Protocol summary
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Study aim
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Determine the effect of topical Henna oil on pain in chronic sciatica patients
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Design
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A randomized controlled clinical trial with parallel groups, double blinded
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Settings and conduct
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The research site is the neurosurgery clinic of Imam Khomeini Hospital and the health centers affiliated to the Faculty of Iranian Medicine of Tehran University of Medical Sciences. Chronic sciatica patients are randomly divided into 3 groups of henna oil(in sesame oil base), sesame oil and placebo. Patients in 3 groups use 10 drops of the oil or placebo, 3 times a day, for 4 weeks, topically on the low back and unilateral painful area from gluteal to middle posterior of thigh; and they can take one diclofenac 25 mg tablet up to 2 times a day, If they have severe pain. Patients and researchers are not aware of treatment allocation.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Chronic unilateral sciatica pain for at least 3 months and more؛ age 18 to 65 years; Pain score of 1 or more on visual analog scale; Willingness to participate in the study; Without communication problems; Not being candidate for surgery; No history of surgery in the low back; No history of alcohol and narcotic abuse; Body mass index between18.5 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; Acute illness or accident during the study; G6PD; Aggravation of pain; Use of other complementary and alternative therapies; Use of analgesics out of the study؛ Cauda equine syndrome; Symptoms require further investigation
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Intervention groups
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Intervention group1: To use topically henna oil(in sesame oil base); Intervention group2: To use topically sesame oil; The Placebo group: To use topically mineral oil
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Main outcome variables
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Pain intensity
General information
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Reason for update
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Recruitment start date was corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210919052522N1
Registration date:
2021-10-10, 1400/07/18
Registration timing:
prospective
Last update:
2021-10-29, 1400/08/07
Update count:
1
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Registration date
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2021-10-10, 1400/07/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-10-11, 1400/07/19
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Expected recruitment end date
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2022-03-21, 1401/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect of topical Henna (Lawsonia inermis L.) oil on pain in chronic sciatica patients; A double-blind randomized clinical trial
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Public title
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The Effect of topical Henna oil on pain in chronic sciatica patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
81
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation to groups is done by balance block randomization method with triple blocks(using the related table to random permutations). The randomized list is provided by a statistical consultant. In this way, the group code of each patient who enters the study (in the order of patient admission) is determined based on a randomized list. These codes, which belong to the three groups of henna oil(in sesame oil base) group and sesame oil group and the placebo group(mineral oil) have been determined by a statistical consultant; and in addition to patients, the researcher will not be informed until the end of the study.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Drugs and the placebo are packed in similar bottles with the same shape, color and smell. The proprietary codes set by the pharmacist on the bottle of drugs and the placebo. Patients and the researcher are not aware of codes.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-09-19, 1400/06/28
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1400.671
Health conditions studied
1
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Description of health condition studied
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Chronic sciatica
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ICD-10 code
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M00-M99
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ICD-10 code description
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Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
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Description
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Pain intensity
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Timepoint
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At the beginning of the study (before the intervention) and 7, 14 and 28 days after the start of the study
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Method of measurement
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Visual Analogue Scale
Secondary outcomes
1
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Description
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Diclofenac tablets taken daily
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Timepoint
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during study
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Method of measurement
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Number
2
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Description
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Disability
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Timepoint
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Before the start of the study and 4 weeks after the start of the study(the end of the study)
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Method of measurement
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Oswestry disability questionnaire
3
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Description
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Quality of Life
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Timepoint
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Before the start of the study and 4 weeks after the start of the study(the end of the study)
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Method of measurement
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The Short form health survey 36 questionnaire (SF-36)
4
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Description
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Skin side effects
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Timepoint
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Days 3, 7, 14 and 28 days after the start of the study
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Method of measurement
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Form of skin side effects based on CTCAE(Common Terminology Criteria for Adverse) version 5
Intervention groups
1
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Description
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First intervention group: Chronic sciatica patients use topically 10 drops(half a cc) of henna oil(in sesame oil base) on the low back and unilateral painful area from gluteal to middle posterior of thigh without massage, 3 times a day, for 4 weeks.
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Category
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Treatment - Drugs
2
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Description
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Second intervention group: Chronic sciatica patients use topically 10 drops(half a cc) of sesame oil on the low back and unilateral painful area from gluteal to middle posterior of thigh without massage, 3 times a day, for 4 weeks.
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Category
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Treatment - Drugs
3
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Description
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Control group: Chronic sciatica patients use topically 10 drops(half a cc) of mineral oil on the low back and unilateral painful area from gluteal to middle posterior of thigh without massage, 3 times a day, for 4 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available