The aim of this study will be to determine and compare the effectiveness of extracorporeal shockwave therapy and high power laser therapy on pain, heel thickness and quality of life in patients with plantar fasciitis.
Design
The laser therapy group will use a gallium arsenide diode laser (model K-laser-cube 4) with a wavelength of 1064 nm, an output power of 8 watts, and an average energy intensity of 6-10 joules per square centimeter. The laser wave is of continuous type and will be applied by scanning method. The total duration of treatment in each session will be 5-7 minutes. All patients will be treated for 3 consecutive weeks (6 sessions)
Settings and conduct
This study will be performed as a single blind (evaluator will be blinded of the type of intervention) in patients referred to Besat Hospital in Hamedan with plantar fasciitis.
Participants/Inclusion and exclusion criteria
The subjects of patients with plantar fasciitis are 18 to 65 years old. Inclusion criteria: The duration of diagnosis is at least 3 months and the minimum pain intensity is greater than 3 according to the VAS criteria.
Comorbidity with other ankle and heel diseases such as tarsal tunnel syndrome, osteomyelitis, malignancy , Recent history of surgery or trauma of the ankle or heel, vascular disease, treatment with corticosteroids now or during the past 4 months and treatment with NSAIDs will be the exclusion criteria.
Intervention groups
ESWT Group: This group will receive an ESWT one session for three weeks consecutively. ESWT will be performed in laying position on a quiet bed at the point where the greatest intensity of tenderness is found. Device settings: frequency 4 Hz, pulse 1500, energy 0.15 mj / mm2.
Main outcome variables
The main outcome of treatment includes changes in pain intensity and heel thickness, which will be assessed with the VAS scale and ultrasound, respectively.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N15
Registration date:2021-07-16, 1400/04/25
Registration timing:prospective
Last update:2021-07-16, 1400/04/25
Update count:0
Registration date
2021-07-16, 1400/04/25
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Extracorporeal shockwave therapy and high-level laser therapy in patients with plantar fasciitis
Public title
Comparison of the therapeutic effect of laser and extracorporeal shock waves in plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of plantar fasciitis according to clinical criteria and para -clinical imaging by a specialist physician
The duration of diagnosis is at least 3 months
Age 65-18 years
Minimum pain intensity > 3 according to VAS scale
Exclusion criteria:
Comorbidity other ankle and heel diseases such as tarsal tunnel syndrome, osteomyelitis, malignancy
History of recent ankle or heel surgery or trauma
Vascular diseases
Treatment corticosteroid past 4 months
NSAID treatment
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 patients with inclusion will be selected by convenience sampling. The samples will be randomly coded with computer software in two groups E and L and the relevant codes will be entered in the raw checklists. Upon patient referral, one of the checklists will be randomly assigned to each patient. If the selected code is E, the patient will be in the ESWT treatment group and if it is L, he/she will be in the laser treatment group
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator of intervention outcome will be blinded to the patients' group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Science
Street address
ُShahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2021-01-16, 1399/10/27
Ethics committee reference number
IR.UMSHA.1399.877
Health conditions studied
1
Description of health condition studied
plantar fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis
Primary outcomes
1
Description
Plantar fascia thickness
Timepoint
3, 6 and 12 weeks after treatment
Method of measurement
Ultrasound examination of the heel in prone position
2
Description
Severity of plantar pain
Timepoint
3, 6 and 12 weeks after treatment
Method of measurement
with Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Life Quality
Timepoint
Before, 3. 6 and 12 weeks after intervention
Method of measurement
SF-12 Questionnaire
2
Description
Treatment Complications
Timepoint
3, 6 and 12 weeks after the intervention
Method of measurement
Examination and observation
Intervention groups
1
Description
Intervention group: Group A will be allocated to ESWT by a physical therapist for 3 consecutive weeks and one session per week. ESWT will be performed while the patient is lying on a quiet bed at the point where the greatest intensity of tenderness is found. Device settings: frequency 4 Hz, pulse 1500, energy 0.15 mj / mm2. will be done
Category
Treatment - Devices
2
Description
Control group: Patients in group B will receive powerful laser therapy. In this group, gallium aluminum arsenide diode laser (model K-laser-cube 4) with a wavelength of 1064 nm, output power of 8 watts, and an average energy intensity of 6-10 joules per square centimeter will be used. The laser wave is of continuous type and will be applied by scanning method. The total duration of treatment in each session will be 5-7 minutes. All patients will be treated for 3 consecutive weeks (6 sessions).
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mohammad Reza Niko
Street address
Besat Hospital, Shahid Beheshti Blv, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Email
Besat@Umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr Saeid Bashirian
Street address
Shahid Fahmide Ave
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
محمدرضا نیکو
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Besat Hospital, Shahid Beheshti Blv, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Email
mohammadrezanikoo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
No 5, Dena Unit, Fatah Alley, Pirozi Alley, Ammar Ave, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6515974544
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available