| CTRI Number |
CTRI/2024/03/064413 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of manual therapy techniques in non specific neck pain |
|
Scientific Title of Study
|
Effect of positional release technique with PNF hold relax stretch in the management of non-specific neck pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fanoos fayaz |
| Designation |
Pg scholar |
| Affiliation |
Amity institute of health allied sciences |
| Address |
Lower ground floor , room no 03 ,F-1 block ,Amity institute of health allied sciences , amity university Noida sec125 Noida 201301 India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8825026608 |
| Fax |
|
| Email |
fanoosfayaz2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anu Bansal |
| Designation |
Assistant Professor III |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
F1-107A, First floor, F-1 block, Amity Institute of Health Allied Sciences, Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Anu Bansal |
| Designation |
Assistant Professor III |
| Affiliation |
Amity institute of Health Allied science |
| Address |
Room no 107A ,first floor, F-1 block, Amity institute of health allied sciences , amity university Noida, sector 125 Noida 201301 India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Health Allied Sciences Amity University Noida Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Fanoos |
| Address |
Amity Institute of health allied science amity university students Noida UP NOIDA |
| 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 Fanoos Fayaz |
cure physiotherapy and rehab center. |
Room no 2 , ground floor Jaitpur extension part2 khadda colony ,New Delhi
South West
DELHI |
8825026608
fanoosfayaz2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Cure physiotherapy and rehab center |
No Objection Certificate |
| Institutional NTCC Committee Amity Institute Of Health Allied Science, Amity University Noida, Sec 125 Noida 201301, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Positional release technique with PNF hold relax stretch |
group A: PRT for upper trapezius and levator scapulae (3 repetitions 1 set 3 days a week for 4 week ) + conventional therapy including hot pack, neck isometrics , chin tuck exercise
GroupB : PNF Hold relax for upper and trapezius and levator scapulae (5 repetitions 1 set 3 days a week for 4weeks) + conventional therapy
|
| Comparator Agent |
Positional release technique with PNF hold relax stretch in non specific neck pain |
Group c : PRT for upper trapezius and levator scapulae (3 repetitions 1 set 3 days a week for 4 week ) , PNF Hold relax for upper and trapezius and levator scapulae (5 repetitions 1 set 3 days a week for 4weeks) and conventional therapy including hot pack, neck isometrics , chin tuck exercise |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Non-specific neck pain for 2–8 weeks Unilateral neck pain patients
Age group between 18 – 25
Both genders male and female
NPRS score of 5 or more than 5
University students
|
|
| ExclusionCriteria |
| Details |
1. Anyone who denies to sign the consent
2. Traumatic injuries
3. Serious pathology such as specific neck pain due to disc prolapsed,
4. Tumor of cervical spine,
5. whiplash injury, cervical fractures,
6. Cervicogenic headache,
7. Nerve root compression
8. Torticollis
9. Cervical OA
10. People falling outside the age group.
11. Forward head posture.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Control Pain and disability, improve Range of Motion (cervical lateral flexion and rotation) and effect on Quality of Life
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve flexibility |
4 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/03/2024 |
| 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
Modification(s)
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Non-specific neck pain is a highly prevalent musculoskeletal disorder that poses a significant socioeconomic burden on a global scale. This condition often arises due to poor posture and strain on the neck, resulting in pain and limited mobility. Physical therapists employ various treatment approaches to address these issues. However, there is limited available evidence to guide the appropriate use of techniques such as positional release technique and PNF in clinical practice. Therefore, this study aimed to investigate the effectiveness of positional release therapy with hold relax PNF technique in alleviating symptoms in individuals suffering from non-specific neck pain. |