Chronic Low Back PainNCT05086159
Effectiveness of Pain Neuroscience Education (PNE) to Veterans With Post-Traumatic Stress and Low Back Pain
A study testing Pain Neuroscience Education, Exercise and Traditional Education in people with Chronic Low Back Pain and Post-traumatic Stress, run by Keller Army Community Hospital at 1 site in United States.
Trial summary
This trial compared traditional pain and stress education plus physical therapy to pain neuroscience education plus physical therapy in individuals with post-traumatic stress and chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain, Post-traumatic Stress
- What is being tested?
- Pain Neuroscience Education, Exercise and Traditional Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Aug 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain located between the 12th rib and buttocks that in the opinion of the screening examiner is originating from the lumbar region
- Current episode of back pain duration of 3 months or longer
- Active duty military or Veteran
- Read and speak English well enough to provide informed consent and follow study instructions
Who cannot join
- History of prior surgery to the lumbosacral spine within the previous 12 months
- Presence of neurogenic LBP defined by a positive contralateral straight leg raise (reproduction of symptoms below 45 degrees) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression
- Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease
- Discharged from physical therapy within the past 3 months for lower back pain
- Current diagnosis of psychotic conditions or medications (bi-polar, schizophrenia, personality disorder).
- Substance abuse or psychosis within 6 months of research.
Show all 9Show fewer
- Unable to discontinue other active therapies until completion of clinical trial follow-up (8 weeks).
- Suicidal ideation
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexington VA Medical Center
Lexington, Kentucky, 40502
About this study
This trial compared traditional pain and stress education plus physical therapy to pain neuroscience education plus physical therapy in individuals with post-traumatic stress and chronic low back pain.
Read the detailed description
Veterans and Service Members with low back pain (LBP) will be recruited for this research. Once Veterans consent to participate in this research, participants will undergo baseline testing. Next, participants will randomly be assigned to one of two types of education: pain neuroscience education or traditional biomedical education. Each Veteran will receive 30 minutes of interactive education once a week for 4 weeks, depending on their group assignment. Following each education session, Veterans will participate in an exercise class that will last approximately 30 minutes. After the 4 week intervention, Veterans will complete the same questionnaires and measures as at the beginning of the program. Veterans will also complete subjective questionnaires at 8 weeks. Finally, healthcare utilization will be measured for 12 months following the research intervention.
- Conditions
- Chronic Low Back Pain, Post-traumatic Stress
- Being tested
- Pain Neuroscience Education, Exercise, Traditional Education
- Keywords
- chronic low back pain, post-traumatic stress, physical therapy, pain neuroscience education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationBehavioural
Weekly education sessions lasting approximately 30 minutes each, once a week for four weeks.
Session 1: the nervous system is like an alarm to protect.
Session 2: common ways the nervous system becomes sensitive.
Session 3: importance of gradual conditioning and neuroplasticity.
Session 4: common ways to decrease nervous system sensitivity.
ExerciseBehavioural
The exercise protocol for each group will be identical and modeled after the "Back to Fitness" program. This program will consist of a 5-10-minute cardiovascular warm-up of walking in place or riding an exercise bike. Next is a 15-minute circuit consisting of 10 different general exercises for 1-minute each. Finally, a 5-minute cool down will consist of light stretching and trunk range of motion exercises. Each exercise will be tailored as easy, medium, or hard depending on the individual patient's tolerance. This program has been shown to be equally as effective as motor control exercises for long-term outcomes in patients with non-specific LBP.
Traditional EducationBehavioural
Weekly education sessions lasting approximately 30 minutes each, once a week for four weeks.
Session 1 will include a basic overview of the anatomy of the spine.
Session 2 will discuss an overview of stress symptoms to include hypervigilance, avoidance, and re-experiencing.
Session 3 will cover common recommendations delivered in stress education: the do's and don'ts of stress management.
