Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care

Официальное название

Combined Chiropractic Care and Tai Chi for Chronic Non-Specific Neck Pain

Обзор

This feasibility project aims to evaluate the effectiveness of chiropractic care combined with Tai Chi (TC) training to reduce pain and disability in adults with chronic non-specific neck pain (CNNP).

Подробное описание

This is a three-armed, mixed-methods pilot study. 48 adults with CNNP will be randomized to receive either 1) 10 chiropractic treatments (delivered over 16 weeks) with concurrent TC training (16 weeks of group training) plus enhanced usual care (EUC) with CNNP educational materials); 2) chiropractic care plus EUC; or 3) EUC alone. Individuals will be followed for 8 weeks after the end of their intervention period to assess longer-term outcomes. Our primary outcomes will be focused on the feasibility of recruiting, retaining and monitoring the safety of adults with CNNP into our trial. Secondary clinical outcomes include following patients centered-outcomes: pain, disability, health-related quality of life, self-efficacy, cognitive and affective outcomes (postural awareness, pain catastrophizing, fear of movement, interoceptive awareness).

Вмешательства

• Другое Chiropractic Care
  Chiropractic care will be delivered by community-based chiropractors that meet pre-set qualifications. Chiropractic treatment protocol will be multimodal and will follow predefined standard operating procedures including the following 6 components: 1) Posture correction and spinal stabilization exercises; 2) Soft tissue release techniques; 3) Manual spinal manipulation; 4) Condition-specific education; 5) Myofascial strengthening and motor control training; 6) Ergonomic and lifestyle modificatio
• Другое Tai Chi
  Tai Chi (TC) will be delivered by community based Tai Chi schools that meet pre-set qualifications. TC programs will emphasize core principles including biomechanically efficient alignment, relaxed integrated movements, deep breathing, and heightened body awareness. Subjects randomized to TC treatment group will attend at least one TC class per week for 16 weeks.
• Другое Enhanced Usual Care
  Enhanced Usual Care will include educational materials about neck pain provided by the study, in addition to usual medical care for CNNP. Usual care for CNNP generally includes medications (non-narcotic analgesics, NSAIDs, muscle relaxants), interventional pain management (e.g., steroid injections), and self-care exercises (all of which will be monitored and recorded in all three study arms).

Первичные конечные точки

• Recruitment rate [Срок оценки: Through study completion (an average of 18 months)]
• Retention rate [Срок оценки: Through study completion (an average of 18 months)]
• Intervention adherence [Срок оценки: Through study completion (an average of 18 months)]

Вторичные конечные точки (11)

• Pain intensity [Срок оценки: Baseline, 16-weeks, and 24-weeks]
• Pain on movement (POM) [Срок оценки: Baseline, 16-weeks, and 24-weeks]
• Bothersomeness of pain [Срок оценки: Baseline, 16-weeks, and 24-weeks]
• Disability [Срок оценки: Baseline, 16-weeks, and 24-weeks]
• Health-related quality of life [Срок оценки: Baseline, 16-weeks, and 24-weeks]
• Self-efficacy [Срок оценки: Baseline, 16-weeks, and 24-weeks]
• Postural awareness [Срок оценки: Baseline, 16-weeks, and 24-weeks]
• Pain Catastrophizing Scale [Срок оценки: Baseline, 16-weeks, and 24-weeks]
• Fear of Movement [Срок оценки: Baseline, 16-weeks, and 24-weeks]
• Interoceptive Awareness [Срок оценки: Baseline, 16-weeks, and 24-weeks]
• Perceptions of treatments [Срок оценки: Baseline and 16-weeks]

Критерии участия

Критерии включения

• Chronic nonspecific neck pain at least 5 days a week for at least 3 consecutive months
• Neck pain averaged over past week of 3 or more on numerical rating scale ranging from 0 to 10, with 10 described as 'worst neck pain imaginable'
• Neck Disability Index score of 5 or greater
• Agreeable to participate in all study procedures and be randomized to all intervention groups
• Fluent in English

Критерии исключения

• Currently, or having received chiropractic care in past 12 months
• Regular practice (on average, weekly) of Yoga, Tai Chi or Qigong in the past 6 months
• Any major systemic illness or unstable medical condition (e.g. Parkinson's disease, cancer) or psychiatric condition requiring immediate treatment or that could lead to difficulty complying with the protocol
• Any disability precluding exercise practice
• History of stroke, carotid artery dissection, or vertebral artery dissection
• Signs of myelopathy or carotid bruits or evidence of pathological hypermobility (e.g. Ehlers Danlos Syndrome) during the clinical exam
• Neck pain caused by congenital deformity of the spine that contraindicate treatment, neck pain related to neoplasm, inflammatory rheumatic disease, neurological disorder, active oncologic disease, severe affective disorder, addiction, or psychosis
• Neck pain associated with unstable radicular pain or radiculopathy
• Pregnancy
• Recent spinal injections (in the past 4 weeks)
• Neck pain with litigation
• Any prior cervical surgery/spinal surgery within previous year
• Persons currently involved in a disability/accident claim

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Osher Clinical Center at Brigham and Women's Hospital — Chestnut Hill

Публикации

• Wayne PM, Vining R, Long CR, Burton WM, Litrownik D, Guzman J, Kilgore K, Hagan TJ, Rist PM, Kowalski MH. Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial. Contemp Clin Trials Commun. 2025 Apr 11;45:101482. doi: 10.1016/j.conctc.2025.101482. eCollection 2025 Jun. PMID 40321971

Идентификаторы

NCT: NCT05726331 · 2021A014141

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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