Spinal Manipulative Therapy for Lower Back Pain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Prior spine surgery, Pregnancy, Radiculopathy, Red flags, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how thoughts and beliefs about low back pain, along with the physical therapist's approach, affect the success of physical therapy treatments. It includes spinal manipulative therapy (a technique involving manual spine adjustment), exercises, and educational support. The goal is to determine if these factors influence the level of pain relief patients experience. The trial seeks participants with persistent lower back pain, possibly affecting one or both legs, who have not undergone spinal surgery or have serious conditions like a fracture or infection. As an unphased trial, it offers a unique opportunity to contribute to understanding how various factors impact the success of physical therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical therapy, so you may not need to change your medication routine, but it's best to confirm with the trial organizers.

What prior data suggests that spinal manipulative therapy is safe for patients with low back pain?

Research has shown that spinal manipulative therapy (SMT) is generally safe and well-tolerated by patients. Studies have examined its effectiveness for treating low back pain and found it safe for most individuals. Treatments often involve quick, controlled movements, which typically do not cause significant harm.

Reports from various studies indicate that serious side effects are rare. However, some individuals might experience mild soreness or discomfort after a session, which is usually temporary and resolves on its own. Those with safety concerns should consult a healthcare professional before starting any new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Spinal Manipulative Therapy (SMT) is unique because it offers a hands-on approach to relieving lower back pain, unlike conventional treatments such as medication or surgery. Researchers are excited about SMT because it focuses on adjusting the spine to improve alignment and function, which can lead to immediate relief and improve mobility without the side effects associated with drugs. Additionally, this therapy can be personalized to each patient's specific condition, potentially making it more effective for those who haven't found relief through other methods.

What evidence suggests that spinal manipulative therapy is effective for lower back pain?

Research has shown that spinal manipulative therapy (SMT) can help reduce pain in people with low back pain. A 2019 review found that SMT is about as effective as other treatments for long-term low back pain. Additionally, moderate-quality evidence suggests that SMT can effectively treat chronic low back pain in adults. Some studies compare different SMT techniques and demonstrate that both quick, small movements and gentler methods can be beneficial. Overall, SMT is considered a valid option for managing low back pain, with effectiveness similar to other available therapies.

This trial will involve patients seeking physical therapy for low back pain and the physical therapists treating them, focusing on the application of SMT techniques. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic low back pain. Participants will be receiving physical therapy tailored to their condition, which may include spinal manipulation, exercise, and education. The study focuses on understanding the impact of patients' and therapists' beliefs about back pain treatment.

Inclusion Criteria

Meets NIH Task Force criteria for chronic low back pain

I have pain from my lower back to my buttocks, possibly extending to my legs.

Exclusion Criteria

Currently pregnant

I have had surgery on my lower back.

I am not currently seeing a chiropractor or massage therapist for spine or exercise treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive physical therapy including spinal manipulative therapy, exercise, and education as determined by their physical therapist

26 weeks

Regular visits as determined by the physical therapist

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Manipulative Therapy

Trial Overview The study observes how patients with chronic low back pain respond to various physical therapy treatments provided by their therapists. It also examines the influence of both patient and therapist perspectives on the effectiveness of these treatments.

How Is the Trial Designed?

Group I: Physical therapists Experimental Treatment 1 Intervention

Physical therapists treating enrolled patients

Group II: Patients Experimental Treatment 1 Intervention

Patients seeking physical therapy for low back pain

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

American Academy of Orthopaedic and Manual Physical Therapists

Collaborator

Trials

1

Recruited

100+

Brooks Rehabilitation

Collaborator

Trials

16

Recruited

1,900+

Published Research Related to This Trial

Thoracic spinal manipulative techniques (SMT) were found to significantly reduce temporal sensory summation (TSS) in healthy volunteers, suggesting a potential for regional pain modulation beyond the site of manipulation.

The study involved 90 healthy participants and indicated that while SMT may affect pain sensitivity, the long-term effects and relevance in clinical populations still require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate reduction in temporal sensory summation after thoracic spinal manipulation. Bishop, MD., Beneciuk, JM., George, SZ.[2021]

Spinal manipulative therapy (SMT) shows similar effectiveness to recommended therapies for short-term pain relief in chronic low back pain, with a small improvement in functional status, based on a systematic review of 47 trials involving 9211 participants.

SMT is more effective than non-recommended therapies for improving function in the short term, and while most adverse events related to SMT are mild and transient, clinicians should inform patients about potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. Rubinstein, SM., de Zoete, A., van Middelkoop, M., et al.[2022]

Spinal manipulative therapy (SMT) is considered a cost-effective treatment for managing neck and back pain, especially when compared to general practitioner care, exercise, and physiotherapy, based on a review of six economic evaluations with low risk of bias.

