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CTRI Number  CTRI/2024/07/070658 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 10/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Measuring the mobility and functional limitation of shoulder joint in desktop workers. 
Scientific Title of Study   Assessment of the mobility and functionality of the shoulder complex in desktop workers-A cross sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pradeep K P 
Designation  Master of physiotherapy in musculoskeletal sciences  
Affiliation  Father Muller medical college 
Address  1st year MPT , department of musculoskeletal sciences, Father muller college of physiotherapy kankanady , mangalore.

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9686685983  
Fax    
Email  pradeep.chokkadi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ms Leah Mohandas 
Designation  Associate Professor 
Affiliation  Father Muller medical college 
Address  Father Muller College of Physiotherapy, Department Musculoskeletal Sciences, ashakiran building.
-
Dakshina Kannada
KARNATAKA
575002
India 
Phone  9739863768  
Fax  -  
Email  leahdas86@fathermuller.in  
 
Details of Contact Person
Public Query
 
Name  Pradeep K P 
Designation  Master of physiotherapy in musculoskeletal sciences  
Affiliation  Father Muller medical college 
Address  Father Muller Medical College, Department of physiotherapy

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9686685983  
Fax    
Email  pradeep.chokkadi@gmail.com  
 
Source of Monetary or Material Support  
Father Muller Medical College and Hospital, kankanady , mangalore, pincode- 575002.  
 
Primary Sponsor  
Name  Pradeep K P 
Address  Father Muller College of Physiotherapy, kankanady, mangalore, 575002 
Type of Sponsor  Other [self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep K P  Father Muller Medical College of Physiotherapy  Physiotherapy IPD, R ward, Third Floor Asha Kiran FMMCH
Dakshina Kannada
KARNATAKA 
9686685983

pradeep.chokkadi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Desktop workers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  BMI range from 18.5 to 24.9kg/m2(WHO)
Age from 21 to 60 years.
All genders.
Work hour of minimum 40 hrs/wk.
Only desktop workers. 
 
ExclusionCriteria 
Details  Acute shoulder injuries (less than 3 month).
Past shoulder injuries like fracture, rotator cuff tear or repair.
Carpal tunnel syndrome.
Cervical radiculopathy.
After shoulder arthroplasty surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Shoulder range of motion using digital inclinometer.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Upper extremity functional index-15  baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   25/07/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

BRIEF RESUME OF THE INTENDED WORK

Need for the study

Musculoskeletal pain has become  a common  concern   among   desktop workers who work  in  a   static   position  for  prolonged   periods  thereby    putting  a load  on  soft tissue structures in and   around  the shoulder  joint   leading to loss of  mobility  of   the joint   thus reducing  their  work  efficiency.  Glenohumeral  joint  is   intrinsically unsteady, hence the stability depends heavily on  the soft tissues of the shoulder. It   has been   reported that    the limited   ROM is  due  to tightness  of  shoulder  tissues which  causing functional  limitation in workplace and  day-to-day activities  due  to shoulder Impingement  and  shoulder  labrum lesion.  Using  a keyboard for  4-6 hours daily at work elevates  the  neck and  shoulder  pain by four times  compared  to  minimal users, which  leads to ischemic  cumulative injuries linked  to biochemical  process like  the  conversion of  xanthie dehydrogenase  to xanthine oxidase thereby  reducing mobility.The  shoulder  mobility  is   assessed   using  digital inclinometer  which    has moderate to excellent   reliability. The  effect   of   scapular dysfunction  has  been  studied  in  this  population  and  it  has  been found  that   dyskinesia results in  reduced functional outcome.5 However,  there  is  lack  of  evidence  studying  the effect  of  shoulder  mobility   in functional outcomes among desktop workers.

 

RESEARCH QUESTION: Does shoulder mobility affect functional activity in desktop workers?

ALTERNATE HYPOTHESIS (H1): Shoulder mobility has an effect on functional activity in desktop workers.

NULL HYPOTHESIS (H0):  Shoulder Mobility does not have an effect on functional activity in desktop workers.

 

Review of literature

 Chinedu  et al conducted   a  cross   sectional  study   on   work-related   musculoskeletal disorders among office workers in higher educational institutions. The main aim of this study to know the frequency of musculoskeletal  disorders  in various  higher educational  institutions. Following   the  screening   process  for  inclusion  and  exclusion  criteria, 217  office  workers  were   successfully  enrolled  in   the  study. Musculoskeletal  disorders  among  this population were   assessed  using  the  standardized  Nordic Questionnaire. This  study  found  that  there  are  50.2%  musculoskeletal  problems  in  the  shoulder  with  significant  positive  relationship with  posture,  sustained  posture,  inappropriate   furniture  and   inadequate  rest   breaks. This study  concluded  that  shoulder  is  a  third  most common body part having high prevalence of musculoskeletal problems among this population. 

 

Esmaeilzadeh et al7  conducted   a  randomized   controlled  trial  on  effect  of  ergonomic  intervention  on  work-related   upper  extremity  musculoskeletal  disorders  among  computer workers.The aim of  the study is to  investigate  how  ergonomic  interventions  affect   the occurrence  of   work-related   upper  extremity  musculoskeletal  disorders  among  individuals who   work  with  computers.  In   this  study  94  subjects  were   screened   for  inclusion  and    exclusion   criteria. Randomization  was  done  and  divided  the  group  into  intervention  and  control  group. For control  group,workstation evaluation, comprehensive   ergonomic training, ergonomics  training brochure  are given. Participants  assigned  to  the  control  group did  not partake  in  any  intervention  program   throughout  the   study  period. Musculoskeletal-assessment   is   taken  through   modified  Nordic  Musculoskeletal  Questionnaire  and  upper extremity   function  is  assessed   by  using  upper extremity  functional scale. The  study  had  shown   that  in  the  intervention  group  the  posture,scale. The study work station layout was improved  after 6 months and functional limitation was reduced.

 

Tozzo et al  was  conducted  a  study  on  inclinometer  reliability for shoulder ranges of  motion  in  individuals  with  subacromial  impingement syndrome. The primary  objective of  the  study  is  to  investigate  the  reliability of  both   intra  and inter-rater  assessments of active  and  passive  shoulder  range of  motion  among individuals with  subacromial impingement syndrome,  utilizing  a  digital inclinometer.  The  study involved   50  individuals   diagnosed  with  unilateral subacromial  impingement syndrome,and   the  assessment  of  shoulder   range  of motion conducted  using a digital inclinometer. The   reliability  of   interrater  ranged   from   moderate   to   excellent (ICC2,3 = 0.50-0.95), and    intrarater   it   ranged   from   good   to   excellent (ICC2,3 = 0.74-0.94).  The    digital inclinometer   showed   moderate   to   excellent   reliability   in  assessing  both passive  and active   range  of   motion   in  shoulders  affected  by  unilateral  subacromial  impingement syndrome.

 

AIM OF THE STUDY: To  evaluate  the  shoulder  complex mobility and  the  functional  limitation of the upper limb in desktop workers.

 

OBJECTIVE OF THE STUDY: The  primary  objective  is  to assess  the  shoulder complex mobility using “digital inclinometer” in desktop workers. Secondary objective to correlate the severity of functional limitation using “upper extremity functional index” with mobility the shoulder complex.

 

 

MATERIALS AND METHODS

 

STUDY SETTING: Father Muller Charitable Institutions

STUDY SUBJECTS/PARTICIPANTS: Office/desktop workers

 METHODS OF DATA COLLECTION

STUDY DESIGN: A cross sectional study

STUDY DURATION: 1 year

SAMPLE SIZE CALCULATION: Will be calculated after a pilot study 

 

 OUTCOME MEASURES:

 Upper  extremity  functional  index-15,  which  gives  the  scoring  for  the upper extremity function. The scale contains 15 questions and each question scores are categorized as quite a bit  of difficulty (=1) and moderate difficulty (=2), a  little  bit  of difficulty (=3) and   no difficulty  (=4). Raw  total  scores  (0 =worst state; 59 = best state),  are  transformed   to generate an interval-level total score (0 = worst state;100 = best state).

 

MATERIALS REQUIRED:

Chair

Bed

Digital inclinometer

Data collection sheet

Informed consent form

 

PROCEDURE:

The ethical clearance has been  obtained from the Father Muller Institutional Ethics Committee. Written  informed  consent will  be obtained from  the office/desktop  workers. Subjects will be screened  based  on inclusion and exclusion  criteria. The participants will be explained about    range  of  motion  measurement  procedure using  digital inclinometer. The all the data will be    filled  in  the data collection sheet. The upper  extremity functional index questionnaire will be given, and  participants will  be asked to fill it. The  range of  motion will  then  be compared         with the functional outcome using statistical analysis.

 

STATISTICAL ANALYSIS:

Data  will  be collected  and  analyzed  using  SPSS software, with calculations including  mean, standard deviation, and Karl Pearson correlation.

 

IMPLICATION OF THE STUDY: This study will provide an insight on the effect of prolong working  hour on  shoulder  mobility in desktop workers thereby helping them  to improve the mobility in order to enhance the functional ability.

 
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