| CTRI Number |
CTRI/2024/09/073538 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Calisthenic Exercise v/s Conventional Treatment on Non Specific Neck Pain |
|
Scientific Title of Study
|
Effect of calisthenic
exercise versus conventional treatment on non specific neck pain : A Randomised control 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 |
Shivashri Math |
| Designation |
PG student |
| Affiliation |
KAHER Institute of Physiotherapy Department |
| Address |
KAHER Institute of Physiotherapy Department of Orthopedic Physiotherapy ,OPD NO 39 ,Room 18 , Nehru Nagar ,Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7028194488 |
| Fax |
|
| Email |
shivashrimath30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarti Welling |
| Designation |
Assistant professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY BELGAUM |
| Address |
KAHER Institute of Physiotherapy Department of Orthopedic Physiotherapy ,OPD NO 39 ,Room 18 , Nehru Nagar ,Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aaartiwell88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aarti Welling |
| Designation |
Assistant professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY BELGAUM |
| Address |
KAHER Insitute Of Physiotherapy Department Of Orthopedic Physiotherapy ,OPD NO 39 ,Room NO 18 , Nehru Nagar ,Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aaartiwell88@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research , Nehru Nagar ,Belagavi Karnataka, India,590010 |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research Belagavi |
| Address |
KAHER Institute of Physiotherapy Department of Orthopedic Physiotherapy ,OPD NO 39 ,Room 18 , Nehru Nagar ,Belagavi,590010 Karnataka,India |
| 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 |
| Dr Aarti Welling |
KLEs Dr Prabhakar Kore Hospital |
KAHER Institute of Physiotherapy Department of Orthopedic Physiotherapy ,OPD NO 39 ,Room 18 , Nehru Nagar ,Belagavi, Karnataka
Belgaum
KARNATAKA |
9448814569
aartiwell88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KLEU Institute Of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M258||Other specified joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calisthenic Exercise + Conventional treatment |
Calisthenic exercise with Conventional treatment will be given for 4 weeks alternate days 12 session in total |
| Comparator Agent |
Conventional treatment |
Isometric Exercises will be given for 4 weeks alternate days 12 session in total |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals within the age group 18-50 years, with with non-specific neck pain.
2.Pain intensity more than 3 out of 10 on NPRS(Numerical Pain Rating Scale)
3.Individuals willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.History of fracture, trauma, injury or recent surgeries of cervical, spine and upper limb that would prevent the participants to perform the exercise.
2.Past six month history of fracture, trauma, injury or recent surgeries of cervical, spine and upper limb & lower limb that would prevent the participants to perform the exercise.
3.Pregnant women.
4.Diagnosed cases of serious pathology such as specific neck pain due to disc prolapsed, tumor of cervical spine, whiplash injury, cervical fractures, Cervicogenic head ache, and any neurological signs consistent with nerve root compression.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain will be recorded using Numeric Pain Rating Scale, Assessment of disability using Neck Disability Index, Assessment using Pressure Biofeedback, Craniovertebral angle measured using MB ruler5.3 |
will be done at baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/02/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
EFFECT OF CALLISTHENIC EXERCISES VERSUS CONVENTIONAL TREATMENT ON NON-SPECIFIC NECK PAIN: A RANDOMIZED CONTROLLED TRIAL Aim of the study - To determine and compare the effect of callisthenic exercises versus conventional treatment in individuals with non-specific neck pain. Null hypothesis - There will be no difference in the effect of callisthenic exercises and conventional treatment on pain, cervical muscle endurance and neck disability index in individuals with non-specific neck pain. Alternative hypothesis - There will be a change in the effect of callisthenic exercises and conventional treatment on pain, cervical muscle endurance and neck disability index in individuals with non-specific neck pain. Inclusion criteria - 1. Individuals aged 18-50 years, with non-specific neck pain. 2. Pain intensity more than 3 out of 10 on NPRS(Numerical Pain Rating Scale).3.Individuals willing to participate in the study. Exclusion criteria - 1. History of fracture, trauma, injury or recent surgeries of cervical, spine and upper limb that would prevent the participants to perform the exercise.2. Past six-month history of fracture, trauma, injury or recent surgeries of cervical, spine and upper limb & lower limb that would prevent the participants to perform the exercise.3. Pregnant women.4.Diagnosed cases of serious pathology such as specific neck pain due to disc prolapsed, tumour of cervical spine, whiplash injury, cervical fractures, cervicogenic headache, and any neurological signs consistent with nerve root compression. |