| CTRI Number |
CTRI/2025/02/080615 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| 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
|
COMPARISON OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION WITH SEMISPINALIS CERVICIS TRAINING ON PAIN AND DISABILITY IN NECK PAIN
|
|
Scientific Title of Study
|
EFFECT OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION VERSUS SEMISPINALIS CERVICIS TRAINING ON PAIN AND FUNCTIONAL DISABILITY IN CHRONIC MECHANICAL 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 |
Jyoti Ojha |
| Designation |
Post graduate student(MPT) |
| Affiliation |
School of Health Sciences |
| Address |
Department Of Physiotherapy ,School Of Health Sciences ,Chhatrapati Shahuji Maharaj University ,kanpur Nagar
UTTAR PRADESH
208024
India
Kanpur Nagar UTTAR PRADESH 208024 India |
| Phone |
9630418576 |
| Fax |
|
| Email |
jyotibjri1996@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chandra Shekhar Kumar PT |
| Designation |
Assistant Professor |
| Affiliation |
School of Health Sciences |
| Address |
Room no 128 ,Department Of Physiotherapy ,School Of Health Sciences ,Chhatrapati Shahuji Maharaj University ,kanpur Nagar
UTTAR PRADESH
208024
UTTAR PRADESH
208024
India Department Of Physiotherapy ,School Of Health Sciences ,Chhatrapati Shahuji Maharaj University ,kanpur Nagar
UTTAR PRADESH
208024
India Kanpur Nagar UTTAR PRADESH 208024 India |
| Phone |
9919630553 |
| Fax |
|
| Email |
chandrasekhar@csjmu.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Chandra Shekhar Kumar PT |
| Designation |
Assistant Professor |
| Affiliation |
School of Health Sciences |
| Address |
Room no 128 ,Department Of Physiotherapy ,School Of Health Sciences ,Chhatrapati Shahuji Maharaj University ,kanpur Nagar
UTTAR PRADESH
208024
UTTAR PRADESH
208024
India Department Of Physiotherapy ,School Of Health Sciences ,Chhatrapati Shahuji Maharaj University ,kanpur Nagar
UTTAR PRADESH
208024
India Kanpur Nagar UTTAR PRADESH 208024 India |
| Phone |
9919630553 |
| Fax |
|
| Email |
chandrasekhar@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, School of health sciences, Chhatrapati Shahu ji Maharaj University, kanpur, Uttar pradesh India Pin code 208024 |
|
|
Primary Sponsor
|
| Name |
School of Health Sciences |
| Address |
Room no SHS 106, Department Of Physiotherapy, School of Health Sciences, Chhatrapati Shahuji Maharaj University, Kanpur
UTTAR PRADESH
208024
India |
| Type of Sponsor |
Research institution |
|
|
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 Chandrashekhar Kumar |
School of health sciences, Kanpur Nagar |
Room no SHS 128, Department Of Physiotherapy, Chhatrapati Shahuji Maharaj University, Kanpur Nagar
UTTAR PRADESH
208024
India Kanpur Nagar UTTAR PRADESH |
9919630553
chandrasekhar@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Committee, Chhatrapati shahuji Maharaj University, kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mechanical Neck Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Proprioceptive Neuromuscular Facilitation |
the movement is performed by the patient with the help of therapist on the neck pattern
(a)Cranio-cervical extension with left rotation
(b)Cranio-cervical flexion with right rotation
(c)Cranio-cervical flexion with left rotation
(d)Cranio-cervical extension with a right rotation.
Thrice a week for four weeks. |
| Comparator Agent |
Semispinalis Cervicis Training |
The therapist placed the thumb and index finger on the posterior vertebral arch of C2 and pushed gently into flexion while the opposite hand stabilized the patient shoulder. Patient was asked to resist maximum voluntary contraction in the direction of extension without provocation of neck pain. Thrice a week for four weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Neck pain with a duration of at least 3
months or more.
NDI Scoring greater and equal to 5%
NPRS scoring of greater and equal to 3
|
|
| ExclusionCriteria |
| Details |
Cervical Radiculopathy or Myelopathy
Spinal infection
Cervical or Thoracic spine Fracture /
Dislocation
Surgery of the cervical or thoracic spine
Psychic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS
NDI
Both Outcomes are used to Determine the effect of intervention. |
At baseline,4 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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="2" Months="0" 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
|
Background Neck Pain is the 4th highest Musculoskeletal Condition in the General Population. The Prevalence of neck pain is 352 per 100,000 population and the incidence rate is 806.6. It Is Generally Higher in Females and Middle Age Group people. About two-thirds of people experience neck pain in middle age because of prolonged use of mobile and computer devices, without any physical activity. It is primarily caused by postural or mechanical basis. Need of study Previous studies have shown significant effect of PNF and Semispinalis cervicis training on mechanical neck pain. However, to the best of my knowledge there is no study available which shows that among these intervention which one provides better outcome. Therefore our need of the study is to identify the effect of PNF and semispinalis cervicis training on pain tolerance and functional disability in mechanical neck pain. Aim of study The aim of the study is to Compare the effect of PNF versus semispinalis cervicis training on pain and function in mechanical neck pain. METHODOLOGY In this study, Mechanical Neck Pain patients will be screened first and those fulfilling the inclusion criteria of our study will be selected. The written consent will be signed from the patient to ensure that they are willingly participating in the study. The consent shall be taken before commencement of the study. The participants will be explained about the study procedures. The patients will be randomly divided into two groups (A and B) of equal participants i.e. 25 Patients in each group using block randomization method. Then, the baseline assessments of pain and functional disability will be done. . Protocol for Proprioceptive Neuromuscular Facilitation: The patient was in sitting position and the therapist stands behind the patient. The movement is performed by the patient with the help of therapist on the neck pattern (a) Cranio-cervical extension with left rotation, (b) Cranio-cervical flexion with right rotation, (c) Cranio-cervical flexion with left rotation, (d) Cranio-cervical extension with a right rotation, these movements are combination of isotonic, dynamic reversal, and contract relaxation. Each pattern is performed for 10 repetitions with 10 min. Hold each stretch for 30 seconds, a 10-second push phase followed by 10-second relaxation phases. The treatment was given thrice a week for four weeks. Protocol for Semispinalis Cervicis training: The patients sitting on a stool without a backrest with a hip knee flexed 90 degrees and feet placed on the floor and the therapist stands on the side of the patient. The therapist placed the thumb and index finger on the posterior vertebral arch of C2.and pushed gently into flexion while the opposite hand stabilized the patient shoulder. Patient was asked to resist maximum voluntary contraction in the direction of extension without provocation of neck pain. The exercise was performed 10 minutes per set with 3 sets per day, hold resistance 10 sec, and 30 sec rest was allowed. Treatment to be performed for 10 min. The treatment was given thrice a week for four weeks. |