Condition 1: Chronic spinal pain. Condition 2: Chronic spinal pain. Low back pain Cervicalgia
Conditions
Interventions
Intervention 1: Intervention group: Individuals with indication for inclusion in the intervention group receive ten sessions of physical therapy as the main treatment. They are also treated with Saffr
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age 18 to 60 years chronic spinal pain (more than 3 months) Chronic spinal pain with moderate severity (visual analog scale between 3 to 8) consent to participate in study
Exclusion criteria
Exclusion criteria: Severe psychiatric illness (bipolar disorder, schizophrenia) Substance use Suicidal or homicidal idea Admission indication Cognitive impairment in patients pregnancy Breastfeeding Infectious causes of pain Immunological causes of pain Osteoporosis causes pain Tumor causes pain Inflammatory causes of pain Cauda aquina syndrome Fractures in the lumbar spinal vertebral Progressive neurological defect Major cardiovascular disease Low blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| General Function. Timepoint: At first of study and after 1 month of taking the drug / placebo. Method of measurement: Activity daily livig scale.;Pain. Timepoint: At first of study and after 1 month of taking the drug / placebo. Method of measurement: visual analog scale.;Anxiety. Timepoint: At first of study and after 1 month of taking the drug / placebo. Method of measurement: General Health Questionnaire.;Depression. Timepoint: At first of study and after 1 month of taking the drug / placebo. Method of measurement: General Health Questionnaire.;Drug Complications. Timepoint: At first of study and after 1 month of taking the drug / placebo. Method of measurement: Checklist.;Neck Disability Index score. Timepoint: At first of study and after 1 month of taking the drug / placebo. Method of measurement: Neck Disability Index questionnaire.;Oswestry Questionnaire score. Timepoint: At first of study and after 1 month of taking the drug / placebo. Method of measurement: oswestry questionnaire.;Analgesia consumption. Timepoint: At first of study and after 1 month of taking the drug / placebo. Method of measurement: Checklist. | — |
Secondary
| Measure | Time frame |
|---|---|
| General function. Timepoint: after 1 month and then 3 months of beginning the treatment. Method of measurement: Activity daily livig scale.;Analgesia consumption. Timepoint: after 1 month and then 3 months of beginning the treatment. Method of measurement: Checklist.;Drug side effect. Timepoint: after 1 month and then 3 months of beginning the treatment. Method of measurement: Checklist.;Neck disability index score. Timepoint: after 1 month and then 3 months of beginning the treatment. Method of measurement: Persian version of Neck disability index.;Oswestry questionnaire score. Timepoint: after 1 month and then 3 months of beginning the treatment. Method of measurement: Persian version of oswestry questionnaire.;Spinal pain. Timepoint: after 1 month and then 3 months of beginning the treatment. Method of measurement: Visual analog scale.;Anxiety. Timepoint: after 1 month and then 3 months of beginning the treatment. Method of measurement: General health questionnaire.;Depression. Timepoint: after 1 month and then 3 months of beginning the treatment. Method of measurement: General health questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahboobe Bahrami
Tehran University of Medical Sciences
Outcome results
None listed