Clinical and imaging outcomes after intrathecal injection of umbilical cord tissue mesenchymal stem cells in cerebral palsy: a randomized double-blind sham-controlled clinical trial.

BACKGROUND: This study assessed the safety and efficacy of intrathecal injection of umbilical cord tissue mesenchymal stem cells (UCT-MSC) in individuals with cerebral palsy (CP). The diffusion tensor imaging (DTI) was performed to evaluate the alterations in white-matter integrity. METHODS: Participants (4-14 years old) with spastic CP were assigned in 1:1 ratio to receive either UCT-MSC or sham procedure. Single-dose (2 × 107) cells were administered in the experimental group. Small needle pricks to the lower back were performed in the sham-control arm. All individuals were sedated to prevent awareness. The primary endpoints were the mean changes in gross motor function measure (GMFM)-66 from baseline to 12 months after procedures. The mean changes in the modified Ashworth scale (MAS), pediatric evaluation of disability inventory (PEDI), and CP quality of life (CP-QoL) were also assessed. Secondary endpoints were the mean changes in fractional anisotropy (FA) and mean diffusivity (MD) of corticospinal tract (CST) and posterior thalamic radiation (PTR). RESULTS: There were 36 participants in each group. The mean GMFM-66 scores after 12 months of intervention were significantly higher in the UCT-MSC group compared to baseline (10.65; 95%CI 5.39, 15.91) and control (ß 8.07; 95%CI 1.62, 14.52; Cohen's d 0.92). The increase was also seen in total PEDI scores (vs baseline 8.53; 95%CI 4.98, 12.08; vs control: ß 6.87; 95%CI 1.52, 12.21; Cohen's d 0.70). The mean change in MAS scores after 12 months of cell injection reduced compared to baseline (-1.0; 95%CI -1.31, -0.69) and control (ß -0.72; 95%CI -1.18, -0.26; Cohen's d 0.76). Regarding CP-QoL, mean changes in domains including friends and family, participation in activities, and communication were higher than the control group with a large effect size. The DTI analysis in the experimental group showed that mean FA increased (CST 0.032; 95%CI 0.02, 0.03. PTR 0.024; 95%CI 0.020, 0.028) and MD decreased (CST -0.035 × 10-3; 95%CI -0.04 × 10-3, -0.02 × 10-3. PTR -0.045 × 10-3; 95%CI -0.05 × 10-3, -0.03 × 10-3); compared to baseline. The mean changes were significantly higher than the control group. CONCLUSIONS: The UCT-MSC transplantation was safe and may improve the clinical and imaging outcomes. TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov ( NCT03795974 ).

Granisetron vs. lidocaine injection to trigger points in the management of myofascial pain syndrome: a double-blind randomized clinical trial.

OBJECTIVES: Granisetron and lidocaine injections have been used for the management of myofascial pain syndrome. This study was aimed to compare the efficacy of granisetron and lidocaine injections to trigger points of upper trapezius in the management of myofascial pain syndrome. METHODS: We performed a double-blind randomized clinical trial in an outpatient clinic of physical medicine and rehabilitation at a teaching hospital. A total of 40 patients aged ≥18 with neck pain due to myofascial pain syndrome were included. They had pain for at least one month with the intensity of at least 30 mm on a 100 mm visual analog scale. Each participant received a single dose of 1 mL lidocaine 2% or 1 mg (in 1 mL) granisetron. The solutions were injected into a maximum of three trigger points of the upper trapezius. We instructed all patients to remain active while avoiding strenuous activity for three or four days, and to perform stretch exercise and massage of their upper trapezius muscles. We assessed the patients before the interventions, and one month and three months post-injection. The primary outcome was the Neck Disability Index and the secondary outcome was the Neck Pain and Disability Scale. RESULTS: Both interventions were successful in reducing neck pain and disability (all p-values <0.001). However, the neck pain and disability responded more favorably to lidocaine than granisetron (p=0.001 for Neck Disability Index, and p=0.006 for Neck Pain and Disability Scale). No significant side-effect was recognized for both groups. CONCLUSIONS: Both lidocaine and granisetron injections to trigger points are effective and safe for the management of the syndrome and the benefits remain at least for three months. However, lidocaine is more effective in reducing pain and disability. The injections are well-tolerated, although a transient pain at the site of injections is a common complaint. One mL of lidocaine 2% is more effective than 1 mg (in 1 mL) granisetron for injecting into the trigger points of the upper trapezius in myofascial pain syndrome.

Molecular detection of Propionibacterium acnes in biopsy samples of intervertebral disc with modic changes in patients undergoing herniated disc surgery.

BACKGROUND AND OBJECTIVES: Recent studies have hypothesized that sterile disc infection with the anaerobic Propionibacterium acnes, recently renamed Cutibacterium acnes, occurs in people with intervertebral disc (IVD) herniation. This study aimed to examine the presence of P. acnes in patients who have Low back pain (LBP) with Modic changes observed in their Magnetic Resonance Imaging (MRI). MATERIALS AND METHODS: Thirty-seven patients who were candidates for surgery due to disc herniation and demonstrated Modic changes in MRI were included in the study. Before the surgery, the level of pain in patients was assessed using the visual analog score (VAS). All patients were asked to fill in the Oswestry Low Back Pain Disability Questionnaire. Intervertebral disc changes observed in MRI were recorded for all patients. Then, during surgery, sterile intervertebral disc samples were taken. P. acnes detection was performed using PCR in the laboratory. Data analysis with Chi-squared test, independent samples t-test, and Mann-Whitney U test in SPSS 18.0. RESULTS: The mean age of 37 patients equaled 43.64 years and the mean duration of symptoms was 11.05 months. In molecular examination, of the 37 individuals, the genome of P. acnes was positive in 23 cases (62.2%) and negative in 14 (37.8%). The relationship between VAS, disability score, changes in MRI, and patients' age with the positivity of the intervertebral disc sample was also assessed. Of these variables, only age was significantly correlated with the positive molecular finding, such that with an increase in age, the probability of positive findings was increased (p = 0.022). CONCLUSION: Based on the results, lumbar disc infection with P. acnes may play a significant role in causing Modic changes and the progression of the disease in patients with LBP.