Spinal Manipulative Therapy for Lower Back Pain

Age: 18 - 65

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

102 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to better understand how the thoughts and beliefs of patients with low back pain and their physical therapist influence how much patients benefit from physical therapy. Participants will receive physical therapy as determined by their physical therapist including spinal manipulative therapy, exercise, and education. Participants with low back pain and their physical therapists will complete forms about their thoughts and beliefs about low back pain and treatment.

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 data supports the effectiveness of the treatment Spinal Manipulative Therapy for Lower Back Pain?

Research shows that spinal manipulative therapy (SMT) can be effective for some patients with musculoskeletal pain, including chronic low back pain. ^{1 2 3 4 5}

Is spinal manipulative therapy generally safe for humans?

Spinal manipulative therapy (SMT) is widely used, but there are conflicting conclusions about its safety, especially concerning serious adverse events (SAEs) and the risk of stroke with neck manipulation. ^{6 7 8 9 10}

How does spinal manipulative therapy differ from other treatments for lower back pain?

Spinal manipulative therapy (SMT) is unique because it involves hands-on techniques to adjust the spine, which can immediately reduce pain sensitivity and provide relief for lower back pain. Unlike medications or surgeries, SMT is a non-invasive treatment that focuses on physical manipulation to achieve its effects. ^{1 2 3 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

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]

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]

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]

References

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

Complications of spinal manipulation: a comprehensive review of the literature. [2022]

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

Immediate reduction in temporal sensory summation after thoracic spinal manipulation. [2021]

3. England 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. [2022]

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

Use of spinal manipulative therapy in the treatment of duodenal ulcer: a pilot study. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Spinal manipulation epidemiology: systematic review of cost effectiveness studies. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Internal forces sustained by the vertebral artery during spinal manipulative therapy. [2019]

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

The quality of placebos used in randomized, controlled trials of lumbar and pelvic joint thrust manipulation-a systematic review. [2018]

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

Predictors of instanteous relief from spinal manipulation for non-specific low back pain: a delphi study. [2021]

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

Knowledge, beliefs, and attitudes of spinal manipulation: a cross-sectional survey of Italian physiotherapists. [2022]

11. United States 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. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Spinal manipulative therapy for acute low-back pain. [2022]