Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
160

Inclusion Criterias

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

Exclusion Criterias

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 fracture in the lumbar spine or pelvis of less than 12 months
Concurrent history of active autoimmune disease or inflammatory joint disease evidence of a peripheral neuropathy
...
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 fracture in the lumbar spine or pelvis of less than 12 months
Concurrent history of active autoimmune disease or inflammatory joint disease evidence of a peripheral neuropathy
Recent history (less than 2 years) of active malignancy
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
History of back surgery
Active locus of infection in the body
Concurrent significant depressive illness or evidence of catastrophisation, fibromyalgia
Coagulation disorders, and current anticoagulation therapy, excluding aspirin

Summary

Conditions
  • Degeneration of Lumbar or Lumbosacral Intervertebral Disc
  • Sciatica
  • Spinal Stenosis of Lumbar Region
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: This is a study comparing prolotherapy treatments with an active control, which happens to be the gold standard treatment for radicular pain.Masking: None (Open Label)
  • Masking Description: No masking is possible at this point in time.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

Description

The primary goal of the study is to investigate the long term efficacy of prolotherapy for patients with LBP referring to the leg. The secondary goal is to compare this efficacy with that of epidural steroids. The reason for exploring options other than ESI is that the latter have proved to be disap...

The primary goal of the study is to investigate the long term efficacy of prolotherapy for patients with LBP referring to the leg. The secondary goal is to compare this efficacy with that of epidural steroids. The reason for exploring options other than ESI is that the latter have proved to be disappointing. Comprehensive reviews have been written on interlaminar and transforaminal epidurals which basically show poor long term results of longer than 3 months. In addition, ESI carries risks of neurological damage, epidural hematoma and infection. However, ESI continues to be the most widely used treatment worldwide. Research also shows that with increasing age, there is an increased incidence of ligament laxity, spondylolisthesis and angulation which may in turn lead to nerve impingement and deterioration in function with time. Sprained and strained ligaments are themselves capable of referring pain down the leg even as far as the ankle. Research shows that much of the pain referred down the leg is not from impinged nerve roots but from other soft tissues, such as the above mentioned ligaments; these must be addressed and treated not only to treat pain but in order to improve function. The term prolotherapy is otherwise known as proliferative regeneration therapy and is aimed at doing just the opposite of cortisone, namely, to strengthen the structures injected, usually ligaments. Prolotherapy solutions are also used to treat partially torn tendons, as in the case of partial rotator cuff tears. Research on prolotherapy has shown that this treatment mode produces varying results in the treatment of low back pain and carries fewer risks than epidurals. One can infer from this that it may provide a safer and better long term treatment method than ESI. Yelland's review shows that prolotherapy works for the treatment of LBP if this treatment method is combined with other measures such as exercises or manipulations. In this study, patients with low back pain radiating to the leg will be randomized and receive either epidural steroid injections or prolotherapy injections using a solution made up of 20% dextrose. In light of the results of the research quoted, it was decided to give exercise instructions tailored to every patient's condition. Both patients from the experimental and the control groups will receive this instruction in order to avoid the presence of another confounding variable. A precondition to being included in the trial is having either a CT or MRI of the lumbar spine within the previous 18 months and not having any of the exclusion criteria sited below. Once included in the trial patients will be randomized into the study and the control groups. All epidural injections will be performed under fluoroscopy, and radiocontrast dye will be injected to verify that the injectate will be given in the correct place. Patients in this group will receive 3 interlaminar epidural steroid injections approximately 4 weeks apart. The solution injected will be made up of 80mg methylprednisolone acetate with bupivicaine. The level injected will depend on the clinical picture. All of the prolotherapy dextrose injections will be performed under ultrasound guidance. Prolotherapy patients will receive 5 sessions approximately 4 weeks apart. In each session, 6 injections in different areas of the lumbosacral spine, and sacroiliac ligaments will be injected with 20% dextrose solution using a 25 gauge needle. The targeted structures include the following: the facet joint capsular ligaments, interspinous ligaments, and some of the sacroiliac ligaments, all depending on the clinical assessment. The clinical picture will determine what levels will be injected in each session. As described below, patients will be assessed prior to the study and after the study regarding their pain and function.

Inclusion Criterias

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

Exclusion Criterias

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 fracture in the lumbar spine or pelvis of less than 12 months
Concurrent history of active autoimmune disease or inflammatory joint disease evidence of a peripheral neuropathy
...
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 fracture in the lumbar spine or pelvis of less than 12 months
Concurrent history of active autoimmune disease or inflammatory joint disease evidence of a peripheral neuropathy
Recent history (less than 2 years) of active malignancy
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
History of back surgery
Active locus of infection in the body
Concurrent significant depressive illness or evidence of catastrophisation, fibromyalgia
Coagulation disorders, and current anticoagulation therapy, excluding aspirin

Locations

Jerusalem
Jerusalem

Tracking Information

NCT #
NCT01934868
Collaborators
Reuth Rehabilitation Hospital
Investigators
  • Principal Investigator: Osnat Wende, MD Hadassah Medical Organization
  • Osnat Wende, MD Hadassah Medical Organization