Clinical trial NCT05553444: Effect of Self-management Intervention on Pain Intensity and Functional Disability in Adolescent Patients With Low Back Pain
Official title: The Effect of a Self-management Intervention on Pain Intensity and Functional Disability in Adolescent Patients With Low Back Pain - a Single Case Experimental Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 5
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single subject experimental design
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 15-19 years of age.
2. Experience consistent or fluctuating axial LBP (between T12 and the gluteal fold) for more than 30 days prior to inclusion.
3. Worst pain intensity during the past 24 hours equal to or more than 3 on 0-10 Numeric Pain Rating Scale (NPRS).

Eligible patients are also required to meet two of the following three criteria:

1. Experience functional limitations in one or more daily activities (e.g. sports participation, sitting or lifting). Functional limitation will be assessed with the Patient Specific Functional Scale (PSFS). Patients is characterized as experiencing functional limitations if they score 8 or below on an 11-point scale (0, unable to perform activity; 10, able to perform activity at pre-injury level) in regards to one self-reported activity.
2. Being absent from work and/or school for one or more days during the past 30 days due to LBP.
3. Being worried about their back pain (i.e. scoring 3 or higher on a 0-10 scale in relation to the question; "Are you worried about your back pain" - see the Illness perception item described below).

Exclusion Criteria:

Participant are excluded if they are diagnosed with rheumatic arthritis or a primary neurological disorder (e.g. multiple sclerosis), have an underlying pathology such as infection, cancer or fracture or shows clinical symptoms of cauda equina.

Primary outcomes:
measure: Functional limitations
timeFrame: Will be assessed throughout the study. The primary outcome will be functional limitations 20 weeks after inclusion.
measure: Self-reported pain intensity
timeFrame: Will be assessed throughout the study. The primary outcome will be pain intensity 20 weeks after inclusion.
Secondary outcomes:
measure: Pain Self-efficacy
timeFrame: Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
measure: Pain interference
timeFrame: Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
Other outcomes:
measure: Ilness perception
timeFrame: Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
measure: Physical activity
timeFrame: Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
measure: Health-related quality of life
timeFrame: Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
measure: The Global Rating of Change
timeFrame: Assessed after 6 weeks (T2) and after addtional 12 weeks (T3)
measure: Patient Acceptable Symptom State
timeFrame: Assessed after 6 weeks (T2) and after addtional 12 weeks (T3)
Locations:
city: Aalborg
country: Denmark
facility: Center for General Practice at Aalborg University
state: Northern Jutland
Study officials:
References: