Evaluation of the effectiveness of Methocarbamol in the treatment of spasticity in people with spinal cord injury.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000788-30-PL

Enrollment

Registered

2022-09-29

Start date

2023-04-13

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: Methocarbamol Espefa 500 mg tablets Product Name: Methocarbamol Espefa Pharmaceutical Form: Tablet INN or Proposed INN: Methocarbamol CAS Number: 532-03-6 Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • a history of spinal cord injury; • the presence of increased muscle tension on the Ashwort scale 2 to 4; • time since injury: 3 months; • the patient must be circulatory and respiratory efficient, alert and aware; adapted to a vertical position; • a patient with complete and incomplete spinal cord injury, in the cervical, thoracic and lumbar spine, in whom the flexion and extension function will be maintained in the elbow and wrist joints; • preserved spine stabilization, stabilization of the anastomosis after surgery, completed bone union; • no contraindications to rehabilitation, such as thrombophlebitis, pulmonary embolism, orthostatic drops in blood pressure, epilepsy, infection. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • the patient's use of a myorelaxant other than methocarbamol; • the patient's use of botulinum toxin; • tetraplegia; • joint contractures preventing rehabilitation with robots and other contraindications to robotic therapy, such as severe osteoporosis, circulatory and respiratory system disorders, skin lesions, thrombophlebitis, pulmonary embolism, orthostatic drops in blood pressure, epilepsy, infection; • the presence of open, oozing bedsores; • malnutrition, wasting of the body (muscle atrophy of the paralyzed without signs of malnutrition and wasting of the body are not the cause of exclusion); • lack of the patient's informed consent; • pregnancy or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to test the effectiveness of Methocarbamol in the treatment of spasticity after spinal cord injury.;Secondary Objective: To facilitate the rehabilitation process;Primary end point(s): For the quantitative assessment of spasticity, the electrical activity of the muscles will be used, examined using superficial EMG for the muscles of the hip flexors and knee extensors, expressed in measurement units: uV. The results used for statistical evaluation will represent the average of 4 replicate s EMG measurements taken during passive stretching of the muscle. ;Timepoint(s) of evaluation of this end point: For the quantitative assessment of spasticity, the electrical activity of the muscles will be used, examined using superficial EMG for the muscles of the hip flexors and knee extensors, expressed in measurement units: uV. The results used for statistical evaluation will represent the average of 4 replicate s EMG measurements taken during passive stretching of the muscle.	—

Measure

Time frame

Main Objective: The aim of the study is to test the effectiveness of Methocarbamol in the treatment of spasticity after spinal cord injury.;Secondary Objective: To facilitate the rehabilitation process;Primary end point(s): For the quantitative assessment of spasticity, the electrical activity of the muscles will be used, examined using superficial EMG for the muscles of the hip flexors and knee extensors, expressed in measurement units: uV. The results used for statistical evaluation will represent the average of 4 replicate s EMG measurements taken during passive stretching of the muscle. ;Timepoint(s) of evaluation of this end point: For the quantitative assessment of spasticity, the electrical activity of the muscles will be used, examined using superficial EMG for the muscles of the hip flexors and knee extensors, expressed in measurement units: uV. The results used for statistical evaluation will represent the average of 4 replicate s EMG measurements taken during passive stretching of the muscle.

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Secondary

Measure	Time frame
Secondary end point(s): The reduction of muscle tension achieved with Methocarbamol therapy will allow the use of robotic methods in gait re-education, and as a result, better rehabilitation and functional improvement. The Lokomat gait test will be used to assess functional improvement. During the study, the following will be compared: - distance covered by the patient in a unit of time; - guiding force - the support force from the robot that the patient needed for proper gait. ;Timepoint(s) of evaluation of this end point: The reduction of muscle tension achieved with Methocarbamol therapy will allow the use of robotic methods in gait re-education, and as a result, better rehabilitation and functional improvement. The Lokomat gait test will be used to assess functional improvement. During the study, the following will be compared: - distance covered by the patient in a unit of time; - guiding force - the support force from the robot that the patient needed for proper gait.	—

Measure

Time frame

Secondary end point(s): The reduction of muscle tension achieved with Methocarbamol therapy will allow the use of robotic methods in gait re-education, and as a result, better rehabilitation and functional improvement. The Lokomat gait test will be used to assess functional improvement. During the study, the following will be compared: - distance covered by the patient in a unit of time; - guiding force - the support force from the robot that the patient needed for proper gait. ;Timepoint(s) of evaluation of this end point: The reduction of muscle tension achieved with Methocarbamol therapy will allow the use of robotic methods in gait re-education, and as a result, better rehabilitation and functional improvement. The Lokomat gait test will be used to assess functional improvement. During the study, the following will be compared: - distance covered by the patient in a unit of time; - guiding force - the support force from the robot that the patient needed for proper gait.

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Countries

Poland

Contacts

Public Contactproject manager assistant

Bogumil Korczynski

sekretariat@u-kp.pl+48913821149

Outcome results