100 Participants Needed

Massage Therapy for Scoliosis

KR
TC
MB
Overseen ByMeredith Brooks, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Cook Children's Health Care System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

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.12345

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.678910

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.311121314

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.

Research Team

MB

Meredith Brooks, MD

Principal Investigator

Cook Children's Health Care System

Eligibility Criteria

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.
See 1 more

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.
See 11 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Massage Therapy GroupExperimental Treatment1 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 GroupActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cook Children's Health Care System

Lead Sponsor

Trials
11
Recruited
5,001,000+

Findings from Research

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.
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.
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.
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]

References

Massage for symptom relief in patients with cancer: systematic review. [2022]
Role of massage therapy in cancer care. [2011]
Massage therapy helps to increase range of motion, decrease pain and assist in healing a client with low back pain and sciatica symptoms. [2008]
Effects of the application of therapeutic massage in children with cancer: a systematic review. [2022]
Children with cancer and blood diseases experience positive physical and psychological effects from massage therapy. [2022]
Adverse events of massage therapy in pain-related conditions: a systematic review. [2022]
Beliefs, perceptions and practices of chiropractors and patients about mitigation strategies for benign adverse events after spinal manipulation therapy. [2023]
The value of massage therapy in cancer care. [2011]
Adverse events associated with paediatric massage therapy: a systematic review. [2022]
The risk associated with spinal manipulation: an overview of reviews. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
A community-based survey on massage therapy in Saudi Arabia. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Massage therapy for children, adolescents, and young adults: Clinical delivery and effectiveness in hematology and oncology. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Massage therapy can effectively relieve cancer pain: A meta-analysis. [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
Massage therapy in cancer care: an overview of the past, present, and future. [2019]
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