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

NCT06906107 | Recruiting

• 1 other identifier: 2240854-1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

neck pain; manual therapy; physical therapy

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index

  10-item patient self-report measure of perceived disability. Each question is scored from 0 to 5. Minimum value of 0 and maximum value of 50. Higher scores indicate worse disability and a poorer outcome.

  6 months

Secondary Outcomes (5)

• Global Rating of Change Scale

  6 months

• Numeric Pain Rating Scale

  6 months

• Fear Avoidance Beliefs Questionnaire

  6 months

• Medication Use

  6 months

• Healthcare Utilization

  6 months

Study Arms (2)

Cervical Manipulation

EXPERIMENTAL

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

Procedure: Cervical Manipulation; Procedure: Exercise

Exercise and Mobilizations

OTHER

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

Procedure: Exercise; Procedure: Mobilization

Interventions

Cervical Manipulation PROCEDURE

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

Cervical Manipulation

Exercise PROCEDURE

Therapeutic exercises to the cervical, thoracic, and scapular musculature

Cervical Manipulation; Exercise and Mobilizations

Mobilization PROCEDURE

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

Exercise and Mobilizations

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 to 70
• Primary complaint of neck pain with or without unilateral upper extremity symptoms
• Neck Disability Index (NDI) score of 10 or greater
• Numeric Pain Rating Scale score of 2 or greater

You may not qualify if:

• History of whiplash injury within the past 6 weeks
• Diagnosis of cervical spinal stenosis
• Bilateral upper extremity symptoms
• Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, rheumatoid arthritis, osteoporosis, severe atherosclerosis, dizziness, diplopia, drop attacks, bilateral numbness, nausea, prolonged history of steroid use)
• Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes)
• Two or more positive neurological signs consistent with significant nerve root compression, including any two of the following:
• Muscle weakness involving a major muscle group of the upper extremity
• Diminished upper extremity muscle stretch reflex (biceps, triceps, or brachioradialis)
• Diminished or absent sensation to pinprick or light touch in any upper extremity dermatome
• Prior neck surgery
• Current pregnancy, pregnancy within 6 months, or currently lactating
• Pending legal action pertaining to their neck pain
• Currently receiving manual therapy treatment for neck pain through chiropractic or physical therapy care
• Inability to read English at the 8th grade reading level
• Inability to legally provide informed consent for any other reason

Sponsors & Collaborators

• Baylor University: lead
• Foundation for Physical Therapy Research: collaborator

Study Sites (4)

ActivePT

Rochester, Minnesota, 55901, United States

RECRUITING

PROActivePT

Syracuse, New York, 13201, United States

RECRUITING

ActiveTherapy Alliance

Waco, Texas, 76798, United States

RECRUITING

Emplify by Bellin Health Ashwaubenon

Green Bay, Wisconsin, 54313, United States

RECRUITING

Related Publications (35)

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MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Spinal; Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jessica T Feda, DSc

  Baylor University

  PRINCIPAL INVESTIGATOR

• Emilio J Puentedura, PhD

  Baylor University

  STUDY DIRECTOR

Central Study Contacts

Jessica T Feda, DSc

CONTACT

5079906446; jessica_feda@baylor.edu

Tiffany L Barrett, DSc

CONTACT

702-321-2144; Tiffany.Barrett@augie.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The initial investigator performing the baseline assessment is masked to the treatment. The investigator performing the treatment is masked to the initial investigator's assessment of the patient's categorization on the clinical prediction rule. The outcome assessor is masked to the intervention received and status on the clinical prediction rule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 2, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)