Massage Therapy for Scoliosis

Overseen By Meredith Brooks, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Cook Children's Health Care System

Must not be taking: Opioids, Illicit drugs

Disqualifiers: Chronic pain, Psychosis, Paralysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Up to 6 days

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have chronic opioid usage or a history of chronic pain requiring medical intervention, you may not be eligible to participate.

Is massage therapy generally safe for humans?

Massage therapy is generally considered safe, but it can have some risks. Serious adverse events (unwanted effects) are rare, but they can include issues like disc herniation (a problem with the spine), soft tissue trauma (injury to muscles or ligaments), and spinal cord injury. Most adverse events are mild and temporary. ^{1 2 3 4 5}

How does massage therapy differ from other treatments for scoliosis?

Massage therapy is unique for scoliosis as it involves hands-on techniques to manipulate soft tissues, which can help relieve muscle pain and improve range of motion. Unlike standard medical treatments that may involve medication or surgery, massage therapy is a non-invasive approach that focuses on physical manipulation to address symptoms. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Massage Therapy for Scoliosis?

Research shows that massage therapy can help reduce pain and improve range of motion in people with low back pain, which might be similar to benefits for scoliosis. Additionally, massage therapy has been found to improve relaxation, sleep, and reduce anxiety in cancer patients, suggesting it may have positive effects for scoliosis patients as well. ^{7 11 12 13 14}

Who Is on the Research Team?

Meredith Brooks, MD

Principal Investigator

Cook Children's Health Care System

Are You a Good Fit for This Trial?

This trial is for pediatric patients aged 7 to 19 who are undergoing spinal fusion surgery at Cook Children's Medical Center in Fort Worth, Texas. They must be scheduled for standard thoracic or lumbar surgery and able to participate in follow-up visits.

Inclusion Criteria

I am able to participate in massage therapy for recovery.

I can communicate using spoken words.

I am scheduled for my first spine fusion surgery in the chest or lower back area.

Exclusion Criteria

I have chronic pain that needs medical treatment.

I am scheduled for spinal fusion surgery that is not in my thoracic or lumbar region.

I have been diagnosed with neuromuscular scoliosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive massage therapy or standard care during their inpatient stay post-surgery

Up to 6 days

Daily visits during inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Follow-up visits at weeks 2, 6, 12, and 16

What Are the Treatments Tested in This Trial?

Interventions

• Massage Therapy

Trial Overview The study tests the impact of massage therapy on pain, anxiety, and quality of life after spinal fusion surgery compared to standard care. Participants will be randomly assigned to either receive massage therapy or the usual post-surgery care.

How Is the Trial Designed?

Group I: Massage Therapy Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 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 Is Running the Clinical Trial?

Cook Children's Health Care System

Lead Sponsor

Trials

11

Recruited

5,001,000+

Published Research Related to This Trial

Massage therapy may help reduce anxiety and improve physical symptoms like pain and nausea in cancer patients, based on a review of 10 trials involving various healthcare settings.

However, the current evidence is not strong enough to make definitive conclusions about its overall effectiveness, highlighting the need for more rigorous and larger studies in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage for symptom relief in patients with cancer: systematic review. Wilkinson, S., Barnes, K., Storey, L.[2022]

Massage therapy has been shown to provide significant benefits for cancer patients, including improved relaxation, sleep quality, immune responses, and relief from fatigue, pain, anxiety, and nausea.

Due to these positive effects, some major cancer centers in the U.S. are beginning to incorporate massage therapy into their treatment programs, highlighting its importance in addressing the emotional and physical needs of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of massage therapy in cancer care. Russell, NC., Sumler, SS., Beinhorn, CM., et al.[2011]

Massage therapy was effective in reducing low back pain (LBP) intensity and increasing range of motion (ROM) in a client suffering from LBP and sciatica over a 10-week period, with weekly 45-minute sessions.

The client experienced a steady improvement in daily activities, suggesting that massage therapy could serve as a beneficial non-pharmacological treatment for managing pain and symptoms associated with low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage therapy helps to increase range of motion, decrease pain and assist in healing a client with low back pain and sciatica symptoms. Bell, J.[2008]

A systematic review of 7 clinical trials involving children with cancer found that therapeutic massage can significantly reduce symptoms such as pain, nausea, stress, and anxiety, while also increasing white blood cells and neutrophils.

Different massage techniques, including Swedish massage and effleurage, were used in the studies, indicating that massage may be a beneficial complementary therapy for managing symptoms in pediatric cancer patients, although further research is needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the application of therapeutic massage in children with cancer: a systematic review. Rodríguez-Mansilla, J., González-Sánchez, B., Torres-Piles, S., et al.[2022]

Massage therapy (MT) significantly improved psychological well-being in pediatric oncology and hematology patients, reducing state and trait anxiety and enhancing emotional state, based on a study of 30 children aged 6 months to 17 years.

MT also led to notable physical benefits, including reduced muscle soreness, discomfort, and improved respiratory rate, indicating that it can enhance the overall quality of life for children with cancer and blood diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children with cancer and blood diseases experience positive physical and psychological effects from massage therapy. Haun, JN., Graham-Pole, J., Shortley, B.[2022]

A review of 40 reports from 2003 to 2013 identified 138 adverse events (AEs) related to pain-related massage, highlighting that while serious complications like disc herniation and spinal cord injury can occur, the overall incidence of these events is low.

