Manual Therapy for Chronic Neck Pain

(SS-MECH Trial)

No longer recruiting at 1 trial location

Overseen By Chad E Cook, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Radicular symptoms, Neck surgery, Red flags, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two treatments—manual therapy and exercise—for individuals with chronic neck pain. Researchers seek to determine whether the benefits arise from unique methods or shared techniques. Participants will receive either manual therapy, which involves hands-on manipulation of muscles and joints, or exercise-based therapy to assess which approach is more effective. The study is open to those who have experienced neck pain for at least three months and frequently endure significant discomfort. As an unphased trial, it offers participants the chance to contribute to understanding effective treatments for chronic neck pain.

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's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that manual therapy is generally safe for people with chronic neck pain. Many studies support this, indicating it is well-tolerated with few side effects. Manual therapy includes techniques like stretching and gentle movements, which are usually less painful than other treatments.

Some studies suggest that manual therapy aligns with clinical guidelines and may be slightly more effective than other treatment options. While some debate exists, the overall evidence suggests manual therapy is a safe choice for managing chronic neck pain.

The trial phase is still exploring the safety and effectiveness of the resisted exercise treatment. However, exercise therapies are generally considered safe and are commonly recommended for managing neck pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic neck pain because they offer non-invasive alternatives that target both muscle flexibility and strength, which are often overlooked in standard care options like medications or surgery. Manual therapy stands out by using global soft tissue stretching and specific manipulations to improve range of motion and reduce pain, directly addressing muscular and joint components of neck pain. Meanwhile, the resisted exercise treatment focuses on strengthening neck and upper thoracic muscles through targeted exercises, which can enhance long-term neck stability and function. Both approaches emphasize personalized home exercise programs, promoting patient empowerment and active participation in their own recovery journey.

What evidence suggests that this trial's treatments could be effective for chronic neck pain?

Research has shown that manual therapy, which participants in this trial may receive, can help reduce pain and improve movement in people with long-term neck pain. One study found that spinal manipulative therapy, a type of manual therapy, effectively reduced pain and disability in patients. Another study highlighted that this therapy worked better than some other physical treatments for managing neck pain. These findings suggest that manual therapy can be a good option for easing discomfort and improving quality of life for those with chronic neck pain. Meanwhile, another group in this trial will receive resisted exercise treatment, involving specific exercises targeting neck and thoracic muscles. ^{2 3 6 7 8}

Who Is on the Research Team?

Chad E Cook

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults 18 and older who have had neck pain rated at least a 3 out of 10 nearly every day for the past three months or more, without another diagnosis explaining the pain.

Inclusion Criteria

I have had neck pain for 3 months or more without another diagnosis.

I have had neck pain of 3 or more out of 10 for most days in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either manual therapy or resistance exercise interventions for chronic neck pain

4 weeks

Weekly in-person sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 4 weeks and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Manual Therapy

Trial Overview

The study compares specific effects of manual therapy to exercise in treating chronic neck pain. It also examines 'shared' mechanisms common to both treatments to see which influences outcomes more.

How Is the Trial Designed?

Group I: Manual therapy treatment Experimental Treatment 1 Intervention

Manual therapy treatments will consist of global soft tissue stretching of the upper trapezius, occipital muscles, levator scapula, and scalene muscles as the patient lies in supine. Non-thrust manipulation will consist of unilateral or central posterior-anterior accessory movements (PAIVMs) to the cervical and upper thoracic segments (in prone) at the most symptomatic levels. Passive physiological intervertebral movements of rotation will be performed in supine, as a mechanism to reduce pain and increase range of motion. Individuals with chronic neck pain randomized to the manual therapy arm, will be assigned a HEP twice daily that will consist of cervical rotations with belt or equivalent, side flexion with belt or equivalent, self-stretching exercises that are designed to target the upper thoracic musculature, and corner wall stretches.

Group II: Resisted exercise treatment Active Control 1 Intervention

In-clinic exercises will consist of chin retractions in sitting, supine clock isometric resistance, supine anterior neck flexion exercises that target the deep neck flexors, prone neck extensor exercises (with concurrent chin retraction), and lateral neck raises (bilaterally). The study team will also target the mid and upper thoracic region by performing upright rows, supine chest raises that target the mid-scapular muscles and the paraspinal muscles, prone "I, T, and Y" exercises, and proprioceptive neuromuscular facilitation exercises using a bar or a cane. Individuals randomized to the resistance exercise arm will be assigned a HEP twice daily that will consist of chin retractions in sitting, supine anterior neck flexion exercises, and elastic band rows that replicate the upright rows performed in the clinic.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

The Medical University of South Carolina

Collaborator

Trials

1

Recruited

130+

University of Colorado - Anschutz Medical Campus

Collaborator

Trials

9

Recruited

1,700+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Saint-Joseph University

Collaborator

Trials

55

Recruited

6,200+

Published Research Related to This Trial

Manual therapies can effectively reduce mechanical neck pain in the short term, especially when combined with other treatments, although no single treatment protocol has been identified as the best.

The safety of manual therapy is high, with only a 1%-2% risk of mild symptom aggravation like dizziness, and an extremely low risk (0.0001%) of serious complications or death from neck manipulation, highlighting the importance of proper training for practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy in the treatment of neck pain. Gross, AR., Aker, PD., Quartly, C.[2019]

A systematic analysis of nine clinical trials found that a single session of spinal manipulation provides moderate-to-high quality evidence for immediate pain relief in chronic neck pain, with average reductions in pain scores of about -18.94 mm on a 100-mm scale.

