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

Trial Summary

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 data supports the effectiveness of the treatment Spinal Manipulative Therapy for neck pain?

Research shows that spinal manipulative therapy (SMT) can be effective for managing musculoskeletal pain, which includes neck pain. It is frequently used by health professionals for spinal pain and has been established as a clinically effective treatment for several musculoskeletal disorders. ^{1 2 3 4 5}

Is spinal manipulative therapy generally safe for humans?

Spinal manipulative therapy (SMT) is widely used, but there are concerns about its safety, especially regarding neck manipulation and the risk of stroke. Serious complications are rare but have been reported, and the reporting of adverse events in clinical trials is not always comprehensive. ^{2 4 6 7 8}

How does Spinal Manipulative Therapy for neck pain differ from other treatments?

Spinal Manipulative Therapy (SMT) is unique because it involves hands-on techniques where practitioners use their hands to apply a controlled, sudden force to a spinal joint, which is different from drug-based treatments or surgeries. This approach is often used by chiropractors and is known for its high-velocity, low-amplitude thrusts, which aim to improve physical function and relieve pain. ^{9 10 11 12 13}

What is the purpose of this trial?

The broad long-term objective is to develop an objective biomarker for spinal health based on aberrant or abnormal movement patterns during functional activities to better target spinal manipulation therapy (SMT) and other conservative treatments. The central hypotheses are a) that aberrant spinal motions and their location (area and level) are indicative of underlying spinal dysfunction, and b) that quantified 3D cervical spine intersegmental and global motion patterns during functional tasks can be used as a biomarker for subsequent clinical studies aimed at normalizing cervical kinematics. Specific Aim: Determine the extent to which SMT can modulate, or normalize, intersegmental motion in patients with neck pain. Rationale: SMT is a force-based biomechanical event whose hypothesized mechanism of action relies on moving the segment into the para-physiological zone, resulting in normalization of spinal kinematic function. Hypothesis: Severity of abnormal or aberrant motion, identified in those with NP, will improve following SMT. Approach: Participants with chronic mechanical neck pain will be recruited and randomized into one of three groups: 1) No Treatment, 2) Light Massage (pseudo- sham), and 3) Spinal Manipulative Therapy. Using a repeated measures study design, metrics of quality of spinal motion will be compared before and after the prescribed intervention.

Research Team

Arin Ellingson, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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 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) 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]

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]

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]

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]

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]

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 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]

References

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

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

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

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

3. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

The reporting of adverse events following spinal manipulation in randomized clinical trials-a systematic review. [2022]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

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

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

Ultrasound-guided microwave ablation for secondary hyperparathyroidism: a systematic review and meta-analysis. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Role of minimal invasive surgery for primary and secondary hyperparathyroidism]. [2015]

11. Italy pubmed.ncbi.nlm.nih.gov

[Role of minimally invasive surgery in the treatment of primary hyperparathyroidism]. [2014]

12. Germany pubmed.ncbi.nlm.nih.gov

Video-assisted neck exploration for primary and secondary hyperparathyroidism: initial experience. [2017]

13. Germany pubmed.ncbi.nlm.nih.gov

Dropout associated with osteopathic manual treatment for chronic noncancerous pain in randomized controlled trials. [2021]