Session 4: review and mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Education | Active comparator | Traditional biomedical education for back pain and standard stress education. Education was developed from "Back School", National PTSD Center, and PTSD Coach. Receives: Behavioral: Exercise; Behavioral: Traditional Education |
| Pain Neuroscience Education | Experimental | Pain neuroscience education (PNE) was developed for this research comparing pain and stress symptoms to a radar that can become hypervigilant to threat. Receives: Behavioral: Pain Neuroscience Education; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
The PCL is a 20-item checklist that measures the clusters of symptoms associated with PTSD according to the revised DSM. Scores range from 0-80 with higher numbers indicating higher PTSD symptomology.
Measured: Baseline
PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
The PCL is a 20-item checklist that measures the clusters of symptoms associated with PTSD according to the revised DSM. Scores range from 0-80 with higher numbers indicating higher PTSD symptomology.
Measured: 4-weeks
PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
The PCL is a 20-item checklist that measures the clusters of symptoms associated with PTSD according to the revised DSM. Scores range from 0-80 with higher numbers indicating higher PTSD symptomology.
Measured: 8-weeks
Roland-Morris Disability Questionnaire (RMDQ)
The RMDQ is a subjective measure of disability recommended for LBP. Users are asked to identify among 24 activities or statements that are influenced by their back pain. The answers provide a score between 0 and 24, with higher scores representing more disability.
Measured: Baseline
Roland-Morris Disability Questionnaire (RMDQ)
The RMDQ is a subjective measure of disability recommended for LBP. Users are asked to identify among 24 activities or statements that are influenced by their back pain. The answers provide a score between 0 and 24, with higher scores representing more disability.
Measured: 4-weeks
Roland-Morris Disability Questionnaire (RMDQ)
The RMDQ is a subjective measure of disability recommended for LBP. Users are asked to identify among 24 activities or statements that are influenced by their back pain. The answers provide a score between 0 and 24, with higher scores representing more disability.
Measured: 8-weeks
Numeric Pain Rating Scale (NPRS)
The NPRS is an 11-point scale used to rate subjective pain intensity. The NPRS has been shown to have good validity and reliability. The scale ranges from 0 to 10 and has been shown to have acceptable responsiveness in patients with LBP. This study's scale was anchored at 0, "no pain at all", to 10, "the worst pain you could imagine."
Measured: Baseline
Numeric Pain Rating Scale (NPRS)
The NPRS is an 11-point scale used to rate subjective pain intensity. The NPRS has been shown to have good validity and reliability. The scale ranges from 0 to 10 and has been shown to have acceptable responsiveness in patients with LBP. This study's scale was anchored at 0, "no pain at all", to 10, "the worst pain you could imagine."
Measured: 4-weeks
Numeric Pain Rating Scale (NPRS)
The NPRS is an 11-point scale used to rate subjective pain intensity. The NPRS has been shown to have good validity and reliability. The scale ranges from 0 to 10 and has been shown to have acceptable responsiveness in patients with LBP. This study's scale was anchored at 0, "no pain at all", to 10, "the worst pain you could imagine."
Measured: 8-weeks
Secondary outcomes (21)
"Stressometer"
The stressometer is a short, one-item scale that measures patient distress on a scale from 0-10. The stressometer is valid and responsive and correlates with more in-depth assessments of psychological stress. A score of 4 or higher is considered positive for moderate distress.
Measured: Baseline
"Stressometer"
The stressometer is a short, one-item scale that measures patient distress on a scale from 0-10. The stressometer is valid and responsive and correlates with more in-depth assessments of psychological stress. A score of 4 or higher is considered positive for moderate distress.
Measured: 4-weeks
"Stressometer"
The stressometer is a short, one-item scale that measures patient distress on a scale from 0-10. The stressometer is valid and responsive and correlates with more in-depth assessments of psychological stress. A score of 4 or higher is considered positive for moderate distress.
