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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 July 2023
• Main ID: NCT01934868
• Date of registration: 30/08/2013
• Prospective Registration: Yes
• Primary sponsor: Hadassah Medical Organization
• Public title: Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg
• Scientific title: A Comparison of the Long Term Outcomes of Prolotherapy Versus Interlaminar Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg
• Date of first enrolment: December 1, 2013
• Target sample size: 110
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01934868
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Israel

Contacts

• Name: Osnat Wende, MD
• Affiliation: Hadassah Medical Organization

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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patient will be withdrawn from the trial as treatment may be detrimental to his or her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.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sciatica

Degeneration of Lumbar or Lumbosacral Intervertebral Disc

Spinal Stenosis of Lumbar Region

Intervention(s)

Drug: prolotherapy solution of 20% dextrose

Drug: Epidural Steroid Injection

Primary Outcome(s)

Numerical Rating Scale [Time Frame: 17 months]

Secondary Outcome(s)

Oswestry Back Disability Questionnaire Score [Time Frame: 17 months]

Secondary ID(s)

0309-13-HMO-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Reuth Rehabilitation Hospital