- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07167888
- Original Trial
Low Back and Neck Pain in Nursing Students at The University of The West Indies
The Prevalence of Neck and Low Back Pain With a Randomised Controlled Trial Comparing Spine-Specific and Non-Spine Specific Exercise Interventions in Nursing Students at The University of the West Indies, Mona: A Two-Phase Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neck and low back pain are among the most common musculoskeletal conditions worldwide. Although often self-limiting, these conditions can become disabling, negatively affecting productivity, social participation, and activities of daily living. Occupational factors, prolonged sitting, sustained computer use, awkward postures, and repetitive neck movements are recognised contributors to spinal pain. Nursing students are particularly vulnerable to musculoskeletal disorders, with risk beginning during their training years. During the preclinical phase, students spend prolonged periods attending lectures, studying, and completing assignments, often involving sustained sitting and computer use. In the clinical phase, students are exposed to physically demanding tasks such as prolonged standing, ward rounds, assisting with procedures, and manual patient handling, including lifting and repositioning patients. These activities, combined with poor ergonomic practices and reduced core stability, may contribute to the development of neck and low back pain. International studies have reported a high prevalence of musculoskeletal pain among nursing and medical students, particularly during clinical training. Factors such as increased computer use, elevated body mass index, prior trauma, and family history of musculoskeletal disorders have been identified as contributing risk factors. However, no published study has investigated the prevalence of neck and low back pain among nursing students in Jamaica or the wider Caribbean. Exercise therapy is widely recognised as an effective non-pharmacologic intervention for both acute and chronic low back pain, with evidence showing improvements in pain reduction and functional outcomes. Exercise enhances muscular strength, flexibility, and spinal stability, while promoting nutrient exchange within spinal structures, supporting overall spinal health and reducing the risk of injury. This study aims to determine the prevalence of neck and low back pain among nursing students at The University of the West Indies, Mona, and to compare the effectiveness of a standardized spine-specific exercise programme versus non-spine-specific exercises in reducing pain and improving knowledge, attitudes, and practices related to spinal health. It will be conducted in two phases and guided by a descriptive and experimental framework. In the first phase, the descriptive phase, a cross-sectional design will be used to assess the prevalence of neck and low back pain (NLBP) among all year groups of nursing students at The University of the West Indies, Mona. The University of the West Indies, Mona, currently enrolls approximately 400 nursing students across four years of training. Participants will complete questionnaires to determine the presence of musculoskeletal discomfort in the neck and low back pain, as well as their knowledge, attitude, and practice related to spine health. In the second phase, the experimental phase, nursing students who report musculoskeletal discomfort will be randomised into intervention and control groups. The intervention group will participate in an eight-week spine-specific exercise program, while the control group will receive a non-spine specific exercise in parallel during the study period. Pre- and post-intervention data will be collected using the Numeric Rating Scale (NRS), the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), and custom questionnaires (Questionnaires A & B) to assess changes in assessing knowledge, attitudes and practices toward musculoskeletal health, changes in perceived pain and participants' functional status.
Participant confidentiality will be strictly maintained, with each participant assigned a study identification number. Demographic data, presenting complaints, and outcome measures will be collected for study purposes and managed securely using REDCap, a password-protected, web-based platform compliant with national data protection standards. Statistical analysis will be conducted using the International Business Machines Corporation Statistical Product and Service Solutions (IBM SPSS software), and all study records will be securely stored and destroyed three years after study completion.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shantelle B Peddlar, MBBS
- Phone Number: 8050 1-876-927-1297
- Email: pmrphysiatryclinic@gmail.com
Study Contact Backup
- Name: Paula U. A. Dawson, MBBS, Diplomate ABPMR
- Phone Number: Ext. 8049 1-876-927-1297
- Email: paula.dawson@uwimona.edu.jm
Study Locations
-
-
-
Kingston, Jamaica
- Faculty of Medical Sciences Teaching and Research Complex, University of The West Indies-Mona Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All students enrolled in the student nursing program at the University of the West Indies, Mona Campus, Jamaica during the period October 4, 2025 to October 3, 2026.
- Individuals who express a willingness to consent to the study.
- Individuals who express a willingness to adhere to the standardised exercise program for the stipulated period.
Exclusion Criteria:
- Individuals with a history of having spine surgery.
- Individuals who were previously diagnosed with spine pathology and currently receiving rehabilitation therapy.
