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

Официальное название

Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spinal Manipulation: A Randomized Clinical Trial

Обзор

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.

Подробное описание

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 160 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.

Вмешательства

• Процедура Cervical Manipulation
  High velocity low amplitude thrust joint manipulation to the cervical spine facet joints
• Процедура Exercise
  Therapeutic exercises to the cervical, thoracic, and scapular musculature
• Процедура Mobilization
  Low velocity, low amplitude movements applied to the cervical spine facet joints (Grade I or II)

Первичные конечные точки

• Neck Disability Index [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Global Rating of Change Scale [Срок оценки: 6 months]
• Numeric Pain Rating Scale [Срок оценки: 6 months]
• Fear Avoidance Beliefs Questionnaire [Срок оценки: 6 months]
• Medication Use [Срок оценки: 6 months]
• Healthcare Utilization [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Inability to comply with the treatment and follow-up schedule

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 4 центра

• ActivePT — Rochester
• PROActivePT — Syracuse
• ActiveTherapy Alliance — Waco
• Emplify by Bellin Health Ashwaubenon — Green Bay

Публикации

• 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. PMID 15611489
• 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. PMID 20634268
• Kaale BR, Krakenes J, Albrektsen G, Wester K. Clinical assessment techniques for detecting ligament and membrane injuries in the upper cervical spine region--a comparison with MRI results. Man Ther. 2008 Oct;13(5):397-403. doi: 10.1016/j.math.2007.03.007. Epub 2007 Nov 1. PMID 17936054
• Uitvlugt G, Indenbaum S. Clinical assessment of atlantoaxial instability using the Sharp-Purser test. Arthritis Rheum. 1988 Jul;31(7):918-22. doi: 10.1002/art.1780310715. PMID 3395385
• Hutting N, Scholten-Peeters GG, Vijverman V, Keesenberg MD, Verhagen AP. Diagnostic accuracy of upper cervical spine instability tests: a systematic review. Phys Ther. 2013 Dec;93(12):1686-95. doi: 10.2522/ptj.20130186. Epub 2013 Jul 25. PMID 23886844
• Hengeveld E, Banks K. Maitland's Vertebral Manipulation: Management of Neuromusculoskeletal Disorders - Volume 1. Elsevier Health Sciences; 2013.
• Piva SR, Erhard RE, Childs JD, Browder DA. Inter-tester reliability of passive intervertebral and active movements of the cervical spine. Man Ther. 2006 Nov;11(4):321-30. doi: 10.1016/j.math.2005.09.001. Epub 2006 Jul 11. PMID 16837235
• Harris KD, Heer DM, Roy TC, Santos DM, Whitman JM, Wainner RS. Reliability of a measurement of neck flexor muscle endurance. Phys Ther. 2005 Dec;85(12):1349-55. PMID 16305273

Идентификаторы

NCT: NCT06906107 · 2240854-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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