Measured: 8-weeks
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) measures pain catastrophizing which is defined as an exaggerated negative appraisal of noxious stimuli. The PCS has good validity and excellent reliability in a LBP population. Higher scores indicate more distressing beliefs about pain. Scores range from 0-52.
Measured: Baseline
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) measures pain catastrophizing which is defined as an exaggerated negative appraisal of noxious stimuli. The PCS has good validity and excellent reliability in a LBP population. Higher scores indicate more distressing beliefs about pain. Scores range from 0-52.
Measured: 4-weeks
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) measures pain catastrophizing which is defined as an exaggerated negative appraisal of noxious stimuli. The PCS has good validity and excellent reliability in a LBP population. Higher scores indicate more distressing beliefs about pain. Scores range from 0-52.
Measured: 8-weeks
Brief Survey of Pain Attitudes (SOPA-35)
The Brief Survey of Pain Attitudes (SOPA-35) is a valid, reliable, and sensitive questionnaire that measures beliefs about pain across 7 domains. This study was particularly interested in the harm sub-scale to assess whether patient's beliefs that pain means harm changes after the intervention. Each domain is scored from 0-4 with 0 representing "very untrue" and 4 representing "very true." A higher score for the SOPA-Harm subscale indicates that participants believe that pain is a sign of harm and damage to a greater degree than participants with a lower score on the scale.
Measured: Baseline
Brief Survey of Pain Attitudes (SOPA-35)
The Brief Survey of Pain Attitudes (SOPA-35) is a valid, reliable, and sensitive questionnaire that measures beliefs about pain across 7 domains. This study was particularly interested in the harm sub-scale to assess whether patient's beliefs that pain means harm changes after the intervention. Each domain is scored from 0-4 with 0 representing "very untrue" and 4 representing "very true." A higher score for the SOPA-Harm subscale indicates that participants believe that pain is a sign of harm and damage to a greater degree than participants with a lower score on the scale.
Measured: 4-weeks
Brief Survey of Pain Attitudes (SOPA-35)
The Brief Survey of Pain Attitudes (SOPA-35) is a valid, reliable, and sensitive questionnaire that measures beliefs about pain across 7 domains. This study was particularly interested in the harm sub-scale to assess whether patient's beliefs that pain means harm changes after the intervention. Each domain is scored from 0-4 with 0 representing "very untrue" and 4 representing "very true." A higher score for the SOPA-Harm subscale indicates that participants believe that pain is a sign of harm and damage to a greater degree than participants with a lower score on the scale.
Measured: 8-weeks
Pain Self-Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a questionnaire that measures an individual's self-perceived confidence to cope with physical activities "despite the pain". Studies demonstrate that individuals who have low self-efficacy have higher disability. Higher scores indicate a greater degree of confidence to function in life, "despite pain." Scores range from 0-60.
Measured: Baseline
Pain Self-Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a questionnaire that measures an individual's self-perceived confidence to cope with physical activities "despite the pain". Studies demonstrate that individuals who have low self-efficacy have higher disability. Higher scores indicate a greater degree of confidence to function in life, "despite pain." Scores range from 0-60.
Measured: 4-weeks
Pain Self-Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a questionnaire that measures an individual's self-perceived confidence to cope with physical activities "despite the pain". Studies demonstrate that individuals who have low self-efficacy have higher disability. Higher scores indicate a greater degree of confidence to function in life, "despite pain." Scores range from 0-60.
Measured: 8-weeks
Lumbar Spine Pain Pressure Threshold (PPT)
Patients were tested in the prone position with a pillow under their shins to achieve approximately 15 degrees of knee flexion. A research physical therapist applies a digital algometer probe (SBMEDIC Electronics, Sweden) with a gradual increase in force 5 cm lateral to the spinous process of L3 of the most symptomatic side until the participant reported the pressure as painful and pressed a button attached to the algometer. This procedure was performed three times at the low back and averaged to determine the patient's Pain Pressure Threshold with approximately 30 seconds rest between repetitions. Forces are measured in kPA with higher numbers indicating a greater tolerance for pressure and potentially less pain sensitivity.
