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Back Pain in Medical Students at The University of the West Indies, Mona, Jamaica

Primary Purpose

Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Jamaica
Study Type
Interventional
Intervention
Spine Exercise Program
Sponsored by
The University of The West Indies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Back Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. All second and forth/fifth year students enrolled in the medical program at UWI, Jamaica during the period September 7, 2015 to November 2, 2015.
  2. Willingness to consent to the study.
  3. Preclinical medical students' willingness to adhere to standardized exercise program for the stipulated period.

Exclusion Criteria:

  1. History of having spine surgery
  2. Previously diagnosed with spine pathology and currently receiving rehabilitation therapy.
  3. Unwillingness to participate in study

Sites / Locations

  • Faculty of Medical Sciences Teaching and Research Complex,The University of the West Indies, University Hospital of the West Indies

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Spine exercise program

Arm Description

The preclinical second year medical students will be prospectively randomized into two (2) groups, a control group (Group A) and an intervention group (Group B) that will be given a standardized spine exercise program. They will be asked to complete a Questionnaire B to evaluate changes in knowledge, attitude and practice towards musculoskeletal problem of the back and neck pain after intervention; the numeric rating scale (NRS), and the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) at eight (8) weeks. The standardized spine exercise program will be provided in a handout and given only to the intervention Group B subjects, these are basic low back exercises to be done three (3) times per week for 20mins, as well as a few very brief stretching exercises to be done during periods of sitting for greater than sixty (60) minutes.

Outcomes

Primary Outcome Measures

To assess the change of Cornell Musculoskeletal Discomfort Questionnaire CMDQ
The Cornell Musculoskeletal Discomfort Questionnaire is an outcome measure used widely when examining musculoskeletal disorders in various occupational groups and students alike.The Cornell Musculoskeletal Discomfort Questionnaire was taken from the instruments provided by Human Factors and Ergonomics Laboratory at Cornell University. It is from public domains and permission for its use is not required.

Secondary Outcome Measures

To assess the change in Questionnaire A
It is a self-administered general questionnaire used to evaluate knowledge, attitude and practice towards musculoskeletal problem of back pain.
To assess the change in Questionnaire B
Questionnaire B will be used to evaluate changes in knowledge, attitude and practice towards musculoskeletal problem of the back after intervention
To assess the change in Numeric Rating Scale
The Numeric Rating Scale is an 11-point scale for patient self reporting of pain. It is from public domains and permission for its use is not required.

Full Information

First Posted
October 10, 2018
Last Updated
October 15, 2018
Sponsor
The University of The West Indies
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1. Study Identification

