Massage Therapy After Thoracic or Lumbar Surgery

NCT06424158 | Recruiting

• 1 other identifier: 2020-088
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Scoliosis; Adolescence; Adolescent Idiopathic Scoliosis, Thoracic Region; Adolescent Idiopathic Scoliosis, Lumbar Region

Keywords

Spinal Fusion; Massage Therapy; Pain Management; Scoliosis

Outcome Measures

Primary Outcomes (3)

• 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.

  Post-op day 2, day 4/5, week 2, week 6, and week 12

• 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.

  Post-op day 2, day 4/5, week 2, week 6, and week 12

• 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.

  Post-op day 2, day 4/5, week 2, week 6, and week 12

Secondary Outcomes (7)

• Pediatric Anxiety (PROMIS®)

  Post-op day 2, day 4/5, week 2, week 6, and week 12

• Anxiety Thermometer

  Post-op day 2, day 4/5, week 2, week 6, and week 12

• Blood pressure

  Post-op day 2, day 4/5, week 2, week 6, and week 12

• Heart Rate

  Post-op day 2, day 4/5, week 2, week 6, and week 12

• Respiratory Rate

  Post-op day 2, day 4/5, week 2, week 6, and week 12

Other Outcomes (1)

• Scoliosis Patient Questionnaire (SRS-30)

  Baseline and 12-week post-op

Study Arms (2)

Massage Therapy Group

EXPERIMENTAL

Participants in the massage therapy group are treated by a certified pediatric massage therapist for at least two 30- minute massage therapy sessions performed on postoperative days two and four or five. Participants will continue to receive standard of care, including any pain medications as needed.

Other: Massage Therapy

Control Group

NO INTERVENTION

Participants in control group 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 recorded clinically for post-op days 2 and 4/5; however, no therapeutic intervention will occur.

Interventions

Massage Therapy OTHER

Massage 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.

Massage Therapy Group

Eligibility Criteria

• Age: 7 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Chronic opioid usage
• History of psychosis
• Prolonged bleeding
• Intubation greater than 24 hours
• Illicit/recreation drug use
• Paralysis diagnosis
• History of chronic pain requiring medical intervention
• Neuromuscular scoliosis diagnosis
• Cerebral palsy diagnosis
• Developmental delay characteristics

Sponsors & Collaborators

• Cook Children's Health Care System: lead

Study Sites (1)

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

RECRUITING

Related Publications (25)

• American Massage Therapy Association. Massage Therapy Industry Fact Sheet. (2019). American Massage Therapy Association website. https://www.amtamassage.org/globalassets/documents/src/2019-pdf.pdf. Published 2019. Accessed June 22, 2020.

  BACKGROUND

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  PMID: 20347836 BACKGROUND

• Beider S, Moyer CA. Randomized controlled trials of pediatric massage: a review. Evid Based Complement Alternat Med. 2007 Mar;4(1):23-34. doi: 10.1093/ecam/nel068. Epub 2006 Nov 3.

  PMID: 17342238 BACKGROUND

• Braun LA, Stanguts C, Casanelia L, Spitzer O, Paul E, Vardaxis NJ, Rosenfeldt F. Massage therapy for cardiac surgery patients--a randomized trial. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1453-9, 1459.e1. doi: 10.1016/j.jtcvs.2012.04.027. Epub 2012 Sep 7.

  PMID: 22964355 BACKGROUND

• Blanco JS, Perlman SL, Cha HS, Delpizzo K. Multimodal pain management after spinal surgery for adolescent idiopathic scoliosis. Orthopedics. 2013 Feb;36(2 Suppl):33-5. doi: 10.3928/01477447-20130122-55.

  PMID: 23379574 BACKGROUND

• 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.

  PMID: 24173016 BACKGROUND

• Erdogmus CB, Resch KL, Sabitzer R, Muller H, Nuhr M, Schoggl A, Posch M, Osterode W, Ungersbock K, Ebenbichler GR. Physiotherapy-based rehabilitation following disc herniation operation: results of a randomized clinical trial. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2041-9. doi: 10.1097/BRS.0b013e318145a386.

  PMID: 17762803 BACKGROUND

• Falkensteiner M, Mantovan F, Muller I, Them C. The use of massage therapy for reducing pain, anxiety, and depression in oncological palliative care patients: a narrative review of the literature. ISRN Nurs. 2011;2011:929868. doi: 10.5402/2011/929868. Epub 2011 Aug 23.

  PMID: 22007330 BACKGROUND

• Field TM, Quintino O, Hernandez-Reif M, Koslovsky G. Adolescents with attention deficit hyperactivity disorder benefit from massage therapy. Adolescence. 1998 Spring;33(129):103-8.

  PMID: 9583664 BACKGROUND

• Field T, Grizzle N, Scafidi F, Schanberg S. Massage and relaxation therapies' effects on depressed adolescent mothers. Adolescence. 1996 Winter;31(124):903-11.

