NCT03678922

Brief Summary

Musculoskeletal (MSK) pain in adolescents is much more persistent than commonly appreciated. It has previously been described as a self-limiting condition, but several studies indicate otherwise. In a cohort study of 564 11-year olds with weekly MSK pain, 50% of the participants still reported pain after one year. Prospective cohort studies of adults in general practice show that 16-32% of patients with knee pain still have pain after a year. In accordance with this, Kastelein et al. found that 21% of 12 to 35-year-old patients had knee pain six years after initial general practitioner (GP) contact. Collectively, these studies highlight that a significant proportion of adolescents will continue to report pain even years after the initial onset of pain. Can the adolescents with a high risk of MSK pain at follow-up be investigated? Our recent systematic review on children and adolescents with MSK pain indicates that female sex, depression, anxiety, and parental pain are associated with a higher risk of MSK pain at follow-up. However, the validity of these prognostic factors may be questioned as they have been tested in single cohorts and not validated in new external cohorts. Moreover, in accordance with our results, other studies identify emotional problems, psychological symptoms, and frequent exercise associated to a higher risk of MSK pain at follow-up. Given the paucity of high-quality evidence for prognostic factors in childhood and adolescent MSK pain, robust studies are needed to further explore prognostic factors in this population. The investigators want to follow up on this need and conduct a cohort study with a similar aim as in their review; to investigate prognosis in youth MSK pain. In this cohort study, the investigators will limit their participant group to those who are 8-19 years old, because the participants have to be able to provide self-reported data on a questionnaire. Participants aged 0-7 years will not be included as they will have difficulties in doing so and because they i) only represent 2% of all patients consulting GPs in Denmark, with a musculoskeletal complaint and ii) were sparsely represented in our systematic review which included a total of 23.933 patients. At present we lack age-specific prognostic factors in adolescents with MSK pain, although multiple prognostic factors have been identified in adult MSK pain. One systematic review found that higher pain severity upon presentation to the GP, longer pain duration, multiple-site pain, anxiety and/or depression, higher somatic perceptions and/or distress, low social support, higher baseline disability, and greater movement restriction were all associated with a poor prognosis. Systematic reviews on adult knee pain suggest an association between low/middle education level, non-skeletal comorbidity, duration of knee symptoms of \> 3 months, bilateral knee symptoms, self-reported warm knee, history of non-traumatic knee symptoms, valgus alignment and an unfavorable prognosis. Similar to findings in patients with adult low back pain, there was high evidence that fear-avoidance beliefs and meagre social support at work were associated with an poor prognosis. If future studies are to tailor and target treatment for the adolescents with the highest risk of long-standing MSK pain, there is a need to identify prognostic factors for an unfavorable prognosis. The aim of this prospective cohort study is to identify the most important prognostic factors for adolescents with MSK pain in general practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 4, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

September 4, 2018

Last Update Submit

October 23, 2020

Conditions

Keywords

musculoskeletal painadolescentschildrenprognosisgeneral practicebio-psycho-social

Outcome Measures

Primary Outcomes (2)

  • Activity limiting pain

    Have you experienced pain in the past two weeks that have lead you to not being able to participate in play in the school yard or sparetime activities (ex. football or other sparetime activity? yes/no

    6 months

  • Location of activity limiting pain (must include same location as baseline)

    If yes to Primary Outcome 1: Please mark the areas of your body where you have had pain during the past two weeks (pictured a mannequin)

    6 months

Secondary Outcomes (1)

  • Pain intensity depicted on a NRS (11 point numeric rating scale)

    6 months

Eligibility Criteria

Age8 Years - 19 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The children and adolescents must have self-reported MSK pain at the time of recruitment and consult the GP in relation to their MSK pain. The primary reason for consultation may not necessarily be listed as MSK pain, but to be eligible for inclusion, MSK pain must be mentioned during the consultation with the GP. We do not have a pre-defined minimum or maximum MSK pain duration as a eligibility criteria and patients are eligible whether or not they have previously consulted their GP for their current MSK complaint. We define MSK pain according to the International Association for the Study of Pain (IASP) as: "pain arisen from muscle, tendon, bone, and joint". Pain due to tumor, fracture, infection, or systemic and neurological cause will be excluded. Types of pain will be labelled according to the region affected, e.g. back pain, neck pain, shoulder pain, knee pain etc

You may qualify if:

  • to 19 years
  • Self-reported musculoskeletal pain Traumatic pain caused by soft tissue damage, contusion or otherwise (excluding fracture), will be included.

You may not qualify if:

  • or 20+ years
  • Self-reported musculoskeletal pain due to tumor, fracture, infection, or systemic and neurological causes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, Denmark

Location

Related Publications (2)

  • Pourbordbari N, Jensen MB, Olesen JL, Holden S, Rathleff MS. Prognosis and bio-psycho-social prognostic factors in children and adolescents with musculoskeletal pain consulting general practice. Eur J Pediatr. 2025 Jun 2;184(6):384. doi: 10.1007/s00431-025-06217-2.

  • Pourbordbari N, Jensen MB, Olesen JL, Holden S, Rathleff MS. Bio-psycho-social characteristics and impact of musculoskeletal pain in one hundred children and adolescents consulting general practice. BMC Prim Care. 2022 Jan 25;23(1):20. doi: 10.1186/s12875-022-01628-8.

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of medicine

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 20, 2018

Study Start

October 1, 2018

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Locations