An interventional study of Clinical Control Group (Group A) and Spine Exercise Program (Group B) in Back Pain, Low Back Pain and Neck Pain, sponsored by The University of The West Indies. Recruiting at 2 sites in Jamaica. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by The University of The West Indies · Not applicable, Interventional, and Prevention
The purpose of this study is to identify the prevalence of neck and low back pain in medical students enrolled at the University of the West Indies, Mona; to assess their knowledge, attitude and practice of good spine health and to determine the outcome of a standardised spine exercise program on medical students experiencing neck and low back pain, using a prospective randomised control design.
There is a surfeit of literature on musculoskeletal pain especially that of neck and low 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 prolonged and strenuous activities such as standing during ward rounds, bending forward to examine patients and occasionally engaging in manual handling of patients. During the early phase of preclinical training, medical students primarily sit for extended periods in lectures, use computers or tablets, or study in the library while completing assignments. These practices may all contribute to the increased risk of developing neck and low back pain among other musculoskeletal problems, especially in instances where the strength and stability of the spine is not maintained and safe spine precautions are not taken.
To the researcher's knowledge, there is no published study in Jamaica, or in the wider Caribbean, which looks at the prevalence of musculoskeletal pain -- specifically neck and low back pain in medical students. This study aims to determine the prevalence of neck and low back pain in medical students at the University of the West Indies (UWI), Mona, as well as to assess their knowledge, attitude and practice toward good spine health in preventing neck and low back pain.
Using a prospective randomised control study model for students experiencing neck and low back pain, this study will evaluate the outcome of a standardised spine exercise program in participants over an eight (8) week period. These participants will be randomly assigned to the clinical control group (Group A), which will receive no intervention, or the intervention group (Group B), which will follow a standardised spine exercise program over the stipulated period. Data will be collected using Questionnaires A and B, the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), and the Numeric Rating Scale (NRS). The outcomes of both groups will then be compared to determine the program's effectiveness in reducing discomfort and promoting better knowledge, attitude and practice towards spine health among medical students.
The identity of all participants will be protected and will only be identified by an assigned study number. Basic demographic information, presenting complaints and outcome information will be obtained for the purposes of the study. All data will be managed securely using REDCap, a password-protected, web-based platform compliant with national data protection standards. Data exported for analysis will be handled using SPSS software, ensuring confidentiality is maintained throughout. All records will be securely destroyed three years after study completion.
Exclusion Criteria:
All participants will complete the Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) to assess the frequency, discomfort and interference with work due to musculoskeletal pain; the Numeric Rating Scale (NRS) to assess for perceived pain; as well as Questionnaire A to assess their knowledge, attitude and practice towards musculoskeletal problems of neck or low back pain. Participants who are found to have neck or low back pain will be randomised into two (2) groups: a clinical control group (Group A) and an intervention group (Group B). Group A will not be given any exercise programs over an eight (8) week period after which time, participants will be reassessed using the CMDQ and NRS, as well as a Questionnaire B to evaluate for changes in their knowledge, attitude and practice towards musculoskeletal problems of the neck and low back pain, without having received any intervention.
Behavioral: Clinical Control Group (Group A)
All participants will complete the Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) to assess the frequency, discomfort and interference with work due to musculoskeletal pain; the Numeric Rating Scale (NRS) to assess for perceived pain; as well as Questionnaire A to assess their knowledge, attitude and practice towards musculoskeletal problems of neck or low back pain. Participants who are found to have neck or low back pain will be randomised into two (2) groups: a clinical control group (Group A) and an intervention group (Group B). Group B will be given a standardised spine exercise program over an eight (8) week period, after which time they will be reassessed using the CMDQ and NRS, as well as Questionnaire B to evaluate for changes in their knowledge, attitude and practice towards musculoskeletal problems of the neck and low back pain, having received the intervention.
Behavioral: Spine Exercise Program (Group B)
The participants who reported the presence of neck or low back pain and were assigned to the clinical control group (Group A) after randomisation will not receive the intervention of an exercise program. The interventional group (Group B) will be asked to keep the standardised exercise program confidential and not share with the control group (Group A). After eight (8) weeks, Group A participants will receive: the Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) to assess for changes in the frequency, discomfort and interference with work due to musculoskeletal pain; a Questionnaire B, to ascertain any changes in their pain level using the Numeric Rating Scale (NRS); as well as their knowledge, attitude and practice towards musculoskeletal problems of the neck and low back pain, without having received any intervention.
The standardised spine exercise program will be provided in a handout and given only to the intervention group (Group B), and will include simple basic neck or low back exercises to be done three (3) times per week, as well as brief stretching exercises, to be done during periods of sitting for greater than sixty (60) minutes. The selected participants will be asked to comply with instructions on the handout. Participants who experience worsening of their symptoms, or who develop new symptoms will be assessed as having an adverse outcome and will be withdrawn from the study.
Change from Baseline in the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)
The Cornell Musculoskeletal Discomfort Questionnaire measures the frequency, discomfort and interference with work due to musculoskeletal pain, as reported by participants. The individually reported frequency score is then multiplied by the discomfort score and by the interference score to determine overall severity of pain experienced. This tallied score is then classified by severity into: no discomfort (0), mild (1 to 4.5), moderate (5 to 14), severe (15 - 45) and very severe (45 or higher). All participants will complete this assessment upon enrollment, as well as after an eight (8) week period of treatment, to evaluate any changes in their reported scores.
Time frame: From enrollment to the end of treatment at eight (8) weeks
Knowledge, Attitude and Practice towards Musculoskeletal Problems of Neck and Low back Pain (Questionnaire A)
Questionnaire A is a self-administered general questionnaire used to evaluate knowledge, attitude and practice towards musculoskeletal problems of neck and low back pain.
Time frame: Done at the time of enrollment (Baseline)
Change from Baseline in Knowledge, Attitude and Practice Towards Musculoskeletal Problems of Neck and Low Back Pain (Questionnaire B)
Questionnaire B is a self-administered general questionnaire used to evaluate changes in knowledge, attitude and practice towards musculoskeletal problems of neck and low back pain.
Time frame: From Enrollment to the end of treatment at 8 weeks
Change from Baseline in the Numeric Rating Scale (NRS)
The Numeric Rating Scale is a reliable and valid, unidimensional 11-point scale used for patient self-reporting of perceived pain. Its scale uses integers which range from zero (0) to ten (10), where 0 represents no pain, and 10 represents the worst imaginable pain. This is then categorised into mild (1-3), moderate (4-6), and severe (7-10). All participants will complete this assessment upon enrollment, as well as after an eight (8) week period of treatment, to evaluate any changes in their perceived pain. This scale is from public domains and as such, permission for its use is not required.
Time frame: From Enrollment to the end of treatment at 8 weeks
Plan to share: Undecided
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The University of The West Indies