ClinicalTrials.gg
RecruitingNCT05764681CPSPUpdated Sep 25, 2026

Chronic Postsurgical Pain

An observational study in Cerebral Palsy and Chronic Post Surgical Pain, sponsored by Chantel Burkitt. Recruiting at 2 sites in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Chantel Burkitt · Observational

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
5 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 372 studies in Cerebral Palsy with a site in United States — 76 open to participants now, 105 under way, none of them phase 3. Cerebral Palsy · United States.

Planned enrollment
7th of 71
500 · median 61
Started
2023
with 24 others
Observational
71 of 372
17 open now
Primary completion
2028-02
later than 67 of 104 live
Registered
276th of 372
by date

Among the 372 studies in Cerebral Palsy with a site in United States, this one is the 7th largest by planned enrollment of the 71 observational ones that give a count, is one of 25 that started in 2023, is one of 71 observational ones, reaches primary completion later than 67 of the 104 other live ones, and was the 276th registered.

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

Browse Cerebral Palsy studies →

Open to participants now

76 of the 372 studies in Cerebral Palsy with a site in United States are open now. Recruiting first, the newest first:

71 more — sign in →

All 76 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.

This study: 5 Years to 17 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 372 studies in Cerebral Palsy with a site in United States, or all of them as a file.
02

Study 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. 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.

Participants will complete:

  1. Questionnaires/Surveys via email and text message
  2. In-person Sensory Tests
  3. In-person Gait and Motion Analysis
03

Conditions studied

  • Cerebral Palsy
  • Chronic Post Surgical Pain

Keywords

  • Cerebral Palsy
  • Pain
  • Chronic Pain
  • Post Surgical Pain
  • Orthopedic Surgery
04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Non-English speaking and reading parent/guardian
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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.

    Time frame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Any time preoperative and 12 months postoperative

07

Study locations

2 of 2 sites recruiting
  • Nemour's Children's Hospital
    Wilmington, Delaware 19803, United States
    Recruiting
  • Gillette Children's Specialty Healthcare
    Saint Paul, Minnesota 55101, United States
    Recruiting
08

