |
BPT Undergraduate Student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7876655245 |
| Fax |
|
| Email |
ritika6227@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeksha Sharma |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8146966176 |
| Fax |
|
| Email |
deeksha0075sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arushi Mishra |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8219368147 |
| Fax |
|
| Email |
arushimishra799@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, Himachal Pradesh, India
Pin code 173229 |
|
|
Primary Sponsor
|
| Name |
Ritika Chandel |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Deeksha Sharma |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deeksha Sharma |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
Room no. 510, Department of Physiotherapy, Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, Himachal Pradesh, India
Solan
HIMACHAL PRADESH |
8146966176
deeksha0075sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HAMSTRING MUSCLE TIGHTNESS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neural Mobilization and Hot Fomentation |
For Hot Fomentation, the subject will be in prone lying position. The moist heat pack will be placed over the posterior compartment of the thigh.
Duration will be 20 minutes.
For Neural Mobilization (Lower extremity), the subject will be in high sitting position with his hands held at his back. The therapist will be standing beside the targeted limb. Procedure will be performed in two stages. For first stage, the subject will be instructed to flex his cervical region and simultaneously extend the knee and dorsiflex the ankle. For second stage, subject will restore ankle dorsiflexion, maintain cervical flexion and take knee into flexion at the same time.
Total 3 sets will be performed where one set consists of 15 repetitions.
Treatment will be provided thrice a week for two weeks. |
| Intervention |
Suboccipital Muscle Inhibition Technique along with Proprioceptive Neuromuscular Facilitation Stretching and Hot Fomentation |
For Hot Fomentation, the subject will be in prone lying position. For Suboccipital muscle inhibition technique, the moist heat pack will be applied over the nape of the neck. Duration of the treatment will 20 minutes.
In case of Proprioceptive Neuromuscular Facilitation Stretching, the moist heat pack will be placed over the posterior compartment of the thigh.
For Suboccipital muscle inhibition technique, the subject will be in supine lying position and the therapist will be standing with placing the palms of his hand under the head of the subject.
An upward pressure will be exerted by the therapist with the use of middle and ring fingers of both hands and maintained for 2 minutes.
The procedure will be repeated 3 times for 2 minutes with 20 seconds of rest intervals in between.
Treatment will be given thrice a week for two weeks.
For Proprioceptive Neuromuscular Facilitation Stretching (Contract-relax), the subject will be in supine lying position and stretching will be provided for hamstring muscle. Total 4 sets will be performed where one set consists of 2 repetitions. Treatment will be provided thrice a week for two weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Female subjects with hamstring muscle tightness
Age group between 18-30 years
Patients with Positive Active knee extension test (Popliteal angle range less than 125 degrees) |
|
| ExclusionCriteria |
| Details |
History of trauma, fractures of lower limbs
History of neurological conditions
Paresthesia in lower limbs
Subjects with hip and knee prosthesis
Subjects with musculoskeletal conditions such as low back pain, S.I. dysfunction, genu varum, genu valgum
Subjects using medications that may alter the measurements (example muscle relaxants) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Active knee extension test |
Two point measurements (on day 1 and day 14) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lower extremity functional scale |
Two point measurements (on day 1 & day 14) |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 |
|
Date of First Enrollment (India)
|
27/09/2024 |
| 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
|
Hamstring muscle flexibility is considered as prerequisite for normal mobility and variation in the flexibility can lead to aberrant stress on the musculoskeletal system. It may result in increased risk of injuries as well as reduction in strength, endurance and motor coordination. The prevalence rate of hamstring tightness among university students is 68% with predominance in females. The present study will evaluate the combined effect Suboccipital Muscle Inhibition Technique and Proprioceptive Neuromuscular Facilitation Stretching along with conventional physiotherapy management in improving hamstring muscle flexibility in young females. A total of 102 females will be recruited in the study and will be further divided into two groups on the basis of inclusion and exclusion criteria. Baseline assessment to assess the hamstring flexibility will be done using Active knee extension test and scores of Lower extremity functional scale. Subjects of Group A will be treated with Suboccipital Muscle Inhibition Technique along with Proprioceptive Neuromuscular Facilitation Stretching and Hot fomentation whereas Group B will be treated with Neural Mobilization and Hot fomentation for thrice a week for two weeks. Post intervention assessment will be done on day 14. Data will be analysed and results will be obtained. |