- Individuals who express an unwillingness to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spine Exercise Program (Group B)
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-specific exercise program over an eight (8) week period, after which time they will be 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.
|
The standardised spine-specific exercise program will be provided in a handout and given only to the intervention group (Group B), and will include specific spine 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 and referred for evaluation and treatment if necessary.
|
|
Experimental: Clinical Control (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 A will be given a non-spine specific exercise program 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.
|
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 receive a non-spine specific exercise program provided in a handout.
The interventional group (Group B) will be asked to keep the standardised spine-specific 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)
Time Frame: From enrollment to the end of treatment at eight (8) weeks
|
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.
|
From enrollment to the end of treatment at eight (8) weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Numeric Rating Scale (NRS)
Time Frame: From Enrollment to the end of treatment at 8 weeks
|
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.
|
From Enrollment to the end of treatment at 8 weeks
|
|
Knowledge, Attitude and Practice towards Musculoskeletal Problems of Neck and Low back Pain (Questionnaire A)
Time Frame: Done at the time of enrollment (Baseline)
|
Questionnaire A is a self-administered general questionnaire used to evaluate participants' knowledge, attitudes, and practices regarding musculoskeletal problems of the neck and low back.
Knowledge is scored on a scale of 0-5, with 0-1 indicating poor or inadequate knowledge, 2-3 indicating moderate knowledge, and 4-5 indicating good or adequate knowledge.
Attitude is scored 0-4, with 0-1 representing poor attitude, 2-3 moderate attitude, and 4 good attitude.
Practice is scored 0-56, based on 12 questions, with 0-12 indicating poor or inadequate practices, 13-24 below average or fair, 25-32 average or moderate, 33-43 above average or good, and 44-56 excellent practices.
Higher scores indicate better knowledge, more positive attitudes, and healthier practices related to neck and low back musculoskeletal problems.
The questionnaire is administered at baseline (time of enrolment), and each domain will be analysed separately.
|
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)
Time Frame: From Enrollment to the end of treatment at 8 weeks
|
Questionnaire B is a self-administered general questionnaire used to evaluate participants' knowledge, attitudes, and practices regarding musculoskeletal problems of the neck and low back.
Knowledge is scored on a scale of 0-5, with 0-1 indicating poor or inadequate knowledge, 2-3 indicating moderate knowledge, and 4-5 indicating good or adequate knowledge.
Attitude is scored 0-4, with 0-1 representing poor attitude, 2-3 moderate attitude, and 4 good attitude.
Practice is scored 0-56, based on 12 questions, with 0-12 indicating poor or inadequate practices, 13-24 below average or fair, 25-32 average or moderate, 33-43 above average or good, and 44-56 excellent practices.
Higher scores indicate better knowledge, more positive attitudes, and healthier practices related to neck and low back musculoskeletal problems.
The questionnaire is administered at the end of treatment at 8 weeks, and each domain will be analysed separately.
|
From Enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Paula U.A Dawson, MBBS, Diplomate ABPMR, Division of Physical Medicine and Rehabilitation, Faculty of Medical Sciences, The University of the West Indies, Mona, Jamaica.
Publications and helpful links
General Publications
- O'Sullivan PB, Phyty GD, Twomey LT, Allison GT. Evaluation of specific stabilizing exercise in the treatment of chronic low back pain with radiologic diagnosis of spondylolysis or spondylolisthesis. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2959-67. doi: 10.1097/00007632-199712150-00020.
- Ariens GA, van Mechelen W, Bongers PM, Bouter LM, van der Wal G. Physical risk factors for neck pain. Scand J Work Environ Health. 2000 Feb;26(1):7-19. doi: 10.5271/sjweh.504.
- Mandel JH, Lohman W. Low back pain in nurses: the relative importance of medical history, work factors, exercise, and demographics. Res Nurs Health. 1987 Jun;10(3):165-70. doi: 10.1002/nur.4770100308.
- Lumbar/Core Strength and Stability Exercise. Athlethic Medicine.
- Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. doi: 10.7326/0003-4819-147-7-200710020-00007.
- Smith DR, Leggat PA, Walsh LJ. Workplace hazards among Australian dental students. Aust Dent J. 2009 Jun;54(2):186-8. doi: 10.1111/j.1834-7819.2009.01116_8.x. No abstract available.
- Lorusso A, Vimercati L, L'abbate N. Musculoskeletal complaints among Italian X-ray technology students: a cross-sectional questionnaire survey. BMC Res Notes. 2010 Apr 24;3:114. doi: 10.1186/1756-0500-3-114.
