Scoliosis; AdolescenceNCT06424158
Massage Therapy After Thoracic or Lumbar Surgery
A study testing Massage Therapy in people with Scoliosis; Adolescence and Adolescent Idiopathic Scoliosis, Thoracic Region, run by Cook Children's Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 19 years
- Conditions the study is for
- Scoliosis; Adolescence, Adolescent Idiopathic Scoliosis, Thoracic Region, Adolescent Idiopathic Scoliosis, Lumbar Region
- What is being tested?
- Massage Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
Laurie Bailey, PhD, 682-885-2488, laurie.bailey@cookchildrens.org
Meredith Brooks, MD
About this study
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
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.
Read the 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
- Scoliosis; Adolescence, Adolescent Idiopathic Scoliosis, Thoracic Region, Adolescent Idiopathic Scoliosis, Lumbar Region
- Being tested
- Massage Therapy
- Keywords
- Spinal Fusion, Massage Therapy, Pain Management, Scoliosis
- Medical subject headings
- Scoliosis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-op day 2, day 4/5, week 2, week 6, and week 12
Secondary outcomes (7)
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.
Measured: Post-op day 2, day 4/5, week 2, week 6, and week 12
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.
Measured: Post-op day 2, day 4/5, week 2, week 6, and week 12
Blood pressure
Measured as systolic blood pressure over diastolic blood pressure in units of millimeters of mercury (mmHg)
Measured: Post-op day 2, day 4/5, week 2, week 6, and week 12
Heart Rate
Measured as beats per minute
Measured: Post-op day 2, day 4/5, week 2, week 6, and week 12
Respiratory Rate
Oxygen saturation (%) measured before and after the participant's designated intervention
Measured: Post-op day 2, day 4/5, week 2, week 6, and week 12
Pediatric Quality of Life Inventory (PedsQL™)
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.
Measured: Baseline, and weeks 6, 12 and 16 post-op
Use of opioid analgesics post-surgery
Count of opioid doses administered
Measured: Immediately after surgery, daily for up to 7 days after surgery, week 2, week 6, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start17 Feb 2021
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook Children's Health Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meredith Brooks, MD, Principal investigator, Cook Children's Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424158
- Sponsor's protocol ID
- 2020-088
- Status last verified
- May 2024
- First submitted
- 5 Apr 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
PubMed 20347836Beider 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.
PubMed 17342238Braun 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.
PubMed 22964355Blanco 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.
PubMed 23379574Connelly 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.
PubMed 24173016Erdogmus 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.
PubMed 17762803Falkensteiner 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.
PubMed 22007330Field 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.
PubMed 9583664Field T, Grizzle N, Scafidi F, Schanberg S. Massage and relaxation therapies' effects on depressed adolescent mothers. Adolescence. 1996 Winter;31(124):903-11.
PubMed 8970662Field 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.
PubMed 1537763Gan 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.
PubMed 24237004Jadhav 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.
PubMed 23196313Kain ZN. Postoperative maladaptive behavioral changes in children: incidence, risks factors and interventions. Acta Anaesthesiol Belg. 2000;51(4):217-26. No abstract available.
PubMed 11129622Kain 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.
PubMed 8953995
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06424158
- Acronym / sponsor ID
- 2020-088
- Conditions
- Scoliosis; Adolescence, Adolescent Idiopathic Scoliosis, Thoracic Region, Adolescent Idiopathic Scoliosis, Lumbar Region
- Keywords
- Spinal Fusion, Massage Therapy, Pain Management, Scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cook Children's Health Care SystemUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage Therapy Group | Experimental | Other: Massage TherapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 7 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage TherapyMassage 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. | Other | Massage Therapy Group |
Primary outcome
Pediatric Pain - Short Form (Neuro-QOL™)
Time frame: Post-op day 2, day 4/5, week 2, week 6, and week 12
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
Time frame: Post-op day 2, day 4/5, week 2, week 6, and week 12
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
Time frame: Post-op day 2, day 4/5, week 2, week 6, and week 12
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.
7 secondary outcomes
Pediatric Anxiety (PROMIS®)
Time frame: Post-op day 2, day 4/5, week 2, week 6, and week 12
Anxiety Thermometer
Time frame: Post-op day 2, day 4/5, week 2, week 6, and week 12
Blood pressure
Time frame: Post-op day 2, day 4/5, week 2, week 6, and week 12
Heart Rate
Time frame: Post-op day 2, day 4/5, week 2, week 6, and week 12
Respiratory Rate
Time frame: Post-op day 2, day 4/5, week 2, week 6, and week 12
Pediatric Quality of Life Inventory (PedsQL™)
Time frame: Baseline, and weeks 6, 12 and 16 post-op
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- BackgroundAmerican 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: PubMed 20347836Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
- Background: PubMed 17342238Beider 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.
- Background: PubMed 22964355Braun 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.
- Background: PubMed 23379574Blanco 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.
- Background: PubMed 24173016Connelly 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.
- Background: PubMed 17762803Erdogmus 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.
- Background: PubMed 22007330Falkensteiner 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.
- Background: PubMed 9583664Field 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.
- Background: PubMed 8970662Field T, Grizzle N, Scafidi F, Schanberg S. Massage and relaxation therapies' effects on depressed adolescent mothers. Adolescence. 1996 Winter;31(124):903-11.
- Background: PubMed 1537763Field 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.
- Background: PubMed 24237004Gan 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.
- Individual participant dataSharing planned: No
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Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meredith Brooks, MD principal investigator
Cook Children's Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Therapy in people with Scoliosis; Adolescence and Adolescent Idiopathic Scoliosis, Thoracic Region, run by Cook Children's Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Throy Campbell, PhD (682-885-1044, throy.campbell@cookchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Pain - Short Form (Neuro-QOL™) (time frame: Post-op day 2, day 4/5, week 2, week 6, and week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06424158, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.