The findings suggest that although massage therapies carry some risks, particularly with spinal manipulation, they are generally considered safe when performed by qualified practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of massage therapy in pain-related conditions: a systematic review. Yin, P., Gao, N., Wu, J., et al.[2022]

A significant number of patients (55%) reported experiencing benign adverse events (AEs) like pain and stiffness after spinal manipulative therapy (SMT), highlighting the need for effective management strategies.

While most chiropractors believe in the occurrence of benign AEs and attempt mitigation strategies, only a small percentage of patients feel these strategies are implemented, indicating a gap in communication and patient education that could enhance care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beliefs, perceptions and practices of chiropractors and patients about mitigation strategies for benign adverse events after spinal manipulation therapy. Funabashi, M., Pohlman, KA., Goldsworthy, R., et al.[2023]

Massage therapy has shown potential benefits for cancer patients, particularly in reducing anxiety and pain, making it a supportive therapy in medical centers.

Further research with larger and more consistent patient groups is needed to determine the most effective types of massage for different cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of massage therapy in cancer care. Myers, CD., Walton, T., Small, BJ.[2011]

A systematic review of 60 studies on massage therapy in children found that while many studies did not report adverse events (AEs), 26.6% reported at least one AE, ranging from mild to severe.

Notably, there was a concerning association between abdominal massage and severe AEs, including volvulus in premature infants, which raises safety concerns and suggests caution in using abdominal massage for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with paediatric massage therapy: a systematic review. Karkhaneh, M., Zorzela, L., Jou, H., et al.[2022]

A systematic review of 283 reviews on spinal manipulative therapy (SMT) found that while 46% deemed SMT safe, 13% considered it harmful, indicating a significant divide in opinions on its safety.

Serious adverse events (SAEs) associated with SMT, such as stroke and vertebral artery dissection, were reported, with incidence estimates ranging from 1 in 20,000 to 1 in 250,000,000 manipulations, highlighting that some risk is present.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The risk associated with spinal manipulation: an overview of reviews. Nielsen, SM., Tarp, S., Christensen, R., et al.[2022]

A survey of 436 respondents in Saudi Arabia revealed that 81.4% believe massage therapy (MT) is effective for conditions like muscle pain and stress relief, indicating a positive perception of its benefits.

Despite the general belief in its effectiveness, there is a lack of comprehensive knowledge about MT, with over half of the participants suggesting that patients should consult their physicians before undergoing therapy, highlighting the need for better education on MT's safety and application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based survey on massage therapy in Saudi Arabia. Al-Yousef, HM., Wajid, S., Sales, I.[2020]

A study involving 243 pediatric patients with hematologic and oncologic conditions showed that massage therapy significantly reduced pain, stress, and anxiety, with all patients reporting clinically meaningful improvements after treatment.

Patients with sickle cell disease experienced higher levels of pain, stress, and anxiety before treatment compared to those with other hematologic or oncologic conditions, but all groups benefited from massage therapy, particularly the HemOnc group which reported greater reductions in pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage therapy for children, adolescents, and young adults: Clinical delivery and effectiveness in hematology and oncology. Rodgers-Melnick, SN., Bartolovich, M., Desai, NJ., et al.[2023]

Massage therapy significantly reduces cancer pain, with a standardized mean difference of -1.16 based on a meta-analysis of 13 randomized controlled trials involving 1000 patients.

Foot reflexology and hand acupressure are particularly effective, especially for patients in the perioperative period and those with hematological malignancies, with no reported adverse events in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage therapy can effectively relieve cancer pain: A meta-analysis. Zhang, Y., Wang, S., Ma, X., et al.[2023]

There are still misconceptions among oncology providers and patients regarding the safety of massage therapy in cancer care, particularly the outdated belief that massage could cause cancer to spread (metastasize).

The commentary highlights the need for better cancer-related training in massage education to improve understanding and integration of touch-based therapies in cancer treatment and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage therapy in cancer care: an overview of the past, present, and future. MacDonald, G.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Massage for symptom relief in patients with cancer: systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Role of massage therapy in cancer care. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Massage therapy helps to increase range of motion, decrease pain and assist in healing a client with low back pain and sciatica symptoms. [2008]

4. Brazil pubmed.ncbi.nlm.nih.gov

Effects of the application of therapeutic massage in children with cancer: a systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Children with cancer and blood diseases experience positive physical and psychological effects from massage therapy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events of massage therapy in pain-related conditions: a systematic review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Beliefs, perceptions and practices of chiropractors and patients about mitigation strategies for benign adverse events after spinal manipulation therapy. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The value of massage therapy in cancer care. [2011]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with paediatric massage therapy: a systematic review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The risk associated with spinal manipulation: an overview of reviews. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A community-based survey on massage therapy in Saudi Arabia. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Massage therapy for children, adolescents, and young adults: Clinical delivery and effectiveness in hematology and oncology. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Massage therapy can effectively relieve cancer pain: A meta-analysis. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Massage therapy in cancer care: an overview of the past, present, and future. [2019]