Normal saline for Back Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
Mount Sinai West Hospital, New York, NY
Back Pain+1 More
Normal saline - Drug
Eligibility
18+
All Sexes
Eligible conditions
Back Pain

Study Summary

This study is evaluating whether a medication may help reduce blood loss during spine surgery.

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Eligible Conditions

  • Back Pain
  • Spine Surgeries

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Normal saline will improve 1 primary outcome and 1 secondary outcome in patients with Back Pain. Measurement will happen over the course of Baseline and Post-operative day 1, 2 and 3.

Day 1
Change in Hematocrit level
Day 1
Post-operative drain output

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

Combined Intravenous and Topical TXA group (cTXA group)
Low Dose Intravenous TXA (lTXA group)
Placebo group

This trial requires 75 total participants across 3 different treatment groups

This trial involves 3 different treatments. Normal Saline is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Low Dose Intravenous TXA (lTXA group)Patients assigned to lTXA group will receive 20mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure.
High Dose Intravenous TXA (hTXA group)Patients assigned to hTXA group will receive 50mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure.
Combined Intravenous and Topical TXA group (cTXA group)Patients assigned to cTXA group will received 20mg/kg V TXA loading dose with a 5mg/kg/hr maintenance dose, and 2g topical TXA poured over 5 minutes at the would prior to closure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Normal saline
2013
Completed Phase 4
~2010

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-operative day 1, 2 and 3
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly post-operative day 1, 2 and 3 for reporting.

Who is running the study

Principal Investigator
Y. L.
Prof. Yan Lai, Assistant Professor, Anesthesiology, Perioperative & Pain Medicine
Icahn School of Medicine at Mount Sinai

Closest Location

Mount Sinai West Hospital - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adults 18-80 years old
Undergo major multilevel spine surgery (2-8 levels)
Male or female

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for back pain?

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This survey shows that patients receiving medical care have a variety of expectations for [back pain](https://www.withpower.com/clinical-trials/back-pain) treatment based on the location of their pain. Patient expectations for medical providers may be influenced by their personal beliefs and perceptions, and their knowledge of available guidelines (ie, medical evidence, national and international guidelines) may be affected by patient preference. The patients are eager to receive treatment, and physicians may want to keep their patients satisfied and avoid non-medical interventions. This data will help clinicians determine appropriate treatment for these patients.

Unverified Answer

What is back pain?

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Back pain can be a complex, disabling and disabling condition. It is estimated that about 25% of all adults will have back pain at some point in their lives. Despite the prevalence of back pain, little research is available to help guide treatment to people with back pain.

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How many people get back pain a year in the United States?

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About 19% of American adults over age 18 report having had back pain between the l995s and the 2005s. Nearly half of these adults cite at least two risk factors for developing back pain and over half claim they have at least one of the four most common causes that have been associated with back pain.

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What causes back pain?

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Back pain is a significant health issue for many individuals, the causes of which are not well understood, but may include a variety of biological, behavioural and environmental factors. These factors may need to be taken into account in future prevention and management programs.

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Can back pain be cured?

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Although we have not found evidence of improved back function when we combine a usual treatment of an active physiotherapy and exercise program with a brief, home-based intervention program, we expect to do so within 2 years. However, many people with [back pain](https://www.withpower.com/clinical-trials/back-pain) will continue to have persistent pain, and we also expect to find evidence that this subset will not improve in back function. The intervention program also appears to have a similar short-term benefit to a usual care control group, and we expect this will also be found when we complete the analysis at 2 years.

Unverified Answer

What are the signs of back pain?

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Back pain is reported by nearly all patients with back pain. The signs and symptoms of back pain often have a psychological component.\n\n- "Medical Knowledge" (New Jersey), the "New York Times Manual for General Practice", by Louis I. Schwartz, John E. Batter, and Kenneth B. Schwartz, (1981)\n- "Essentials of Pediatric Internal Medicine", by William S. Foster, (2000)\n- "Essentials of Internal Medicine/Physiology of Internal Diseases", by Kenneth B. Schwartz, James A. Murphy, (2003)\n- "Textbook of Medical Diagnosis", A.J.

Unverified Answer

What does normal saline usually treat?

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If you have pain on a specific site, we usually will inject or infuse medicines into this area: anti-inflammatory drugs like ibuprofen, NSAID; steroids (corticosteroids & local anesthetics such as lidocaine), (bupivacaine) or other drugs depending on the specific problem and the condition and type of pain causing it. Since, pain specialists, doctors specializing in pain medicine, do not usually treat with analgesics or pain medicines. This is an area of speciality of a specialist: a pain specialist or a pain medicine specialist. If you have pain on a specific site (e.g.

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Does normal saline improve quality of life for those with back pain?

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In a recent study, findings of this study found that normal saline does not improve overall HRQoL over oral ibuprofen for the management of acute [back pain](https://www.withpower.com/clinical-trials/back-pain). However, this trial did demonstrate that a more balanced approach to pain treatment may be beneficial when treating people with chronic back pain.

Unverified Answer

Have there been other clinical trials involving normal saline?

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In a recent study, findings support this review confirming the superiority of normal saline compared to all other forms of treatment. This suggests that a saline-based solution of lidocaine and triamcinolone acetonide may be more effective than other types of injection solutions. (J Interventional Radiol 2010; 22 (12): 1694-6.

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Who should consider clinical trials for back pain?

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The evidence supporting some treatment options for chronic low back pain is moderate or weak. Clinical trials provide a robust source of evidence from which to decide on treatment options, as evidenced in the present review. Overall, clinicians recommend clinical trials for treatment decisions in those patients with weak evidence supporting the use of these alternatives.

Unverified Answer

How serious can back pain be?

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Most sufferers with back pain will not require hospital admission or surgical exploration unless other causes of back pain have been excluded. However, sufferers should consider obtaining a formal report on their symptoms from an appropriately qualified medical practitioner. If this does not reassure them then they should be referred to a medically trained health care worker and an enquiry should be made about the potential need of surgery. Follow-up investigations may be necessary but this depends on the investigation being undertaken.

Unverified Answer

How does normal saline work?

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Results from a recent paper from this comparative study have demonstrated that there is no evidence that normal saline used in addition to standard of care is superior or inferior to standard of care alone. Both groups were statistically significantly more effective than the comparator of sham (no treatment) and active placebo groups.

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