Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424158
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-04-05
Brief Title:
Massage Therapy After Thoracic or Lumbar Surgery
Sponsor:
Cook Childrens Health Care System
Organization:
Cook Childrens Health Care System
Study Overview
Official Title:
The Impact of Massage Therapy on Post-Surgical Pain Anxiety Quality of Life and Opioid Analgesia Exposure on Children After Thoracic or Lumbar Surgery
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to look at the effect of massage therapy on the pain anxiety and quality of life that pediatric patients have after undergoing spinal fusion surgery This is a single-site prospective randomized interventional study design that will involve post-thoracic and post-lumbar spinal fusion surgeries of pediatric patients from 7 to 19 years of age that present to Cook Childrens Medical Center in Fort Worth Texas These patients will be identified prior to their scheduled spinal fusion surgery and recruited to enroll in the study The planned spinal fusion surgeries are not considered part of this research project but rather considered standard of care and would occur whether the patient is enrolled in this project or not Enrolled participants will be followed during their inpatient stay and through their subsequent follow-up visits at weeks 2 6 and 12 Participants will be randomly assigned to either a massage therapy group or a group that receives the standard normal care for recovery after surgery The final study involvement will occur at week 16 post-hospital discharge where a study team member will administer a quality of life PedsQL questionnaire via phone or mail with the subject Data will be collected after study related procedures are completed
Detailed Description:
There has been an increasing amount of spinal fusion surgeries in the United States These patients struggle with anxiety and stress before surgery and experience significant hardship during postoperative recovery including management of opioid related side effects effective pain control delay in mobilization and prolonged length of stay A growing body of research however has shown massage therapy MT as an effective alternative to conventional treatments MT raises the temperature of local tissues dilates capillaries accelerates the circulation of blood and lymph promotes the absorption of local tissue metabolism and mass inflammation improves the nutritional supply of surrounding muscle groups promotes their growth and development and relieves pain
The aim of this present study is to assess the effect of MT on perceived post-surgical pain anxiety and quality of life experienced by pediatric patients who have undergone thoracic and lumbar spinal fusion
Potential participants will be identified prior to their scheduled spinal fusion surgery and recruited to enroll in the study The planned spinal fusion surgeries are not considered part of this research project but rather considered standard of care and would occur whether the patient is enrolled in this project or not After surgery another review of inclusion and exclusion criteria will be done to determine the subjects continued eligibility for participation If criteria are met the child participant will be randomized into one of two study groups 1 Massage Therapy Group or 2 A Control Group for their post-surgery recovery plan Enrolled participants will be followed during their inpatient stay and through their subsequent follow-up visits at weeks 2 6 and 12 The final study involvement will occur at week 16 post-hospital discharge where a study team member will administer a quality of life questionnaire via phone or mail with the subject
All participants whom are randomized into the massage therapy group are treated by a certified pediatric massage therapist At least two 30- minute massage therapy sessions are performed on postoperative days two and four or five Either post-operative day 4 or 5 can be selected as a second in-patient massage therapy session as long as the session occurs Monday through Friday as the massage therapy service is not offered during the weekend hours of Saturday or Sunday If the participants length of stay is six days or longer the participant continues to receive treatment every other day for the duration of hospitalization Each individual patient is treated according to what their needs are which means one participant may prefer neck and shoulder massage and another may prefer legs and feet The participant remains in a position of comfort which for spinal fusion patients is generally in the supine sitting or side laying position A combination of therapies including myofascial release compression and Swedish massage will be employed Light and medium touch are applied but never deep tissue While scar mobilization is a desired outcome postoperatively this is not an immediate goal The incision site remains clean and covered without any manipulation Rehabilitation goals are to maximize mobility and flexibility of surrounding structures but is only addressed by the physical therapy team Massage therapy does not involve any form of stretching or range of motion techniques The study team will obtain vital data Blood Pressure Heart Rate and O2 stats along with VAS pain scale and anxiety rating scale measures before and after every session from the patients medical records
For those participants randomized into the control group they will continue to receive the normal standard of care as usual for their recovery and will be monitored by hospital staff in obtaining the same data points eg BP values HR value O2 levels recorded clinically for post-op days 2 and 45 as the investigators are collecting in the massage group however no therapeutic intervention will occur If the participants length of stay is greater than five days the study staff will continue to record these values every other day for the duration of hospitalization Study staff will retrieve these data variables via the patients electronic medical record and enter data into the study database A study member will visit with the subject on day 2 day 45 and every other day if length of stay is greater than five days to collect anxiety and pain scores measurements
The aim of this present study is to assess the effect of MT on perceived post-surgical pain anxiety and quality of life experienced by pediatric patients who have undergone thoracic and lumbar spinal fusion
Potential participants will be identified prior to their scheduled spinal fusion surgery and recruited to enroll in the study The planned spinal fusion surgeries are not considered part of this research project but rather considered standard of care and would occur whether the patient is enrolled in this project or not After surgery another review of inclusion and exclusion criteria will be done to determine the subjects continued eligibility for participation If criteria are met the child participant will be randomized into one of two study groups 1 Massage Therapy Group or 2 A Control Group for their post-surgery recovery plan Enrolled participants will be followed during their inpatient stay and through their subsequent follow-up visits at weeks 2 6 and 12 The final study involvement will occur at week 16 post-hospital discharge where a study team member will administer a quality of life questionnaire via phone or mail with the subject
All participants whom are randomized into the massage therapy group are treated by a certified pediatric massage therapist At least two 30- minute massage therapy sessions are performed on postoperative days two and four or five Either post-operative day 4 or 5 can be selected as a second in-patient massage therapy session as long as the session occurs Monday through Friday as the massage therapy service is not offered during the weekend hours of Saturday or Sunday If the participants length of stay is six days or longer the participant continues to receive treatment every other day for the duration of hospitalization Each individual patient is treated according to what their needs are which means one participant may prefer neck and shoulder massage and another may prefer legs and feet The participant remains in a position of comfort which for spinal fusion patients is generally in the supine sitting or side laying position A combination of therapies including myofascial release compression and Swedish massage will be employed Light and medium touch are applied but never deep tissue While scar mobilization is a desired outcome postoperatively this is not an immediate goal The incision site remains clean and covered without any manipulation Rehabilitation goals are to maximize mobility and flexibility of surrounding structures but is only addressed by the physical therapy team Massage therapy does not involve any form of stretching or range of motion techniques The study team will obtain vital data Blood Pressure Heart Rate and O2 stats along with VAS pain scale and anxiety rating scale measures before and after every session from the patients medical records
For those participants randomized into the control group they will continue to receive the normal standard of care as usual for their recovery and will be monitored by hospital staff in obtaining the same data points eg BP values HR value O2 levels recorded clinically for post-op days 2 and 45 as the investigators are collecting in the massage group however no therapeutic intervention will occur If the participants length of stay is greater than five days the study staff will continue to record these values every other day for the duration of hospitalization Study staff will retrieve these data variables via the patients electronic medical record and enter data into the study database A study member will visit with the subject on day 2 day 45 and every other day if length of stay is greater than five days to collect anxiety and pain scores measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None