NCT07399145

Comparison of Prolotherapy and Rehabilitation Treatments in Low Back Pain (CPRTLBP)

Comparison of the Effects of Prolotherapy and Rehabilitation Treatments in Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Balnear and Rehabilitation Sanatorium Techirghiol · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Prolotherapy	A volume of 1 mL of prolotherapy solution was administered at each injection site. The injected solution consisted of a 1:1 dilution of 33% dextrose and 1% lidocaine, resulting in a final dextrose concentration of 16.5%. This formulation was used consistently across all injection sites to ensure standardized delivery and reproducibility of the therapeutic effect. All infiltration procedures were performed under strict aseptic conditions. The interventions were conducted under intravenous analgosedation, using a single-dose regimen of midazolam (2 mg), propofol (approximately 60 mg), and fentanyl (0.1 mg), administered to ensure patient comfort and procedural compliance. After each treatment session, patients were observed clinically to monitor for any immediate adverse events or procedure-related complications.
OTHER	Balneotherapy plus Physiotherapy	The intervention was based on the region's specific natural therapeutic resources and was conducted under continuous medical supervision. The treatment schedule included saline therapeutic pool baths combined with supervised exercise therapy and applications of sapropelic therapeutic mud, with sessions performed daily, five days per week. Alongside balneological treatments, patients received daily electrotherapy following a standardized protocol, which consisted of lumbar magnetotherapy, interferential current therapy, and therapeutic ultrasound. The rehabilitation program also incorporated daily massage therapy and supervised therapeutic exercises carried out in a dedicated rehabilitation gym.
OTHER	Physiotherapy	The therapeutic program consisted of physiotherapy combined with structured exercise therapy targeting lumbar spine stabilization and mobility, along with electrotherapy and massage therapy. No balneological interventions or prolotherapy procedures were included in the management of this group.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-05-01
• Completion: 2025-12-15
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: Romania