Measured: Baseline
Lumbar Spine Pain Pressure Threshold (PPT)
Patients were tested in the prone position with a pillow under their shins to achieve approximately 15 degrees of knee flexion. A research physical therapist applies a digital algometer probe (SBMEDIC Electronics, Sweden) with a gradual increase in force 5 cm lateral to the spinous process of L3 of the most symptomatic side until the participant reported the pressure as painful and pressed a button attached to the algometer. This procedure was performed three times at the low back and averaged to determine the patient's Pain Pressure Threshold with approximately 30 seconds rest between repetitions. Forces are measured in kPA with higher numbers indicating a greater tolerance for pressure and potentially less pain sensitivity.
Measured: 4-weeks
Suprascapular Pain Pressure Threshold (PPT)
Patients were tested in the prone position with a pillow under their shins to achieve approximately 15 degrees of knee flexion. A research physical therapist applies a digital algometer probe (SBMEDIC Electronics, Sweden) with a gradual increase in force at the suprascapular region contralateral to the side tested in the low back, mid-way between the posterior border of the acromion and the 7th spinous process of the cervical spine. This procedure was performed three times and averaged to determine the patient's Pain Pressure Threshold with approximately 30 seconds rest between repetitions. Forces are measured in kPA with higher numbers indicating a greater tolerance for pressure and potentially less pain sensitivity.
Measured: Baseline
Suprascapular Pain Pressure Threshold (PPT)
Patients were tested in the prone position with a pillow under their shins to achieve approximately 15 degrees of knee flexion. A research physical therapist applies a digital algometer probe (SBMEDIC Electronics, Sweden) with a gradual increase in force at the suprascapular region contralateral to the side tested in the low back, mid-way between the posterior border of the acromion and the 7th spinous process of the cervical spine. This procedure was performed three times and averaged to determine the patient's Pain Pressure Threshold with approximately 30 seconds rest between repetitions. Forces are measured in kPA with higher numbers indicating a greater tolerance for pressure and potentially less pain sensitivity.
Measured: 4-weeks
Spinal flexion
Participants were asked to bend forward at the waist while keeping their knees straight and attempting to touch the floor. The distance from the floor to the patient's most distal finger-tip was measured to the nearest tenth of a centimeter (cm). Participants were instructed to stop "whenever you feel you need to stop." Participants completed this procedure two times and the measures were averaged. Lower numbers indicate greater range of motion with the lowest score possible 0cm.
Measured: Baseline
Spinal flexion
Participants were asked to bend forward at the waist while keeping their knees straight and attempting to touch the floor. The distance from the floor to the patient's most distal finger-tip was measured to the nearest tenth of a centimeter (cm). Participants were instructed to stop "whenever you feel you need to stop." Participants completed this procedure two times and the measures were averaged. Lower numbers indicate greater range of motion with the lowest score possible 0cm.
Measured: 4-weeks
Post-program questionnaire
This study adapted a questionnaire to assess the satisfaction and acceptability of the intervention on a numerical scale from 0-10 with 10 indicating "strongly agree" and 0 "strongly disagree".
Measured: 8-weeks
Healthcare utilization, Cost
Any medical appointment in the Veterans Affairs or Department of Defense health system in which a patient sought care or was evaluated for complaints of LBP for 12-months following study enrollment according to a medical provider's electronic documentation of the visit. Subsequently, a physical therapist who was blinded to participant group allocation verified each medical encounter and then extracted all current procedural terminology (CPT) codes that were charged for each visit related to LBP. In the Military and Veterans Health Affairs, costs are estimated based on the American Medical Association and Medicare equivalents for CPT codes.
