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Cerebral PalsyCPSPNCT05764681

Chronic Postsurgical Pain

An observational study of Cerebral Palsy and Chronic Post Surgical Pain, run by Chantel Burkitt at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study purpose is to document the typical trajectory of perioperative pain experience in Cerebral Palsy (CP) and to identify important predictive factors for the development of chronic postsurgical pain. The main aims of the investigators are to: 1. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Cerebral Palsy, Chronic Post Surgical Pain
How many people
500 participants
Where
2 sitesUnited States
Study dates
17 Mar 2023to Jan 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Individuals with Cerebral Palsy undergoing an orthopedic surgery at Gillette Children's Specialty Healthcare or Nemour's Children Hospital, Delaware

Who may be able to join

  • CP diagnosis
  • Have a scheduled lower extremity or spine orthopedic surgery

Who cannot join

  • Non-English speaking and reading parent/guardian

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maykala Owens contact

6512291717

maykalajowens@gillettechildrens.com

Lisa Lykken contact

6512291768

LisaALykken@gillettechildrens.com

United States2 sites, 2 recruiting

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota, 55101

    Chantel Burkitt, PhD, CBurkitt@gillettechildrens.com

    Chantel Burkitt, PhD

    Recruiting

  • Nemour's Children's Hospital

    Wilmington, Delaware, 19803

    Wade Shrader, MD, Wade.Shrader@nemours.org

    Wade Shrader, MD

    Recruiting

Other trials in United States

About this study

Official title: Chronic Postsurgical Pain in Cerebral Palsy

The study purpose is to document the typical trajectory of perioperative pain experience in Cerebral Palsy (CP) and to identify important predictive factors for the development of chronic postsurgical pain. The main aims of the investigators are to:

  1. Quantify the trajectory of pain and opioid use in the context of orthopedic surgery in children with CP.
  2. Identify predictors for CPSP in children with CP and develop an applicable risk index.
  3. Examine relationships between perioperative pain severity and functional/mobility outcomes achieved by orthopedic surgery in children with CP.
Read more

Participants will complete:

  1. Questionnaires/Surveys via email and text message
  2. In-person Sensory Tests
  3. In-person Gait and Motion Analysis
Keywords
Cerebral Palsy, Pain, Chronic Pain, Post Surgical Pain, Orthopedic Surgery
Medical subject headings
Cerebral Palsy, Pain, Postoperative, Pain, Chronic Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative

    The BPI assesses pain location, pain intensity at worst, least, average, and right now as well as the degree to which pain interferes with activities of daily living (e.g., sleep, relationships, and mobility). Items are scored on an 11-point scale (0 = does not interfere, 10 = completely interferes) creating a total interference score ranging from 0-120 (higher scores mean more pain interference). The BPI has been adapted for and tested with individuals with severe CP, resulting in excellent internal consistency (Cronbach's alpha = 0.89) and validity evidence [1, 29, 30]. The BPI will take parents/children 1-2 minutes to complete.

    Measured: 1 month preoperative, and 1, 3, 6, and 12 months postoperative

Secondary outcomes (4)

  1. Dalhousie Pain Interview (DPI)

    The DPI uses a 10-item survey to quantify pain intensity (Primary outcome variable; scored 0-10 with higher scores indicating more pain), duration (minutes/seconds in pain), and pain frequency (number of pain episodes) for each type of pain reported in the last week. The type and dose of pain-related medications is also collected. The DPI was developed to assess acute and chronic pain in children with developmental disabilities. The investigative team has considerable experience with the DPI and pain parameters have shown sensitivity to change after treatment [30, 31]. The DPI will take parents/children 5-15 minutes to complete.

    Measured: 1 month preoperative, and 1, 3, 6, and 12 months postoperative

  2. Numeric Rating Scale (NRS)

    The NRS of pain is considered the 'gold standard' and has been widely used to quantify pain intensity (0-10 scale; 0=no pain, 10=worst possible pain). We will use the NRS specific to head, shoulders, upper arm, elbow, forearm, wrist/hand, back, hip, upper leg, knee, lower leg, ankle, and foot pain. The NRS will complement the DPI since it is joint-specific, which is a critical element to capture when assessing orthopedic outcomes. The NRS will take parents/children 3 minutes to complete.

    Measured: From Post-Operative Day (POD) 3-90

  3. SNAKE (Schlaffragebogen für Kinder mit Neurologischen und Anderen Komplexen Erkrankungen)Sleep Questionnaire

    We will also collect the SNAKE Sleep Questionnaire via parent-report, a 43-item tool that measures the sleep environment, sleep patterns, and sleep behaviors (scores ranging from 23-92 with higher scores indicating more sleep difficulties). This tool was designed specifically for individuals with severe disabilities, and individuals with CP were included in the validation sample. The SNAKE will take parents 2-5 minutes to complete.

    Measured: 1 month preoperative, and 1, 3, 6, and 12 months postoperative

  4. Gait Outcomes Assessment List (GOAL)

    The GOAL had initial data published on it in 2011 [33]. It was developed for individuals with ambulatory CP and their parents as a comprehensive assessment of gait-related function. It is an outcome tool that incorporates all domains of the International Classification of Functioning, Disability and Health, including the influence of environment and personal factors [34].It contains 7 different domains and scores for each domain and for the total survey are standardized and range from 0 (worst) to 100 (best). A novel component of the GOAL is that it also incorporates the family's priorities for treatment.

