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

Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05553444
• Other study ID #: CAM-AAU 241-2
• Status: Completed
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: June 22, 2023

Study information

• Verified date: June 2023
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pain

Intervention

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.

Locations

Country	Name	City	State
Denmark	Center for General Practice at Aalborg University	Aalborg	Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ilness perception	"Are you worried about your back pain"? The response options will be a 11-point scale with 0 being equal to "not worried at all" whereas 10 will be equal to "very worried"	Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
Other	Physical activity	"How often do you usually exercise at a level where you get short of breath or sweat". This question will have 7 response options.	Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
Other	Health-related quality of life	Will be assessed with two questions: "Have you felt satisfied with your life?" The response options for this question are; not at all, slightly, moderately, very and extremely; "Have you felt under pressure?" The response options for this question are; never, seldom, quite often, very often, always.	Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
Other	The Global Rating of Change	The Global Rating of Change Scale (GROC) will be used to assess self-reported improvement. The scale is based on a single question along with a 7-point Likert scale ranging from "much improved" to "much worse".	Assessed after 6 weeks (T2) and after addtional 12 weeks (T3)
Other	Patient Acceptable Symptom State	The Patient Acceptable Symptom State (PASS) consists of a single question; "Who do you experience you LBP now compared to before you initiated the treatment", with a yes/no response option.	Assessed after 6 weeks (T2) and after addtional 12 weeks (T3)
Primary	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.
Primary	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	Pain Self-efficacy	Will be assess with the 2-item short form of the Pain Self-Efficacy Questionnaire. This questionnaire is based on 2 items evaluating to which degree patients feel confident in engaging in different task despite pain being present. Each question has a corresponding 7-point Likert scale ranging from 0 (not confident at all) to 6 (very confident).	Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
Secondary	Pain interference	Please check the box which best describes how your back pain affects your usual activities through a normal day (e.g. go to school, participate in sport, be with friends and family". This question will have the following 5 response options.	Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)