Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg

NCT01934868 | Completed Phase 4 DMC

• 1 other identifier: 0309-13-HMO-CTIL
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis is that in the treatment of low back pain (LBP) radiating to the leg, the long-term results of prolotherapy are more effective than those of the current conventional treatment: epidural steroid injections (ESI). This research will examine the efficacy of prolotherapy injections versus epidural steroid injections for the treatment of low back pain radiating to the leg. This is a randomized, unblinded study, in which patients seen in the principle investigator's pain clinic will be randomly divided to receive treatments from either the experimental, prolotherapy group, or the active control, ESI group.

Conditions

Sciatica; Spinal Stenosis of Lumbar Region; Degeneration of Lumbar or Lumbosacral Intervertebral Disc

Keywords

low back pain; sciatica; spinal stenosis; epidural injections; prolotherapy; sacroiliac pain or dysfunction.; Ligament laxity

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale

  Prior to the first treatment session, patients from both groups will fill out a questionnaire (described later) which will begin with an added item at the beginning: the NRS (numerical rating scale) score. This is to ascertain the intensity of pain he or she suffers in the lower back and or leg. This is a score given between 0 and 10 to estimate the subjective level of pain felt. 10 is a score given to the worst possible imaginable pain, and 0 is no pain at all. At 4 points in time: 1, 3, 6 and 12 months after the last treatment session, patients will be telephoned by a nurse trained in pain to assess pain level according to NRS score. The nurse will be an independent and unbiased investigator. Because patients often suffer from several sorts of pain, it must be stressed to the patients that what is being measured is the very same pain that the patient came to be treated for initially, and not another area which may have developed pain at some later point in time.

  17 months

Secondary Outcomes (1)

• Oswestry Back Disability Questionnaire Score

  17 months

Other Outcomes (1)

• Number of patients suffering from adverse effects

  1 week after a particular procedure

Study Arms (2)

Prolotherapy Injections

EXPERIMENTAL

Each patient will be evaluated clinically and the spinal levels to be injected will be decided upon during each visit. The levels to be injected will largely depend on the pain referral patterns. All prolotherapy injections will be performed under ultrasound guidance. A prolotherapy solution of 20% dextrose combined with 1% lidocaine will be injected to facet capsular ligaments and interspinous ligaments of the lumbar spine and the posterior sacroiliac ligaments. Six points will be injected in each treatment session. These sessions will be 4 weeks apart.

Drug: prolotherapy solution of 20% dextrose

Epidural Steroid Injections (ESI)

ACTIVE COMPARATOR

Those patients assigned to the ESI group will receive epidural steroid injections with 80mg methylprednisolone and 10mg buvicaine to the interlaminar space. These will be performed 4 weeks apart and under fluoroscopy. The level that will be injected will depend both on the clinical presentation as well as the size of the interlaminar space seen under fluoroscopy.

Drug: Epidural Steroid Injection

Interventions

prolotherapy solution of 20% dextrose DRUG

After verifying the anatomy of the lumbosacral spine under ultrasound, a 9cm 22 gauge needle will be used to inject the prolotherapy solution to each of the points specified. In order to view the needle under ultrasound, a needle at least as thick as 22G is required. In order for the prolotherapy injections to be safe, bone must be contacted in order to avoid nerve damage. At each point a total of 1cc prolotherapy solution will be injected.

Also known as: Dextrose 20% solution

Prolotherapy Injections

Epidural Steroid Injection DRUG

Prior to the epidural injection a local anaesthetic solution of 1% lidocaine will be injected into the relevant subcutaneous and ligamentous interlaminar space. The injectant solution will be comprised of 80mg methylprednisolone combined with 10mg (2cc) 0.5% bupivicaine. The resulting 4cc will be diluted with another 4cc of normal saline giving a total volume of 8cc. A loss of resistance technique will be used and radiocontrast dye will be injected to verify the placement of the needle prior to injecting the steroid solution.

Epidural Steroid Injections (ESI)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain radiating down one or both legs or to the groin of at least 12 weeks' duration
• Patients with disc lesions with radiating pain to the leg(s)
• Mild spinal stenosis

You may not qualify if:

• History of back surgery
• Recent history (less than 2 years) of active malignancy
• Recent fracture in the lumbar spine or pelvis of less than 12 months
• Active locus of infection in the body
• Coagulation disorders, and current anticoagulation therapy, excluding aspirin
• Chronic medication with corticosteroids and NSAIDS (which are said to possibly neutralise the effect of prolotherapy) - the latter must be stopped 24 hours prior to the first treatment session
• Recent injection of cortisone for back pain or any other pathology elsewhere in the body- patients must wait 2 weeks before commencement of the study
• Concurrent significant depressive illness or evidence of catastrophisation, fibromyalgia
• Concurrent history of active autoimmune disease or inflammatory joint disease evidence of a peripheral neuropathy
• NOTE:
• If any of the above illnesses appear during the time of the treatment in any patient, the patient will be withdrawn from the trial as treatment may be detrimental to his or her health. In addition, follow-up is not relevant to compare a diseased patient with any of the above with patients who are free of the above illnesses.

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Reuth Rehabilitation Hospital: collaborator

Study Sites (1)

Pain Unit, Hadassah Medical Center

Jerusalem, Israel

Location

Related Publications (7)

• Benyamin RM, Manchikanti L, Parr AT, Diwan S, Singh V, Falco FJ, Datta S, Abdi S, Hirsch JA. The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain. Pain Physician. 2012 Jul-Aug;15(4):E363-404.

  PMID: 22828691 BACKGROUND

• Manchikanti L, Buenaventura RM, Manchikanti KN, Ruan X, Gupta S, Smith HS, Christo PJ, Ward SP. Effectiveness of therapeutic lumbar transforaminal epidural steroid injections in managing lumbar spinal pain. Pain Physician. 2012 May-Jun;15(3):E199-245.

  PMID: 22622912 BACKGROUND

• Iguchi T, Kanemura A, Kasahara K, Kurihara A, Doita M, Yoshiya S. Age distribution of three radiologic factors for lumbar instability: probable aging process of the instability with disc degeneration. Spine (Phila Pa 1976). 2003 Dec 1;28(23):2628-33. doi: 10.1097/01.BRS.0000097162.80495.66.

  PMID: 14652480 BACKGROUND

• Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available.

  PMID: 19762151 BACKGROUND

• Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.

  PMID: 23253394 BACKGROUND

• Yelland MJ, Del Mar C, Pirozzo S, Schoene ML. Prolotherapy injections for chronic low back pain: a systematic review. Spine (Phila Pa 1976). 2004 Oct 1;29(19):2126-33. doi: 10.1097/01.brs.0000141188.83178.b3.

  PMID: 15454703 BACKGROUND

• Wilkinson HA. Injection therapy for enthesopathies causing axial spine pain and the "failed back syndrome": a single blinded, randomized and cross-over study. Pain Physician. 2005 Apr;8(2):167-73.

  PMID: 16850071 BACKGROUND

MeSH Terms

Conditions

Sciatica; Low Back Pain; Spinal Stenosis; Joint Instability

Interventions

Glucose; Solutions

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Pharmaceutical Preparations

Study Officials

• Osnat Wende, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is possible at this point in time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a study comparing prolotherapy treatments with an active control, which happens to be the gold standard treatment for radicular pain.

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 4, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2023
• Study Completion: April 10, 2023
• Last Updated: June 29, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: When all of the follow-up is completed - hopefully within 12 months

Locations

IL (1)