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CompletedNCT01974791GET LivingUpdated Mar 29, 2018

GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain

An interventional study of GET Living in Chronic Pain, Neuralgia and Musculoskeletal Pain, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
8 Years to 18 Years
Sex
All
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Study summary

The broad aim of the 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. Pain-related fear is an important psychological factor associated with poor outcomes in children suffering with chronic pain. To examine the efficacy of GET Living in addressing pain-related fears the investigators propose to use a sequential replicated randomized single-case experimental phase design with multiple measures. The specific aims are to 1) evaluate the effectiveness and acceptability of individually tailored GET Living for children with high pain-related fear and functional disability and 2) define anatomical and resting state connectivity patterns in the brains of children and adolescents with complex chronic pain prior to and after participation in GET Living.

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Conditions studied

  • Chronic Pain
  • Neuralgia
  • Musculoskeletal Pain
  • Headache
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In context

Musculoskeletal Pain

493 studies on the registry are indexed under Musculoskeletal Pain; 114 are open to participants now.

This study's enrollment of 34 is below the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pain-related fear (score >40 on the Fear of Pain Questionnaire (FOPQ (Simons et al., 2011a))
  • Musculoskeletal, neuropathic limb or back pain, or headache
  • Functional limitations (score > 12 on the Functional Disability Inventory (FDI (Kashikar-Zuck et al., 2001; Walker and Greene, 1991)).

Exclusion criteria

Exclusion Criteria:

  • Significant cognitive impairment (e.g., intellectual disability)
  • Serious psychopathology (e.g., active suicidality).
  • Acute trauma (e.g., spondylolithesis, disk herniation, fracture, acute tendonitis)
  • Systemic disease in active inflammatory state
  • Biomechanical deficit that would limit ability to engage in exposure activities (e.g. severe muscle atrophy)
  • Making gains in current physical therapy or have not had physical therapy, but it is clearly indicated
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    GET Living Treatment

    Behavioral: GET Living

Interventions

  • BehavioralGET Living

    GET Living is an exposure based treatment jointly delivered by a cognitive-behavioral therapist and physical therapy to help children and adolescents suffering with chronic pain and headache progressively return to valued life activities.

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What researchers measure

Primary outcomes

  1. Decrease in Fear of Pain

    Time frame: Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average

Secondary outcomes

  1. Decrease in Functional Disability

    Time frame: Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average

  2. Improvement in School Functioning

    Time frame: Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average

  3. Decrease in Pain Catastrophizing

    Time frame: Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average

  4. Decrease in Pain Intensity

    Time frame: Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average

  5. Increase in Physical Activity

    Time frame: Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average

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Study locations

1 site
  • Boston Children's Hospital Waltham
    Waltham, Massachusetts 02453, United States
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References and documents

Publications

  • Beebe JA, Kronman C, Mahmud F, Basch M, Hogan M, Li E, Ploski C, Simons LE. Gait Variability and Relationships With Fear, Avoidance, and Pain in Adolescents With Chronic Pain. Phys Ther. 2021 Apr 4;101(4):pzab012. doi: 10.1093/ptj/pzab012. PubMed 33482005 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01974791
Lead sponsor
Boston Children's Hospital
Responsible party
Laura Simons(Giardi) (Staff Psychologist, Boston Children's Hospital) — Principal investigator
First posted
Nov 3, 2013
Start date
Oct 2013
Primary completion
Jan 2018
Completion
Jan 2018
Last update
Mar 29, 2018

Study contacts

Laura E Simons, PhD
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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