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Effect of Self-management Intervention on Pain Intensity and Functional Disability in Adolescent Patients With Low Back Pain

NCT05553444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-07-03

No results posted yet for this study

Summary

Low back pain (LBP) is prevalent among adolescents from the general population and in general practice. Not only is LBP associated with pain and functional limitation among patients, also the socioeconomic burden of the condition is substantial worldwide. Chronic cases of LBP are not uncommon in adolescents, especially among those whose parents are suffering from chronic pain. Several individual factors influence LBP among adolescents. Especially previous episodes of LBP, low pain self-efficacy levels and worries about LBP has been identified as worsening factors in regard to pain and disability.

At present there is little evidence to inform a large randomized experimental study to investigate the effect of a given treatment modality in this group of young patients. Furthermore, it remains to be investigated if individual factors, such as, pain self-efficacy levels and worries about LBP may mediate the effect of a behavioral intervention regarding pain and disability. However, the single case experimental design allows for close monitoring of the patients during a controlled treatment course. As such, the single case experimental design study can provide vital and fundamental knowledge regarding treatment effect and mediating factors in relation to an intervention aimed at improving self-management in adolescent LBP patients.

This study aims to investigate the effect of an intervention to improve self-management among adolescent LBP patients assessed by pain intensity and functional disability in a single case experimental design. We further aimed to investigate if LBP related worries and pain self-efficacy would mediate the effect of the intervention. We hypothesized that the self-management intervention would lead to lower pain intensity scores and decrease disability levels on a patient level.

Conditions

  • Low Back Pain

Interventions

BEHAVIORAL

Self-management intervention

The procedure will be based on the A - B - A'/B' design. After recruitment, patients will attend an initial session with CLS where written and oral information about the study will be provided. In this study, the A phase will serve as baseline to establish fluctuation in pain intensity prior to initiating the treatment. During phase A, patients will be assessed every day for a minimum of 8 days and maximum of 14 days. During phase B, CLS will facilitate the intervention based on the initial session, pain levels during phase A and the patients' goals. During phase B, patients will attend a 1-hour weekly session over 6 weeks. During phase A', the participants will be followed weekly for 12 weeks. During the phase A', participants will not receive treatment. Phase B' contains 3 x 1 hour criterion-based booster sessions which are delivered over 3 consecutive weeks.

Sponsors & Collaborators

  • Aalborg University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2023-06-22
Completion
2023-06-22

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05553444 on ClinicalTrials.gov