Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief

Summary

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, 160 patients with primary complaints of neck pain will be enrolled from 9 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.

Conditions

• Neck Pain Musculoskeletal
• Neck Pain Treatment
• Cervicalgia

Interventions

PROCEDURE

Cervical Manipulation

High velocity low amplitude thrust joint manipulation to the cervical spine facet joints

PROCEDURE

Exercise

Therapeutic exercises to the cervical, thoracic, and scapular musculature

PROCEDURE

Mobilization

Low velocity, low amplitude movements applied to the cervical spine facet joints (Grade I or II)

Sponsors & Collaborators

• Foundation for Physical Therapy Research

  collaborator OTHER

• Baylor University

  lead OTHER

Principal Investigators

• Jessica T Feda, DSc · Baylor University

• Emilio J Puentedura, PhD · Baylor University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations