Trial reportTrials2017
The influence of surface EMG-triggered multichannel electrical stimulation on sensomotoric recovery in patients with lumbar disc herniation: study protocol for a randomized controlled trial (RECO).
Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 2 citations in OpenAlex.
- A systematic review and meta-analysis on the efficacy of physiotherapy intervention in management of lumbar prolapsed intervertebral disc.International journal of health sciencesReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIntervertebral disc degeneration is one of the most common reasons for chronic low back pain and sensomotoric deficits, often treated by lumbar sequestrectomy. Nevertheless, the prognostic factors relevant for time and quality of recovery, of the surgical procedure, relative to conservative treatment, remain controversial and require further investigation. Surface electrical stimulation (SES) may be an influential intervention, already showing positive impact on motor and sensory recovery in different patient groups. Since mechanisms of SES still remain unclear, further inquiry is needed. METHODS/
designThis is a prospective, monocentric, randomized, controlled clinical trial. A total of 80 adult patients suffering from a lumbar disc herniation (LDH; 40 treated surgically, 40 conservatively) are allocated in a ratio of 1:1. Patients in the treatment group will receive surface electromyography (EMG)-triggered electrical stimulation for eight weeks, whereas patients in the control group will not obtain any additional treatment. The primary outcome parameter is defined as the cold detection threshold (CDT), determined by quantitative sensory testing (QST), 24 months after intervention. Secondary outcome parameters include the inquiry of sensory nerve function by two-point discrimination and QST, the assessment of motor nerve function by manual muscle testing, and validated scales and scores. These include: the Oswestry Disability Index (ODI) and the Core Outcome Measures Index (COMI) assessing the domains pain, back-specific function, work disability, and patient satisfaction; the EQ-5D investigating the patient's generic health status; the painDETECT questionnaire (PD-Q) to identify neuropathic pain components; and the Beck Depression Inventory (BDI) to assess severity of depression. Moreover, neurological status, pain medication usage, and blood samples (CRP, TNFα, IL-1β, IL-6) will be evaluated. Study data generation (study site) and data storage, processing, and statistical analysis are clearly separated. DISCUSSION: The results of the RECO study will detect the effect of EMG-triggered multichannel SES on the improvement of mechanical and thermal sensitivity and the effect on motor recovery and pain, associated with clinical and laboratory parameters. Furthermore, data comparing surgical and conservative treatment can be collected. This will hopefully allow treatment recommendations for patients with LDH accompanied by a sensomotoric deficit.
trial registrationISRCTN, ISRCTN12741173 . Registered on 15 January 2017.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.