Comparison of the Effects of Prolotherapy and Rehabilitation Treatments in Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
Chronic low back pain (CLBP) represents one of the leading causes of long-term disability among adults and places a substantial strain on healthcare systems globally. The clinical course of CLBP is highly heterogeneous, with considerable variability in symptom persistence and functional impairment, which complicates therapeutic decision-making in routine practice.
Conventional physiotherapy is commonly prescribed for patients with CLBP; however, evidence comparing its short-term effectiveness with alternative interventions such as balneotherapy and prolotherapy remains scarce. Balneotherapy, often used as an adjunct to physiotherapy, is widely applied in the management of chronic musculoskeletal conditions and is believed to provide therapeutic benefits through a combination of thermal and mechanical effects.
In addition, psychosocial factors play a crucial role in the evolution of low back pain. Increased stress, insufficient social support, occupational dissatisfaction, and mood disorders have been associated with a higher likelihood of pain chronicification and reduced response to treatment.
The objective of the present study was to evaluate and compare short-term clinical outcomes of standard physiotherapy, combined balneotherapy and physiotherapy, and prolotherapy in individuals with chronic low back pain. Outcomes were assessed using validated instruments measuring pain severity, functional disability, lumbar spine mobility, quality of life, and psychological well-being at baseline and after a four-week intervention period.
The study enrolled adults aged 18 to 70 years with CLBP persisting for more than three months and a baseline Visual Analog Scale (VAS) score of at least 4. Participants were assigned to one of three treatment modalities: physiotherapy alone, balneotherapy combined with physiotherapy, or prolotherapy. Participants allocated to the dextrose prolotherapy group (PG) and the standard physiotherapy control group (CG) were treated at Ovidius Clinical Hospital, Romania, while patients included in the balneotherapy plus physiotherapy group (BG) underwent treatment at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania. Evaluations were conducted at baseline (T0) and at the four-week follow-up (T1), encompassing measures of pain intensity, functional limitation, lumbar mobility, quality of life, and psychological status.
The results highlight the potential benefits of multimodal and regenerative therapeutic approaches within personalized conservative treatment strategies for patients with chronic low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of CLBP lasting more than three months, confirmed by lumbar radiography or magnetic resonance imaging
- •Pain intensity of at least 4 on the Visual Analog Scale
- •Age between 18 and 70 years
- •Patients who can comply with the study protocol and scheduled evaluations
- •Patients who provided written informed consent before participation
排除标准
- •Lumbar disc herniation with surgical indication or severe radiculopathy
- •Active infections
- •Systemic inflammatory or autoimmune diseases
- •A history of allergy to substances used in dextrose prolotherapy
- •Contraindications to balneotherapy, such as severe cardiovascular disease, renal insufficiency, or severe dermatological conditions
- •Prior prolotherapy or balneotherapy within six months before enrollment
- •Decompensated chronic cardiovascular, hepatic, renal, respiratory, or neurological diseases at the time of inclusion
- •Pregnancy
- •Breastfeeding
- •Active neoplastic disease
- •Decompensated psychiatric disorders
- •Allergies to natural therapeutic factors that could lead to treatment interruption
- •Refusal to participate in the study
研究组 & 干预措施
Prolotherapy group (PG)
The prolotherapy intervention was delivered over three sessions, performed at three-week intervals. All procedures were performed bilaterally under continuous ultrasound guidance using a BK Medical Flex Focus 800 ultrasound system with a convex probe.
The prolotherapy solution was administered at predefined anatomical sites identified sonographically, including one injection point corresponding to the piriformis muscle, five points along the iliac crests corresponding to ligamentous insertions, three points at the sacral level, and five points at the level of the lumbar transverse processes targeting paravertebral ligamentous insertions. In addition, five unilateral injections were performed at the level of the lumbar spinous processes. In total, 33 injection points were used per session.
干预措施: Prolotherapy (Other)
Balneotherapy plus Physiotherapy Group (BG)
Participants assigned to the balneotherapy group (BG) completed a structured two-week inpatient rehabilitation program comprising 10 treatment days at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania.
干预措施: Balneotherapy plus Physiotherapy (Other)
Physiotherapy Control Group (CG)
Participants allocated to the control group (CG) were assessed and managed at the Ovidius Clinical Hospital in Romania, where they received a conventional conservative treatment program.
干预措施: Physiotherapy (Other)
结局指标
主要结局
Pain intensity
时间窗: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion
Pain intensity was assessed using the Visual Analog Scale (VAS). Participants were asked to rate their current pain intensity by marking a point on a 100-mm horizontal line, where 0 indicates "no pain", and 100 indicates "worst pain imaginable." The score was recorded in millimeters (mm). Outcome range and interpretation: Minimum value: 0, Maximum value: 100. Higher scores indicate worse pain intensity.
次要结局
- Functional disability(Baseline and follow-up assessments were conducted at 4 weeks after treatment completion)
- Lumbar spine mobility(Baseline and follow-up assessments were conducted at 4 weeks after treatment completion)
- Psychological status(Baseline and follow-up assessments were conducted at 4 weeks after treatment completion)
研究者
Elena-Valentina Ionescu
Professor (Associate) Dr. Ionescu Elena Valentina
Balnear and Rehabilitation Sanatorium Techirghiol