Status:
RECRUITING
Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief in 140 Participants With Neck Pain
Lead Sponsor:
Baylor University
Collaborating Sponsors:
Foundation for Physical Therapy Research
Conditions:
Neck Pain Musculoskeletal
Neck Pain Treatment
Eligibility:
All Genders
18-70 years
Phase:
NA
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 po...
Detailed Description
This study's primary objective will examine whether a previously derived clinical prediction rule (CPR) exhibits validity for identifying a subgroup of patients who respond favorably to cervical thrus...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Inability to read English at the 8th grade reading level
- Inability to legally provide informed consent for any other reason
- Inability to comply with the treatment and follow-up schedule
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06906107
Start Date
June 1 2025
End Date
December 31 2026
Last Update
June 18 2025
Active Locations (3)
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1
ActivePT
Rochester, Minnesota, United States, 55901
2
PROActivePT
Syracuse, New York, United States, 13201
3
ActiveTherapy Alliance
Waco, Texas, United States, 76798