Chronic Low-back PainNCT06236529
Self-Management of Chronic Low Back Pain: Targeting Patient Activation
A study testing Health Behavior Change Counseling and Self-management program in people with Chronic Low-back Pain and Patient Activation, run by Johns Hopkins University at 1 site in United States.
Trial summary
Patients with chronic low back (cLBP) pain report reduced physical function and ability to participate in social roles and are more likely to use opioid pain medications. While self-management interventions have been shown to support these patients, effectiveness has been limited due to poor patient engagement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain, Patient Activation
- What is being tested?
- Health Behavior Change Counseling and Self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2022to 11 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18+ years of age)
- Seen in primary or specialty care practice for non-specific low back pain
- Chronic low back pain per the NIH Task Force on Research Standards for cLBP
- Worst back pain of at least 4/10 points
- Oswestry disability index of at least 24%
- English speaking
Who cannot join
- History of lumbar spine decompression/laminectomy or fusion surgery in the past 6 months
- Possible non-musculoskeletal cause for LBP symptoms diagnosis at baseline
- "Red flag" LBP diagnosis in the previous 6 months (e.g., cauda equina syndrome, osteomyelitis, or spinal neoplasm)
- Neurological disorder resulting in moderate to severe movement dysfunction
- Presence of any psychotic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Supporting Patient Activation for Self-Management of Chronic Low Back Pain With a Targeted Intervention Based on Key Influencing Characteristics
Patients with chronic low back (cLBP) pain report reduced physical function and ability to participate in social roles and are more likely to use opioid pain medications. While self-management interventions have been shown to support these patients, effectiveness has been limited due to poor patient engagement. "Patient activation" encompasses the skills, knowledge, and motivation that a person has to manage the person's health. Supporting patient activation may improve the effectiveness of self-management for cLBP.
In this single-masked pilot study of adults with cLBP, patients were randomized to receive either no intervention (control) or 6 weekly sessions of an evidence-based web-based self-management program (SMP) with or without health behavior change counseling (HBCC) using motivational interviewing. Participants were assessed at baseline and at 12 and 26 weeks using the Patient Activation Measure, Oswestry Disability Index and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function, social role participation, and pain interference. The investigators assessed acceptability and feasibility based on recruitment, session attendance, and follow-up.
- Conditions
- Chronic Low-back Pain, Patient Activation
- Being tested
- Health Behavior Change Counseling, Self-management program
- Keywords
- Self-management, Nurse-led, Web-based
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Behavior Change CounselingBehavioural
A telephone-based intervention employing principles and practices of motivational interviewing.
Self-management programBehavioural
An evidence-based 6-week SMP led by a registered nurse. The SMP was based on the Arthritis Self-Management Program and the Chronic Disease Self-Management Program.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants receive no intervention. |
| Self-management program (SMP) | Active comparator | Participants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks. Receives: Behavioral: Self-management program |
| Self-management program (SMP) with Health Behavior Change Counseling (HBCC) | Experimental | Participants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks and receive three telephone-based health behavioral change counseling sessions based on the principles and practices of motivational interviewing. Receives: Behavioral: Health Behavior Change Counseling; Behavioral: Self-management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of research
Acceptability - at least 50% of individuals approached agree to eligibility screening for the study, having at least 30% of those who were deemed eligible for the study agree to participate
Measured: Baseline
Feasibility of study
Feasibility - (1) having at least 80% of enrolled participants attend at least 3 of the 6 scheduled self-management program sessions; and (2) having a loss to follow-up rate of < 20% of enrolled participants over the 26-week study
Measured: Baseline
Secondary outcomes (2)
Patient Activation Measure (PAM) score
The Patient Activation Measure (PAM) is a 13-item instrument where patients are provided 5 response options, ranging from "strongly agree" to "strongly disagree." Based on their answers, patients were assigned a numerical score ranging from 0 (no activation) to 100 (highest activation), and the score was used to stratify patients into 1 of 4 stages of activation: stage 1 (believes taking an active role is important), stage 2 (has the confidence and knowledge to take action), stage 3 (takes action), and stage 4 (stays the course under stress)
Measured: 12 weeks
Oswestry Disability Index (ODI) score
Pain-related disability was assessed using the ODI, a 10-item measure of low back pain-related disability that evaluates the current effect of a patient's low back pain on various aspects of daily living. ODI scores range from 0 to 100, with higher scores indicating greater disability.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start16 Jul 2022
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard L Skolasky, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236529
- Sponsor's protocol ID
- IRB00313911
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skolasky RL, Nolan S, Pierre R, Vinch P, Taylor JL. Nurse-led web-based self-management program to improve patient activation and health outcomes in patients with chronic low back pain: an acceptability and feasibility pilot study. BMC Nurs. 2024 Jul 31;23(1):524. doi: 10.1186/s12912-024-02155-w.
