Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP)

NCT07296653 | Recruiting Early Phase 1

• 1 other identifier: 621, 12.09.2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic non-specific low back pain (CNSLBP) is among the most prevalent causes of disability on the planet, which often proves to be refractory to conventional pharmacological, interventional, and rehabilitation approaches. Although acupuncture has also shown analgesic effectiveness, its variability and reliance on practitioner skill limit its universal introduction into Western medical practice. Prolotherapy, an emerging regenerative injection treatment with hypertonic dextrose solutions, has been of potential benefit in managing musculoskeletal pain by triggering tissue repair and controlling neurogenic inflammation. Interestingly, several acupuncture points correspond to neuroanatomically relevant sites. This single-blind randomized controlled trial aims to ascertain whether combinational prolotherapy with dextrose 15% and lidocaine 1% is superior to lidocaine 1% in patients with CNSLBP. Sixty patients will be allocated randomly into two equal-sized groups and receive a maximum of 15 ultrasound-guided injections into standardized acupoints of the lumbar area (BL23, BL25, BL31, BL54, GV3, GV4, and Ashi points) during three treatment sessions. Outcomes will be evaluated using the Numeric Rating Scale (NRS), the Oswestry Disability Index (ODI), the TUG (Timed Up and Go) test, the BPI (Brief Pain Inventory) scale, the Rolland-Morris Low Back Pain Disability Questionnaire and the Global Impression of Pain Questionnaire at baseline, and at 15, 30, and 90 days post-treatment. Outcomes should clarify whether dextrose-enhanced prolotherapy provides improved analgesia and functional return in comparison with local anesthetic injection alone. This study can present an uncomplicated, low-cost, and integrative regimen for CNSLBP with significant clinical and socioeconomic implications.

Conditions

Chronic Non-specific Low Back Pain

Keywords

prolotherapy; acupoints; dextrose; low back pain

Outcome Measures

Primary Outcomes (1)

• Pain severity score 15 days after completion of the intervention

  Pain severity score from the short Brief Pain Inventory (BPI) form, 15 days after completion of the infiltrations. Minimum value: 0 and Maximum value: 10 Higher scores correspond to worse outcome - i.e. greater pain severity or greater interference with functioning.

  15 days after completion of infiltrations of first participant until 15 days after completion of infiltration of the last participant.

Secondary Outcomes (7)

• Pain severity score at 90 days after completion of the therapy

  From 90 days after completion of the infiltrations of the first participant until 1 month after completion of infiltrations of the last participant. Just before the first infiltration a baseline measurement will be also made.

• Oswestry disability index (ODI) at baseline, 15, 30 and 90 days after completion of therapy

  Before first infiltration of the first participant up to 3 months after completion of the therapy of the last one.

• Short term changes after the first infiltration

  24 hours (Day 1) after first infiltration of the first participant until 24 hours after first infiltration of the last participant.

• TUG (timed up and go) test

  Just before the first infiltration until 3 months after completion of the therapy of the last participant

• Global impression of change

  From one month after completion of therapy of the first participant until 3 months after completion of therapy of the last participant.

Other Outcomes (1)

• Subanalyses of the scales measured

  Time frames are pre-determined as stated from the above mentioned scales: DAY 1, DAY 15, DAY 30, (immediately after the interventions), DAY 90 after the first infiltration

Study Arms (2)

Lidocaine

SHAM COMPARATOR

Infiltration of back acupoints with lidocaine 1%

Drug: Lidocaine 1% infiltration

Dextrose and lidocaine

ACTIVE COMPARATOR

Infiltration of back acupoints with dextrose 15% and lidocaine 1%

Drug: Dextrose 15% and lidocaine 1% infiltration

Interventions

Lidocaine 1% infiltration DRUG

Infiltration of dextrose and lidocaine in back acupoints

Lidocaine

Dextrose 15% and lidocaine 1% infiltration DRUG

Infiltration of back acupoints

Dextrose and lidocaine

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) up to 45 kg/m2
• Diagnoses corresponding to \>1 of the following ICD-10 (International Classification of Diseases):
• M51.3 Degeneration of intervertebral discs
• M54.5 Low back pain
• M54.8 Other forms of back pain
• M54.9 Various forms of back pain
• S33.5 Sprain of the lumbar spine
• S33.6 Sprain of sacroiliac joint
• S33.7 Sprain of other and various parts of lumbar spine and pelvis
• Diagnosis of chronic nonspecific low back pain: Chronic nonspecific low back pain refers to pain in the lower back with or without radiation to the lower extremities, lasting for more than 3 months and not attributable to a specific anatomical structure or pathology on imaging, for example generalized degenerative changes, but no pathological findings (such as spinal stenosis or disorders of the sagittal/coronal architecture or intervertebral foramen stenosis) with neurological deficits and no symptoms specific to the predominant pathology.
• Numerical Rating Scale (NRS) \> 3/10 for at least 3 months prior to the study
• Positive response to \>1 muscle strength assessment tests in chronic low back pain A. prone plank bridge test (PBT) B. side bridge test (SBT) C. supine bridge test (SUBT) D. Range of Motion (ROM) E. Back Performance Scale (BPS) F. Straight leg raise test (SLR)
• Pain, inability to walk, and stiffness in the lumbar spine, persisting for at least three months prior to the study.
• Radiological imaging tests such as MRI or CT and, in cases of clinical suspicion (where appropriate), X-rays with dynamic flexion/extension or whole spine X-rays.
• Signing of written consent prior to the injection of pharmaceutical agents.

You may not qualify if:

• Any infection of the skin of the lumbar spine area, such as cellulitis, or periarticular or intra-articular infection or spondylodiscitis during the last 3 months
• History of periarticular or intra-articular injection in the LMS with corticosteroids, local anesthetic, hyaluronic acid, radiofrequency application, electroacupuncture, or prolotherapy within the last three months.
• Previous surgery (e.g., spinal fusion) in the LMS
• Oral corticosteroids for low back pain or uncontrolled opioids
• History of the following diseases:
• connective tissue disease affecting the intervertebral spaces
• insulin-dependent diabetes mellitus without adequate control
• acute lumbosacral radiculopathy or peripheral neuropathy
• neurological/psychiatric disease
• history of malignancy in the area or any other active malignancy in the body
• Bleeding disorder
• Trauma during the previous three months without imaging investigation
• Systemic diseases such as rheumatic diseases
• Known abdominal aortic aneurysm
• Pregnancy (based on history)

Sponsors & Collaborators

• Attikon Hospital: collaborator
• National and Kapodistrian University of Athens: lead

Study Sites (1)

University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School

Athens, Attica, 12461, Greece

RECRUITING

Related Publications (30)

• Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.

  PMID: 10960937 BACKGROUND

• Sakthivadivel V, Geetha J, Gaur A, Kaliappan A. Performance-Oriented Mobility Assessment test and Timed Up and Go test as predictors of falls in the elderly - A cross-sectional study. J Family Med Prim Care. 2022 Nov;11(11):7294-7298. doi: 10.4103/jfmpc.jfmpc_1294_22. Epub 2022 Dec 16.

  PMID: 36993044 BACKGROUND

• Barry E, Galvin R, Keogh C, Horgan F, Fahey T. Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2014 Feb 1;14:14. doi: 10.1186/1471-2318-14-14.

  PMID: 24484314 BACKGROUND

• Han SP, Han JS. Acupuncture and Related Techniques for Pain Relief and Treatment of Heroin Addiction: Mechanisms and Clinical Application. Med Acupunct. 2020 Dec 1;32(6):403-404. doi: 10.1089/acu.2020.1485. Epub 2020 Dec 16.

  PMID: 33362900 BACKGROUND

• Koldas Dogan S, Sonel Tur B, Kurtais Y, Atay MB. Comparison of three different approaches in the treatment of chronic low back pain. Clin Rheumatol. 2008 Jul;27(7):873-81. doi: 10.1007/s10067-007-0815-7. Epub 2008 Jan 11.

  PMID: 18188660 BACKGROUND

• Last AR, Hulbert K. Chronic low back pain: evaluation and management. Am Fam Physician. 2009 Jun 15;79(12):1067-74.

  PMID: 19530637 BACKGROUND

• Fan Z, Dou B, Wang J, Wu Y, Du S, Li J, Yao K, Li Y, Wang S, Gong Y, Guo Y, Xu Z. Effects and mechanisms of acupuncture analgesia mediated by afferent nerves in acupoint microenvironments. Front Neurosci. 2024 Feb 7;17:1239839. doi: 10.3389/fnins.2023.1239839. eCollection 2023.

