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Trial registered on ANZCTR


Registration number
ACTRN12617000761369
Ethics application status
Approved
Date submitted
19/04/2017
Date registered
23/05/2017
Date last updated
1/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Extracorporeal shock wave and low level laser in the management of plantar fasciitis
Scientific title
Clinical Effectiveness of Low-Level Laser Therapy as an Adjunct to Extracorporeal Shock wave therapy for the management of plantar fasciitis: A Randomized Controlled Trial
Secondary ID [1] 291431 0
None
Universal Trial Number (UTN)
U1111-1194-1800
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Calcaneal spur 302449 0
plantar fasciitis 302450 0
Condition category
Condition code
Musculoskeletal 302016 302016 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 302017 302017 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After the physical examination and data collection, participants will then be randomly assigned into 4 groups.
Group A: 20 patient will receive Extracorporeal Shock Wave Therapy (ESWT) and low level laser therapy (LLLT) with stretching exercise and ice massage twice a week for 3 weeks.
Group B: 20 patient will receive ESWT with stretching exercise and ice massage twice a week for 3 weeks.
Group C: 20 patient will receive LLLTwith stretching exercise and ice massage twice a week for 3 weeks.
Group D: 20 patient in Control group will receive stretching exercise and ice massage twice a week for 3 weeks.
Treatment application:
Four blinded physical therapists with experience ranging from 3-5 years will deliver each treatment in each group. They will be blinded to other treatment groups, to the recruitment of subjects and as well as the physical examination. To monitor adherence to treatment sessions, each physical therapist will register attendance of sessions in a note book.

1- Extracorporeal Shock Wave Therapy (ESWT) application: Intellect RPW chattanoga (model 2074 - 230 V- , 50Hz Mexico) shockwave device will be used. Device specification includes a compressed air output of 1.4- 5 bar, power increment settings at 2 bar, pulse frequency 0.5-35 Hz and Pulse Width of Approx. 6 - 12 ms with a single or continuous mode. Patient will lie in the supine position; barefooted, the area treated will be marked. Ultra Sound gel will be then applied on the region that will receive the shock wave twice a week for 3 weeks. Dosage will be 3x3000 shock waves/session of high energy 0.2 mJ/mm2, 8hz and 2 bars for 15-20 minutes
2- LLLT will be administered with a gallium–arsenide (GaAs) laser with an infrared wavelength of 904 nm (Irradia medical laser, M/D Laser Professional, Stockholm, Sweden) with three infrared diodes. With the patient in a supine position and barefooted, laser emitting a divergent 635-nm (red) laser light generating a 17-mW output will be applied twice a week for 3 weeks. Exposure time during the LLLT will be 10 minutes across the dorsal foot, the myofascial junction of the heel, and the plantar aspect of the heel, simultaneously.
3- Stretching for plantar fascia: with the patient sitting, he will cross the affected leg over the other leg. then the therapist will hold the affected foot and pull the toes back towards shin. This creates tension/stretch in the arch of the foot/plantar fascia.
Therapist will then check for the appropriate stretch position by gently rubbing the thumb over the arch of the affected foot. The plantar fascia should feel firm, like a guitar string.
the stretch will be then held for a count of 20, and repeated 3-5 repetitions.
4- Ice Massage: using an ice cone, with the patient in seated position,he will cross the affected leg over the other leg the ice will be massaged around the whole plantar fascia in vertical, longitudinal and circular strokes for 10-15 minutes
Intervention code [1] 297469 0
Treatment: Devices
Intervention code [2] 297990 0
Treatment: Other
Comparator / control treatment
Control group will take standard treatment of ice massage and stretching of planter fascia twice a week for 3 weeks
Control group
Active

Outcomes
Primary outcome [1] 301813 0
Pain will be assessed using the visual analogue scale
Timepoint [1] 301813 0
Prior to the intervention as baseline measure and at the end of the 3 week intervention period
Secondary outcome [1] 333945 0
Foot Functional Index
Timepoint [1] 333945 0
Prior to the intervention as baseline measure and at the end of the 3 week intervention period

