Low Back PainCPRTLBPNCT07399145
Comparison of Prolotherapy and Rehabilitation Treatments in Low Back Pain (CPRTLBP)
A study testing Prolotherapy, Balneotherapy plus Physiotherapy and Physiotherapy in people with Low Back Pain, run by Balnear and Rehabilitation Sanatorium Techirghiol at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Prolotherapy, Balneotherapy plus Physiotherapy and Physiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteRomania
- Study dates
- 1 Apr 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Romania1 site
Balneal and Rehabilitation Sanatorium of Techirghiol
Constanța, Techirghiol, 906100
About this study
Official title: Comparison of the Effects of Prolotherapy and Rehabilitation Treatments in Low Back Pain
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.
Read more
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
- Being tested
- Prolotherapy, Balneotherapy plus Physiotherapy, Physiotherapy
- Keywords
- chronic low back pain, physiotherapy, balneotherapy, prolotherapy, pain assessment, functional disability, quality of life
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlotherapyOther
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 PhysiotherapyOther
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.
PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion
Secondary outcomes (3)
Functional disability
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).
Measured: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion
Lumbar spine mobility
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).
Measured: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion
Psychological status
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).
Measured: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Apr 2025
- Primary completion1 May 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balnear and Rehabilitation Sanatorium Techirghiol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena-Valentina Ionescu, Balnear and Rehabilitation Sanatorium Techirghiol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399145
- Sponsor's protocol ID
- StelianMociu
- Acronym
- CPRTLBP
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33866427Owen 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.
PubMed 31666220Anheyer 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.
PubMed 32759244Linton 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.
PubMed 10788861Maher 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.
PubMed 27745712Zemedikun 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.
PubMed 33974661Mociu SI, Ionescu EV, Uzun AB, Ciufu N, Ciota AE, Iliescu TE, Calatoiu I, Petcu LC, Iliescu MG. 4-Week Comparative Outcomes of Standard Physiotherapy, Balneotherapy Plus Physiotherapy and Dextrose Prolotherapy in Patients with Low Back Pain: A Non-Randomized Study. Medicina (Kaunas). 2026 Mar 25;62(4):623. doi: 10.3390/medicina62040623.
PubMed 42075495
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Prolotherapy and Rehabilitation Treatments in Low Back Pain
- ClinicalTrials.gov ID
- NCT07399145
- Acronym / sponsor ID
- CPRTLBP / StelianMociu
- Conditions
- Low Back Pain
- Keywords
- chronic low back pain, physiotherapy, balneotherapy, prolotherapy, pain assessment, functional disability, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Balnear and Rehabilitation Sanatorium TechirghiolUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prolotherapy group (PG) | Experimental | Other: ProlotherapyThe 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. |
| Balneotherapy plus Physiotherapy Group (BG) | Experimental | Other: Balneotherapy plus PhysiotherapyParticipants 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. |
| Physiotherapy Control Group (CG) | Active comparator | Other: PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProlotherapyA 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 | Prolotherapy group (PG) |
| Balneotherapy plus PhysiotherapyThe 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 | Balneotherapy plus Physiotherapy Group (BG) |
| PhysiotherapyThe 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. | Other | Physiotherapy Control Group (CG) |
Primary outcome
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.
3 secondary outcomes
Functional disability
Time frame: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion
Lumbar spine mobility
Time frame: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion
Psychological status
Time frame: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 33866427Antonelli 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.
- Background: PubMed 31666220Owen 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.
- Background: PubMed 32759244Anheyer 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.
- Background: PubMed 10788861Linton 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.
- Background: PubMed 27745712Maher 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.
- Background: PubMed 33974661Zemedikun 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.
- Derived from this study: PubMed 42075495Mociu SI, Ionescu EV, Uzun AB, Ciufu N, Ciota AE, Iliescu TE, Calatoiu I, Petcu LC, Iliescu MG. 4-Week Comparative Outcomes of Standard Physiotherapy, Balneotherapy Plus Physiotherapy and Dextrose Prolotherapy in Patients with Low Back Pain: A Non-Randomized Study. Medicina (Kaunas). 2026 Mar 25;62(4):623. doi: 10.3390/medicina62040623.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolotherapy, Balneotherapy plus Physiotherapy and Physiotherapy in people with Low Back Pain, run by Balnear and Rehabilitation Sanatorium Techirghiol at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline and follow-up assessments were conducted at 4 weeks after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07399145, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.