Protein supplement for Low Back Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
SpineZone, San Diego, CA
Low Back Pain
Protein supplement - DietarySupplement
Eligibility
18+
All Sexes
Eligible conditions
Low Back Pain

Study Summary

This study is evaluating whether a physical therapy program with nutritional supplements may help individuals with neck, back, or shoulder pain.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Protein supplement will improve 1 primary outcome and 4 secondary outcomes in patients with Low Back Pain. Measurement will happen over the course of 3 months, 6 months.

3 months, 6 months
Patient Goal Achievement
Year 2
Change in disability
Change in strength (lbs*deg)
Muscle size
Symptom inference - change in pain. Visual Analogue Scale (VAS), 0-100mm

Trial Safety

Trial Design

2 Treatment Groups

Control
Protein Intervention Group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Protein Supplement is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Protein Intervention Group
DietarySupplement
Patients who receive the protein nutritional supplement as part of their prescribed exercise-based rehabilitation program.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Protein supplement
2013
N/A
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months, 6 months, 1 year, 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months, 6 months, 1 year, 2 years for reporting.

Closest Location

SpineZone - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
is not only a matter of personal health, but also a responsible decision that can improve the quality of life for you and your loved ones show original
The ability to consume a protein shake and follow the storage, timing, and preparation instructions is important. show original
The text means that the person should consult a health care professional to see if they are safe to participate in an exercise-based rehabilitation program. show original
To be able to read and comprehend the English language, you first need to know the alphabet show original

Patient Q&A Section

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

Does protein supplement improve quality of life for those with low back pain?

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There does not appear to be an important impact of protein supplement on functional improvements. However, further high quality evidence is needed to establish the effectiveness of this supplement to treat low back pain.

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What are the signs of low back pain?

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Results from a recent paper suggest that an examination and test is appropriate for determining whether low back pain is related to a specific underlying diagnosis such as disc herniation.

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What causes low back pain?

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It is not clear which factors are responsible for triggering low [back pain](https://www.withpower.com/clinical-trials/back-pain), but evidence indicates that a combination of factors may trigger the onset and maintenance of pain. These include genetic risk inherited from the mother, poor physical fitness, a generalised body weight distribution, smoking and high levels of stress. A recent article in the International Journal of Medical and Environmental Issues (2009) has summarised the literature on low back pain, and reviewed the evidence for possible reasons for why the disease may occur.

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What is low back pain?

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Although low back pain occurs across the lifespan, prevalence is highest during adolescence. As many as 25% of adolescents aged 13 to 17years have low back pain.

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Can low back pain be cured?

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There is no conclusive evidence that low [back pain](https://www.withpower.com/clinical-trials/back-pain) can be cured. In those with disabling chronic low back pain, some people may improve somewhat, but there is no evidence that they experience complete or long-term relief. All types of non-specific low back pain (NSLP) such as nociceptive back pain, neuropathic back pain, visceral pain, or cancer back pain worsen regardless of the treatment used.

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

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It is estimated there is about 1.7 percent incidence of LBP from a given year, but only about 8 percent of LBP is severe or disabling. Approximately 60 percent of patients are discharged after inpatient hospitalization.

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What are common treatments for low back pain?

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A surprising number of previously validated treatments for low back pain are often practiced. However, the use of such treatments was generally lower when patients felt that the current treatment had not worked. Physicians should be aware that validated treatments have been widely prescribed and are currently being practiced.

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Have there been any new discoveries for treating low back pain?

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In the last decade, many new therapies have been introduced for treating low back pain. The research into low back pain is very recent, but all the therapies have shown to be effective in many trials. The researchers believe that the only way to find long-term effectiveness and minimize side-effects is using many complementary and multimodal therapies. Most of the therapies have a limitation of being used in certain situations and therefore their use in low back pain treatment is still limited. There are new findings in the literature for treating low back pain. However, their long-term, randomized, placebo-controlled trials have not shown satisfactory resolution of low back pain.

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How does protein supplement work?

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The current evidence suggests that PS improves muscle function, reduces disability, improves pain, and does not cause adverse side effects in patients with post-injury or other types of chronic low back pain. Despite significant improvements in strength and function, most studies demonstrate only small improvements in pain. The magnitude of the improvements achieved in the current studies is moderate due to the heterogeneity of patient populations and the wide variety of PS products used and dosing regimens.

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Is protein supplement safe for people?

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Although this study was limitations by the design and small sample size, the results suggest that a supplement of casein is safe in patients with non-specific musculoskeletal pain and chronic low back pain.

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What are the common side effects of protein supplement?

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Almost all studies found statistically significant supplement-related changes in the levels of serum proteins that typically are indicative of the protein supplement. Although a few of the side effects may be surprising, it is important to remember that protein supplements are typically meant to be taken for a long period of time, often in doses of several grams per day; long term safety checks such as that afforded by this review could not begin to be implemented until well-designed clinical studies show that the safety risks of protein supplements are acceptable and outweigh the benefit.

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What is the latest research for low back pain?

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There is still evidence of the necessity of surgical treatment for lumbar disk herniation. A review confirms the advantages of the fusion procedure. The procedure of the fusion is the same as that of the laminectomy. The fused intervertebral disk can stabilize the spine, and the patient's overall physical quality of life are improved. Other treatments for lumbar disk herniation include steroid injections and nonsteroidal anti-inflammatory drugs, acupuncture, and interspinous stabilization. Lateral spondylodesis is a kind of surgical operation for lumbar myelomeningocele in children. The surgery is only efficient when in combination with other treatments.

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