## Protocol Section
### Identification Module
**NCT ID:** NCT06424158

**Brief Title:** Massage Therapy After Thoracic or Lumbar Surgery

**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

#### Organization Study ID Info
**ID:** 2020-088
#### Organization
**Class:** OTHER
**Full Name:** Cook Children's Health Care System
### Status Module
#### Completion Date
**Date:** 2026-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-17

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-05
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cook Children's Health Care System

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 subject's 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 participant's 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 patient's 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 (e.g., BP values, HR value, O2 levels) recorded clinically for post-op days 2 and 4/5; as the investigators are collecting in the massage group; however, no therapeutic intervention will occur. If the participant's 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 patient's electronic medical record and enter data into the study database. A study member will visit with the subject on day 2, day 4/5 (and every other day if length of stay is greater than five days) to collect anxiety and pain scores measurements.

### Conditions Module

**Conditions:**

- Scoliosis; Adolescence

- Adolescent Idiopathic Scoliosis, Thoracic Region

- Adolescent Idiopathic Scoliosis, Lumbar Region

**Keywords:**

- Spinal Fusion

- Massage Therapy

- Pain Management

- Scoliosis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Massage Therapy

**Label:** Massage Therapy Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Massage Therapy Group

**Description:** 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.

**Name:** Massage Therapy

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** 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.

**Measure:** Scoliosis Patient Questionnaire (SRS-30)

**Time Frame:** Baseline and 12-week post-op

#### Primary Outcomes

**Description:** 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.

**Measure:** Pediatric Pain - Short Form (Neuro-QOL™)

**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12

**Description:** 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.

**Measure:** Visual Analogue Scale (VAS) Pain Rating Scale

**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12

**Description:** 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.

**Measure:** Wong-Baker FACES® Pain Rating Scale

**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12

#### Secondary Outcomes

**Description:** 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.

**Measure:** Pediatric Anxiety (PROMIS®)

**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12

**Description:** 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.

**Measure:** Anxiety Thermometer

**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12

**Description:** Measured as systolic blood pressure over diastolic blood pressure in units of millimeters of mercury (mmHg)

**Measure:** Blood pressure

**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12

**Description:** Measured as beats per minute

**Measure:** Heart Rate

**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12

**Description:** Oxygen saturation (%) measured before and after the participant's designated intervention

**Measure:** Respiratory Rate

**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12

**Description:** A quality of life scale with 15 questions. Responses range from "Never" (1) to "Almost Always" (5) with the minimum score being 15 and the maximum being 75. Higher scores indicate worse outcome.

**Measure:** Pediatric Quality of Life Inventory (PedsQL™)

**Time Frame:** Baseline, and weeks 6, 12 and 16 post-op

**Description:** Count of opioid doses administered

**Measure:** Use of opioid analgesics post-surgery

**Time Frame:** Immediately after surgery, daily for up to 7 days after surgery, week 2, week 6, and week 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Maximum Age:** 19 Years

**Minimum Age:** 7 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** throy.campbell@cookchildrens.org

**Name:** Throy Campbell, PhD

**Phone:** 682-885-1044

**Role:** CONTACT

**Contact 2:**

**Email:** kristy.reyes@cookchildrens.org

**Name:** Kristy Reyes

**Phone:** 682-885-1044

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fort Worth

**Contacts:**

***Contact 1:***

- **Email:** laurie.bailey@cookchildrens.org

- **Name:** Laurie Bailey, PhD

- **Phone:** 682-885-2488

- **Role:** CONTACT

***Contact 2:***

- **Name:** Meredith Brooks, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Cook Children's Medical Center

**State:** Texas

**Status:** RECRUITING

**Zip:** 76104

#### Overall Officials

**Official 1:**

**Affiliation:** Cook Children's Health Care System

**Name:** Meredith Brooks, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 20347836

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**PMID:** 17342238

**Citation:** 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

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**PMID:** 23379574

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**PMID:** 24173016

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**PMID:** 17762803

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**PMID:** 22007330

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**PMID:** 8970662

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**PMID:** 1537763

**Citation:** 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

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**PMID:** 23196313

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013121

- Term: Spinal Curvatures

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15417

- Name: Scoliosis

- Relevance: HIGH

- As Found: Scoliosis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M15918

- Name: Spinal Curvatures

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012600

- Term: Scoliosis

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

### Intervention Browse Module - Browse Leaves

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