The findings support the use of SMT in clinical practice, but more high-quality research is needed to confirm its cost-effectiveness across different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal manipulation epidemiology: systematic review of cost effectiveness studies. Michaleff, ZA., Lin, CW., Maher, CG., et al.[2022]

In a study involving 36 participants with low back pain, spinal manipulative therapy (SMT) was found to significantly reduce temporal summation of pain, indicating a specific local effect on pain perception in the lumbar region.

Unlike other interventions like stationary cycling or low back extension exercises, SMT did not show changes in Adelta fiber-mediated pain perception, suggesting that SMT may modulate pain sensitivity through mechanisms affecting the spinal cord's excitability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Bialosky, JE., Bishop, MD., Robinson, ME., et al.[2022]

Spinal manipulative therapy (SMT) provided significant pain relief for patients with ulcer disease, with an average relief time of 3.8 days, and led to clinical remission about 10 days earlier than traditional medical treatments.

The study involved 11 adults aged 18-44 and suggests that SMT may positively influence gastrointestinal symptoms, although the exact physiological mechanisms behind these effects are still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of spinal manipulative therapy in the treatment of duodenal ulcer: a pilot study. Pikalov, AA., Kharin, VV.[2006]

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 cadaveric study involving six vertebral arteries showed that spinal manipulative therapy (SMT) caused strains to the vertebral artery that were significantly lower than the levels required for mechanical failure, suggesting a low risk of injury during typical SMT procedures.

The average strain on the vertebral artery during SMT was 6.2% for the distal loop and 2.1% for the proximal loop, which is about one ninth of the strain needed to cause mechanical disruption, indicating that SMT is likely safe under normal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal forces sustained by the vertebral artery during spinal manipulative therapy. Symons, BP., Leonard, T., Herzog, W.[2019]

A survey of 575 Italian physiotherapists revealed that most consider high-velocity low-amplitude spinal manipulation (SM) safe and effective for the thoracic (74.1%) and lumbar (72.2%) spines, but only 56.8% felt the same about the upper cervical spine.

Physiotherapists with knowledge of clinical prediction rules were more likely to feel comfortable performing SM and to view it as safe, while those without musculoskeletal specialization tended to be more cautious, especially regarding upper cervical SM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, beliefs, and attitudes of spinal manipulation: a cross-sectional survey of Italian physiotherapists. Mourad, F., Yousif, MS., Maselli, F., et al.[2022]

Spinal manipulative therapy (SMT) can lead to serious complications, with vertebrobasilar accidents (VBAs) being the most common, occurring primarily after cervical manipulations with a rotatory component, with an estimated risk ranging from 1 in 20,000 to 1 in 1 million treatments.

Cauda equina syndrome (CES) is a rare complication of SMT, estimated to occur in less than 1 in 1 million treatments, and most complications can be avoided by screening patients for contraindications before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of spinal manipulation: a comprehensive review of the literature. Assendelft, WJ., Bouter, LM., Knipschild, PG.[2022]

This systematic review analyzed 25 randomized, placebo-controlled trials of spinal manipulative therapy (SMT) and found that most studies used sham SMT procedures as placebos, but many had high or unclear risk of bias.

The review highlighted that many trials did not adequately assess subject blinding or ensure that placebos were truly inert, which could lead to skewed results and unreliable conclusions about the efficacy of SMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The quality of placebos used in randomized, controlled trials of lumbar and pelvic joint thrust manipulation-a systematic review. Puhl, AA., Reinhart, CJ., Doan, JB., et al.[2018]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK574527/

High-Velocity Low-Amplitude Manipulation Techniques - NCBI Usage results show that comparatively high speed and low amplitude manual procedure occurs for most patients who undergo spinal manipulation.

2. jospt.org jospt.org/doi/10.2519/jospt.2025.13103

Efficacy of Spine High-Velocity Low-Amplitude Thrust ... The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. ... Spinal manipulative therapy for acute low- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0031940621000250

The effect of spinal manipulative therapy on pain relief and ... A 2019 review concluded that spinal manipulative therapy (SMT) results in similar benefit compared to other interventions for chronic low back pain (LBP).

4. bmj.com bmj.com/content/364/bmj.l689

Benefits and harms of spinal manipulative therapy for the ... In the treatment of chronic low back pain in adults, moderate quality evidence suggests that spinal manipulative therapy (SMT) results in ...

5. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/ChiropracticCare.pdf

The Effectiveness and Harms of Spinal Manipulative Therapy ... of spinal manipulative therapy for acute low back pain ... (3) Cook 2012 Manual Therapy article also directly compares thrust to non-thrust manipulation for LBP.

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0328048

Systematic review on biomechanical effects of high-velocity ... Spinal manipulative therapy uses high-velocity low-amplitude (HVLA) thrusts which are clinically effective, but underlying mechanisms are still unknown.