Chronic Postsurgical Pain

Cerebral Palsy Clinical Trial

— CPSP  

Official title:

Chronic Postsurgical Pain in Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764681
• Other study ID #: STUDY00014668
• Secondary ID: 1R01HD108406-01A
• Status: Recruiting
• Start date: March 17, 2023
• Est. completion date: January 2029

Study information

• Verified date: January 2024
• Source: Gillette Children's Specialty Healthcare
• Contact: Maykala Owens
• Phone: 6512291717
• Email: maykalajowens[@]gillettechildrens.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2029
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• CP diagnosis

• Have a scheduled lower extremity or spine orthopedic surgery

Exclusion Criteria:

• Non-English speaking and reading parent/guardian

Related Conditions & MeSH terms

• Cerebral Palsy
• Chronic Post Surgical Pain
• Pain, Postoperative

Locations

Country	Name	City	State
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota
United States	Nemour's Children's Hospital	Wilmington	Delaware

Sponsors (5)

Lead Sponsor	Collaborator
Chantel Burkitt	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Nemours Children's Hospital, Delaware, University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (36)

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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. — View Citation

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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. — View Citation

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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. — View Citation

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month preoperative, and 1, 3, 6, and 12 months postoperative
Secondary	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.	1 month preoperative, and 1, 3, 6, and 12 months postoperative
Secondary	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.	From Post-Operative Day (POD) 3-90
Secondary	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.	1 month preoperative, and 1, 3, 6, and 12 months postoperative
Secondary	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.	Any time preoperative and 12 months postoperative