In contrast, the evidence for spinal mobilization and ischemic compression is less robust, showing smaller immediate changes in pain, and there is no evidence supporting the effectiveness of massage or manual traction for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic mechanical neck pain in adults treated by manual therapy: a systematic review of change scores in randomized controlled trials of a single session. Vernon, H., Humphreys, BK.[2021]

Manual soft tissue therapy (MSTT) significantly reduces pain in patients with chronic neck pain, as shown in a meta-analysis of 12 randomized controlled trials involving 566 participants, with an effect size of 0.83.

The analysis suggests that while MSTT is effective, the variability in pain measurement tools used across studies may affect the results, indicating a need for more standardized clinical trials in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of manual soft tissue therapy on the pain in patients with chronic neck pain: A systematic review and meta-analysis. Wang, SQ., Jiang, AY., Gao, Q.[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]

Moderate quality evidence from 19 trials indicates that a combination of mobilisation, manipulation, and soft tissue techniques significantly reduces pain and improves patient satisfaction for acute neck pain compared to short wave diathermy.

Low quality evidence suggests that mobilisation and manipulation can provide clinically important pain relief and improved function for chronic cervicogenic headaches, although no significant differences were found when combined with other physical medicine modalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy with or without physical medicine modalities for neck pain: a systematic review. D'Sylva, J., Miller, J., Gross, A., et al.[2018]

In a study of 771 patients undergoing manual therapy for back and neck pain, mild or moderate adverse events did not significantly affect recovery rates at seven weeks, suggesting that these events are generally not detrimental to short-term recovery.

Interestingly, at the three-month follow-up, mild adverse events were associated with a better chance of recovery in men, with an odds ratio of 2.44, indicating that experiencing mild discomfort may correlate with improved outcomes for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do adverse events after manual therapy for back and/or neck pain have an impact on the chance to recover? A cohort study. Tabell, V., Tarkka, IM., Holm, LW., et al.[2020]

Manual therapy (MT) significantly reduces pain intensity in patients with nonspecific neck pain, with an average decrease of 3.4 points on a scale from 0 to 10, indicating a large effect size (Cohen's d 1.98).

MT also improves daily activities and overall patient recovery, as evidenced by a 9.5-point improvement on the Neck Disability Index and positive feedback on the Global Perceived Effect scale, suggesting that patients feel 'improved' or 'much improved' after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Manual therapy in non-specific neck pain]. Bakhtadze, MA., Kuz'minov, KO., Bolotov, DA.[2018]

In a study of 767 patients seeking treatment for back and neck pain, adverse events after manual therapy were common, with 51% experiencing at least one event, primarily muscle soreness, increased pain, and stiffness.

The type of manual therapy used (including or excluding spinal manipulation or stretching) did not significantly affect the occurrence of adverse events, but women reported more short and long moderate adverse events compared to men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial. Paanalahti, K., Holm, LW., Nordin, M., et al.[2022]

A scoping review of 113 clinical trials on manual therapy (MT) for neck pain found that only 4.4% provided detailed descriptions of the MT interventions, highlighting a significant gap in reporting standards that could affect the reproducibility of results.

The majority of MT was delivered by physical therapists (77.9%), with limited representation from other practitioners like chiropractors and osteopaths, suggesting a need for more diverse clinician involvement in future studies to enhance the generalizability of findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incomplete reporting of manual therapy interventions and a lack of clinician and setting diversity in clinical trials for neck pain limits replication and real-world translation. A scoping review. Leech, JB., Owen, WE., Young, JL., et al.[2023]

A systematic review of five studies on spinal manipulation (SM) found that about half of patients experience mild and transient adverse events after treatment, indicating that while side effects are common, they are generally not severe.

There is currently no reliable data on the incidence of serious adverse events related to spinal manipulation, suggesting that while they are likely rare, further research is needed to better understand their frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective investigations into the safety of spinal manipulation. Ernst, E.[2019]

A systematic review of five studies comparing manipulation, mobilization, and the Activator instrument for non-specific neck pain found no single therapy to be more effective than the others.

The overall quality of the studies was mostly poor, indicating a need for further high-quality research to determine the most effective manual therapy for treating neck pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of manipulation, mobilisation and the activator instrument in treatment of non-specific neck pain: a systematic review. Gemmell, H., Miller, P.[2021]

A new sham cervical manipulation technique was successfully validated, effectively masking participants' awareness of their treatment group allocation, which is crucial for clinical trials.

In a study of 67 subjects with chronic neck pain, no significant differences were found in pain, tenderness, or range of motion between the real manipulation and sham groups, indicating that the sham procedure is clinically inert.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a novel sham cervical manipulation procedure. Vernon, HT., Triano, JJ., Ross, JK., et al.[2021]

Citations

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Spinal manipulative therapy (SMT) is frequently used to manage neck pain; however, its efficacy and safety in treating acute neck pain (ANP) ...

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Safety of different types SMT on ANP. Numerous studies have demonstrated that SMT is a safe treatment option for chronic neck pain [41–45].

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Manual Therapy for Chronic Non-Cancer Back and Neck Pain

Objective: To investigate the effectiveness and safety of mobilization and manipulation therapies for adults with chronic low back pain.

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Manipulation and mobilization for treating chronic low back ...

The present study aims to determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for treatment of chronic low ...