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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AR072921-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The broad aim of this study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain at the Stanford Pediatric Pain Management Clinic (PPMC). The investigators will evaluate the effectiveness and acceptability of this intervention for children with high levels of pain-related fear and functional disability. If proven efficacious, it will allow for the dissemination of this innovative treatment model to others working with children and adolescents with chronic pain.
The treatment intervention to be tested in this clinical trial is Graded in-vivo Exposure Treatment (GET Living) compared to Multidisciplinary Pain Management (MPM) in adolescents with chronic musculoskeletal pain. Participants will be randomized into GET Living or MPM, and will be instructed to not seek new treatments for pain for the duration of the study. Both treatments consist of 12 1-hour patient sessions delivered twice a week across 6- weeks and 3 parent-only sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Graded Exposure Therapy (GET Living) | Experimental | GET Living is jointly delivered by a pain psychologist and a physical therapist. The GET Living treatment was based on a published graded in-vivo exposure treatment manual for adults with adaptations to target a pediatric audience. |
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| Multidisciplinary Pain Management (MPM) | Active Comparator | MPM is a treatment intervention that is representative of current standards of care in a multidisciplinary pain clinic setting. It consists of Cognitive Behavioral Therapy (CBT) and Physical Therapy (PT) sessions, delivered separately by a pain psychologist and a physical therapist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Graded Exposure Therapy (GET Living) | Behavioral | The protocol consists of 12 interdisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Phase I-III are conducted with the psychologist, physical therapist, adolescent, and parent (as developmentally appropriate). Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain-related Fear and Avoidance | Fear of Pain Questionnaire (FOPQ-C): a 24-item validated patient-report measure of pain-related fear and avoidance. The FOPQ-C contains two subscales: Fear of Pain (11 items; Min=0, Max=44) and Avoidance of Activities (13 items; Min=0, Max=52). Higher scores on each subscale indicate greater pain related fear and avoidance of activities. | Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Disability | Functional Disability Inventory (FDI): a 15-item validated patient-report measure of difficulties in physical, social and recreational activities (score Min=0, Max=60; Lower score means less disability/better outcome) | Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Simons, PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Pain Management Clinic - Stanford Children's Health | Menlo Park | California | 94025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31650069 | Background | Simons LE, Harrison LE, O'Brien SF, Heirich MS, Loecher N, Boothroyd DB, Vlaeyen JWS, Wicksell RK, Schofield D, Hood KK, Orendurff M, Chan S, Lyons S. Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design. Contemp Clin Trials Commun. 2019 Sep 10;16:100448. doi: 10.1016/j.conctc.2019.100448. eCollection 2019 Dec. | |
| 35686576 | Result |
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Individual participant data (text, tables, figures, appendices) that underlie the results reported in an article related to this trial will, after de-identification, be shared with researchers who provide a methodologically sound proposal.
Beginning 3 months and ending 5 years following article publication.
Proposals should be directed to Dr. Laura Simons at lesimons@stanford.edu. To gain access, data requestors will need to sign a data usage agreement with Stanford University.
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| ID | Title | Description |
|---|---|---|
| FG000 | Graded Exposure Therapy (GET Living) | Graded Exposure Therapy (GET Living) is jointly delivered by a pain psychologist and a physical therapist: The protocol consists of 12 interdisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Phase I-III are conducted with the psychologist, physical therapist, adolescent, and parent (as developmentally appropriate). |
| FG001 | Multidisciplinary Pain Management (MPM) | Multidisciplinary Pain Management (MPM) protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological Cognitive Behavioral Therapy (CBT) sessions and Physical Therapy sessions. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase (Baseline to 3-Month FU) |
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| 6-month Follow Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Graded Exposure Therapy (GET Living) | Graded Exposure Therapy (GET Living) is jointly delivered by a pain psychologist and a physical therapist: The protocol consists of 12 interdisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Phase I-III are conducted with the psychologist, physical therapist, adolescent, and parent (as developmentally appropriate). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pain-related Fear and Avoidance | Fear of Pain Questionnaire (FOPQ-C): a 24-item validated patient-report measure of pain-related fear and avoidance. The FOPQ-C contains two subscales: Fear of Pain (11 items; Min=0, Max=44) and Avoidance of Activities (13 items; Min=0, Max=52). Higher scores on each subscale indicate greater pain related fear and avoidance of activities. | Participants with data available at each time point are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up. |
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Adverse events (AEs) were identified from signing of ICF to end of treatment, an average duration of 6 weeks. During the 3 month and 6 month follow-up contacts, the study staff asked patient and parent if any AEs occurred since the end of treatment.
