Comparison of the efficacy of triamcinolone and dexmedetomidine injection in the treatment of pain caused by plantar fasciitis
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2-3 on 40 patients. Block randomization method was used.
Settings and conduct
40 participants who met the entry criteria, among the patients who were candidates for dexmedetomidine/triamcinolone injection, referring to the pain clinic of Akhtar Hospital in 2022, were randomly divided into two control (triamcinolone) and intervention (dexmedetomidine) groups. Blinding is a double-blind method, and the patient and the outcome assessor will be unaware of which group they are in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 years and older; patients with initial complaint of heel pain after weight bearing after a period of rest; chronic heel pain of three months or more without evidence of acute trauma to the heel; Pain score more than 5 after removal The first step is to seek rest.
Exclusion criteria: mechanical posterior heel pain; traumatic heel pain; arthritic heel pain; skin ulcer around the heel; acute infection; diabetes; sensory neuropathy; peripheral vascular disease/autoimmune disease; fibromyalgia.
Intervention groups
Intervention group (dexmedetomidine-local anesthetic): Injection of 1 microgram per kilogram of dexmedetomidine plus 2 ml lidocaine 2% under ultrasound guidance with a 22-gauge needle, after prepping the injection site with 1% betadine, with a standard approach in the space between the plantar fascia and periosteum is performed. The injection is done in one session.
Control group: triamcinolone: injection of one milliliter (40 milligram) of triamcinolone plus 2 ml of lidocaine 2%. The injection method is similar to the intervention group.
Main outcome variables
Pain Level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170423033615N2
Registration date:2022-12-02, 1401/09/11
Registration timing:registered_while_recruiting
Last update:2022-12-02, 1401/09/11
Update count:0
Registration date
2022-12-02, 1401/09/11
Registrant information
Name
Mahshid Ghasemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 5454
Email address
mahshidghasemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-30, 1401/09/09
Expected recruitment end date
2023-03-18, 1401/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of triamcinolone and dexmedetomidine injection in the treatment of pain caused by plantar fasciitis
Public title
Comparison of the effect of triamcinolone and dexmedetomidine injections in the treatment of heel pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and above
Patients with initial complaint of heel pain after weight bearing after a period of rest
Heel pain and plantar fasciitis for more than three months
Patients with unilateral chronic plantar fasciitis
Failure to respond to conservative treatments
Pain that goes away after a few minutes of walking but returns after prolonged walking or standing
Pain caused by palpation of medial calcaneal tuberosity, dorsiflexion of the foot passively
Chronic heel pain of three months or more without evidence of acute trauma to the heel
VAS > 5 after taking the first step following rest
Patients with satisfaction to participate in the study
Exclusion criteria:
Mechanical pains in the posterior part of the heel in the form of Achilles tendonitis/bursitis
Neurological heel pain caused by nerve rupture
Heel arthritis pain
Traumatic heel pain
Bilateral plantar fasciitis
Heel pain for more than three months
Skin ulcer around the heel and treatment of that area
Sciatica pain; benign and malignant tumors; acute infection; diabetes; sensory neuropathy; peripheral vascular disease / autoimmune disease; fibromyalgia; chronic fatigue syndrome
Light sensitivity disorder
Pregnancy and breastfeeding
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done as a block randomization method. So, initially, in the Excel software, there are 6 blocks of 4 as (AA, BB), (BB, AA), (AB, BA), (BA, AB). (AB, AB), (BA, BA) are prepared and then these blocks will be arranged from one to six. A is the confirmation of the treatment or intervention group and B is the confirmation of the control group. Then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned to the treatment or control groups. The random process of selecting blocks and assigning people to the intervention and control groups will continue until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the study subjects, before the random assignment, it is explained how the work process is and they may receive one of the two treatments randomly, and the drug used for the subjects is not known in advance, the form of the intervention drug and control and also, the frequency and times of administration of these two will be similar, so that it is not possible for the patient to distinguish them from each other, so the patient will not know which group she is in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tabnak Street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-11-12, 1401/08/21
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.532
Health conditions studied
1
Description of health condition studied
Chronic heel pain and plantar fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis
Primary outcomes
1
Description
Pain level
Timepoint
Before starting treatment, 4 and 12 weeks after injection
Intervention group: Injection of 1 microgram per kilogram of dexmedetomidine plus 2 ml lidocaine 2% under ultrasound guidance with a 22-gauge needle, after prepping the injection site with 1% betadine, is performed with a standard approach in the space between the plantar fascia and the periosteum. The injection is done in one session.
Category
Treatment - Drugs
2
Description
Control group: injection of one milliliter (40 milligram) of triamcinolone plus 2 ml of lidocaine 2%. The injection method is similar to the intervention group.