The Effect of topical Henna oil on pain in chronic sciatica patients

Phase 3

Recruiting

Conditions: Chronic sciatica.
Diseases of the musculoskeletal system and connective tissue
M00-M99

Registration Number: IRCT20210919052522N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 81

Inclusion Criteria

Patients with chronic unilateral sciatica pain (lumbar radiculopathy in this study defined chronic back pain that spread to a leg. Pain described as sharp, burning with numbness and/or tingling.) For at least 3 months and more
Age 18 to 65 years
Pain score of 1 or more on visual analog scale (VAS) of 0 to 10
Willingness of patients to participate in the study
Patients without communication problems (vision, hearing, speaking and understanding)
Pain not attributable to malignancy, inflammatory arthritis such as rheumatoid arthritis, or blood diseases and coagulation and infectious diseases
Patients without congenital spinal abnormalities, bone fractures, scoliosis, kyphosis and spondylosis
Patients are not candidate for surgery
No history of surgery in the lower back
No history of alcohol and narcotic abuse
Body mass index(BMI) between 18.5 to 34.9

Exclusion Criteria

Pregnancy or lactation
Severe allergy to any of the medications used in the study
Severe side effects
Unwillingness to continue participating in the study
No use of oils more than twice in a row
Occurring acute illness or accident during the study
Patients with G6PD
Aggravation of pain
Use of other complementary and alternative therapies
Use of analgesics out of the study during the study
Cauda equine syndrome symptoms include numbness and weakness in both legs, pain in the anal area, perineal numbness, paralysis of the sphincters
Symptoms require further investigation during the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity. Timepoint: At the beginning of the study (before the intervention) and 7, 14 and 28 days after the start of the study. Method of measurement: Visual Analogue Scale.

Secondary Outcome Measures

Name	Time	Method
Diclofenac tablets taken daily. Timepoint: during study. Method of measurement: Number.;Disability. Timepoint: Before the start of the study and 4 weeks after the start of the study(the end of the study). Method of measurement: Oswestry disability questionnaire.;Quality of Life. Timepoint: Before the start of the study and 4 weeks after the start of the study(the end of the study). Method of measurement: The Short form health survey 36 questionnaire (SF-36).;Skin side effects. Timepoint: Days 3, 7, 14 and 28 days after the start of the study. Method of measurement: Form of skin side effects based on CTCAE(Common Terminology Criteria for Adverse) version 5.