Acute Lumbosacral Radicular Syndrome pain in leg
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Male/female, 20 to 50 years - Patients with a first time presentation of aLRS in the involved dermatome - Pain radiating in the leg, following spinal segments L4, L5 or S1 - Predominantly leg pain - Pain score of NRS *6 - The symptoms are present for less than six months - There is no indication for immediate referral to a neurologist or neurosurgeon, according to the Dutch lumbosacral radicular syndrome guideline. - Subject is able and willing to provide informed consent - Subject is able and willing to comply with the protocol and follow-up schedule The current guideline from the Dutch Spine Society provides extensive screening methods to diag-nose aLRS. For instance, prominent leg pain, typical dermatomeric pain and increase in radiating pain at pressure-increasing moments have shown to be strong predictors of nerve root compression.1 If anamnesis shows there is a chance of underlying suffering (exclusion criteria), patients are referred to a neurologist, conform the guideline.
Exclusion criteria
Exclusion criteria: - History of back surgery - History of LRS with radiation that follows the same side and segmental pattern - Pain present since recent trauma - Unexplained weight loss - Severe back pain with fever - Predominantly back pain during the night - Previous Borrelia Burgdorferi infection - Patient has a (history of) malignancy - Bilateral limb pain - Predominantly back pain of *50% - Pain score of NRS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is pain improvement three weeks after TFESI. Pain improvement will be assessed using a 5-point Likert scale previously used to assess decline in pain intensity for patients with acute pain. Patients will be asked whether they experience: (1) no improvement, (2) minimal improvement, (3) much improvement, (4) very much improvement or (5) complete pain relief. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are intensity of pain measured with the Numeric pain Rating Scale (NRS), severi-ty of pain measured with the Brief Pain Inventory (BPI), quality of life measured with the Short Form 12 Item Health Survey version 2 (SF12v2), anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS), catastrophizing of pain measured with the Pain Catastrophizing Scale (PCS), effect of treatment measured with a Global Perceived Effect (GPE) scale, and complications. | — |
Countries
Netherlands