Manual Therapy and Exercise for Neck Pain

Recruiting at 2 trial locations

Overseen By Tiffany L Barrett, DSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor University

Disqualifiers: Whiplash, Spinal stenosis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

Duration: 5 sessions

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to determine which reduces neck pain more effectively. Participants will receive either cervical spine manipulation (a form of manual therapy) or a gentle hands-on therapy, both followed by exercise sessions. The trial aims to discover if some individuals with neck pain benefit more from cervical spine manipulation than others. Those with neck pain as their main issue, with or without symptoms like tingling or numbness in one arm, might be suitable for this trial. The results could help doctors quickly decide on the best treatment for neck pain. As an unphased trial, this study allows participants to contribute to valuable research that could lead to more personalized neck pain treatments.

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 trial coordinators or your doctor.

What prior data suggests that this method is safe for neck pain treatment?

Studies have shown that neck adjustments are generally safe and effective. Side effects, if they occur, are usually mild and resolve quickly. The World Health Organization also states that this type of neck adjustment is safe. Research suggests that exercise therapy can help reduce neck pain and prevent its recurrence. These findings provide a clear understanding of the safety expectations for both treatments under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for neck pain because they explore the benefits of manual therapy and exercise in new ways. The cervical manipulation technique involves specific hand movements to adjust the neck, which might provide quicker relief compared to more traditional methods like medication or general physical therapy. Meanwhile, the exercise and mobilizations approach combines gentle neck mobilizations with targeted exercises, potentially enhancing recovery by improving flexibility and strength. These methods could offer non-invasive alternatives that focus on directly addressing the mechanical aspects of neck pain.

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

This trial will compare the effectiveness of cervical manipulation with exercise and mobilizations for neck pain. Studies have shown that certain neck treatments can speed recovery and enhance the effectiveness of neck exercises. Research supports that these treatments can reduce pain and disability in individuals with neck issues. In one study, more than half of the patients reported a significant reduction in pain within six weeks of treatment. Exercises are also known to reduce the chance of neck pain recurrence by over 50%. Regular exercise can lessen neck pain and improve neck function. Both neck treatments and exercises show promise for those with neck pain. ^{2 4 6 7 8}

Who Is on the Research Team?

Emilio J Puentedura, PhD

Principal Investigator

Baylor University

Jessica T Feda, DSc

Principal Investigator

Baylor University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 to 70 with neck pain, who have a Neck Disability Index score of at least 10 and a Numeric Pain Rating Scale score of at least 2. It's not specified who can't join the trial.

Inclusion Criteria

My neck pain affects my daily activities.

My pain level is 2 or higher on a scale of 0-10.

I am between 18 and 70 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cervical spine manipulation or low-grade mobilizations followed by therapeutic exercises

5 sessions

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-ups at 1 week, 4 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cervical Manipulation
• Exercise

Trial Overview The study tests if people likely to respond well to cervical spine manipulation will show more improvement in disability than those receiving gentle hands-on treatment. Both groups also get exercise sessions. The effects are measured over time up to six months.

How Is the Trial Designed?

Group I: Exercise and Mobilizations Experimental Treatment 2 Interventions

Patients will receive low-grade cervical mobilizations on 2 visits, followed by 3 visits of therapeutic exercises

Group II: Cervical Manipulation Experimental Treatment 2 Interventions

Patients will receive cervical manipulation on 2 visits, followed by 3 visits of therapeutic exercise.

Who Is Running the Clinical Trial?

Baylor University

Lead Sponsor

Trials

65

Recruited

67,600+

Foundation for Physical Therapy Research

Collaborator

Trials

4

Recruited

1,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12519666/

Effectiveness of musculoskeletal manipulations in patients ... In this systematic review, we compared the effectiveness of musculoskeletal manipulations, including 7 interventions, from 101 RCTs. Our ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1744388125000349

Cervical manipulation accelerates recovery and further ... Cervical manipulation enhances the effectiveness of neck retraction exercise, which promotes rapid recovery from neck pain and stiffness.

3. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-025-02855-7

Efficacy and safety of spinal manipulative therapy in the ... The evidence supports the use of SMT as an effective and safe intervention for reducing pain, improving CROM, and decreasing disability in patients with ANP.

4. jospt.org jospt.org/doi/10.2519/jospt.2023.11708

Benefits and Harms of Spinal Manipulative Therapy for ... Overall, the effectiveness of cervical SMT for reducing pain and disability varies between studies and their results depend on symptoms staging, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1447299/

Clinical Outcomes From the UCLA Neck-Pain Study More than 50% of the participants exhibited pain reductions of 2 or more scale points at 6 weeks, and about 65% exhibited such reductions at 6 months. Clinical ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40312450/

Efficacy and safety of spinal manipulative therapy in the ... The evidence supports the use of SMT as an effective and safe intervention for reducing pain, improving CROM, and decreasing disability in patients with ANP.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161475425000028

Observational Study of the Safety of Chiropractic vs ... Adverse outcomes of manipulation of the cervical spine are uncommon; when they do occur, they are generally mild and transient. A recent ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17906581/

Safety of chiropractic manipulation of the cervical spine Summary of background data: The risk of a serious adverse event following chiropractic manipulation of the cervical spine is largely unknown.