the neurogenic constipation after spinal cord injury
Conditions
Interventions
Intervention group:Transcutaneous posterior tibial nerve stimulation+Conventional therapy
Control group:Placebo therapy+Conventional therapy
Sponsors
the Second School of Clinical Medical of Nanjing University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. At least 18 years old; 2. Traumatic and non-traumatic spinal cord injury; a lesion of the spinal cord above the conus medullaris; been confirmed in previous electrophysio- logical studies and magnetic resonance imaging surveys; undergoing surgical decompression and neural repair; suffering a spinal cord Injury at least 12 months before enrollment; recovering from spinal shock; 3. Rome III diagnostic criteria for functional constipation: (1) Must include two or moreof the following: a. straining during at least 25% of defecation, (2) lumpy or hard stools in at least 25% of defecations, (3) Sensation of incomplete evacuation for at least 25% of defecations, (4) Sensation of anorectal obstruction/blockage for at least 25% of defecations; (5) manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor), (6) fewer than three defecations per week; (7) Loose stools are rarely present without the use of laxatives; (8) Insufficient criteria for irritable bowel syndrome; (9) Criteria fulfilled for the last 3 months with symptom, onset at least 6 months prior to diagnosis; 4. Having an obvious correlation between constipation and spinal cord injury; 5. Having no response to conventional therapy, such as dietary modification or laxative, for at least 6 months, and be not satisfied with conventional therapy; 6. Foot sensory or motor response can be caused by transcutaneous posterior tibial nerve stimulation therapy 7. Signed informed consent forms, and be willing to accept treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Having a history of central nerve system disease unrelated to spinal cord injury, such as Parkinson, stroke, traumatic brain injury, cerebral palsy, multiple sclerosis and having periphera nerve lesions such as diabetic polyneuropathy, metabolic polyneuropathy; 2. Previous abdominal or perineal surgery (excluding minor surgery such as appendectomy or hemorrhoidectomy), evidence of other bowel diseases, such as bowel obstruction, inflammatory bowel disease; 3. Poorly-controlled hypertension; 4. Pregnancy or lactation; 5. Treatment with more than 5 mg/day prednisolone; 6. Having a cardiac pacemaker or other metal devices; 7. Performance of transcutaneous posterior tibial nerve stimulation therapy and sacral nerve stimulation on a regular basis; 8. Cognitive impairment, mental instability such as serious anxiety and depression; 9. Alcohol abuse; 10. Having anatomical limitations preventing the successful placement of an electrode; 11. Be involved in other clinical trials in the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cleveland Constipation Score;Bristol Stool Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The Short Form (36) Health Survey;Zung Self-Rating Depression Scale;Zung Self-Rating Anxiety Scale;Urinary tract infection;the satisfaction with bowel management program;the need for assistance during bowel management; | — |
Countries
China
Contacts
Public ContactYue Yu-Shan
Outcome results
None listed