Validating a Clinical Prediction Rule to Guide Manual Therapy and Exercise for Neck Pain Relief in 140 Participants With Neck Pain
NCT ID: NCT06906107
Last Updated: 2025-06-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
140 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-06-01
Study Completion Date
2026-12-31
Brief Summary
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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.
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Detailed Description
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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 thrust joint manipulation (C-TJM). The secondary objective will determine if patients who are positive on the derived CPR and receive C-TJM will exhibit reduced downstream healthcare costs. This multicenter randomized clinical trial will enroll 140 patients with primary complaints of neck pain. Participants will be randomized into two groups: (1) 2 sessions of C-TJM followed by 3 sessions of stretching and strengthening exercises, and (2) 2 sessions of low-grade mobilizations followed by 3 sessions of the same stretching and strengthening exercises. The primary outcome is the change in disability measured four weeks post-treatment, with pain as the secondary outcome. Follow-up assessments will occur at one week, 4 weeks, 3 months and 6 months to evaluate both short-term and long-term effects. The exact inclusion and exclusion criteria from the CPR derivation study will be used within this validation study to determine participant eligibility. Data will be collected using standardized self-report measures and physical examination, and statistical analyses will be performed using a linear mixed model with repeated measures. The investigators hypothesize that patients identified by the clinical prediction rule to benefit from C-TJM will show substantial improvements in disability and pain. This study will offer valuable insight into the effectiveness of C-TJM for neck pain. Successful validation of the clinical prediction rule could lead to more efficient and cost-effective patient care, potentially reducing the burden of neck pain on healthcare systems and improving patient outcomes. As PI, responsibilities include protocol development, training, data collection, analysis, manuscript development and dissemination of findings.
Conditions
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Neck Pain Musculoskeletal
Neck Pain Treatment
Cervicalgia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Caregivers
Investigators
Outcome Assessors
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.
Study Groups
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Cervical Manipulation
Patients will receive cervical manipulation on 2 visits, followed by 3 visits of therapeutic exercise.
Group Type
EXPERIMENTAL
Cervical Manipulation
Intervention Type
PROCEDURE
High velocity low amplitude thrust joint manipulation to the cervical spine facet joints
Exercise
Intervention Type
PROCEDURE
Therapeutic exercises to the cervical, thoracic, and scapular musculature
Exercise and Mobilizations
Patients will receive low-grade cervical mobilizations on 2 visits, followed by 3 visits of therapeutic exercises
Group Type
OTHER
Exercise
Intervention Type
PROCEDURE
Therapeutic exercises to the cervical, thoracic, and scapular musculature
Mobilization
Intervention Type
PROCEDURE
Low velocity, low amplitude movements applied to the cervical spine facet joints (Grade I or II)
Interventions
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Cervical Manipulation
High velocity low amplitude thrust joint manipulation to the cervical spine facet joints
Intervention Type
PROCEDURE
Exercise
Therapeutic exercises to the cervical, thoracic, and scapular musculature
Intervention Type
PROCEDURE
Mobilization
Low velocity, low amplitude movements applied to the cervical spine facet joints (Grade I or II)
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 Criteria
* 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:
1. Muscle weakness involving a major muscle group of the upper extremity
2. Diminished upper extremity muscle stretch reflex (biceps, triceps, or brachioradialis)
3. 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
* 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:
1. Muscle weakness involving a major muscle group of the upper extremity
2. Diminished upper extremity muscle stretch reflex (biceps, triceps, or brachioradialis)
3. 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Foundation for Physical Therapy Research
OTHER
Sponsor Role
collaborator
Baylor University
OTHER
Sponsor Role
lead
Responsible Party
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Jessica Feda
Clinical Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jessica T Feda, DSc
Role: PRINCIPAL_INVESTIGATOR
Baylor University
Emilio J Puentedura, PhD
Role: STUDY_DIRECTOR
Baylor University
Locations
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ActivePT
Rochester, Minnesota, United States
Site Status
RECRUITING
PROActivePT
Syracuse, New York, United States
Site Status
RECRUITING
ActiveTherapy Alliance
Waco, Texas, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Childs JD, Fritz JM, Flynn TW, Irrgang JJ, Johnson KK, Majkowski GR, Delitto A. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med. 2004 Dec 21;141(12):920-8. doi: 10.7326/0003-4819-141-12-200412210-00008.
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Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2240854-1
Identifier Type: -
Identifier Source: org_study_id
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