Spinal Manipulative Therapy for Neck Pain

Overseen By Stephany Nathe

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Chronic opioids, Botox

Disqualifiers: ASA Class III, Cervical surgery, 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: 4-6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spinal manipulative therapy (SMT) can improve neck pain by normalizing spinal movements. Researchers aim to determine if specific spinal movement patterns can serve as markers to better target treatments. Participants will be divided into three groups: one receiving SMT, another getting a light massage, and a third receiving no treatment. Ideal candidates have experienced mechanical neck pain for over 12 weeks, with pain affecting their daily life. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future neck pain treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using chronic opioids, you would not be eligible to participate.

What prior data suggests that spinal manipulative therapy is safe for neck pain?

Research shows that spinal manipulative therapy (SMT) is generally safe for most people. Studies indicate that SMT often treats back and neck pain and is commonly used by chiropractors and other manual therapists.

Reported side effects are usually mild, such as temporary soreness or stiffness, while serious side effects are rare. Most people handle SMT well without major issues.

For those considering joining a trial for SMT, it is reassuring that previous patients have mostly found it safe and manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Spinal Manipulative Therapy (SMT) for neck pain because it offers a drug-free approach that directly targets the spine to provide relief. Unlike standard treatments such as medications or physical therapy, SMT involves hands-on techniques to adjust the spine, potentially providing quicker relief by improving joint function and reducing nerve irritation. This non-invasive method could appeal to those looking to avoid medication side effects and offers a fresh alternative by focusing on the body's natural ability to heal through spinal adjustments.

What evidence suggests that Spinal Manipulative Therapy is effective for neck pain?

Research shows that spinal manipulative therapy (SMT), which participants in this trial may receive, can reduce pain and disability in people with spine problems. Studies have found that SMT often works as well as other treatments for long-term pain, such as low back pain. This therapy uses quick, gentle movements to adjust the spine, potentially restoring normal movement and reducing pain. Some evidence suggests that SMT can improve spinal movement, which might relieve neck pain. Overall, while not a cure-all, SMT is considered a helpful option for managing certain types of neck and back pain. ^{1 2 3 6 7}

Who Is on the Research Team?

Arin Ellingson, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 39 who have been experiencing nonspecific, mechanical neck pain of moderate intensity or higher (more than a 3 on a scale from 0-10) for over three months. It's not suitable for individuals outside this age range or those with different types of neck pain.

Inclusion Criteria

My pain level is above 3 on a scale of 0 to 10.

I have had neck pain without a specific cause for more than 12 weeks.

Exclusion Criteria

I cannot be exposed to radiation due to health risks.

I am currently receiving non-drug treatments for neck pain.

Pregnancy, currently trying to get pregnant, lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three groups: No Treatment, Light Massage (pseudo-sham), or Spinal Manipulative Therapy. Metrics of quality of spinal motion will be compared before and after the prescribed intervention.

4-6 weeks

Follow-up

Participants are monitored for changes in intersegmental and global range of motion, neck pain intensity, neck disability, and overall function.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Manipulative Therapy

Trial Overview The study aims to see if Spinal Manipulative Therapy (SMT) can correct abnormal neck movements in people with chronic neck pain by comparing it against light massage and no treatment at all. Participants will be randomly assigned to one of these three groups.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 1 Intervention

Spinal Manipulative therapy group

Group II: No treatment group Active Control 1 Intervention

No Treatment: participants will be placed in a similar position to the other groups for the same duration, but no treatment or touch will be administered.

Group III: Pseudo sham group Placebo Group 1 Intervention

Light massage group

Spinal Manipulative Therapy is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Spinal Manipulative Therapy for:

• Mechanical neck pain
• Chronic neck pain
• Headache

Approved in Canada as Spinal Manipulation for:

• Mechanical neck pain
• Chronic neck pain
• Headache
• Upper limb pain

Approved in European Union as Chiropractic Adjustment for:

• Mechanical neck pain
• Chronic neck pain
• Headache
• Back pain

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

A systematic review of 11 studies involving 1,015 chronic noncancerous pain patients found that osteopathic manual therapy (OMTh) had similar rates of all-cause dropouts (ACD) compared to control interventions, indicating it is generally well tolerated.

