Epidural Steroid Injection for Restless Legs Symptoms in Lumbar Stenosis
NCT07637643
Dyssomnias, Lumbar Central Spinal Stenosis
Ankara, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT00887289
The main goal of this open-label, prospective, non-controlled, non-interventional post marketing surveillance study is to evaluate how pramipexole treatment works when applied in actual practice. In actual practice patients who would have been excluded in the clinical registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will also be treated with pramipexole. Thus, during this post marketing surveillance study additional information on the efficacy and safety of pramipexole in those patients will be obtained. The objectives of this post marketing surveillance study are:
* To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain Questionnaire. * To assess if improvement of sensory symptoms correlates with overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with secondary symptoms like sleeping problems and daytime tiredness (items 1 & 6 from Restless Legs Syndrome-6). * To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) differs between patients with high pain scores and patients with lower pain scores. * To compare General Practitioner and neurologist sites patient populations in terms of demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at Visit 3. * To evaluate the development of behavioural changes under pramipexole treatment.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Boehringer Ingelheim Investigational Site, Aalen, Germany
Study Design:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Time frame: Baseline to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Time frame: Baseline to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Time frame: Baseline to Visit 3
Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.
Time frame: Baseline to Visit 3
Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.
Time frame: Baseline to Visit 3
Number of patients with occurence of behavioural changes in terms of impulse control disorders
Boehringer Ingelheim
Industry
Non-interventional Observational Study on the Influence of Pramipexole (PPX) on Sensory Symptoms of Restless Legs Syndrome (RLS)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07637643
Dyssomnias, Lumbar Central Spinal Stenosis
Ankara, Turkey (Türkiye)
View Trial DetailsNCT00949806
Dyssomnias, Mental Disorders
Pessac, France
View Trial DetailsNCT03218969
Augmentation, Dyssomnias
Houston, Texas, United States
View Trial DetailsNCT07292077
Craniomandibular Disorders, Dyssomnias
Yozgat, Turkey (Türkiye)
View Trial Details