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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| United States Naval Medical Center, Portsmouth | FED |
| Henry M. Jackson Foundation for the Advancement of Military Medicine | OTHER |
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The study objective is to establish feasibility of implementing a psychologically informed rehabilitation strategy while concurrently assessing its' effectiveness in Active duty service members (ADSM) with musculoskeletal disorders (MSD) seeking care in a US Navy shore-based healthcare setting. This intervention is intended to improve the management of chronic pain in order to optimize ADSM function.
The study team is proposing an observational prospective comparative cohort study. This study tests an implementation/strategy while observing/gathering information on the clinical intervention and related outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Training Arm (Control) | To receive physical therapy treatment as usual, before PiPT occurs | ||
| Post-Training Arm (Intervention) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological-informed Physical Therapy (PiPT) Training | Behavioral | An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Disability Index (PDI) Score | PDI consists of 7 categories of life activity. The participant is asked to circle the number on the scale that describes the level of disability on typically experiences. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which one would normally be involved have been totally disrupted or prevented by pain. The total range of score is 0-70; the higher the score, the greater the person's disability due to pain. | Baseline, Follow-up 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Catastrophizing Scale (PCS) Score | PCS is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. Each item is rated on a 5-point Likert scale, from 0 (not at all) to 4 (all the time). The total range of score is 0-52; a higher score indicates a higher level of catastrophizing. A total score >30 indicates clinically relevant level of catastrophizing. |
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Inclusion Criteria:
Exclusion Criteria:
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US active duty service members (ADSM) receiving physical therapy for musculoskeletal disorders at Naval Medical Center Portsmouth (NMCP) and its branch health clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Marco Campello, PT, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to marco.campello@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Training Arm (Control) | To receive physical therapy treatment as usual, before PiPT occurs |
| FG001 | Post-Training Arm (Intervention) | Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Training Arm (Control) | To receive physical therapy treatment as usual, before PiPT occurs |
| BG001 | Post-Training Arm (Intervention) | Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Disability Index (PDI) Score | PDI consists of 7 categories of life activity. The participant is asked to circle the number on the scale that describes the level of disability on typically experiences. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which one would normally be involved have been totally disrupted or prevented by pain. The total range of score is 0-70; the higher the score, the greater the person's disability due to pain. | Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis. | Posted | Mean | Standard Deviation | Change in PDI score | Baseline, Follow-up 4 weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Training Arm (Control) | To receive physical therapy treatment as usual, before PiPT occurs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marco Campello, PT, PhD | NYU Langone Health | 212-255-6690 | Marco.campello@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2021 | Apr 25, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 22, 2022 | Feb 8, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Baseline, Follow-up 4 weeks |
| Change in Hospital Anxiety and Depression Scale (HADS) Score | HADS consists of two separate sub-sections: Anxiety and Depression. Each sub-section contains 7 items, where participants reply with responses that are closest to how he/she has been feeling in the past week with a score of 0-3. The total score range for both sub-sections is 0-21; a score of 0-7 indicates a "normal" range of anxiety, 8-10 = borderline abnormal, 11-21 = abnormal. The higher the score, the more abnormal the participant feels. | Baseline, Follow-up 4 weeks |
| Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score | FABQ is a self-reported questionnaire consisting of 16 questions scaled from 0-6. FABQ assesses the fear-avoidance beliefs of patients with chronic low back pain The total range of score is 0-96; a higher score indicates fear avoidance behaviors. For the purposes of this study, "I have a claim for compensation for my pain" will be excluded due to no relevance to the study. | Baseline, Follow-up 4 weeks |
| Change in Pain Self-Efficacy Questionnaire (PSEQ) Score | PSEQ is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. The total range of score is 0-60; a higher score indicates greater levels of confidence in dealing with pain. High scores are strongly associated with clinically-significant functional levels. | Baseline, Follow-up 4 weeks |
| MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction With Process of Care Score | Satisfaction with process of care is measured by the "process of care" subscale of the MRPS. There are 8 items in this subscale scored on a Likert scale of 1-5. The total score range is 8-40; the higher the score, the greater the satisfaction. | Follow-up 4 weeks |
| Core Outcome Measures Index (COMI) - Satisfaction With the Outcome Score | Satisfaction with the outcome is measured by a single item derived from COMI: "If you had to spend the rest of life with the symptoms you have right now, how would you feel about it?". The total range of score is 0-10; the higher the score, the worse one feels about the outcome. | Follow-up 4 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Post-Training Arm (Intervention) | Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation. |
|
|
| Secondary | Change in Pain Catastrophizing Scale (PCS) Score | PCS is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. Each item is rated on a 5-point Likert scale, from 0 (not at all) to 4 (all the time). The total range of score is 0-52; a higher score indicates a higher level of catastrophizing. A total score >30 indicates clinically relevant level of catastrophizing. | Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis. | Posted | Mean | Standard Deviation | Change in PCS score | Baseline, Follow-up 4 weeks |
|
|
|
| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) Score | HADS consists of two separate sub-sections: Anxiety and Depression. Each sub-section contains 7 items, where participants reply with responses that are closest to how he/she has been feeling in the past week with a score of 0-3. The total score range for both sub-sections is 0-21; a score of 0-7 indicates a "normal" range of anxiety, 8-10 = borderline abnormal, 11-21 = abnormal. The higher the score, the more abnormal the participant feels. | Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis. | Posted | Mean | Standard Deviation | Change in HADS score | Baseline, Follow-up 4 weeks |
|
|
|
| Secondary | Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score | FABQ is a self-reported questionnaire consisting of 16 questions scaled from 0-6. FABQ assesses the fear-avoidance beliefs of patients with chronic low back pain The total range of score is 0-96; a higher score indicates fear avoidance behaviors. For the purposes of this study, "I have a claim for compensation for my pain" will be excluded due to no relevance to the study. | Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis. | Posted | Mean | Standard Deviation | Change in FABQ score | Baseline, Follow-up 4 weeks |
|
|
|
| Secondary | Change in Pain Self-Efficacy Questionnaire (PSEQ) Score | PSEQ is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. The total range of score is 0-60; a higher score indicates greater levels of confidence in dealing with pain. High scores are strongly associated with clinically-significant functional levels. | Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis. | Posted | Mean | Standard Deviation | Change in PSEQ score | Baseline, Follow-up 4 weeks |
|
|
|
| Secondary | MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction With Process of Care Score | Satisfaction with process of care is measured by the "process of care" subscale of the MRPS. There are 8 items in this subscale scored on a Likert scale of 1-5. The total score range is 8-40; the higher the score, the greater the satisfaction. | Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Follow-up 4 weeks |
|
|
|
| Secondary | Core Outcome Measures Index (COMI) - Satisfaction With the Outcome Score | Satisfaction with the outcome is measured by a single item derived from COMI: "If you had to spend the rest of life with the symptoms you have right now, how would you feel about it?". The total range of score is 0-10; the higher the score, the worse one feels about the outcome. | Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Follow-up 4 weeks |
|
|
|
| 0 |
| 219 |
| 0 |
| 219 |
| 0 |
| 219 |
| EG001 | Post-Training Arm (Intervention) | Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation. | 0 | 208 | 0 | 208 | 0 | 208 |
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