  PMID: 8970662 BACKGROUND

• Field T, Morrow C, Valdeon C, Larson S, Kuhn C, Schanberg S. Massage reduces anxiety in child and adolescent psychiatric patients. J Am Acad Child Adolesc Psychiatry. 1992 Jan;31(1):125-31. doi: 10.1097/00004583-199201000-00019.

  PMID: 1537763 BACKGROUND

• Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.

  PMID: 24237004 BACKGROUND

• Jadhav MP, Jadhav PM, Shelke P, Sharma Y, Nadkar M. Assessment of use of complementary alternative medicine and its impact on quality of life in the patients attending rheumatology clinic, in a tertiary care centre in India. Indian J Med Sci. 2011 Feb;65(2):50-7.

  PMID: 23196313 BACKGROUND

• Kain ZN. Postoperative maladaptive behavioral changes in children: incidence, risks factors and interventions. Acta Anaesthesiol Belg. 2000;51(4):217-26. No abstract available.

  PMID: 11129622 BACKGROUND

• Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.

  PMID: 8953995 BACKGROUND

• Martin CT, Pugely AJ, Gao Y, Mendoza-Lattes SA, Ilgenfritz RM, Callaghan JJ, Weinstein SL. Increasing hospital charges for adolescent idiopathic scoliosis in the United States. Spine (Phila Pa 1976). 2014 Sep 15;39(20):1676-82. doi: 10.1097/BRS.0000000000000501.

  PMID: 24983937 BACKGROUND

• Mathews L. Pain in children: neglected, unaddressed and mismanaged. Indian J Palliat Care. 2011 Jan;17(Suppl):S70-3. doi: 10.4103/0973-1075.76247.

  PMID: 21811376 BACKGROUND

• McGregor AH, Dore CJ, Morris TP, Morris S, Jamrozik K. Function after spinal treatment, exercise and rehabilitation (FASTER): improving the functional outcome of spinal surgery. BMC Musculoskelet Disord. 2010 Jan 26;11:17. doi: 10.1186/1471-2474-11-17.

  PMID: 20102625 BACKGROUND

• Muhly WT, Sankar WN, Ryan K, Norton A, Maxwell LG, DiMaggio T, Farrell S, Hughes R, Gornitzky A, Keren R, McCloskey JJ, Flynn JM. Rapid Recovery Pathway After Spinal Fusion for Idiopathic Scoliosis. Pediatrics. 2016 Apr;137(4):e20151568. doi: 10.1542/peds.2015-1568. Epub 2016 Mar 23.

  PMID: 27009035 BACKGROUND

• Noshchenko A, Hoffecker L, Lindley EM, Burger EL, Cain CM, Patel VV, Bradford AP. Predictors of spine deformity progression in adolescent idiopathic scoliosis: A systematic review with meta-analysis. World J Orthop. 2015 Aug 18;6(7):537-58. doi: 10.5312/wjo.v6.i7.537. eCollection 2015 Aug 18.

  PMID: 26301183 BACKGROUND

• Rumalla K, Yarbrough CK, Pugely AJ, Koester L, Dorward IG. Spinal fusion for pediatric neuromuscular scoliosis: national trends, complications, and in-hospital outcomes. J Neurosurg Spine. 2016 Oct;25(4):500-508. doi: 10.3171/2016.2.SPINE151377. Epub 2016 May 20.

  PMID: 27203810 BACKGROUND

• Smith SL, Lux R, Haley S, Slater H, Beachy J, Moyer-Mileur LJ. The effect of massage on heart rate variability in preterm infants. J Perinatol. 2013 Jan;33(1):59-64. doi: 10.1038/jp.2012.47. Epub 2012 Apr 26.

  PMID: 22538325 BACKGROUND

• Staveski SL, Boulanger K, Erman L, Lin L, Almgren C, Journel C, Roth SJ, Golianu B. The Impact of Massage and Reading on Children's Pain and Anxiety After Cardiovascular Surgery: A Pilot Study. Pediatr Crit Care Med. 2018 Aug;19(8):725-732. doi: 10.1097/PCC.0000000000001615.

  PMID: 29912070 BACKGROUND

• Theologis AA, Sing DC, Chekeni F, Diab M. National Trends in the Surgical Management of Adolescent Idiopathic Scoliosis: Analysis of a National Estimate of 60,108 Children From the National Inpatient Sample Over a 13-Year Time Period in the United States. Spine Deform. 2017 Jan;5(1):56-65. doi: 10.1016/j.jspd.2016.09.001.

  PMID: 28038695 BACKGROUND

• Yang S, Werner BC. Risk Factors for Prolonged Postoperative Opioid Use After Spinal Fusion for Adolescent Idiopathic Scoliosis. J Pediatr Orthop. 2019 Nov/Dec;39(10):500-504. doi: 10.1097/BPO.0000000000001139.

  PMID: 31599858 BACKGROUND

MeSH Terms

Conditions

Scoliosis; Agnosia

Interventions

Massage

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Meredith Brooks, MD

  Cook Children's Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Throy Campbell, PhD

CONTACT

682-885-1044; throy.campbell@cookchildrens.org

Kristy Reyes

CONTACT

682-885-1044; kristy.reyes@cookchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: May 22, 2024
• Study Start: February 17, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)