Effectiveness of the 'Algo(S)Therapy' Pain Neuroscience Education Program Emphasizing Physiotherapists' Communication Skills in Patients With Chronic Musculoskeletal Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale - NPRS
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of the "Algo(S)Therapy" Pain Neuroscience Education (PNE) program in patients with chronic musculoskeletal pain. The study will assess whether the integration of communication skills training for physiotherapists enhances the outcomes of PNE. Participants will be randomly assigned to one of three groups: (1) PNE with communication-focused delivery, (2) PNE without communication emphasis, or (3) standard- usual physiotherapy care. The primary objective is to determine whether PNE combined with enhanced communication skills leads to greater improvements in pain, function, and psychosocial outcomes compared to the other interventions.
详细描述
This randomized controlled trial investigates the effectiveness of the "Algo(S)Therapy" Pain Neuroscience Education (PNE) program in the management of chronic musculoskeletal pain (CMP), with a focus on the added value of physiotherapists' communication skills. The study will be conducted in accordance with the CONSORT guidelines.
Eligible participants will be men and women aged 18 to 65 years, diagnosed with chronic musculoskeletal pain in the lumbar spine, neck, shoulder, or knee for more than 3 months, reporting a pain intensity ≥3/10 on the Numeric Pain Rating Scale (NPRS), and experiencing symptoms on most days of the week. All participants must be fluent in the Greek language. Exclusion criteria include acute pain, neurological or neuromuscular disorders, malignancy, recent surgeries or fractures within the past year, fibromyalgia, pregnancy, corticosteroid use, cognitive impairments that affect communication or questionnaire completion, or participation in other therapeutic programs during the study period.
Participants will be randomized into one of three groups:
Experimental Group 1: Participants will receive individualized PNE-based physiotherapy delivered by physiotherapists who have completed the full "Algo(S)Therapy" program, which includes both pain neuroscience and communication skills training specific to managing patients with chronic pain.
Experimental Group 2: Participants will receive the same PNE-based physiotherapy intervention, but from physiotherapists who have completed only the pain neuroscience component of the "Algo(S)Therapy" program. These therapists will not have received any training in communication skills or related modules.
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
- Single (Participant)
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
- •Adults aged 18 to 65 years
- •Diagnosis of chronic musculoskeletal pain in the lumbar spine, cervical spine, shoulder, or knee
- •Pain duration longer than 3 months
- •Pain intensity ≥3/10 on the Numeric Pain Rating Scale (NPRS)
- •Pain present most days of the week
- •Able to understand and speak the Greek language
排除标准
- •Acute pain in any body region
- •Neurological disorders or myopathies
- •Chronic pain of non-musculoskeletal origin
- •Active cancer diagnosis
- •History of trauma, fractures, or surgery in the past year
- •Pregnancy
- •Diagnosis of fibromyalgia
- •Cognitive impairments affecting communication or completion of questionnaires
- •Current use of corticosteroid medication
- •Participation in other treatment programs or alternative therapies during the study period
- •Concurrent enrollment in another clinical trial
研究组 & 干预措施
PNE + Communication Skills
Participants in this group will receive an individualized Pain Neuroscience Education (PNE) program plus usual physiotherapy care delivered by physiotherapists who completed the full "Algo(S)Therapy" training. This training included education in the neurophysiology of pain, assessment and management of chronic musculoskeletal pain, as well as the development and application of communication skills. The communication training focused on strategies such as motivational interviewing, empathy, active listening, and patient-centered interaction specifically tailored for individuals with chronic pain. The intervention will be administered over a 5-week period, with 2 sessions per week.
干预措施: Pain Neuroscience Education with Communication Training (Behavioral)
PNE without Communication Training
Participants in this group will receive an individualized Pain Neuroscience Education (PNE) intervention plus usual physiotherapy care, delivered by physiotherapists who completed only the pain neurophysiology and clinical management components of the "Algo(S)Therapy" program. These physiotherapists did not receive any formal training in communication skills, such as motivational interviewing or empathy techniques. The intervention will be administered over a 5-week period, with 2 sessions per week.
干预措施: Pain Neuroscience Education without Communication Training (Behavioral)
Usual Physiotherapy Treatment
Participants in this group will receive usual physiotherapy care. Physiotherapists in this group have not received any training in Pain Neuroscience Education or communication techniques related to chronic pain management. No components of the "Algo(S)Therapy" program will be applied in this group.
干预措施: Usual Physiotherapy Treatment (Behavioral)
结局指标
主要结局
Numeric Pain Rating Scale - NPRS
时间窗: Baseline, Post-intervention (Week 5), and 3-Month Follow-Up
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), where participants rate their average pain on a scale from 0 (no pain) to 10 (worst imaginable pain). The measure will be used to determine the effectiveness of each intervention in reducing chronic musculoskeletal pain.
次要结局
- Central Sensitisation Inventory (CSI)(Baseline, Post-intervention (Week 5), and 3-Month Follow-Up)
- Pain Catastrophizing Scale (PCS)(Baseline, Post-intervention (Week 5), and 3-Month Follow-Up)
- Tampa Scale for Kinesiophobia (TSK)(Baseline, Post-intervention (Week 5), and 3-Month Follow-Up)
- Pain Sensitivity Questionnaire (PSQ)(Baseline, Week 5, and 3-Month Follow-Up)
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, Week 5, and 3-Month Follow-Up)
- Brief Illness Perception Questionnaire (B-IPQ)(Baseline, Week 5, and 3-Month Follow-Up)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, Week 5, and 3-Month Follow-Up)
- State-Trait Anxiety Inventory (STAI)(Baseline, Week 5, and 3-Month Follow-Up)
- Working Alliance Inventory - Short Revised (WAI-SR)(Week 5 (Post-intervention only))
- Satisfaction with Treatment (Global Rating of Change - GROC)(Post-intervention (Week 5) and 3-Month Follow-Up)
- Pain Medication Consumption(Weekly during the 5-week intervention and at 3-Month Follow-Up)
- Adherence to Intervention(Throughout the 5-week intervention period)
- Adverse Effects(Monitored continuously throughout the 5-week intervention)
- Central Sensitisation Inventory (CSI)(Baseline, Post-intervention (Week 5), and 3-Month Follow-Up)
- Pain Catastrophizing Scale (PCS)(Baseline, Post-intervention (Week 5), and 3-Month Follow-Up)
- Tampa Scale for Kinesiophobia (TSK)(Baseline, Post-intervention (Week 5), and 3-Month Follow-Up)
- Pain Sensitivity Questionnaire (PSQ)(Baseline, Week 5, and 3-Month Follow-Up)
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, Week 5, and 3-Month Follow-Up)
- Brief Illness Perception Questionnaire (B-IPQ)(Baseline, Week 5, and 3-Month Follow-Up)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, Week 5, and 3-Month Follow-Up)
- State-Trait Anxiety Inventory (STAI)(Baseline, Week 5, and 3-Month Follow-Up)
- Pain Disability Index (ODI)(Baseline, Week 5, and 3-Month Follow-Up)
- Working Alliance Inventory - Short Revised (WAI-SR)(Week 5 (Post-intervention only))
- Satisfaction with Treatment (Global Rating of Change - GROC)(Post-intervention (Week 5) and 3-Month Follow-Up)
- Pain Medication Consumption(Weekly during the 5-week intervention and at 3-Month Follow-Up)
- Adherence to Intervention(Throughout the 5-week intervention period)
- Adverse Effects(Monitored continuously throughout the 5-week intervention)
研究者
Konstantina Savvoulidou
PhD Candidate
University of Thessaly