Measured: 12-months
Healthcare utilization, Invasive Procedures
Any medical appointment in the Veterans Affairs or Department of Defense health system in which a patient sought care or was evaluated for complaints of LBP for 12-months following study enrollment according to a medical provider's electronic documentation of the visit. Subsequently, a physical therapist who was blinded to participant group allocation verified each medical encounter and then extracted all current procedural terminology (CPT) codes that were charged for each visit related to LBP. In the Military and Veterans Health Affairs, costs are estimated based on the American Medical Association and Medicare equivalents for CPT codes. CPT codes were then classified as non-invasive or invasive (surgery, imaging, or injections).
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Jul 2017
- Primary completion1 May 2019
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Timothy Benedict, Keller Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086159
- Sponsor's protocol ID
- GAM-16-024-HE
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004 Sep-Oct;20(5):324-30. doi: 10.1097/00002508-200409000-00007.
PubMed 15322439Moeller-Bertram T, Keltner J, Strigo IA. Pain and post traumatic stress disorder - review of clinical and experimental evidence. Neuropharmacology. 2012 Feb;62(2):586-97. doi: 10.1016/j.neuropharm.2011.04.028. Epub 2011 May 10.
PubMed 21586297Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
PubMed 22133255Ruzek JI, Hoffman J, Ciulla R, Prins A, Kuhn E, Gahm G. Bringing Internet-based education and intervention into mental health practice: afterdeployment.org. Eur J Psychotraumatol. 2011;2. doi: 10.3402/ejpt.v2i0.7278. Epub 2011 Nov 17.
PubMed 22893824Kuhn E, Greene C, Hoffman J, Nguyen T, Wald L, Schmidt J, Ramsey KM, Ruzek J. Preliminary evaluation of PTSD Coach, a smartphone app for post-traumatic stress symptoms. Mil Med. 2014 Jan;179(1):12-8. doi: 10.7205/MILMED-D-13-00271.
PubMed 24402979Clewley D, Rhon D, Flynn T, Koppenhaver S, Cook C. Health seeking behavior as a predictor of healthcare utilization in a population of patients with spinal pain. PLoS One. 2018 Aug 1;13(8):e0201348. doi: 10.1371/journal.pone.0201348. eCollection 2018.
PubMed 30067844Davies, C. C., & Nitz, A. J. (2009). Psychometric properties of the Roland-Morris Disability Questionnaire compared to the Oswestry Disability Index: a systematic review. Physical Therapy Reviews, 14(6), 399-408.
Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH task force on research standards for chronic low back pain. Spine (Phila Pa 1976). 2014 Jun 15;39(14):1128-43. doi: 10.1097/BRS.0000000000000434.
PubMed 24887571Jensen, M. P., Turner, J. A., & Romano, J. M. (2000). Pain belief assessment: A comparison of the short and long versions of the surgery of pain attitudes. The Journal of Pain, 1(2), 138-150.
Keegan D, Byrne K, Cullen G, Doherty GA, Dooley B, Mulcahy HE. The Stressometer: A Simple, Valid, and Responsive Measure of Psychological Stress in Inflammatory Bowel Disease Patients. J Crohns Colitis. 2015 Oct;9(10):881-5. doi: 10.1093/ecco-jcc/jjv120. Epub 2015 Jul 27.
PubMed 26221000Linton SJ, Kamwendo K. Low back schools. A critical review. Phys Ther. 1987 Sep;67(9):1375-83. doi: 10.1093/ptj/67.9.1375.
PubMed 2957704Moffett, J. K., & Frost, H. (2000). Back to fitness programme: The manual for physiotherapists to set up the classes. Physiotherapy, 86(6), 295-305.
Neziri AY, Curatolo M, Limacher A, Nuesch E, Radanov B, Andersen OK, Arendt-Nielsen L, Juni P. Ranking of parameters of pain hypersensitivity according to their discriminative ability in chronic low back pain. Pain. 2012 Oct;153(10):2083-2091. doi: 10.1016/j.pain.2012.06.025. Epub 2012 Jul 28.
