The Influence of Contextual Effects on Biochemical Parameters Associated With Inflammation and the Analgesic Efficacy of Spinal Joint Manipulation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Pain intensity score on the 11-point Numeric Pain Rating Scale (NPRS-11)
研究概览
简要总结
The goal of this clinical trial is to learn whether contextual effects created by observational learning can change pain relief and inflammation-related biological responses after spinal joint manipulation in adults with chronic non-specific low back pain. The main questions it aims to answer are:
Does positive, neutral, or negative observational learning change pain after spinal joint manipulation? Does it change disability, lumbar range of motion, stress, fear of movement, empathy, and treatment expectations? Does it change pressure pain threshold, lumbar tissue temperature, and blood markers related to inflammation, including interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10)?
The researchers will compare 3 groups: a positive expectation group, a neutral group, and a negative expectation group. Before the treatment, each participant will have a short interaction with a trained simulated patient. The simulated patient will present a positive, neutral, or negative experience with spinal manipulation, depending on group assignment. After this, all the participants will receive the same spinal joint manipulation procedure.
The participants will:
- be randomly assigned to 1 of 3 study groups,
- complete baseline questionnaires and clinical tests before treatment,
- take part in a brief observational learning session before manipulation,
- receive 1 spinal joint manipulation treatment,
- complete outcome measurements before treatment, about 60 minutes after treatment, and 24 hours after treatment,
- provide blood samples for analysis of inflammation-related biomarkers.
This study will include adults aged 18 to 65 years with chronic non-specific low back pain. The main outcome is pain intensity. Secondary outcomes include disability, stress, empathy, fear of movement, lumbar range of motion, tissue temperature, pressure pain threshold, and treatment expectations. Exploratory outcomes include blood biomarkers related to inflammation.
详细描述
Chronic non-specific low back pain is a common and disabling condition. Spinal joint manipulation is frequently used in its management, but the mechanisms underlying its effects are not fully understood. Increasing attention has been given to contextual factors, including treatment expectations, which may influence pain-related outcomes through psychological and neurophysiological pathways. One potentially important mechanism is observational learning, in which expectations are shaped by observing another person's experience with treatment. This mechanism has been studied in experimental pain settings, but it has been investigated only rarely in clinical populations and has not been adequately tested in the context of spinal manipulation for chronic non-specific low back pain.
The purpose of this study is to evaluate whether observational learning before treatment can modify the effects of spinal joint manipulation in adults with chronic non-specific low back pain. The trial is designed to examine whether a brief peer-modeling interaction presented before treatment can influence clinical outcomes, psychological responses, and selected mechanistic measures, including inflammatory biomarkers. The study will compare positive, neutral, and negative observational learning conditions to determine whether expectation-related contextual effects alter response to the same manual therapy procedure.
This study is a prospective, parallel-group, three-arm randomized controlled trial with follow-up assessment. The participants will be randomly assigned in a 1:1:1 ratio to one of three groups: positive observational learning, neutral observational learning, or negative observational learning. The target analyzed sample is 66 participants, and the recruitment target has been increased to 73 participants to account for possible dropout. Allocation concealment will be ensured using opaque, sequentially numbered envelopes prepared by an independent researcher. The participants, treating physiotherapists, outcome assessors, and statisticians will remain blinded to group allocation and study hypotheses throughout the trial.
The participants will be adults aged 18 to 65 years with chronic non-specific low back pain lasting more than 3 months and pain intensity of at least 4 out of 10 during the previous 24 hours. Eligibility will be based on clinical criteria for chronic non-specific low back pain. Key exclusion criteria include prior spinal manipulation, major spinal red flags, recent lumbar trauma or surgery, selected systemic or psychiatric conditions, pregnancy, active infection, relevant medication use that could affect pain or inflammatory responses, and factors that could interfere with understanding the observational learning procedure. A screening log will be maintained to document exclusions and reasons for non-enrollment.
All the participants will undergo the same spinal manipulation intervention. The manipulation will be delivered as a high-velocity, low-amplitude lumbar technique. The procedure will be applied on the symptomatic side identified by the participant; if the participant cannot identify the more symptomatic side, the physiotherapist will decide. If cavitation is not obtained, the physiotherapist may attempt the procedure on the opposite side. A maximum of two attempts per side will be allowed. This approach is intended to standardize the specific treatment component across all study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The participants, care providers, and outcome assessors will be blinded to group assignment. In addition, the statisticians will remain blinded to group allocation and study hypotheses during the trial. Allocation concealment will be ensured using sequentially numbered, opaque sealed envelopes prepared by an independent researcher. The participants will be informed about the true study aims after completion of their participation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •people with low back pain lasting longer than 3 months, aged 18 to 65 years,
- •highest reported pain intensity during the last 24 hours of at least 4 out of 10 on the 11-point Numeric Pain Rating Scale (NPRS-11), where 0 = no pain and 10 = worst imaginable pain,
- •clinical diagnosis of chronic non-specific low back pain (NSCLBP) based on symptoms located in the lumbar spine region and not on imaging findings,
- •no use of nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 7 days before the study,
- •no use of pain medication for at least 24 hours before the study,
- •no use of corticosteroids,
- •no previous spinal manipulation therapy,
- •no alcohol, nicotine, or coffee consumption for at least 12 hours before the study,
- •written informed consent to participate in the study.
排除标准
- •physiotherapy students,
- •presence of red flags, such as a history of cancer, constant or non-mechanical pain, progressive or radiating pain, sensory deficits in the trunk or - lower limbs, lower limb muscle weakness, or bladder/bowel dysfunction,
- •body mass index (BMI) greater than 30,
- •previous lumbar spine surgery,
- •lumbar spine injury within 6 months before the study,
- •diagnosed diabetes,
- •diagnosed rheumatic diseases,
- •affective disorders such as post-traumatic stress disorder (PTSD) or schizophrenia,
- •spondylolisthesis or spondylolysis confirmed by imaging,
- •diagnosed endometriosis,
- •use of hormonal medications,
- •sleep disorders,
- •shift work,
- •musculoskeletal injury within the last 14 days,
- •active infection,
- •pregnancy,
- •endocrine disorders such as hyperthyroidism or hypothyroidism,
- •use of opioid medications, including over-the-counter combination products such as codeine with paracetamol,
- •current or recent use of antidepressants affecting serotonin or dopamine (including SSRIs, SNRIs, tricyclic antidepressants, MAO inhibitors, or ketamine),
- •current diagnosis of major depressive disorder or bipolar disorder, as well as PTSD or schizophrenia,
- •ongoing psychotherapy during the study period,
- •cognitive impairment or significant hearing impairment that may interfere with understanding or processing the observational learning procedure.
研究组 & 干预措施
Positive Observational Learning + Spinal Joint Manipulation
The participants are exposed to a standardized positive observational learning procedure before treatment. A simulated patient describes clear improvement in low back pain and lumbar mobility after spinal manipulation and demonstrates comfortable lumbar movement. After this interaction, the participants receive the same spinal joint manipulation procedure as in the other study arms.
干预措施: Observational Learning (Behavioral)
Neutral Observational Learning + Spinal Joint Manipulation
The participants are exposed to a standardized neutral observational learning procedure before treatment. A simulated patient has a brief neutral interaction and does not describe treatment effects or demonstrate functional improvement. After this interaction, the participants receive the same spinal joint manipulation procedure as in the other study arms.
干预措施: Observational Learning (Behavioral)
Positive Observational Learning + Spinal Joint Manipulation
The participants are exposed to a standardized positive observational learning procedure before treatment. A simulated patient describes clear improvement in low back pain and lumbar mobility after spinal manipulation and demonstrates comfortable lumbar movement. After this interaction, the participants receive the same spinal joint manipulation procedure as in the other study arms.
干预措施: Spinal Joint Manipulation (Procedure)
Neutral Observational Learning + Spinal Joint Manipulation
The participants are exposed to a standardized neutral observational learning procedure before treatment. A simulated patient has a brief neutral interaction and does not describe treatment effects or demonstrate functional improvement. After this interaction, the participants receive the same spinal joint manipulation procedure as in the other study arms.
干预措施: Spinal Joint Manipulation (Procedure)
Negative Observational Learning + Spinal Joint Manipulation
The participants are exposed to a standardized negative observational learning procedure before treatment. A simulated patient reports little or no improvement in low back pain after spinal manipulation and demonstrates limited lumbar movement with visible discomfort. After this interaction, the participants receive the same spinal joint manipulation procedure as in the other study arms.
干预措施: Observational Learning (Behavioral)
Negative Observational Learning + Spinal Joint Manipulation
The participants are exposed to a standardized negative observational learning procedure before treatment. A simulated patient reports little or no improvement in low back pain after spinal manipulation and demonstrates limited lumbar movement with visible discomfort. After this interaction, the participants receive the same spinal joint manipulation procedure as in the other study arms.
干预措施: Spinal Joint Manipulation (Procedure)
结局指标
主要结局
Pain intensity score on the 11-point Numeric Pain Rating Scale (NPRS-11)
时间窗: Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.
Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS-11), where 0 indicates no pain and 10 indicates the worst imaginable pain. This is the primary outcome measure.
次要结局
- Pressure pain threshold at lumbar levels L3-L5 measured by pressure algometry(Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.)
- Stress score on the 11-point Stress Numeric Rating Scale (SNRS-11)(Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.)
- Perceived stress score on the 10-item Perceived Stress Scale (PSS-10)(Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.)
- Empathic concern score on the Interpersonal Reactivity Index(Baseline (pre-intervention))
- Disability score related to low back pain on the Roland-Morris Disability Questionnaire(Baseline (pre-intervention), 24 hours after spinal joint manipulation.)
- Kinesiophobia score on the Tampa Scale of Kinesiophobia(Baseline (pre-intervention), 24 hours after spinal joint manipulation.)
- Lumbar range of motion(Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.)
- Lumbar tissue temperature measured by infrared thermography(Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.)
- Lumbar flexion and extension range of motion measured by Medi-Mouse(Baseline (pre-intervention), 60 minutes after spinal joint manipulation, and 24 hours after spinal joint manipulation.)
- Expected treatment benefit score on a 0-100 Visual Analog Scale (VAS)(Baseline (pre-intervention) and immediately after the observational learning procedure, before spinal joint manipulation.)
- Fulfillment of treatment expectations score on a 0-100 Visual Analog Scale (VAS)(60 minutes after spinal joint manipulation and 24 hours after spinal joint manipulation.)
- Attitude toward manual therapy score on a 0-100 Visual Analog Scale (VAS)(Baseline (pre-intervention))
- Patient satisfaction score on an 11-point numeric rating scale(24 hours after spinal joint manipulation.)