References and documents

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 ↗
  • Goubert L, Eccleston C, Vervoort T, Jordan A, Crombez G. Parental catastrophizing about their child's pain. The parent version of the Pain Catastrophizing Scale (PCS-P): a preliminary validation. Pain. 2006 Aug;123(3):254-263. doi: 10.1016/j.pain.2006.02.035. Epub 2006 Apr 27. PubMed 16644128 ↗
  • Engel JM, Wilson S, Tran ST, Jensen MP, Ciol MA. Pain catastrophizing in youths with physical disabilities and chronic pain. J Pediatr Psychol. 2013 Mar;38(2):192-201. doi: 10.1093/jpepsy/jss103. Epub 2012 Oct 1. PubMed 23033363 ↗
  • Breau LM, MacLaren J, McGrath PJ, Camfield CS, Finley GA. Caregivers' beliefs regarding pain in children with cognitive impairment: relation between pain sensation and reaction increases with severity of impairment. Clin J Pain. 2003 Nov-Dec;19(6):335-44. doi: 10.1097/00002508-200311000-00001. PubMed 14600533 ↗
  • Bursch B, Tsao JC, Meldrum M, Zeltzer LK. Preliminary validation of a self-efficacy scale for child functioning despite chronic pain (child and parent versions). Pain. 2006 Nov;125(1-2):35-42. doi: 10.1016/j.pain.2006.04.026. Epub 2006 Jun 5. PubMed 16740360 ↗
  • Duckworth AL, Quinn PD. Development and validation of the short grit scale (grit-s). J Pers Assess. 2009 Mar;91(2):166-74. doi: 10.1080/00223890802634290. PubMed 19205937 ↗
  • Perpina-Galvan J, Richart-Martinez M, Cabanero-Martinez MJ, Martinez-Dura I. Content validity of the short version of the subscale of the State-Trait Anxiety Inventory (STAI). Rev Lat Am Enfermagem. 2011 Jul-Aug;19(4):882-7. doi: 10.1590/s0104-11692011000400005. English, Portuguese, Spanish. PubMed 21876939 ↗
  • Connelly M, Fulmer RD, Prohaska J, Anson L, Dryer L, Thomas V, Ariagno JE, Price N, Schwend R. Predictors of postoperative pain trajectories in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2014 Feb 1;39(3):E174-81. doi: 10.1097/BRS.0000000000000099. PubMed 24173016 ↗
  • Fernandez-Blazquez MA, Avila-Villanueva M, Lopez-Pina JA, Zea-Sevilla MA, Frades-Payo B. Psychometric properties of a new short version of the State-Trait Anxiety Inventory (STAI) for the assessment of anxiety in the elderly. Neurologia. 2015 Jul-Aug;30(6):352-8. doi: 10.1016/j.nrl.2013.12.015. Epub 2014 Jan 28. English, Spanish. PubMed 24484757 ↗
  • Hermann C, Hohmeister J, Zohsel K, Ebinger F, Flor H. The assessment of pain coping and pain-related cognitions in children and adolescents: current methods and further development. J Pain. 2007 Oct;8(10):802-13. doi: 10.1016/j.jpain.2007.05.010. Epub 2007 Jul 12. PubMed 17631054 ↗
  • Ravens-Sieberer U, Gosch A, Rajmil L, Erhart M, Bruil J, Duer W, Auquier P, Power M, Abel T, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J, Kidscreen Group E. KIDSCREEN-52 quality-of-life measure for children and adolescents. Expert Rev Pharmacoecon Outcomes Res. 2005 Jun;5(3):353-64. doi: 10.1586/14737167.5.3.353. PubMed 19807604 ↗
  • Hidecker MJ, Paneth N, Rosenbaum PL, Kent RD, Lillie J, Eulenberg JB, Chester K Jr, Johnson B, Michalsen L, Evatt M, Taylor K. Developing and validating the Communication Function Classification System for individuals with cerebral palsy. Dev Med Child Neurol. 2011 Aug;53(8):704-10. doi: 10.1111/j.1469-8749.2011.03996.x. Epub 2011 Jun 27. PubMed 21707596 ↗
  • Harrison, P.L., Oakland, T., Adaptive Behavior Assessment System, Third Edition [Manual]. 2015, Torrance, CA: Western Psychological Services.
  • Bell KL, Benfer KA, Ware RS, Patrao TA, Garvey JJ, Arvedson JC, Boyd RN, Davies PSW, Weir KA. Development and validation of a screening tool for feeding/swallowing difficulties and undernutrition in children with cerebral palsy. Dev Med Child Neurol. 2019 Oct;61(10):1175-1181. doi: 10.1111/dmcn.14220. Epub 2019 Apr 1. PubMed 30937885 ↗
  • Breau LM, Camfield CS, McGrath PJ, Finley GA. The incidence of pain in children with severe cognitive impairments. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1219-26. doi: 10.1001/archpedi.157.12.1219. PubMed 14662579 ↗
  • Barney CC, Krach LE, Rivard PF, Belew JL, Symons FJ. Motor function predicts parent-reported musculoskeletal pain in children with cerebral palsy. Pain Res Manag. 2013 Nov-Dec;18(6):323-7. doi: 10.1155/2013/813867. PubMed 24308022 ↗
  • Rivard PF, Nugent AC, Symons FJ. Parent-proxy ratings of pain before and after botulinum toxin type A treatment for children with spasticity and cerebral palsy. Clin J Pain. 2009 Jun;25(5):413-7. doi: 10.1097/AJP.0b013e31819a6d07. PubMed 19454875 ↗
  • Tyler EJ, Jensen MP, Engel JM, Schwartz L. The reliability and validity of pain interference measures in persons with cerebral palsy. Arch Phys Med Rehabil. 2002 Feb;83(2):236-9. doi: 10.1053/apmr.2002.27466. PubMed 11833028 ↗
  • Savedra MC, Holzemer WL, Tesler MD, Wilkie DJ. Assessment of postoperation pain in children and adolescents using the adolescent pediatric pain tool. Nurs Res. 1993 Jan-Feb;42(1):5-9. PubMed 8424069 ↗
  • Matson JL, Malone CJ. Validity of the sleep subscale of the Diagnostic Assessment for the Severely Handicapped-II (DASH-II). Res Dev Disabil. 2006 Jan-Feb;27(1):85-92. doi: 10.1016/j.ridd.2005.03.001. Epub 2005 May 31. PubMed 15927446 ↗
  • Blankenburg M, Tietze AL, Hechler T, Hirschfeld G, Michel E, Koh M, Zernikow B. Snake: the development and validation of a questionnaire on sleep disturbances in children with severe psychomotor impairment. Sleep Med. 2013 Apr;14(4):339-51. doi: 10.1016/j.sleep.2012.12.008. Epub 2013 Mar 1. PubMed 23453904 ↗
  • Jenkins BN, Kain ZN, Kaplan SH, Stevenson RS, Mayes LC, Guadarrama J, Fortier MA. Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery. Paediatr Anaesth. 2015 Jul;25(7):738-45. doi: 10.1111/pan.12678. Epub 2015 May 9. PubMed 25958978 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Feb 2028, 59 months after the start.

Of 214 non-industry observational studies under Cerebral Palsy, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 60. This study's planned 59 months is above that.

Counting every sponsor, half of 218 studies reached it within 21 months; a quarter within 8 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2023
First posted
Mar 13, 2023
StartActual
Mar 17, 2023
Primary completionEst.
Feb 2028
CompletionEst.
Jan 2029
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and oversight details
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05764681
Lead sponsor
Chantel Burkitt
Responsible party
Chantel Burkitt (Principal Investigator, Gillette Children's Specialty Healthcare) — Sponsor-investigator
First posted
Mar 13, 2023
Start date
Mar 17, 2023
Primary completion
Feb 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Sep 25, 2026

Study contacts

Maykala Owens
Contact
maykalajowens@gillettechildrens.com
6512291717
Lisa Lykken
Contact
LisaALykken@gillettechildrens.com
6512291768
Chantel Burkitt, PhD
principal investigator · Gillette Children's, University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion