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Completed

NCT Number: NCT07399145

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balneal and Rehabilitation Sanatorium of Techirghiol

Constanța, Techirghiol, 906100, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolotherapy

Other

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.

Balneotherapy plus Physiotherapy

Other

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.

Physiotherapy

Other

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.

Primary outcomes

  1. Pain intensity

    Time frame: 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.

Secondary outcomes

  1. Functional disability

    Time frame: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion

    Functional disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The questionnaire consists of 24 items related to physical activities and daily functioning affected by low back pain. Participants were asked to mark each statement that applied to their condition on the day of assessment. Each marked item was scored 1 point, and unmarked items were scored 0 points. The total score was calculated by summing all marked items and is reported as a unitless score. Outcome range and interpretation: Minimum value: 0, Maximum value: 24. Higher scores indicate greater functional disability (worse outcome), while lower scores indicate less disability (better outcome).

  2. Lumbar spine mobility

    Time frame: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion

    Lumbar spine mobility was assessed using the Schober test. With the participant standing upright, a point was marked at the level of the lumbosacral junction (L5-S1), and a second point was marked 10 cm above the first mark. Participants were then asked to bend forward maximally, and the distance between the two marks was remeasured. The increase in distance during trunk flexion was recorded in centimeters (cm) and used as the measure of lumbar spine mobility. Outcome range and interpretation: Minimum value: 0 cm, Maximum value: depending on individual mobility. Higher values indicate greater lumbar spine mobility (better outcome), while lower values indicate reduced mobility (worse outcome).

  3. Psychological status

    Time frame: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion

    Psychological status was assessed using the Hospital Anxiety and Depression Scale (HADS), which consists of 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D), each containing 7 items. Participants were asked to rate how they had been feeling over the previous week. Each item is scored on a 4-point Likert scale ranging from 0 to 3. Subscale scores were calculated by summing the relevant item scores and are reported as unitless scores.Outcome range and interpretation: HADS-A (Anxiety): Minimum value: 0, Maximum value: 21. Higher scores indicate greater anxiety severity (worse psychological status). HADS-D (Depression): Minimum value: 0, Maximum value: 21. Higher scores indicate greater depressive symptom severity (worse psychological status).

Sponsors and collaborators

Lead sponsor

Balnear and Rehabilitation Sanatorium Techirghiol

Other

Registry information

Official study title

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

Acronym: CPRTLBP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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