Unique Protocol Identification Number
NCT03707288
Brief Title
Back Pain in Medical Students at The University of the West Indies, Mona, Jamaica
Official Title
Back Pain in Preclinical and Clinical Medical Students at The University of the West Indies, Mona, Jamaica
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of The West Indies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to identify the prevalence of back pain in preclinical second year and clinical fourth/fifth year medical students at the University of the West Indies; to assess their knowledge, attitude and practice of good spine health; and to determine the outcome of a standardize spine exercise program on one group, the clinical second year medical students, using a prospective randomized control design.
Detailed Description
There is a surfeit of literature on musculoskeletal pain especially that of back pain, which are commonly associated with lifestyle practices including varied occupations that affect individuals of all ages. Medical students in the clinical years of training are more likely to be involved in strenuous activities such as prolonged standing for ward rounds, bending forward to examine patients and sometimes being engaged in manual handling of patients, as compared to medical students in the preclinical years. During the early period of preclinical training, medical students primarily sit for extended periods in lectures, use computers or tablets, or in the library, studying and completing assignments. These practices can all be attributable to the increased risk of developing low back among other musculoskeletal problems; especially in instances where the strength and stability of the spine is not maintained and safe spine precautions are not done. There is no published study in Jamaica or to the researcher's knowledge in the Caribbean which looks at the prevalence of musculoskeletal pain, specifically low back pain in medical students. This study is to determine the prevalence of low back pain in second and fourth/fifth year medical students at the University of the West Indies (UWI); assess their knowledge, attitude and practice toward good spine health in preventing back and neck pain; and using a prospective randomized control study model, evaluate the outcome of a standardized spine exercise program on back pain in the preclinical second year medical students over an eight (8) week period from September 7, 2015 to November 2, 2015. Both groups will be followed up over the stipulated period. The identity of all participants will be protected and will only be identified by an assigned study number. Basic demographics, presenting complaints and outcome information will be obtained for the purposes of the study. Questionnaires will be carefully constructed from the objectives of the study to determine the presence of back and neck pain in the medical students and their knowledge, attitude and practice towards the musculoskeletal problem of the back.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spine exercise program
Arm Type
Other
Arm Description
The preclinical second year medical students will be prospectively randomized into two (2) groups, a control group (Group A) and an intervention group (Group B) that will be given a standardized spine exercise program. They will be asked to complete a Questionnaire B to evaluate changes in knowledge, attitude and practice towards musculoskeletal problem of the back and neck pain after intervention; the numeric rating scale (NRS), and the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) at eight (8) weeks. The standardized spine exercise program will be provided in a handout and given only to the intervention Group B subjects, these are basic low back exercises to be done three (3) times per week for 20mins, as well as a few very brief stretching exercises to be done during periods of sitting for greater than sixty (60) minutes.
Intervention Type
Other
Intervention Name(s)
Spine Exercise Program
Other Intervention Name(s)
Desk stretches
Intervention Description
Spine exercises should be done 20 minutes/ 3 days per week Desk stretches should be done when exposed to prolonged sitting for greater than 60 mins
Primary Outcome Measure Information:
Title
To assess the change of Cornell Musculoskeletal Discomfort Questionnaire CMDQ
Description
The Cornell Musculoskeletal Discomfort Questionnaire is an outcome measure used widely when examining musculoskeletal disorders in various occupational groups and students alike.The Cornell Musculoskeletal Discomfort Questionnaire was taken from the instruments provided by Human Factors and Ergonomics Laboratory at Cornell University. It is from public domains and permission for its use is not required.
Time Frame
Change of CMDQ at 8 weeks
Secondary Outcome Measure Information:
Title
To assess the change in Questionnaire A
Description
It is a self-administered general questionnaire used to evaluate knowledge, attitude and practice towards musculoskeletal problem of back pain.
Time Frame
Change in Questionnaire A at 8 weeks
Title
To assess the change in Questionnaire B
Description
Questionnaire B will be used to evaluate changes in knowledge, attitude and practice towards musculoskeletal problem of the back after intervention
Time Frame
Change in Questionnaire B at 8 weeks
Title
To assess the change in Numeric Rating Scale
Description
The Numeric Rating Scale is an 11-point scale for patient self reporting of pain. It is from public domains and permission for its use is not required.
Time Frame
Change in Numeric Rating Scale at 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All second and forth/fifth year students enrolled in the medical program at UWI, Jamaica during the period September 7, 2015 to November 2, 2015. Willingness to consent to the study. Preclinical medical students' willingness to adhere to standardized exercise program for the stipulated period. Exclusion Criteria: History of having spine surgery Previously diagnosed with spine pathology and currently receiving rehabilitation therapy. Unwillingness to participate in study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paula UA Dawson, MBBS
Phone
1-876-927-1297
Ext
8049
Email
paula.dawson@uwimona.edu.jm
First Name & Middle Initial & Last Name or Official Title & Degree
Rishika V Banhan-Chin, MBBS
Phone
1-876-927-1660-9
Ext
8050
Email
rishika.banhan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula UA Dawson, MBBS
Organizational Affiliation
Division of Physical Medicine and Rehabilitation, Faculty of Medical Sciences, The University of the West Indies, Mona, Jamaica.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maxim US Christmas, DM (Ortho)
Organizational Affiliation
Division of Orthopaedics, Department of Surgery, Radiology, Anaesthesia and Intensive Care. University Hospital of the West Indies, Kingston 7, Jamaica.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medical Sciences Teaching and Research Complex,The University of the West Indies, University Hospital of the West Indies
City
Kingston
ZIP/Postal Code
JMAAW15
Country
Jamaica
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula UA Dawson, MBBS
Phone
1-876-927-1297
Ext
8049
Email
paula.dawson@uwimona.edu.jm
First Name & Middle Initial & Last Name & Degree
Rishika V Banhan-Chin, MBBS
Phone
1-876-927-1660-9
Ext
8050
Email
rishika.banhan@gmail.com

12. IPD Sharing Statement

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Back Pain in Medical Students at The University of the West Indies, Mona, Jamaica

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