Sono-guided prolotherapy/ oxygen-ozone/ corticosteroid therapy for the treatment of musculoskeletal pain in physical and rehabilitation medicine: Interventional pain management for trochanteric bursitis: a prospective, randomized, double-blind, positive control, multicenter clinical trial.
Comparison of the effects of ozone injection, corticosteroids and prolotherapy in reducing pain caused by various musculoskeletal disorders such as trochanteric bursitis, a model for reducing pain in these patients
Design
A double-blind randomized clinical trial (patient and analyst) was multicenter with a positive control group and in the group of patients with musculoskeletal disorders
Settings and conduct
Shohada and Imam Reza (AS) Educational and Medical Center affiliated to Tabriz University of Medical Sciences and Hazrat Rasoul Akram (AS) Hospital, Iran University of Medical Sciences and Iran Neuromuscular Center
Participants/Inclusion and exclusion criteria
Inclusion criteria: pain in the back of the trochanter that also has local tenderness.
Exclusion criteria: the presence of pathology in the hip joint; Rheumatic disease; calcification at the injection site; any skin infection at the injection site; history of injection or on-site physiotherapy in the last 2 months; coagulation disorders; existence of lumbosacral radiculopathy.
Intervention groups
group A of ozone
group B corticosteroid
group C prolotherapy
Main outcome variables
ROM (Range of Motion); CGI (Clinical Global Impression); Visual Analogue Scale (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100827004641N16
Registration date:2020-08-24, 1399/06/03
Registration timing:registered_while_recruiting
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-18, 1398/10/28
Expected recruitment end date
2021-01-17, 1399/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sono-guided prolotherapy/ oxygen-ozone/ corticosteroid therapy for the treatment of musculoskeletal pain in physical and rehabilitation medicine: Interventional pain management for trochanteric bursitis: a prospective, randomized, double-blind, positive control, multicenter clinical trial.
Public title
Sono-guided prolotherapy/ oxygen-ozone/ corticosteroid therapy for the treatment of musculoskeletal pain in physical and rehabilitation medicine: Interventional pain management for trochanteric bursitis: a prospective, randomized, double-blind, positive control, multicenter clinical trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain in the back of the trochanter that also has local tenderness
Exclusion criteria:
The presence of pathology in the hip joint
Rheumatic disease
Calcification at the injection site
Any skin infection at the injection site
History of injection or on-site physiotherapy in the last 2 month
Coagulation disorders
Existence of lumbosacral radiculopathy
Age
From 46 years old to 46 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method will be used to allocate participants to the groups with a 1:1:1 allocation using random allocation software (RAS) with block sizes of 3 and 6. Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package
Blinding (investigator's opinion)
Double blinded
Blinding description
Away from the patient's eye, prepare the injection material in the syringe and cover the syringes with an aluminum foil so that the person does not know the type of injection material.
Patients in each group will be evaluated by a physical medicine and rehabilitation assistant who is not aware of the type of injection before the injection, one week later, and two months after the injection. It should be noted that in each center, all injections are performed by a fixed person (specialist in physical medicine and rehabilitation).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
5166614756
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.IUMS.REC.1398.1107
Health conditions studied
1
Description of health condition studied
Trochanteric bursitis
ICD-10 code
M70.6
ICD-10 code description
Trochanteric bursitis
Primary outcomes
1
Description
Pain intensity
Timepoint
Evaluating the visual analogue scale at the beginning of the study (before intervention) and 7 and 60 days after injection
Method of measurement
Visual analogue Scale
2
Description
Overall recovery rate
Timepoint
Evaluating the overall recovery rate at 7 and 60 days after injection
Method of measurement
Patient Global Impression of Improvement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A :after providing sterile conditions with Povidone-Iodine solution, anesthesia is performed locally with 1 cc of 2% lidocaine and 22 gage needle. For all patients, the injection will be performed under ultrasound guidance and using needle number 27 after aspiration and ensuring the correct placement of the needle. Any other medication should be avoided during treatment and follow-up will be one week after injection and two months after injection.
Category
Treatment - Drugs
2
Description
Intervention group B: after providing sterile conditions with Povidone-Iodine solution, anesthesia is performed locally with 1 cc of 2% lidocaine and 22 gage needle. For all patients, the injection will be performed under ultrasound guidance and using needle number 27 after aspiration and ensuring the correct placement of the needle. Any other medication should be avoided during treatment and follow-up will be one week after injection and two months after injection.
Category
Treatment - Drugs
3
Description
Intervention group C: after providing sterile conditions with Povidone-Iodine solution, anesthesia is performed locally with 1 cc of 2% lidocaine and 22 gage needle. For all patients, the injection will be performed under ultrasound guidance and using needle number 27 after aspiration and ensuring the correct placement of the needle. Any other medication should be avoided during treatment and follow-up will be one week after injection and two months after injection.