NCT03707288

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Oct 2018Dec 2026

Study Start

First participant enrolled

October 1, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2026

Expected
Last Updated

September 10, 2025

Status Verified

July 1, 2025

Enrollment Period

7.3 years

First QC Date

October 10, 2018

Last Update Submit

September 3, 2025

Conditions

Keywords

lower back painlow back painneck painneck and back painspine healthmedical studentsuniversity studentsmusculoskeletal pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of treatment at eight (8) weeks

Secondary Outcomes (3)

  • Knowledge, Attitude and Practice towards Musculoskeletal Problems of Neck and Low back Pain (Questionnaire A)

    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)

    From Enrollment to the end of treatment at 8 weeks

  • Change from Baseline in the Numeric Rating Scale (NRS)

    From Enrollment to the end of treatment at 8 weeks

Study Arms (2)

Clinical Control (Group A)

OTHER

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)

Spine Exercise Program (Group B)

OTHER

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)

Interventions

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.

Clinical Control (Group A)

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.

Spine Exercise Program (Group B)

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsCisgender males and females
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All students enrolled in the medical program at the University of the West Indies, Mona Campus, Jamaica during the period October 1, 2018 to January 2, 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Kingston, Kingston, JMAAW15, Jamaica

NOT YET RECRUITING

Faculty of Medical Sciences Teaching and Research Complex, University of The West Indies-Mona Campus

Kingston, Jamaica

RECRUITING

Related Publications (13)

  • Ehrlich GE. Low back pain. Bull World Health Organ. 2003;81(9):671-6. Epub 2003 Nov 14.

    PMID: 14710509BACKGROUND
  • 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.

    PMID: 16299708BACKGROUND
  • 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.

    PMID: 16736200BACKGROUND
  • 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.

    PMID: 16639985BACKGROUND
  • Falavigna A, Teles AR, Mazzocchin T, de Braga GL, Kleber FD, Barreto F, Santin JT, Barazzetti D, Lazzaretti L, Steiner B, Beckenkamp NL. Increased prevalence of low back pain among physiotherapy students compared to medical students. Eur Spine J. 2011 Mar;20(3):500-5. doi: 10.1007/s00586-010-1646-9. Epub 2010 Dec 7.

    PMID: 21136121BACKGROUND
  • 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.

    PMID: 23815853BACKGROUND
  • 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.

    PMID: 15615575BACKGROUND
  • 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.

    PMID: 20416101BACKGROUND
  • 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.

    PMID: 19473172BACKGROUND
  • 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.

    PMID: 17909210BACKGROUND
  • 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.

    PMID: 9431633BACKGROUND
  • 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.

    PMID: 2954190BACKGROUND
  • 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.

    PMID: 10744172BACKGROUND

MeSH Terms

Conditions

Back PainLow Back PainNeck PainMusculoskeletal PainCollagen Diseases

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula U. A. Dawson, MBBS, Diplomate ABPMR

CONTACT

Shantelle B Peddlar, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Physical Medicine and Rehabilitation. Principal Investigator

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 16, 2018

Study Start

October 1, 2018

Primary Completion

January 2, 2026

Study Completion (Estimated)

December 2, 2026

Last Updated

September 10, 2025

Record last verified: 2025-07

Locations