| CTRI Number |
CTRI/2024/07/071214 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physiotherapy including Yoga] |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Effects Of Yoga Asanas And PNF For Chronic Non-Specific Neck Pain: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Comparative Effects Of Yoga Asanas And Proprioceptive Neuromuscular Facilitation On Pain, Cervical Range, Endurance And Function In Chronic Non-Specific Neck Pain: A Randomized Clinical Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Patil |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD No 39, Room No 18, Nehru Nagar Belagavi, Karnataka
KAHER institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD No 39, Room No 18, Nehru Nagar Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
08180947938 |
| Fax |
|
| Email |
shivanipatil1219@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Peeyoosha Gurudut |
| Designation |
Professor and Head of Orthopedic Department |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD No 39, Room No 18, Nehru Nagar Belagavi, Karnataka
KAHER institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD No 39, Room No 18, Nehru Nagar Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Peeyoosha Gurudut |
| Designation |
Professor and Head of Orthopedic Department |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD No 39, Room No 18, Nehru Nagar Belagavi, Karnataka
KAHER INSTITUTE OF PHYSIOTHERAPY, DEPARTMENT OF ORTHOPARDIC PHYSIOTHERAPY, OPD NO 39, ROOM NO 18, NEHRU NAGAR BELAGAVI, KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy Of Higher Education And Research, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
KLE Academy Of Higher Education And Research |
| Address |
KAHER institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD No 39, Room No 18, Nehru Nagar Belagavi, Karnataka |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Peeyoosha Gurudut |
KLEs DR. Prabhakar kores hospital and medical research center |
KAHER Institute Of Physiotherapy, Department Of Orthopedic Physiotherapy, OPD NO 39, Room No 18, Nehru Nagar Belagavi, Karnataka
Belgaum
KARNATAKA |
9844821355
peeyooshagurudut@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Proprioceptive Neuromuscular Facilitation
|
PNF will be given thrice a week for 4 weeks
|
| Intervention |
Yoga Asanas |
Yoga Asanas will be given for thrice a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female
2. Participants aged between 18-50 years
3. Participants having chronic Non-specific neck pain with duration of more than 12 weeks
4. Participants having neck pain with intensity ranging from 2-6 on numerical pain rating scale.
5. Participants willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Participants with history of injury, tumour or infections in the cervical region.
2. Participation having history of fracture of upper and lower limb and spine.
3. Participants who has the history of whiplash injury.
4. Participants diagnosed with osteoporosis, osteoarthritis, rheumatoid arthritis.
5. Participants diagnosed case of psychological deficit.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neck pain intensity using numerical pain rating scale, Functional ability of neck using neck disability index, cranio-cervical flexion test using chattanooga pressure biofeedback, assessment of cervical range of motion using universal goniometer |
Pre assessment will be taken before giving the intervention and post assessment will be done after 4 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
COMPARATIVE EFFECTS OF YOGA ASANAS AND PROPRICEPTIVE NEUROMUSCULAR FACILITATION ON PAIN, CERVICAL RANGE, ENDURANCE AND FUNCTION IN CHRONIC NON-SPECIFIC NECK PAIN: A RANDOMIZED CLINICAL TRIAL. Aim of the study- To assess and compare the effect of yoga asanas vs PNF on pain, cervical range, endurance and function in participants with chronic non-specific neck pain. Null hypothesisH0- There will be no difference in the effect of yoga asanas and PNF on pain, cervical range, endurance, and function in chronic non-specific neck pain. Alternate hypothesis-There will be difference in the effect of yoga asanas and PNF on pain, cervical range, endurance and function in chronic non-specific neck pain. Inclusion criteria-Both male and female, participants aged between 18-50 years, participants having chronic non specific neck pain with duration of more than 12 weeks, participants having neck pain with intensity from 2-6 on numerical pain rating scale, participants willing to participate in the study. Exclusion criteria-participants having history of injury, tumour or infections in the cervical region, participants having history of fracture of upper and lower limb and spine, participants who has history of whiplash injury, participants diagnosed with osteoporosis, osteoarthritis, rheumatoid arthritis, participants diagnosed case of psychological deficit.
|