Comparison of Prolotherapy and Rehabilitation Treatments in Low Back Pain (CPRTLBP)
CompletedNot applicableNCT07399145
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 Clini…
Study details
- Official title
- Comparison of the Effects of Prolotherapy and Rehabilitation Treatments in Low Back Pain
- Conditions
- Interventions
- Other: Prolotherapy
- Other: Balneotherapy plus Physiotherapy
- Other: Physiotherapy
- Sponsor
- Balnear and Rehabilitation Sanatorium Techirghiol
- Start date
- 2025-04-01
- Primary completion
- 2025-05-01
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- Romania
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07399145