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

NCT05553444 | Completed

• 1 other identifier: CAM-AAU 241-2
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Functional limitations

  In this questionnaire, the participants will identify one to three activities which they find themselves limited accomplishing. These activities are rated from a 0 (unable to perform activity) to 10 (able to perform activity at pre-injury level). The primary outcome for each patient will be the activity with the lowest score on the PSFS. If two or more activity have equally low scores, the patient will determine which should be the primary outcome

  Will be assessed throughout the study. The primary outcome will be functional limitations 20 weeks after inclusion.

• Self-reported pain intensity

  The 11-point Numeric Pain Rating Scale (NRPS) (0 equals no pain and 10 equals worst possible pain) will be used to assess worst pain during the past 24 hours.

  Will be assessed throughout the study. The primary outcome will be pain intensity 20 weeks after inclusion.

Secondary Outcomes (2)

• Pain Self-efficacy

  Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)

• Pain interference

  Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)

Other Outcomes (5)

• Ilness perception

  Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)

• Physical activity

  Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)

• Health-related quality of life

  Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)

Study Arms (1)

Self-management intervention

EXPERIMENTAL

The intervention is based on the 5 key skills for successful self-management which are; 1. Problem solving 2. Decision-making 3. Utilizing resources 4. Forming partnerships with healthcare providers 5. Taking action. It is important to keep in mind, that not all included patients will necessarily lack all 5 skills. As such, the intervention will be tailored to each participant based on the initial assessment and continuous clinical reasoning.

Behavioral: Self-management intervention

Interventions

Self-management intervention BEHAVIORAL

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.

Self-management intervention

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age.
• 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:
• 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.
• Being absent from work and/or school for one or more days during the past 30 days due to LBP.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Center for General Practice at Aalborg University

Aalborg, Northern Jutland, 9220, Denmark

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc. Ph.D Fellow

Model Details: Single subject experimental design

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 23, 2022
• Study Start: August 30, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)