This is an open-label, randomized, multi-center clinical trial to evaluate the safety and efficacy in peripheral neuropathies patients treated with Mecobalamin Injection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,072
Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks
Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks
Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
The 1st Hospital of Anhui Medical University
Hefei, Anhui, China
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
The TSS of peripheral neuropathy is used to score the intensity \& frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), \& continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.
Time frame: Baseline & End of Week 4
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
TSS of peripheral neuropathy is used to score the intensity \& frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), \& continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 4 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.
Time frame: Baseline and End of Week 4
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
The institute of rehabilitation medicine
Beijing, Beijing Municipality, China
Nanfang Hospital of Nanfang Medical Unversity
Guangzhou, Guangdong, China
The 1st People Hospital of Guangzhou
Guangzhou, Guangdong, China
the 1st Hospital affliated to Guangxi Medical University
Nanning, Guangxi, China
The 3rd Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
the people Hospital
Wuhan, Hubei, China
Tongji Hospital
Wuhan, Hubei, China
Xiehe Hospital
Wuhan, Hubei, China
...and 14 more locations
The TSS of peripheral neuropathy is used to score the intensity \& frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), \& continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 2 weeks of treatment.
Time frame: Baseline and End of Week 2
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
TSS of peripheral neuropathy is used to score the intensity/ frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), \& continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 2 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.
Time frame: Baseline and End of Week 2
Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip \& knee flexion/ extension \& remote foot dorsiflexion/ plantar flexion \[scored as normal, 25% weak, 50% weak, 75% weak, and paralysis\]), reflex (response at the quadriceps \& ankle \[normal score=0, decreased score=1, absent score=2\], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position \[normal score=0, decreased score=1, absent score=2\]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.
Time frame: Baseline and End of Week 4
Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip \& knee flexion/ extension \& remote foot dorsiflexion/ plantar flexion \[scored as normal, 25% weak, 50% weak, 75% weak, and paralysis\]), reflex (response at the quadriceps \& ankle \[normal score=0, decreased score=1, absent score=2\], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position \[normal score=0, decreased score=1, absent score=2\]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment. Rate of NIS-LL change = (NIS-LL difference value/NIS-LL before treatment)×100%.
Time frame: Baseline and End of Week 4