Examining the Influence of Opioid Use on the Effects of Spinal Manipulative Therapy for Low Back Pain: Administrative Supplement to UH3AT009293 - Optimization of Spinal Manipulative Therapy (SMT) Protocols
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Pain intensity: 0-10 numeric pain rating
研究概览
简要总结
This project is a supplement to the parent project (UH3AT009293) entitled "Optimization of Spinal Manipulative Therapy (SMT) Protocols". The goal of the parent project is to examine strategies to optimize SMT treatment protocols for patients with low back pain (LBP). The parent project is investigating mechanistic and clinical outcomes of SMT combined with varying co-interventions. This supplemental project will examine the impact of opioid use on these outcomes.
详细描述
This supplement expands the parent research project to include three additional Aims and the recruitment of the 70 additional participants. The additional participants will undergo the same assessment and intervention procedures outlined in the parent project to permit leveraging the full cohort to evaluate the supplemental Aims.
The overall objective is to examine the impact of opioid use on patient-centered and mechanistic outcomes related to SMT and explore the impact on SMT followed by various co-interventions. The goal of this research is to better tailor SMT protocols to optimize outcomes for patients with LBP who are opioid users and facilitate efforts to reduce reliance on opioid pain management among those with LBP. Accomplishing this goal will facilitate future research evaluating the efficacy of non-pharmacologic alternative pain management strategies for individuals with LBP.
Specific Aims to be addressed through this supplement are:
- Compare baseline psychological, mechanistic and LBP-related characteristics between sub-groups of participants with LBP based on opioid use.
- Examine the association of opioid use with changes in mechanistic and patient-centered outcomes between a baseline assessment and subsequent assessment after 1-week and completion of a 2-session SMT intervention protocol.
- Explore the moderating effects of opioid use on mechanistic and patient-centered outcomes obtained 4 weeks following SMT intervention with varied co-intervention components.
Examining these aims as a supplement to the parent project will allow evaluation of whether or not opioid use impacts short-term mechanistic and patient-centered outcomes of SMT (Aim 2), and will explore if the longer-term effects of the three co-interventions differ between opioid users and non-users. (Aim 3). This research will also compare baseline characteristics between participants who are or are not opioid users (Aim 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Design precludes blinding of patients or care providers. Research personnel conducting outcomes assessments and the principal investigator are blind to participants' group assignment throughout the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the examiner, originate from the lumbar region.
- •Age 18 - 60 years
- •Oswestry disability score > 20%
- •Self-reported
排除标准
- •Prior surgery to the lumbosacral spine
- •Currently pregnant
- •Currently receiving mind-body or exercise treatment for LBP from a healthcare provider (e.g., chiropractic, physical therapy, massage therapy, etc.)
- •Neurogenic signs including any of the following: positive ipsi- or contra-lateral straight leg raise test; reflex, sensory, or strength deficit in a pattern consistent with lumbar nerve root compression
研究组 & 干预措施
SMT Only
All patients receive 2 SMT sessions in the first week.
干预措施: SMT (Behavioral)
SMT extended
All patients receive 2 SMT sessions in the first week. This arm also involves 6 additional SMT sessions. Each SMT session is conducted as described previously.
干预措施: SMT (Behavioral)
SMT extended
All patients receive 2 SMT sessions in the first week. This arm also involves 6 additional SMT sessions. Each SMT session is conducted as described previously.
干预措施: Extended SMT (Behavioral)
SMT with Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm receives 6 additional sessions of activation exercises.
干预措施: Activation Exercises (Behavioral)
SMT with Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm receives 6 additional sessions of activation exercises.
干预措施: SMT (Behavioral)
SMT with Mobilizing Exercises
All patients receive 2 SMT sessions in the first week.
This arm involves 6 additional sessions of mobilizing exercise.
干预措施: Mobilizing Exercises (Behavioral)
SMT with Mobilizing Exercises
All patients receive 2 SMT sessions in the first week.
This arm involves 6 additional sessions of mobilizing exercise.
干预措施: SMT (Behavioral)
SMT with Mobilizing and Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm involves 6 additions sessions including both activation and mobilizing exercises.
干预措施: SMT (Behavioral)
SMT with Mobilizing and Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm involves 6 additions sessions including both activation and mobilizing exercises.
干预措施: Activation Exercises (Behavioral)
SMT with Mobilizing and Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm involves 6 additions sessions including both activation and mobilizing exercises.
干预措施: Mobilizing Exercises (Behavioral)
SMT extended with Mobilizing Exercises
All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including both SMT and mobilizing exercises.
干预措施: SMT (Behavioral)
SMT extended with Mobilizing Exercises
All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including both SMT and mobilizing exercises.
干预措施: Mobilizing Exercises (Behavioral)
SMT extended with Mobilizing Exercises
All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including both SMT and mobilizing exercises.
干预措施: Extended SMT (Behavioral)
SMT extended with Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including both SMT and activation exercises.
干预措施: SMT (Behavioral)
SMT extended with Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including both SMT and activation exercises.
干预措施: Activation Exercises (Behavioral)
SMT extended with Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including both SMT and activation exercises.
干预措施: Extended SMT (Behavioral)
SMT extended with Mobilizing and Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.
干预措施: Activation Exercises (Behavioral)
SMT extended with Mobilizing and Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.
干预措施: Mobilizing Exercises (Behavioral)
SMT extended with Mobilizing and Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.
干预措施: SMT (Behavioral)
SMT extended with Mobilizing and Activation Exercises
All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.
干预措施: Extended SMT (Behavioral)
结局指标
主要结局
Pain intensity: 0-10 numeric pain rating
时间窗: 1 week
A 0-10 numeric pain rating is used to assess pain intensity. Higher numbers indicate greater pain intensity.
Oswestry
时间窗: 1 week
The Oswestry Index measures back pain-related disability. The scale contains 10 items with a final score ranging from 0-100. Higher numbers indicate more disability.
次要结局
- Multifidus Activation(Baseline, 1-week, 4-weeks, 3 months)
- Spinal Stiffness(Baseline, 1-week, 4-weeks, 3 months)