PubMed 22846347Pincus T, Anwar S, McCracken LM, McGregor A, Graham L, Collinson M, McBeth J, Watson P, Morley S, Henderson J, Farrin AJ; OBI Trial Management Team. Delivering an Optimised Behavioural Intervention (OBI) to people with low back pain with high psychological risk; results and lessons learnt from a feasibility randomised controlled trial of Contextual Cognitive Behavioural Therapy (CCBT) vs. Physiotherapy. BMC Musculoskelet Disord. 2015 Jun 16;16:147. doi: 10.1186/s12891-015-0594-2.
PubMed 26076755Sullivan, M. J., Bishop, S. R., & Pivik, J. (1995). The pain catastrophizing scale: development and validation. Psychological assessment, 7(4), 524.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Neuroscience Education (PNE) to Veterans With Post-Traumatic Stress and Low Back Pain
- ClinicalTrials.gov ID
- NCT05086159
- Acronym / sponsor ID
- GAM-16-024-HE
- Conditions
- Chronic Low Back Pain, Post-traumatic Stress
- Keywords
- chronic low back pain, post-traumatic stress, physical therapy, pain neuroscience education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 20 Oct 2021 (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.
This trial compared traditional pain and stress education plus physical therapy to pain neuroscience education plus physical therapy in individuals with post-traumatic stress and chronic low back pain.
Detailed description
Veterans and Service Members with low back pain (LBP) will be recruited for this research. Once Veterans consent to participate in this research, participants will undergo baseline testing. Next, participants will randomly be assigned to one of two types of education: pain neuroscience education or traditional biomedical education. Each Veteran will receive 30 minutes of interactive education once a week for 4 weeks, depending on their group assignment. Following each education session, Veterans will participate in an exercise class that will last approximately 30 minutes. After the 4 week intervention, Veterans will complete the same questionnaires and measures as at the beginning of the program. Veterans will also complete subjective questionnaires at 8 weeks. Finally, healthcare utilization will be measured for 12 months following the research intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Education | Active comparator | Behavioral: Exercise, Behavioral: Traditional EducationTraditional biomedical education for back pain and standard stress education. Education was developed from "Back School", National PTSD Center, and PTSD Coach. |
| Pain Neuroscience Education | Experimental | Behavioral: Pain Neuroscience Education, Behavioral: ExercisePain neuroscience education (PNE) was developed for this research comparing pain and stress symptoms to a radar that can become hypervigilant to threat. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pain located between the 12th rib and buttocks that in the opinion of the screening examiner is originating from the lumbar region
- Current episode of back pain duration of 3 months or longer
- Active duty military or Veteran
- Read and speak English well enough to provide informed consent and follow study instructions
Key exclusion criteria (9 listed)
- History of prior surgery to the lumbosacral spine within the previous 12 months
- Presence of neurogenic LBP defined by a positive contralateral straight leg raise (reproduction of symptoms below 45 degrees) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression
- Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease
- Discharged from physical therapy within the past 3 months for lower back pain
- Current diagnosis of psychotic conditions or medications (bi-polar, schizophrenia, personality 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 |
|---|---|---|
| Pain Neuroscience EducationWeekly education sessions lasting approximately 30 minutes each, once a week for four weeks. Session 1: the nervous system is like an alarm to protect. Session 2: common ways the nervous system becomes sensitive. Session 3: importance of gradual conditioning and neuroplasticity. Session 4: common ways to decrease nervous system sensitivity. | Behavioural | Pain Neuroscience Education |
| ExerciseThe exercise protocol for each group will be identical and modeled after the "Back to Fitness" program. This program will consist of a 5-10-minute cardiovascular warm-up of walking in place or riding an exercise bike. Next is a 15-minute circuit consisting of 10 different general exercises for 1-minute each. Finally, a 5-minute cool down will consist of light stretching and trunk range of motion exercises. Each exercise will be tailored as easy, medium, or hard depending on the individual patient's tolerance. This program has been shown to be equally as effective as motor control exercises for long-term outcomes in patients with non-specific LBP. | Behavioural | Pain Neuroscience Education, Traditional Education |
| Traditional EducationWeekly education sessions lasting approximately 30 minutes each, once a week for four weeks. Session 1 will include a basic overview of the anatomy of the spine. Session 2 will discuss an overview of stress symptoms to include hypervigilance, avoidance, and re-experiencing. Session 3 will cover common recommendations delivered in stress education: the do's and don'ts of stress management. Session 4: review and mindfulness. | Behavioural | Traditional Education |
Primary outcome
PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
Time frame: Baseline
The PCL is a 20-item checklist that measures the clusters of symptoms associated with PTSD according to the revised DSM. Scores range from 0-80 with higher numbers indicating higher PTSD symptomology.
PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
Time frame: 4-weeks
The PCL is a 20-item checklist that measures the clusters of symptoms associated with PTSD according to the revised DSM. Scores range from 0-80 with higher numbers indicating higher PTSD symptomology.
PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL)
Time frame: 8-weeks
The PCL is a 20-item checklist that measures the clusters of symptoms associated with PTSD according to the revised DSM. Scores range from 0-80 with higher numbers indicating higher PTSD symptomology.
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Baseline
The RMDQ is a subjective measure of disability recommended for LBP. Users are asked to identify among 24 activities or statements that are influenced by their back pain. The answers provide a score between 0 and 24, with higher scores representing more disability.
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: 4-weeks
The RMDQ is a subjective measure of disability recommended for LBP. Users are asked to identify among 24 activities or statements that are influenced by their back pain. The answers provide a score between 0 and 24, with higher scores representing more disability.
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: 8-weeks
The RMDQ is a subjective measure of disability recommended for LBP. Users are asked to identify among 24 activities or statements that are influenced by their back pain. The answers provide a score between 0 and 24, with higher scores representing more disability.
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline
The NPRS is an 11-point scale used to rate subjective pain intensity. The NPRS has been shown to have good validity and reliability. The scale ranges from 0 to 10 and has been shown to have acceptable responsiveness in patients with LBP. This study's scale was anchored at 0, "no pain at all", to 10, "the worst pain you could imagine."
Numeric Pain Rating Scale (NPRS)
Time frame: 4-weeks
The NPRS is an 11-point scale used to rate subjective pain intensity. The NPRS has been shown to have good validity and reliability. The scale ranges from 0 to 10 and has been shown to have acceptable responsiveness in patients with LBP. This study's scale was anchored at 0, "no pain at all", to 10, "the worst pain you could imagine."
Numeric Pain Rating Scale (NPRS)
Time frame: 8-weeks
The NPRS is an 11-point scale used to rate subjective pain intensity. The NPRS has been shown to have good validity and reliability. The scale ranges from 0 to 10 and has been shown to have acceptable responsiveness in patients with LBP. This study's scale was anchored at 0, "no pain at all", to 10, "the worst pain you could imagine."
21 secondary outcomes
"Stressometer"
Time frame: Baseline
"Stressometer"
Time frame: 4-weeks
"Stressometer"
Time frame: 8-weeks
Pain Catastrophizing Scale (PCS)
Time frame: Baseline
Pain Catastrophizing Scale (PCS)
Time frame: 4-weeks
Pain Catastrophizing Scale (PCS)
Time frame: 8-weeks
Brief Survey of Pain Attitudes (SOPA-35)
Time frame: Baseline
Brief Survey of Pain Attitudes (SOPA-35)
Time frame: 4-weeks
Brief Survey of Pain Attitudes (SOPA-35)
Time frame: 8-weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 4-weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 8-weeks
Lumbar Spine Pain Pressure Threshold (PPT)
Time frame: Baseline
Lumbar Spine Pain Pressure Threshold (PPT)
Time frame: 4-weeks
Suprascapular Pain Pressure Threshold (PPT)
Time frame: Baseline
Suprascapular Pain Pressure Threshold (PPT)
Time frame: 4-weeks
Spinal flexion
Time frame: Baseline
Spinal flexion
Time frame: 4-weeks
Post-program questionnaire
Time frame: 8-weeks
Healthcare utilization, Cost
Time frame: 12-months
Healthcare utilization, Invasive Procedures
Time frame: 12-months
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 27 Oct 2021.
