| CTRI Number |
CTRI/2018/02/012048 [Registered on: 21/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of specific exercises on patients with neck pain. |
|
Scientific Title of Study
|
Effect of Scapular Stabilization with Upper Limb Proprioceptive Training in Chronic Non specific Neck Pain Patients on Function and Related Parameters |
| Trial Acronym |
SSULPT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zubia Veqar |
| Designation |
Assistant professor |
| Affiliation |
Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia |
| Address |
Centre For Physiotherapy And Rehabilitation Sciences
Jamia Millia Islamia
South DELHI 110025 India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Zubia Veqar |
| Designation |
Assistant professor |
| Affiliation |
Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia |
| Address |
room no 204, second floor
Centre For Physiotherapy And Rehabilitation Sciences
Jamia Millia Islamia
South DELHI 110025 India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anam fatima |
| Designation |
Student |
| Affiliation |
Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia |
| Address |
Centre For Physiotherapy And Rehabilitation Sciences
Jamia Millia Islamia
South DELHI 110025 India |
| Phone |
9958993486 |
| Fax |
|
| Email |
anam93fatima@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Maulana mohd Ali gauhar marg,Okhla, Delhi, India |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
okhla |
| Type of Sponsor |
Other [Central university] |
|
|
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 Zubia Veqar |
centre for Physiotherapy and rehabilitaton sciences |
Physiotherapy clinic, ground floor,Centre For Physiotherapy and Rehabilitation Scienced
Jamia Millia Islamia South DELHI |
9958993486
veqar.zubia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, JAMIA MILLIA ISLAMIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physiotherapy |
Cervical Stabilization Exercises.
The following will be a four week protocol.
It will begin with postural education that will include teaching the subjects to sit with front and side mirror views and to maintain a neutral balanced position of the lumbar, thoracic, and cervical spine. This will be followed by Cervical Stabilization Exercise Program A. The cervical bracing technique performed in neurodevelopment stages, and then extremity range of motion exercises.
B. Cervical dynamic isometric exercises: Will be performed directly forward, obliquely, toward right and left, and directly backward by maintaining stabile spine and progressed with elastic resistive bands. |
| Intervention |
Physiotherapy |
Scapulothoracic and Upper limb proprioceptive exercises
It will be a four week protocol.
These will be Scapular orientation exercise; that will include Isometrics; Scapular pinches, Low Row Wall isometrics and isotonics ; Prone shoulder, Horizontal abduction and progress into Resistive exercises i.e. Scapular pinches using theraband, Dynamic Hug, Cheerleader Exercise, Manually Resisted Scapular Strengthening, Scaption with external rotation, and Side-lying external Dumbbell. Upper extremity proprioceptive training will include, Mirroring Upper Extremity, Duplicating Position, Double and Single Arm Balancing and Ball Balancing with eyes open and eyes closed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
•Subjects with chronic (≥3months) nonspecific neck pain of mechanical origin with symptoms provoked by neck postures, movements, or palpation.
•Males/females between 18 to 59 years of age.
•Subjects willing to attend a 4 week treatment program
•Numerical pain rating scale score ≤ 6 and ≥ 2.
•Working knowledge of English to complete the questionnaires.
•A score of more than 6 in Pittsburgh Sleep Quality Index
|
|
| ExclusionCriteria |
| Details |
1. Subjects with cervical spine surgery or any previous history of cervical spine fracture or spinal stenosis.
2.Subjects suffering from debility any other co morbid conditions.
3.Subjects with bilateral upper extremity symptoms, positive radicular signs consistent with nerve root compression.
•Subjects having vertebrobasilar insufficiency symptoms.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck pain and Disability
Scapular muscles strength
Upper limb proprioception (Constant error)
Sleep
Quality of life
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neck Disability
Sleep
Quality of life |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2018 |
| Date of Study Completion (India) |
30/04/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2018 |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction: Neck
pain is a world-wide health problem and is one of the causes of individual
suffering and a large
burden for the society. It is counted
among the most common musculoskeletal problem in health care. Pain
results in sleep disturbances affecting sleep maintenance, sleep latency and is
responsible for wakefulness. Pain
triggers certain mechanisms that worsen the sleep quality.Groups
will receive specific exercises with a set standardization of parameters and
type which are internationally accepted. The main musculatures involved in
chronic neck pain are Upper trapezius, Middle Trapezius and Lower Trapezius,
Serratus Anterior, Pectolaris Minor, Levator Scapulae and Rhomboids. Goal
directed movements and position matching acuity are found to be affected in
chronic nonspecific neck pain patients. Upper limb acuity i.e. position
matching was found to be reduced in people with chronic neck pain patients.
Active joint repositioning training utilizes the procedure that is used for
testing purposes of joint position sense. Here, the starting angle and target
angles are selected which are the most vulnerable to injuries. Then the patient
moves from the beginning position to the target angle and holds at that
position for approximately for five seconds. This is done first with eyes open
followed by eyes closed .A combined effect of upper limb proprioceptive exercises
and stabilization exercises is the corner stone of this study. Stability and
goal directed movements training induced changes will be examined at the end of
the programme.
Objective: To
find the Effects of scapular stabilization with upper limb proprioception
training on pain, functional disability, QOL and Sleep of patients with chronic
nonspecific neck pain.
Significance
of the study: This
study will help us to develop Scapular Stabilization with Upper limb
Proprioceptive Training as a better therapeutic measure for the Chronic Neck
Pain patients with disturbed Sleep, Quality Of Life and Functional Disability and
Pain.
Method: Total of 28 sample of
(14=GroupA, 14=Group B) will be taken from Jamia Millia Islamia, New Dellhi.
Research
design: A randomized, therapy-controlled trial. Procedure: Subjects will be divided randomly
into two groups: Group 1: Conventional physiotherapy only; Group 2: Scapular
stabilization with upper extremity proprioceptive Training including
conventional exercises. All identifying information on the consent form and
demographic/injury history questionnaire will be kept confidential by assigning
number to each subject.Data will be collected on 1st day and at the
4th week of intervention. |