Eligibility
Key inclusion criteria
1-Age ranged from 40-60 years old of both genders (Krukowska et al; 2016).
2-Participants suffering from pain for at least 3 months with no prior physical therapy for at least 3 months prior to the study and an unsuccessful treatment using non-steroidal anti-inflammatory drugs (NSAID)
3-Particiapents whom have plantar fasciitis due to calcaneal spur that is confirmed with a plain X-ray.
4- A positive windlass test
Minimum age
40 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Muscloskeletal injuries at foot, ankle, knee or spine.
2- Diabetic foot
3- Pregnant female
4- Individuals whom receive local corticosteroid injection in the last two months.
5- Individuals that undergone physical therapy prior to the study in the past 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Age, weight, height will be analyzed statistically by using descriptive statistics to calculate the mean and standard deviation of each group. Multiple-Way ANOVA will be used to compare between 4 groups. The level of significance will be set less than 0.05.
Power analysis will be performed from pervious reported data, based on an estimated 45% increase in VAS, with a power of 95%, type 1 error was set at o.o5, mean of 6.9 and 4 with a standard deviation of 2.7. The sample of each group was 20 subjects.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8829 0
Egypt
State/province [1] 8829 0
Cairo

Funding & Sponsors
Funding source category [1] 295898 0
Self funded/Unfunded
Name [1] 295898 0
Mary Kamal Nassif Takla
Address [1] 295898 0
School of Physical therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country [1] 295898 0
Egypt
Primary sponsor type
University
Name
School of Physical Therapy, Cairo University
Address
School of Physical therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country
Egypt
Secondary sponsor category [1] 294772 0
None
Name [1] 294772 0
Address [1] 294772 0
Country [1] 294772 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297178 0
The Board Council of Higher Education of the School of Physical Therapy, Cairo university
Ethics committee address [1] 297178 0
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
Ethics committee country [1] 297178 0
Egypt
Date submitted for ethics approval [1] 297178 0
07/02/2017
Approval date [1] 297178 0
21/02/2017
Ethics approval number [1] 297178 0

Summary
Brief summary
Eighty participants with plantar fasciitis due to calcaneal spur will be selected from the outpatient clinic of the faculty of physical therapy, Cairo University. Participants then will undergo a physical examination and data collection by a blinded therapist to the treatment allocation and application and with more than 9 years of experience. A Plain X-ray will be performed to confirm the presence of calcaneal spur. Additionally, Windlass test will be used to determine plantar fascia abnormalities in weight bearing and non-weight bearing positions. Outcome measure will be collected prior to the first treatment session as a baseline measure and at the end of the 3-week intervention period as a post-intervention measure, and it will include pain assessed by a Visual analogue scale and Foot Functional Index. After the physical examination and data collection, participants will then be randomly assigned into 4 groups.
Group A: 20 patients will receive Extracorporeal Shock Wave Therapy (ESWT) and low level laser therapy (LLLT) with stretching exercise and ice massage twice a week for 3 weeks.
Group B: 20 patients will receive ESWT with stretching exercise and ice massage twice a week for 3 weeks.
Group C: 20 patients will receive LLLT with stretching exercise and ice massage twice a week for 3 weeks.
Group D: 20 patients in Control group will receive stretching exercise and ice massage twice a week for 3 weeks.
Treatment application:
Four blinded physical therapists with experience ranging from 3-5 years will deliver each treatment in each group. They will be blinded to other treatment groups, to the recruitment of subjects and as well as the physical examination. To monitor adherence to treatment sessions, each physical therapist will register attendance of sessions in a note book.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73246 0
A/Prof Mary Kamal Nassif Takla
Address 73246 0
School of Physical therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country 73246 0
Egypt
Phone 73246 0
+201222817512
Fax 73246 0
Email 73246 0
marytakla@hotmail.com
Contact person for public queries
Name 73247 0
A/Prof Mary Kamal Nassif Takla
Address 73247 0
School of Physical therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country 73247 0
Egypt
Phone 73247 0
00201222817512
Fax 73247 0
Email 73247 0
marytakla@hotmail.com
Contact person for scientific queries
Name 73248 0
A/Prof Mary Kamal Nassif Takla
Address 73248 0
School of Physical therapy, Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. 11432
Country 73248 0
Egypt
Phone 73248 0
00201222817512
Fax 73248 0
Email 73248 0
marytakla@hotmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary