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

NCT ID: NCT05553444

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2023-06-22

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-management intervention

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.

Group Type: EXPERIMENTAL

Self-management intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Christian Lund Straszek

M.Sc. Ph.D Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for General Practice at Aalborg University

Aalborg, Northern Jutland, Denmark

Countries

Denmark

Other Identifiers

CAM-AAU 241-2

Identifier Type: -

Identifier Source: org_study_id