  PMID: 38384495 BACKGROUND

• Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.

  PMID: 10470716 BACKGROUND

• Mauck MC, Aylward AF, Barton CE, Birckhead B, Carey T, Dalton DM, Fields AJ, Fritz J, Hassett AL, Hoffmeyer A, Jones SB, McLean SA, Mehling WE, O'Neill CW, Schneider MJ, Williams DA, Zheng P, Wasan AD. Evidence-based interventions to treat chronic low back pain: treatment selection for a personalized medicine approach. Pain Rep. 2022 Sep 30;7(5):e1019. doi: 10.1097/PR9.0000000000001019. eCollection 2022 Sep-Oct.

  PMID: 36203645 BACKGROUND

• Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.

  PMID: 34580864 BACKGROUND

• Edwards RR, Schreiber KL, Dworkin RH, Turk DC, Baron R, Freeman R, Jensen TS, Latremoliere A, Markman JD, Rice ASC, Rowbotham M, Staud R, Tate S, Woolf CJ, Andrews NA, Carr DB, Colloca L, Cosma-Roman D, Cowan P, Diatchenko L, Farrar J, Gewandter JS, Gilron I, Kerns RD, Marchand S, Niebler G, Patel KV, Simon LS, Tockarshewsky T, Vanhove GF, Vardeh D, Walco GA, Wasan AD, Wesselmann U. Optimizing and Accelerating the Development of Precision Pain Treatments for Chronic Pain: IMMPACT Review and Recommendations. J Pain. 2023 Feb;24(2):204-225. doi: 10.1016/j.jpain.2022.08.010. Epub 2022 Oct 2.

  PMID: 36198371 BACKGROUND

• Strudwick MW, Hinks RC, Choy ST. Point injection as an alternative acupuncture technique--an exploratory study of responses in healthy subjects. Acupunct Med. 2007 Dec;25(4):166-74. doi: 10.1136/aim.25.4.166.

  PMID: 18160927 BACKGROUND

• Giordano L, Murrell WD, Maffulli N. Prolotherapy for chronic low back pain: a review of literature. Br Med Bull. 2021 Jun 10;138(1):96-111. doi: 10.1093/bmb/ldab004.

  PMID: 33884404 BACKGROUND

• Knezevic NN, Mandalia S, Raasch J, Knezevic I, Candido KD. Treatment of chronic low back pain - new approaches on the horizon. J Pain Res. 2017 May 10;10:1111-1123. doi: 10.2147/JPR.S132769. eCollection 2017.

  PMID: 28546769 BACKGROUND

• Sirh SJ, Sirh SW, Mun HY, Sirh HM. Importance of quadratus lumborum muscle trigger point injection and prolotherapy technique for lower back and buttock pain. Front Pain Res (Lausanne). 2022 Nov 22;3:997645. doi: 10.3389/fpain.2022.997645. eCollection 2022.

  PMID: 36483943 BACKGROUND

• Singh S, Patel AA, Singh JR. Intervertebral Disc Degeneration: The Role and Evidence for Non-Stem-Cell-Based Regenerative Therapies. Int J Spine Surg. 2021 Apr;15(s1):54-67. doi: 10.14444/8055. Epub 2021 Apr 19.

  PMID: 34376496 BACKGROUND

• Hauser RA, Matias D, Woznica D, Rawlings B, Woldin BA. Lumbar instability as an etiology of low back pain and its treatment by prolotherapy: A review. J Back Musculoskelet Rehabil. 2022;35(4):701-712. doi: 10.3233/BMR-210097.

  PMID: 34957989 BACKGROUND

• Chen CPC, Suputtitada A. Prolotherapy at Multifidus Muscle versus Mechanical Needling and Sterile Water Injection in Lumbar Spinal Stenosis. J Pain Res. 2023 Jul 18;16:2477-2486. doi: 10.2147/JPR.S417444. eCollection 2023.

  PMID: 37483410 BACKGROUND

• Dagenais S, Yelland MJ, Del Mar C, Schoene ML. Prolotherapy injections for chronic low-back pain. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD004059. doi: 10.1002/14651858.CD004059.pub3.

  PMID: 17443537 BACKGROUND

• Wang F, Cheung CW, Wong SSC. Regenerative medicine for the treatment of chronic low back pain: a narrative review. J Int Med Res. 2023 Feb;51(2):3000605231155777. doi: 10.1177/03000605231155777.

