Chronic Pain, Widespread, Musculoskeletal Pain, Pediatric Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALGraded Exposure Therapy (GET Living)
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.
BEHAVIORALMultidisciplinary 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.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Laura E Simons
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 8 - 18 years old; Male or Female * Musculoskeletal pain (e.g. localized \[back, limb\], diffuse) not due to acute trauma (e.g. active sprain or fracture). * Moderate to high pain-related fear ( ≥ 35 on the FOPQ-C) * Moderate to high functional disability ( ≥ 13 on the FDI) * English Language Proficiency
Exclusion criteria
* Significant cognitive impairment (e.g., brain injury) * Significant medical or psychiatric problem that would interfere (e.g., seizures, psychosis, suicidality)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain-related Fear and Avoidance | Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Disability | Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up. | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 33 |
| 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. | 35 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 6-month Follow Up | Lost to Follow-up | 2 | 3 |
| Treatment Phase (Baseline to 3-Month FU) | Physician Decision | 7 | 2 |
Baseline characteristics
| Characteristic | Graded Exposure Therapy (GET Living) | Multidisciplinary Pain Management (MPM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 33 Participants | 35 Participants | 68 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.1 years STANDARD_DEVIATION 2.92 | 14.2 years STANDARD_DEVIATION 2.24 | 14.1 years STANDARD_DEVIATION 2.57 |
| Avoidance of Activities | 26.67 score on a scale STANDARD_DEVIATION 8.59 | 25.06 score on a scale STANDARD_DEVIATION 8.71 | 25.84 score on a scale STANDARD_DEVIATION 8.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 26 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| FDI | 25.06 score on a scale STANDARD_DEVIATION 10.26 | 27 score on a scale STANDARD_DEVIATION 9.35 | 25.90 score on a scale STANDARD_DEVIATION 9.68 |
| Fear of Pain | 32.36 score on a scale STANDARD_DEVIATION 8.83 | 30.03 score on a scale STANDARD_DEVIATION 9.59 | 31.16 score on a scale STANDARD_DEVIATION 9.24 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 28 Participants | 27 Participants | 55 Participants |
| Region of Enrollment United States | 33 Participants | 35 Participants | 68 Participants |
| Sex: Female, Male Female | 31 Participants | 24 Participants | 55 Participants |
| Sex: Female, Male Male | 2 Participants | 11 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 35 |
| other Total, other adverse events | 0 / 33 | 0 / 35 |
| serious Total, serious adverse events | 0 / 33 | 0 / 35 |
Outcome results
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.
Time frame: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.
Population: Participants with data available at each time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Graded Exposure Therapy (GET Living) | Pain-related Fear and Avoidance | Fear of Pain_Baseline | 32.36 score on a scale | Standard Deviation 8.83 |
| Graded Exposure Therapy (GET Living) | Pain-related Fear and Avoidance | Fear of Pain_Discharge | 25.15 score on a scale | Standard Deviation 9.14 |
| Graded Exposure Therapy (GET Living) | Pain-related Fear and Avoidance | Fear of Pain_3 month follow-up | 22.24 score on a scale | Standard Deviation 11.53 |
| Graded Exposure Therapy (GET Living) | Pain-related Fear and Avoidance | Fear of Pain_6 month follow-up | 20.17 score on a scale | Standard Deviation 11.25 |
| Graded Exposure Therapy (GET Living) | Pain-related Fear and Avoidance | Avoidance of Activities_Baseline | 26.67 score on a scale | Standard Deviation 8.59 |
| Graded Exposure Therapy (GET Living) | Pain-related Fear and Avoidance | Avoidance of Activities_Discharge | 20.81 score on a scale | Standard Deviation 8.66 |
| Graded Exposure Therapy (GET Living) | Pain-related Fear and Avoidance | Avoidance of Activities_3 month follow-up | 18.92 score on a scale | Standard Deviation 10.75 |
| Graded Exposure Therapy (GET Living) | Pain-related Fear and Avoidance | Avoidance of Activities_6 month follow-up | 18.61 score on a scale | Standard Deviation 10.81 |
| Multidisciplinary Pain Management (MPM) | Pain-related Fear and Avoidance | Avoidance of Activities_6 month follow-up | 16.77 score on a scale | Standard Deviation 9.63 |
| Multidisciplinary Pain Management (MPM) | Pain-related Fear and Avoidance | Fear of Pain_Baseline | 30.03 score on a scale | Standard Deviation 9.59 |
| Multidisciplinary Pain Management (MPM) | Pain-related Fear and Avoidance | Avoidance of Activities_Baseline | 25.06 score on a scale | Standard Deviation 8.71 |
| Multidisciplinary Pain Management (MPM) | Pain-related Fear and Avoidance | Fear of Pain_Discharge | 25.64 score on a scale | Standard Deviation 10.64 |
| Multidisciplinary Pain Management (MPM) | Pain-related Fear and Avoidance | Avoidance of Activities_3 month follow-up | 18.73 score on a scale | Standard Deviation 9.89 |
| Multidisciplinary Pain Management (MPM) | Pain-related Fear and Avoidance | Fear of Pain_3 month follow-up | 20.03 score on a scale | Standard Deviation 11.54 |
| Multidisciplinary Pain Management (MPM) | Pain-related Fear and Avoidance | Avoidance of Activities_Discharge | 21.61 score on a scale | Standard Deviation 8.72 |
| Multidisciplinary Pain Management (MPM) | Pain-related Fear and Avoidance | Fear of Pain_6 month follow-up | 21.15 score on a scale | Standard Deviation 12.78 |
p-value: <0.05Mixed Models Analysis
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)
Time frame: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.
Population: Participants with data available at each time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Graded Exposure Therapy (GET Living) | Functional Disability | Baseline | 25.06 score on a scale | Standard Deviation 10.26 |
| Graded Exposure Therapy (GET Living) | Functional Disability | Discharge (approx. week 6) | 20.59 score on a scale | Standard Deviation 10.45 |
| Graded Exposure Therapy (GET Living) | Functional Disability | 3-month Follow Up | 20.08 score on a scale | Standard Deviation 12.75 |
| Graded Exposure Therapy (GET Living) | Functional Disability | 6-month Follow Up | 19.82 score on a scale | Standard Deviation 13.21 |
| Multidisciplinary Pain Management (MPM) | Functional Disability | 6-month Follow Up | 19.62 score on a scale | Standard Deviation 12.28 |
| Multidisciplinary Pain Management (MPM) | Functional Disability | Baseline | 27 score on a scale | Standard Deviation 9.35 |
| Multidisciplinary Pain Management (MPM) | Functional Disability | 3-month Follow Up | 19.24 score on a scale | Standard Deviation 10.08 |
| Multidisciplinary Pain Management (MPM) | Functional Disability | Discharge (approx. week 6) | 22 score on a scale | Standard Deviation 9.58 |
p-value: <0.05Mixed Models Analysis