- Background: PubMed 15322439Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004 Sep-Oct;20(5):324-30. doi: 10.1097/00002508-200409000-00007.
- Background: PubMed 21586297Moeller-Bertram T, Keltner J, Strigo IA. Pain and post traumatic stress disorder - review of clinical and experimental evidence. Neuropharmacology. 2012 Feb;62(2):586-97. doi: 10.1016/j.neuropharm.2011.04.028. Epub 2011 May 10.
- Background: PubMed 22133255Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
- Background: PubMed 22893824Ruzek JI, Hoffman J, Ciulla R, Prins A, Kuhn E, Gahm G. Bringing Internet-based education and intervention into mental health practice: afterdeployment.org. Eur J Psychotraumatol. 2011;2. doi: 10.3402/ejpt.v2i0.7278. Epub 2011 Nov 17.
- Background: PubMed 24402979Kuhn E, Greene C, Hoffman J, Nguyen T, Wald L, Schmidt J, Ramsey KM, Ruzek J. Preliminary evaluation of PTSD Coach, a smartphone app for post-traumatic stress symptoms. Mil Med. 2014 Jan;179(1):12-8. doi: 10.7205/MILMED-D-13-00271.
- Background: PubMed 30067844Clewley D, Rhon D, Flynn T, Koppenhaver S, Cook C. Health seeking behavior as a predictor of healthcare utilization in a population of patients with spinal pain. PLoS One. 2018 Aug 1;13(8):e0201348. doi: 10.1371/journal.pone.0201348. eCollection 2018.
- BackgroundDavies, C. C., & Nitz, A. J. (2009). Psychometric properties of the Roland-Morris Disability Questionnaire compared to the Oswestry Disability Index: a systematic review. Physical Therapy Reviews, 14(6), 399-408.
- Background: PubMed 24887571Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH task force on research standards for chronic low back pain. Spine (Phila Pa 1976). 2014 Jun 15;39(14):1128-43. doi: 10.1097/BRS.0000000000000434.
- BackgroundJensen, M. P., Turner, J. A., & Romano, J. M. (2000). Pain belief assessment: A comparison of the short and long versions of the surgery of pain attitudes. The Journal of Pain, 1(2), 138-150.
- Background: PubMed 26221000Keegan D, Byrne K, Cullen G, Doherty GA, Dooley B, Mulcahy HE. The Stressometer: A Simple, Valid, and Responsive Measure of Psychological Stress in Inflammatory Bowel Disease Patients. J Crohns Colitis. 2015 Oct;9(10):881-5. doi: 10.1093/ecco-jcc/jjv120. Epub 2015 Jul 27.
- Background: PubMed 2957704Linton SJ, Kamwendo K. Low back schools. A critical review. Phys Ther. 1987 Sep;67(9):1375-83. doi: 10.1093/ptj/67.9.1375.
- BackgroundMoffett, J. K., & Frost, H. (2000). Back to fitness programme: The manual for physiotherapists to set up the classes. Physiotherapy, 86(6), 295-305.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education, Exercise and Traditional Education in people with Chronic Low Back Pain and Post-traumatic Stress, run by Keller Army Community Hospital 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 4 inclusion and 9 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 27 Oct 2021. 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?
PTSD Check-list for Diagnostic and Statistical Manual of Mental Disorders (DSM 5) (PCL) (time frame: Baseline). The study lists 9 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 NCT05086159, which also lists 16 linked publications.
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 27 Oct 2021.