    Measured: Any time preoperative and 12 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start17 Mar 2023
  3. Primary completionFeb 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05764681
Sponsor's protocol ID
STUDY00014668
Other IDs
1R01HD108406-01A1
Acronym
CPSP
Status last verified
Sep 2026
First submitted
2 Feb 2023
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barney CC, Stibb SM, Merbler AM, Summers RLS, Deshpande S, Krach LE, Symons FJ. Psychometric properties of the brief pain inventory modified for proxy report of pain interference in children with cerebral palsy with and without cognitive impairment. Pain Rep. 2018 Jul 17;3(4):e666. doi: 10.1097/PR9.0000000000000666. eCollection 2018 Jul-Aug.

    PubMed 30123858

  • Chidambaran V, Ding L, Moore DL, Spruance K, Cudilo EM, Pilipenko V, Hossain M, Sturm P, Kashikar-Zuck S, Martin LJ, Sadhasivam S. Predicting the pain continuum after adolescent idiopathic scoliosis surgery: A prospective cohort study. Eur J Pain. 2017 Aug;21(7):1252-1265. doi: 10.1002/ejp.1025. Epub 2017 Mar 27.

    PubMed 28346762

  • Delafontaine A, Presedo A, Mohamed D, Lopes D, Wood C, Alberti C. Equimolar mixture of nitroux oxyde and oxygen during post-operative physiotherapy in patients with cerebral palsy: A randomized, double-blind, placebo-controlled study. Eur J Pain. 2017 Nov;21(10):1657-1667. doi: 10.1002/ejp.1071. Epub 2017 Jul 20.

    PubMed 28726270

  • Boyer ER, Stout JL, Laine JC, Gutknecht SM, Araujo de Oliveira LH, Munger ME, Schwartz MH, Novacheck TF. Long-Term Outcomes of Distal Femoral Extension Osteotomy and Patellar Tendon Advancement in Individuals with Cerebral Palsy. J Bone Joint Surg Am. 2018 Jan 3;100(1):31-41. doi: 10.2106/JBJS.17.00480.

    PubMed 29298258

  • Dreher T, Thomason P, Svehlik M, Doderlein L, Wolf SI, Putz C, Uehlein O, Chia K, Steinwender G, Sangeux M, Graham HK. Long-term development of gait after multilevel surgery in children with cerebral palsy: a multicentre cohort study. Dev Med Child Neurol. 2018 Jan;60(1):88-93. doi: 10.1111/dmcn.13618. Epub 2017 Nov 24.

    PubMed 29171016

  • Munger ME, Aldahondo N, Krach LE, Novacheck TF, Schwartz MH. Long-term outcomes after selective dorsal rhizotomy: a retrospective matched cohort study. Dev Med Child Neurol. 2017 Nov;59(11):1196-1203. doi: 10.1111/dmcn.13500. Epub 2017 Aug 8.

    PubMed 28786493

  • Thomason P, Baker R, Dodd K, Taylor N, Selber P, Wolfe R, Graham HK. Single-event multilevel surgery in children with spastic diplegia: a pilot randomized controlled trial. J Bone Joint Surg Am. 2011 Mar 2;93(5):451-60. doi: 10.2106/JBJS.J.00410.

    PubMed 21368077

  • Wilson NC, Chong J, Mackey AH, Stott NS. Reported outcomes of lower limb orthopaedic surgery in children and adolescents with cerebral palsy: a mapping review. Dev Med Child Neurol. 2014 Sep;56(9):808-14. doi: 10.1111/dmcn.12431. Epub 2014 Mar 28.

    PubMed 24673603

  • Geil D, Thomas C, Zimmer A, Meissner W. Chronified Pain Following Operative Procedures. Dtsch Arztebl Int. 2019 Apr 12;116(15):261-266. doi: 10.3238/arztebl.2019.0261.

    PubMed 31130157

  • Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

    PubMed 29026331

  • Tucker A, McCusker D, Gupta N, Bunn J, Murnaghan M. Orthopaedic Enhanced Recovery Programme for Elective Hip and Knee Arthroplasty - Could a Regional Programme be Beneficial? Ulster Med J. 2016 May;85(2):86-91.

    PubMed 27601761

  • Totsch SK, Quinn TL, Strath LJ, McMeekin LJ, Cowell RM, Gower BA, Sorge RE. The impact of the Standard American Diet in rats: Effects on behavior, physiology and recovery from inflammatory injury. Scand J Pain. 2017 Oct;17:316-324. doi: 10.1016/j.sjpain.2017.08.009. Epub 2017 Sep 18.

    PubMed 28927908

  • Barney CC, Tervo R, Wilcox GL, Symons FJ. A Case-Controlled Investigation of Tactile Reactivity in Young Children With and Without Global Developmental Delay. Am J Intellect Dev Disabil. 2017 Sep;122(5):409-421. doi: 10.1352/1944-7558-122.5.409.

    PubMed 28846038

  • Barney CC, Merbler AM, Simone DA, Walk D, Symons FJ. Investigating the Feasibility of a Modified Quantitative Sensory Testing Approach to Profile Sensory Function and Predict Pain Outcomes Following Intrathecal Baclofen Implant Surgery in Cerebral Palsy. Pain Med. 2020 Jan 1;21(1):109-117. doi: 10.1093/pm/pnz114.

    PubMed 31268147

  • Haskett ME, Ahern LS, Ward CS, Allaire JC. Factor structure and validity of the parenting stress index-short form. J Clin Child Adolesc Psychol. 2006 Jun;35(2):302-12. doi: 10.1207/s15374424jccp3502_14.

    PubMed 16597226

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy and Chronic Post Surgical Pain, run by Chantel Burkitt at 2 sites 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maykala Owens (6512291717, maykalajowens@gillettechildrens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative (time frame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative). 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 NCT05764681, which also lists 36 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 25 Sep 2026.

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Chronic Postsurgical Pain (NCT05764681) | AzTrials