| CTRI Number |
CTRI/2020/12/030040 [Registered on: 24/12/2020] Trial Registered Prospectively |
| Last Modified On: |
13/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the effectiveness of two different exercise training i.e. training neck muscle with extra load and training neck muscle without extra load, in individuals with neck pain. |
|
Scientific Title of Study
|
Effectiveness of Dynamic Neck Strength and Dynamic neck endurance training in reducing neck pain and improving function among patients with mechanical neck pain -A Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUKTI CHAND MURAU |
| Designation |
PG student |
| Affiliation |
Laxmi Memorial College of Physiotherapy |
| Address |
1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore 1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore Dakshina Kannada KARNATAKA 575002 India |
| Phone |
8792149397 |
| Fax |
|
| Email |
memuktimourya2@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Priya S |
| Designation |
Associate Professor |
| Affiliation |
Laxmi Memorial College of Physiotherapy |
| Address |
1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore 1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9449729147 |
| Fax |
|
| Email |
priya.sv1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
MUKTI CHAND MURAU |
| Designation |
PG student |
| Affiliation |
Laxmi Memorial College of Physiotherapy |
| Address |
AJ1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore 1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore Dakshina Kannada KARNATAKA 575002 India |
| Phone |
8792149397 |
| Fax |
|
| Email |
memuktimourya2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Laxmi Memorial College of Physiotherapy, Mangalore |
|
|
Primary Sponsor
|
| Name |
Laxmi Memorial College of Physiotherapy |
| Address |
AJ Towers, Balmatta, Mangalore, 575002 |
| Type of Sponsor |
Other [Private Physiotherapy College] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MUKTI CHAND MURAU |
AJ Towers, Balmatta, Mangalore 575002 |
| SANJAY EAPEN SAMUEL |
AJ Towers, Balmatta, Mangalore 575002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priya S |
AJ Institute of Medical Sciences |
Department of Physiotherapy, NH66, Kuntikana, Mangalore,575004 Dakshina Kannada KARNATAKA |
9449729147
priya.sv1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, A J Institute of Medical Sciences & Research Centre |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dynamic Neck Endurance Training |
Patiets in Endurance training group will perform dynamic endurance training which includes cranio-cervical flexion exercise for deep neck flexor, lifting head backwards in prone on elbow in two ways i.e. head extension for sub-occipital muscles and lower cervical extension for long neck extensor. Each exercise will be done for 3 sets with 15-20 repetition in each set with no extra weight other than weight of the head. |
| Intervention |
Dynamic Neck Strength training |
Patients in Strength training group will perform dynamic strength training which includes lifting head up with chin tucked in from supine position for deep neck flexors, lifting head backward in prone on elbow in two ways i.e head extension for sub-occipital muscles and lower cervical extension for long neck extensors. Each exercise will be done with half kilogram weight cuff attached around forehead for 3 sets with 8-10 repetition in each set. Fatigue will be taken into consideration to plan the number of repetitions. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patient with subacute and chronic stage neck pain
Asymmetrical neck pain worsens as day progresses
Cervical spondylosis
Medically stable |
|
| ExclusionCriteria |
| Details |
Neck pain with NPRS less than 4 or NDI less than 20%
Acute pain and inflammation
Torticollis
Symptomatic herniated disc or severe disorders of cervical spine
Unstable or Acute Osteoarthritis
Recent fractures
Vertigo
Vertebro-basilar Insufficiency
Stroke patient
Pregnency |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale (NPRS)
% of Neck Disability Index (NDI) |
Baseline and after 2 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale (NPRS)
% of NDI |
1 Week after commencement of treatment |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2021 |
| Date of Study Completion (India) |
15/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/04/2021 |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Need of Study
Neck pain is a common health problem that is
associated with significant level of disability. It has been
associated with decreased health related quality of life (HRQ0L) in several
studies. Change in workplace environment with reliance on technologies for
work and predominantly sedentary life style could be possible factors of the
high prevalence of neck pain. Chronic
mechanical neck pain represents the vast majority of cases contributing to
substantial health care costs, work absenteeism, and loss of productivity at
all levels of employment. In order to decrease this social burden of
disability, the use of interventions with demonstrated efficacy for specific
outcomes is clearly essential. There are numerous treatment options in
literature for conservatively managing chronic neck pain that varies from
passive rest, electro-therapeutic modalities like therapeutic ultrasound,
passive techniques to active exercises. Exercise is recommended as an effective
way of managing neck pain disorders and has been shown to be more effective in
comparison to more passive interventions. There is also evidence that both
strengthening and endurance regimens have superior benefits over other form of
activities, such as stretching or massage techniques. Dynamic exercises
are superior than isometric exercise as it involves movement of the joints,
resulting in capsular, ligamentous and muscular flexibility and increased
cartilage nutrition. Muscle strengthening occurs in all joint ranges achieved
during the exercise and results in functionally more efficient muscle-joint
complex. Several researchers have found beneficial effect of dynamic
strengthening exercises of neck muscles to reduce neck pain and improve neck
function. Similarly, researchers have also found positive effect of
dynamic endurance training in individuals with mechanical neck pain. But
studies regarding comparison of these exercises, for their relative
effectiveness are limited. Therefore, the need of this study is to
find out whether anyone of this intervention is superior to another or both
have same efficacy to reduce neck pain and improve neck function.
Research question
Is there any difference in effectiveness of dynamic strength training
and dynamic endurance training in reducing neck pain and improving function in
patients with mechanical neck pain?
Null Hypothesis
There is no significant difference in effectiveness of dynamic strength
training and dynamic endurance training in reducing neck pain and improving
function in patients with mechanical neck pain.
Alternative hypothesis
There is significant difference in effectiveness of dynamic strength training
and dynamic endurance training in reducing neck pain and improving function in
patients with mechanical neck pain.
Methodology
Patients will be
recruited from an OPD of tertiary hospital. Written consent will be taken from
each patient after explanation of procedure. Patient will be allocated to
either dynamic neck strength or dynamic neck endurance training. Baseline neck
pain and neck disability will be assessed using Numeric Pain Rating Scale
(NPRS) and Neck Disability Index (NDI). Patient will receive the allocated
treatment for 2 weeks under direct supervision of investigator. after
completion of 2 weeks of regimen NPRS and NDI will be taken as outcome.
Statistical analysis: Paired t-test
will be used to test significant difference between pre and Post NPRS and NDI
within the groups. Student’s t-test will be used to test the significant
difference in the NPRS and NDI between the two groups. |