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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 | Graded Exposure Therapy (GET Living) | Graded Exposure Therapy (GET Living) is jointly delivered by a pain psychologist and a physical therapist: The protocol consists of 12 interdisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Phase I-III are conducted with the psychologist, physical therapist, adolescent, and parent (as developmentally appropriate). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Simons | Stanford University Medical School | (650) 736-0838 | lesimons@stanford.edu |
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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 | Jan 21, 2021 | Jan 9, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2021 | Jul 8, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Adolescents will be randomized to either GET Living or TPM and stratified on fear (moderate/high; FOPQ-C: moderate [35-49] high [50-96]) and disability (moderate/high; moderate [13-29] severe [30-60]), to minimize the possibility of imbalance between the two treatment arms. To allow the use of small blocks while minimizing the probability of a blinded staff member predicting the next assignment we will use blocks of size two and four and randomly choose block sizes.
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| Multidisciplinary Pain Management (MPM) | Behavioral | The protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological CBT sessions and Physical Therapy sessions. Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills. |
|
| Shear D, Harrison LE, O'Brien S, Khazendar Z, Lyons S, Morgan JJ, Chan SK, Feinstein AB, Simons LE. Rapid Transition to Virtual Assessment and Treatment in an Interdisciplinary Randomized Clinical Trial for Youth With Chronic Pain: Adaptations and Implications for Future Trials. Clin J Pain. 2022 Jul 1;38(7):459-469. doi: 10.1097/AJP.0000000000001040. |
| 37624900 | Derived | Simons LE, Harrison LE, Boothroyd DB, Parvathinathan G, Van Orden AR, O'Brien SF, Schofield D, Kraindler J, Shrestha R, Vlaeyen JWS, Wicksell RK. A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain. Pain. 2024 Jan 1;165(1):177-191. doi: 10.1097/j.pain.0000000000003010. Epub 2023 Aug 25. |
| 36892929 | Derived | Schemer L, Hess CW, Van Orden AR, Birnie KA, Harrison LE, Glombiewski JA, Simons LE. Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach. J Particip Med. 2023 Mar 9;15:e41292. doi: 10.2196/41292. |
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| BG001 | Multidisciplinary Pain Management (MPM) | Multidisciplinary Pain Management (MPM) protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological CBT sessions and Physical Therapy sessions. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Fear of Pain | Fear of Pain Questionnaire (FOPQ-C): a 24-item validated patient-report measure of pain-related fear and avoidance. The FOPQ-C contains two subscales: Fear of Pain (11 items; Min=0, Max=44) and Avoidance of Activities (13 items; Min=0, Max=52). Higher scores on each subscale indicate greater pain related fear and avoidance of activities. Here we are presenting the Fear of Pain score only. | Mean | Standard Deviation | score on a scale |
|
| Avoidance of Activities | Fear of Pain Questionnaire (FOPQ-C): a 24-item validated patient-report measure of pain-related fear and avoidance. The FOPQ-C contains two subscales: Fear of Pain (11 items; Min=0, Max=44) and Avoidance of Activities (13 items; Min=0, Max=52). Higher scores on each subscale indicate greater pain related fear and avoidance of activities. Here we are presenting the Avoidance of Activity score only. | Mean | Standard Deviation | score on a scale |
|
| FDI | Functional Disability Inventory (FDI): a 15-item validated patient-report measure of difficulties in physical, social and recreational activities (score Min=0, Max=60; Lower score means less disability/better outcome). | Mean | Standard Deviation | score on a scale |
|
| OG001 | Multidisciplinary Pain Management (MPM) | MPM is a treatment intervention that is representative of current standards of care in a multidisciplinary pain clinic setting. It consists of Cognitive Behavioral Therapy (CBT) and Physical Therapy (PT) sessions, delivered separately by a pain psychologist and a physical therapist. Multidisciplinary Pain Management (MPM): The protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological CBT sessions and Physical Therapy sessions. Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills. |
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| Secondary | Functional Disability | Functional Disability Inventory (FDI): a 15-item validated patient-report measure of difficulties in physical, social and recreational activities (score Min=0, Max=60; Lower score means less disability/better outcome) | Participants with data available at each time point are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up. |
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| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Typical Pain Management (TPM) | Typical Pain Management (TPM) protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological Cognitive Behavioral Therapy (CBT) sessions and Physical Therapy sessions. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| Discharge (approx. week 6) |
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| 3-month Follow Up |
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| 6-month Follow Up |
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