- Smith DR, Leggat PA. Musculoskeletal disorders among rural Australian nursing students. Aust J Rural Health. 2004 Dec;12(6):241-5. doi: 10.1111/j.1440-1854.2004.00620.x.
- Alshagga MA, Nimer AR, Yan LP, Ibrahim IA, Al-Ghamdi SS, Radman Al-Dubai SA. Prevalence and factors associated with neck, shoulder and low back pains among medical students in a Malaysian Medical College. BMC Res Notes. 2013 Jul 1;6:244. doi: 10.1186/1756-0500-6-244.
- Solomon A, Wilson S, Meyer M, Sharma N. Prevalence of low back pain among nursing students compared to physical therapy students. International Journal of Nursing Education9(3):115, Jan 2017.
- Smith DR, Wei N, Ishitake T, Wang RS. Musculoskeletal disorders among Chinese medical students. Kurume Med J. 2005;52(4):139-46. doi: 10.2739/kurumemedj.52.139.
- Lis AM, Black KM, Korn H, Nordin M. Association between sitting and occupational LBP. Eur Spine J. 2007 Feb;16(2):283-98. doi: 10.1007/s00586-006-0143-7. Epub 2006 May 31.
- Punnett L, Pruss-Utun A, Nelson DI, Fingerhut MA, Leigh J, Tak S, Phillips S. Estimating the global burden of low back pain attributable to combined occupational exposures. Am J Ind Med. 2005 Dec;48(6):459-69. doi: 10.1002/ajim.20232.
- Ehrlich GE. Low back pain. Bull World Health Organ. 2003;81(9):671-6. Epub 2003 Nov 14.
- Erdinc O HK, Ozkaya M. CROSS-CULTURAL ADAPTATION,VALIDITY AND RELIABILITY OFCORNELL MUSCULOSKELETAL DISCOMFORT QUESTIONNAIRE (CMDQ) IN TURKISH LANGUAGE. 2008.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREC-MN.0192,2024/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lower Back Pain
-
Adia Med of Winter Park LLCRecruitingLower Back Pain | Chronic Lower Back Pain | Chronic Mechanical Lower Back PainUnited States
-
University of MichiganRecruiting
-
AppliedVR Inc.Completed
-
Canandaigua VA Medical CenterFoot Levelers, Inc.; Northeast College of Health SciencesTerminatedBack Pain Lower Back ChronicUnited States
-
Clinique de la Côte d'EmeraudeNot yet recruiting
-
University of MichiganUnited States Department of DefenseRecruiting
-
Texas Back InstituteRecruitingChronic Lower Back PainUnited States
-
New York Institute of TechnologyRecruitingChronic Lower Back PainUnited States
-
National Taiwan University Hospital Hsin-Chu BranchUnknownConditions for Lower Back Pain Working Nurse
-
Neuronoff, IncOhio Pain ClinicCompletedChronic Pain | Lower Back Pain ChronicUnited States
Clinical Trials on Spine Exercise Program (Group B)
-
The University of The West IndiesThe University of The West Indies, MonaNot yet recruitingBack Pain | Low Back Pain | Musculoskeletal Pain | Neck Pain | Rehabilitation | Physical Therapy | Physiotherapy | Physiotherapist Students | Spine HealthJamaica
-
The University of The West IndiesThe University of The West Indies, MonaNot yet recruitingBack Pain | Low Back Pain | Musculoskeletal Pain | Neck Pain | Work Related Illnesses | Spine | Work Related Musculoskeletal DisordersJamaica
-
The University of The West IndiesThe University of The West Indies, MonaRecruitingLower Back Pain | Back Pain | Low Back Pain | Musculoskeletal Pain | Neck Pain | Musculoskeletal Pain Disorder | Neck Pain Musculoskeletal | Spine HealthJamaica
-
National Taiwan University HospitalCompletedNeuropathic Pain | Degenerative Lumbar DiseaseTaiwan
-
University of West AtticaActive, not recruitingKnee Osteoarthritis | Telerehabilitation | Knee Osteoarthritis \(OA\)Greece
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
Istanbul University - Cerrahpasa (IUC)RecruitingMultiple SclerosisTurkey
-
Chang Gung Memorial HospitalCompleted
-
Rosimeire Simprini PadulaUnknownMusculoskeletal Disorder of the NeckBrazil
-
Universidad Politecnica de MadridUnknown