  PMID: 36802994 BACKGROUND

• Maniquis-Smigel L, Dean Reeves K, Jeffrey Rosen H, Lyftogt J, Graham-Coleman C, Cheng AL, Rabago D. Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial. Anesth Pain Med. 2016 Dec 6;7(1):e42550. doi: 10.5812/aapm.42550. eCollection 2017 Feb.

  PMID: 28920043 BACKGROUND

• Furlan AD, Yazdi F, Tsertsvadze A, Gross A, Van Tulder M, Santaguida L, Gagnier J, Ammendolia C, Dryden T, Doucette S, Skidmore B, Daniel R, Ostermann T, Tsouros S. A systematic review and meta-analysis of efficacy, cost-effectiveness, and safety of selected complementary and alternative medicine for neck and low-back pain. Evid Based Complement Alternat Med. 2012;2012:953139. doi: 10.1155/2012/953139. Epub 2011 Nov 24.

  PMID: 22203884 BACKGROUND

• Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.

  PMID: 27429562 BACKGROUND

• Acupoint injection for nonspecific chronic low back pain: A protocol of systematic review: Erratum. Medicine (Baltimore). 2019 Nov;98(45):e18084. doi: 10.1097/MD.0000000000018084. No abstract available.

  PMID: 31702688 BACKGROUND

• DeBar LL, Justice M, Avins AL, Cook A, Eng CM, Herman PM, Hsu C, Nielsen A, Pressman A, Stone KL, Teets RY, Wellman R. Acupuncture for chronic low back pain in older adults: Design and protocol for the BackInAction pragmatic clinical trial. Contemp Clin Trials. 2023 May;128:107166. doi: 10.1016/j.cct.2023.107166. Epub 2023 Mar 27.

  PMID: 36990274 BACKGROUND

• Cherkin DC, Sherman KJ, Hogeboom CJ, Erro JH, Barlow WE, Deyo RA, Avins AL. Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial. Trials. 2008 Feb 28;9:10. doi: 10.1186/1745-6215-9-10.

  PMID: 18307808 BACKGROUND

• Lai P, Cheng S, Chen X, Cheng F, Cheng J, Xin M, Zhu D, Li Z, Wu X, Zeng F. The Emotion Regulation of Acupuncture in Chronic Low Back Pain: A Clinical Neuroimaging Protocol. J Pain Res. 2024 Mar 1;17:817-825. doi: 10.2147/JPR.S450589. eCollection 2024.

  PMID: 38444878 BACKGROUND

• Barber J, Lodo F, Nugent-Head A, Zeng X. Comparative Techniques of Acupuncture and Dry Needling Intersecting with Trigger Point Physiology and Diagnostics: A Cross-Discipline Narrative Review. Med Acupunct. 2023 Oct 1;35(5):220-229. doi: 10.1089/acu.2023.0031. Epub 2023 Oct 17.

  PMID: 37900872 BACKGROUND

• Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.

  PMID: 11124727 BACKGROUND

• Borg-Stein J, Stein J. Trigger points and tender points: one and the same? Does injection treatment help? Rheum Dis Clin North Am. 1996 May;22(2):305-22. doi: 10.1016/s0889-857x(05)70274-x.

  PMID: 8860801 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Low Back Pain

Interventions

Glucose; Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Konstantinos Kalimeris, Assoc Prof of Anesthesiology

  National and Kapodistrian University of Athens

  STUDY CHAIR

• Theodosios Saranteas, Professor of Anesthesiology

  National and Kapodistrian University of Athens

  STUDY CHAIR

• Lampis Stavrinou, Assist Prof of Neurosurgery

  National and Kapodistrian University of Athens

  STUDY CHAIR

Central Study Contacts

Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor

CONTACT

+302105831997; kkalimeris@med.uoa.gr

Ioannis Evgenidis MD, MSc, MBA, PhD candidate

CONTACT

+30 6979872857; jean.evgenidis@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 22, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: They will be available from the end of the recording of the response of the last patient to the infiltrations and for 5 years thereafter.
• Access Criteria: Researchers that would have come in contact with our team firstly and that shall be able to prove that they will use the data solely for research purposes and not for commercial use.

Locations

GR (1)