PubMed 39085831
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Patient Activation for Self-Management of Chronic Low Back Pain With a Targeted Intervention Based on Key Influencing Characteristics
- ClinicalTrials.gov ID
- NCT06236529
- Acronym / sponsor ID
- IRB00313911
- Conditions
- Chronic Low-back Pain, Patient Activation
- Keywords
- Self-management, Nurse-led, Web-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 16 Jul 2022 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with chronic low back (cLBP) pain report reduced physical function and ability to participate in social roles and are more likely to use opioid pain medications. While self-management interventions have been shown to support these patients, effectiveness has been limited due to poor patient engagement. "Patient activation" encompasses the skills, knowledge, and motivation that a person has to manage the person's health. Supporting patient activation may improve the effectiveness of self-management for cLBP.
In this single-masked pilot study of adults with cLBP, patients were randomized to receive either no intervention (control) or 6 weekly sessions of an evidence-based web-based self-management program (SMP) with or without health behavior change counseling (HBCC) using motivational interviewing. Participants were assessed at baseline and at 12 and 26 weeks using the Patient Activation Measure, Oswestry Disability Index and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function, social role participation, and pain interference. The investigators assessed acceptability and feasibility based on recruitment, session attendance, and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants receive no intervention. |
| Self-management program (SMP) | Active comparator | Behavioral: Self-management programParticipants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks. |
| Self-management program (SMP) with Health Behavior Change Counseling (HBCC) | Experimental | Behavioral: Health Behavior Change Counseling, Behavioral: Self-management programParticipants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks and receive three telephone-based health behavioral change counseling sessions based on the principles and practices of motivational interviewing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (18+ years of age)
- Seen in primary or specialty care practice for non-specific low back pain
- Chronic low back pain per the NIH Task Force on Research Standards for cLBP
- Worst back pain of at least 4/10 points
- Oswestry disability index of at least 24%
Key exclusion criteria (5 listed)
- History of lumbar spine decompression/laminectomy or fusion surgery in the past 6 months
- Possible non-musculoskeletal cause for LBP symptoms diagnosis at baseline
- "Red flag" LBP diagnosis in the previous 6 months (e.g., cauda equina syndrome, osteomyelitis, or spinal neoplasm)
- Neurological disorder resulting in moderate to severe movement dysfunction
- Presence of any psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Behavior Change CounselingA telephone-based intervention employing principles and practices of motivational interviewing. | Behavioural | Self-management program (SMP) with Health Behavior Change Counseling (HBCC) |
| Self-management programAn evidence-based 6-week SMP led by a registered nurse. The SMP was based on the Arthritis Self-Management Program and the Chronic Disease Self-Management Program. | Behavioural | Self-management program (SMP), Self-management program (SMP) with Health Behavior Change Counseling (HBCC) |
Primary outcome
Acceptability of research
Time frame: Baseline
Acceptability - at least 50% of individuals approached agree to eligibility screening for the study, having at least 30% of those who were deemed eligible for the study agree to participate
Feasibility of study
Time frame: Baseline
Feasibility - (1) having at least 80% of enrolled participants attend at least 3 of the 6 scheduled self-management program sessions; and (2) having a loss to follow-up rate of < 20% of enrolled participants over the 26-week study
2 secondary outcomes
Patient Activation Measure (PAM) score
Time frame: 12 weeks
Oswestry Disability Index (ODI) score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 39085831Skolasky RL, Nolan S, Pierre R, Vinch P, Taylor JL. Nurse-led web-based self-management program to improve patient activation and health outcomes in patients with chronic low back pain: an acceptability and feasibility pilot study. BMC Nurs. 2024 Jul 31;23(1):524. doi: 10.1186/s12912-024-02155-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard L Skolasky principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Behavior Change Counseling and Self-management program in people with Chronic Low-back Pain and Patient Activation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of research (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06236529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.