The analysis revealed that there were no significant differences in dropouts due to adverse effects (AEs) between OMTh and other treatments, suggesting that OMTh is a safe option for managing chronic pain, although more detailed reporting on AEs is needed in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dropout associated with osteopathic manual treatment for chronic noncancerous pain in randomized controlled trials. Rehman, Y., Ferguson, H., Bozek, A., et al.[2021]

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]

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]

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]

A study of 123 patients undergoing parathyroidectomy showed that minimally invasive techniques can be effectively used for primary hyperparathyroidism (pHPT), leading to reduced operation time and comparable outcomes to traditional bilateral exploration.

For secondary hyperparathyroidism (sHPT), bilateral exploration remains necessary, highlighting the importance of proper preoperative localization of the diseased gland for the success of minimally invasive approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of minimal invasive surgery for primary and secondary hyperparathyroidism]. Röösli, C., Bortoluzzi, L., Linder, TE., et al.[2015]

Minimally invasive parathyroid surgery is an effective alternative to traditional surgery for patients diagnosed with a single parathyroid adenoma, utilizing advanced imaging and intraoperative techniques to enhance success rates.

This approach not only reduces postoperative pain but also improves aesthetic outcomes, making it a preferred choice in specialized surgical centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of minimally invasive surgery in the treatment of primary hyperparathyroidism]. Calzolari, F., Misso, C., D'Ajello, M., et al.[2014]

Out of 368 randomized clinical trials (RCTs) involving spinal manipulative therapy (SMT), only 38% reported adverse events, indicating a significant gap in safety reporting.

Since the introduction of the 2010 CONSORT guidelines, there has been an increase in adverse event reporting, but the overall level remains inadequate, with only 15.7% of articles mentioning adverse events in their abstracts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reporting of adverse events following spinal manipulation in randomized clinical trials-a systematic review. Gorrell, LM., Engel, RM., Brown, B., 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]

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) 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]

Microwave ablation (MWA) significantly reduces parathyroid hormone (PTH) levels in patients with severe secondary hyperparathyroidism (SHPT), with notable reductions observed at both 1 month and 6 months post-treatment, based on a review of 26 studies involving 932 patients.

MWA is considered a safe and effective minimally invasive treatment for SHPT, with the most common complications being hypocalcemia (35.2%) and transient hoarseness (9.2%), but no major complications or deaths reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided microwave ablation for secondary hyperparathyroidism: a systematic review and meta-analysis. Zhou, X., Shen, Y., Zhu, Y., et al.[2021]

In a study of 35 patients undergoing video-assisted neck exploration for primary and secondary hyperparathyroidism, the procedure showed a high cure rate with only 2.85% experiencing postoperative complications, indicating it is a safe and effective minimally invasive option.

The mean operative time was relatively short, averaging 48.9 minutes for primary hyperparathyroidism, suggesting that video-assisted techniques can lead to efficient surgeries with minimal patient discomfort, as reflected by a low median pain intensity of 0.5 on the visual analogue scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-assisted neck exploration for primary and secondary hyperparathyroidism: initial experience. Mourad, M., Ngongang, C., Saab, N., et al.[2017]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8915715/

Clinical Effectiveness and Efficacy of Chiropractic Spinal ... One of the conservative management options available is spinal manipulative therapy (SMT), the main intervention used by chiropractors and other manual ...

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

Efficacy of Spine High-Velocity Low-Amplitude Thrust ... ... manual therapy, HVLAT, exercise therapy, education, stretching, other ... Spinal manipulative therapy for acute low-back pain. Cochrane ...

3. 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.

4. jospt.org jospt.org/doi/10.2519/jospt.2025.12707

The Effectiveness of Spinal Manipulative Therapy in ... The average treatment effect of spinal manipulative therapy (SMT) for reducing pain and disability in patients with spinal pain appears ...

5. 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).

6. bmj.com bmj.com/content/364/bmj.l689

Benefits and harms of spinal manipulative therapy for the ... Objective To assess the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. Design ...

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

The Effectiveness and Harms of Spinal Manipulative Therapy ... SPINAL MANIPULATIVE THERAPY FOR ACUTE LOW BACK PAIN ... neck collar alone, transcutaneous nerve stimulation, or manual non-thrust manipulation.