Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT01934868
Eligibility 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If any of the above illnesses appear during the time of the treatment in any patient, the patient will be withdrawn from the trial as treatment may be detrimental to his or her health.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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01934868
Study Brief:
Protocol Section:
NCT01934868