About this trial
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 Children's 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled to undergo their first thoracic or lumbar spinal fusion surgery
Able to participate and perform in a massage therapy as a recovery option
Participant needs to be verbal
Ability to understand study procedures and to comply with them for the entire length of the study
Disqualifiers
Prospective patients scheduled to undergo any spinal fusion other than a thoracic or lumbar spinal fusion surgery.
Prospective patients scheduled to undergo a second or multiple thoracic or lumbar spinal fusion surgery
Previous cardiac surgery
Chronic pain syndromes
Trial design
Parallel
Treatments tested in this trial
Massage Therapy
Other interventionMassage therapy (MT) has been proven as an alternative non-opioid pain management intervention, particularly towards reducing pain, diminishing depression, improving immune function, and increasing alertness in the adult population. 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.
Treatment groups
Trial outcomes
Primary outcomes
Pediatric Pain - Short Form (Neuro-QOL™)
A pain scale with 10 items. Responses range from "Never" (1) to "Almost Always" (5) with the minimum score being 10 and the maximum score being 50. Higher scores indicate worse outcome.
Visual Analogue Scale (VAS) Pain Rating Scale
A pain scale with one question asking patients to choose a number from 0 to 10 that best describes their pain from "No Pain" (0) to "Unbearable Pain" (10) with the minimum score being 0 and the maximum being 10. Higher scores indicate worse outcome.
Wong-Baker FACES® Pain Rating Scale
A pain scale with one question asking patients to choose a number from 0 to 5 that best describes their pain from "No Hurt" (0) to "Hurts Worst" (10) with the minimum score being 1 and the maximum score being 5. Higher scores indicate worse outcome.
Secondary outcomes
Pediatric Anxiety (PROMIS®)
An anxiety measure with 14 statements. Responses range from "Never" (1) to "Almost Always" (5). with the minimum score being 14 and the maximum being 70. Higher scores indicate worse outcome.
Anxiety Thermometer
An anxiety scale with one question asking patients to choose a number between 1 "Calm and content" and 10 "Extremely anxious, unable to function" that best describes their level of anxiety. The minimum score is 1 and the maximum score is 10. Higher scores indicate worse outcome.
Blood pressure
Measured as systolic blood pressure over diastolic blood pressure in units of millimeters of mercury (mmHg)
Heart Rate
Measured as beats per minute
Other outcomes
Scoliosis Patient Questionnaire (SRS-30)
A questionnaire with 30 questions related to health-related quality of life. Each question is scored on 1-5 scale with the minimum value being 30 and the maximum 150. Higher scores indicate worse outcome.
Sponsors and contacts
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