140 Participants Needed

Manual Therapy and Exercise for Neck Pain

Recruiting at 2 trial locations
JT
TL
Overseen ByTiffany L Barrett, DSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Baylor University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Neck pain is a common issue that can lead to long-term disability and lost work time for many individuals. Despite numerous studies, finding effective treatment strategies has been challenging. One possible reason for this is that treatments may not have been tested on the specific groups of people who would benefit most. A method was developed to identify people with neck pain who are likely to see significant improvements from a manipulation technique used by physical therapists, called cervical spine thrust joint manipulation. The investigators believe that patients identified as likely responders to cervical spine manipulation will show greater improvements in disability. The investigators aim to test whether this method works with different patients and therapists across the country through a multicenter randomized clinical trial. In this study, 140 patients with primary complaints of neck pain will be enrolled from 20 clinical sites. Designed with stringent criteria for inclusion, this study is a testament to our commitment to participant safety and the effectiveness of the treatment. Participants will be randomly assigned to one of two groups: (1) one group will receive 2 sessions of cervical spine manipulation followed by 3 sessions of exercise, and (2) the other group will receive 2 sessions of gentle hands-on treatment followed by 3 sessions of exercise. The primary goal is to measure changes in disability 4 weeks after starting treatment, with follow-ups after one week, 4 weeks, 3 months, and 6 months to assess both immediate and long-term effects. By providing crucial data on the reliability of our method in identifying patients who will benefit most from cervical spine manipulation, this study has the potential to significantly enhance decision-making leading to rapid improvement. Results from this study will provide clearer guidelines on the optimal use of cervical spine manipulation, potentially revolutionizing the way patients recover from neck pain.

Who Is on the Research Team?

JT

Jessica T Feda, DSc

Principal Investigator

Baylor University

EJ

Emilio J Puentedura, PhD

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.
See 1 more

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?
2Treatment groups
Experimental Treatment
Group I: Exercise and MobilizationsExperimental Treatment2 Interventions
Patients will receive low-grade cervical mobilizations on 2 visits, followed by 3 visits of therapeutic exercises
Group II: Cervical ManipulationExperimental Treatment2 Interventions
Patients will receive cervical manipulation on 2 visits, followed by 3 visits of therapeutic exercise.

Find a Clinic Near You

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+
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