search
Back to results

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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Self-management intervention
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for General Practice at Aalborg University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-management intervention

Arm Description

The intervention is based on the 5 key skills for successful self-management which are; Problem solving Decision-making Utilizing resources Forming partnerships with healthcare providers 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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
August 24, 2022
Last Updated
June 30, 2023
Sponsor
Aalborg University
search

1. Study Identification

Unique Protocol Identification Number
NCT05553444
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
June 22, 2023 (Actual)
Study Completion Date
June 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single subject experimental design
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-management intervention
Arm Type
Experimental
Arm Description
The intervention is based on the 5 key skills for successful self-management which are; Problem solving Decision-making Utilizing resources Forming partnerships with healthcare providers 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.
Intervention Type
Behavioral
Intervention Name(s)
Self-management intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional limitations
Description
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
Time Frame
Will be assessed throughout the study. The primary outcome will be functional limitations 20 weeks after inclusion.
Title
Self-reported pain intensity
Description
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.
Time Frame
Will be assessed throughout the study. The primary outcome will be pain intensity 20 weeks after inclusion.
Secondary Outcome Measure Information:
Title
Pain Self-efficacy
Description
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).
Time Frame
Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
Title
Pain interference
Description
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.
Time Frame
Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
Other Pre-specified Outcome Measures:
Title
Ilness perception
Description
"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"
Time Frame
Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
Title
Physical activity
Description
"How often do you usually exercise at a level where you get short of breath or sweat". This question will have 7 response options.
Time Frame
Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
Title
Health-related quality of life
Description
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.
Time Frame
Assessed at baseline (T0), after 8-14 days (T1), after addtional 6 weeks (T2) and after addtional 12 weeks (T3)
Title
The Global Rating of Change
Description
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".
Time Frame
Assessed after 6 weeks (T2) and after addtional 12 weeks (T3)
Title
Patient Acceptable Symptom State
Description
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.
Time Frame
Assessed after 6 weeks (T2) and after addtional 12 weeks (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 15-19 years of age. Experience consistent or fluctuating axial LBP (between T12 and the gluteal fold) for more than 30 days prior to inclusion. 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). 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.
Facility Information:
Facility Name
Center for General Practice at Aalborg University
City
Aalborg
State/Province
Northern Jutland
ZIP/Postal Code
9220
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs