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

NCT07399145 | Completed

• 1 other identifier: StelianMociu
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chronic low back pain; physiotherapy; balneotherapy; prolotherapy; pain assessment; functional disability; quality of life

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  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.

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

Secondary Outcomes (3)

• 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

Study Arms (3)

Prolotherapy group (PG)

EXPERIMENTAL

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.

Other: Prolotherapy

Balneotherapy plus Physiotherapy Group (BG)

EXPERIMENTAL

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.

Other: Balneotherapy plus Physiotherapy

Physiotherapy Control Group (CG)

ACTIVE COMPARATOR

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.

Other: Physiotherapy

Interventions

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.

Prolotherapy group (PG)

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.

Balneotherapy plus Physiotherapy Group (BG)

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.

Physiotherapy Control Group (CG)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Balnear and Rehabilitation Sanatorium Techirghiol: lead

Study Sites (1)

Balneal and Rehabilitation Sanatorium of Techirghiol

Constanța, Techirghiol, 906100, Romania

Location

Related Publications (6)

• Antonelli M, Donelli D, Veronesi L, Vitale M, Pasquarella C. Clinical efficacy of medical hydrology: an umbrella review. Int J Biometeorol. 2021 Oct;65(10):1597-1614. doi: 10.1007/s00484-021-02133-w. Epub 2021 Apr 17.

  PMID: 33866427 BACKGROUND

• Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30.

  PMID: 31666220 BACKGROUND

• Anheyer D, Klose P, Koch AK, Haller H, Dobos G, Cramer H. Comparative efficacy of different exercise interventions in chronic non-specific low back pain: protocol of a systematic review and network meta-analysis. BMJ Open. 2020 Aug 5;10(8):e036050. doi: 10.1136/bmjopen-2019-036050.

  PMID: 32759244 BACKGROUND

• Linton SJ. A review of psychological risk factors in back and neck pain. Spine (Phila Pa 1976). 2000 May 1;25(9):1148-56. doi: 10.1097/00007632-200005010-00017.

  PMID: 10788861 BACKGROUND

• Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.

  PMID: 27745712 BACKGROUND

• Zemedikun DT, Kigozi J, Wynne-Jones G, Guariglia A, Roberts T. Methodological considerations in the assessment of direct and indirect costs of back pain: A systematic scoping review. PLoS One. 2021 May 11;16(5):e0251406. doi: 10.1371/journal.pone.0251406. eCollection 2021.

  PMID: 33974661 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Prolotherapy; Balneology; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) Dr. Ionescu Elena Valentina

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 10, 2026
• Study Start: April 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: December 15, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

RO (1)