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Comparison of trigger points Dry needling and Shockwave therapy on pain, function and quality of life in patients with chronic plantar fasciitis

Protocol summary

Study aim
Comparison of trigger points Dry needling and Shockwave therapy on pain, function and quality of life in patients with chronic plantar fasciitis
Design
This is a randomized clinical trial with subjects in two groups of 42 people. the examiner is blind and Block Randomization and sealed opaque envelopes concealment will perform.
Settings and conduct
84 patients were randomly assigned into two groups of shockwave therapy and dry needles. The shockwave therapy group undergoes three sessions of treatment for three weeks and once a week. Dry needle group also undergoes three sessions of treatment for three weeks and once a week. Assessments will performed before the intervention , after and five weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years Resistance to treatment in the last 6 months Point pain on the inside of the calcaneus and origin of plantar fasciitis Having a minimum score of numerical scale of pain 4 in the first step Having or not having heel spur Having trigger points in the initial assessment of cuff muscles Adoption interrupted of analgesics, anti-inflammatory and non-steroidal drugs and topical or oral analgesics for at least 14 days before the initial assessment and during the study. Ability to walk 50 meters without assistance Exclusion criteria: Dry needle contraindication Secondary heel pain leads to more serious problems such as fractures, cancer and infection History of coagulation disorders or taking anticoagulants other than acetylsalicylic acid to a dose of 325 mg / day Dermatological Disease Previous experience in using dry needles or acupuncture A history of chronic diseases Systemic or topical neurological disorders Spinal deformities Lower limb bone disorders
Intervention groups
Groups consist two groups of shockwave therapy and dry needles.
Main outcome variables
pain; function; quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190715044217N1
Registration date: 2019-09-04, 1398/06/13
Registration timing: prospective

Last update: 2019-09-04, 1398/06/13
Update count: 0
Registration date
2019-09-04, 1398/06/13
Registrant information
Name
tahere salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
t_salehi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of trigger points Dry needling and Shockwave therapy on pain, function and quality of life in patients with chronic plantar fasciitis
Public title
Comparison of trigger points dry needling and shockwave therapy on pain, function and quality of life in patients with chronic plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Resistance to treatment in the last 6 months Point pain on the inside of the calcaneus and origin of plantar fasciitis Having a minimum score of numerical scale of pain 4 in the first step Having or not having heel spur Adoption interrupted of analgesics, anti-inflammatory and non-steroidal drugs and topical or oral analgesics for at least 14 days before the initial assessment and during the study Having trigger points in the initial assessment of cuff muscles Ability to walk 50 meters without assistance
Exclusion criteria:
Dry needle contraindications include: Needle phobia, People with a history of needle or injection abnormal reactions, Emergency situations, Anticoagulant drugs, Lymphedema, Vascular Diseases, Diabetes, Pregnancy, Epilepsy, and Metal Sensitivity latex Secondary heel pain leads to more serious problems such as fractures, cancer and infection History of coagulation disorders or taking anticoagulants except acetylsalicylic acid to a dose of 325 mg / day Dermatological Disease in place of dry needle Previous experience in using dry needles or acupuncture connective tissue disease A history of chronic diseases such as RA, PSORIATIC, SCIATIC History of Plantar Fascia Surgery or Injection 3 months ago Systemic or topical neurological disorders Spinal deformities Lower limb bone disorders such as gout and Paget's
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly allocated blocks and hiding in a non-transparent envelope sealed into two groups
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the evaluator and analyst are blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Shiraz School of Rehabilitation Sciences
Street address
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
City
shiraz
Province
Fars
Postal code
33669-71947
Approval date
2019-07-13, 1398/04/22
Ethics committee reference number
IR.SUMS.REHAB.REC.1398.020

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
Pain
Timepoint
Before the intervention, one week and five weeks after the intervention
Method of measurement
Numeric rate scale

2

Description
Function
Timepoint
Before the intervention, one week and five weeks after the intervention
Method of measurement
FAAM questionnaire

3

Description
Quality of life
Timepoint
Before the intervention, one week and five weeks after the intervention
Method of measurement
Short form 12 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, 3 sessions of shockwave therapy will apply for three weeks and once a week
Category
Rehabilitation

2

Description
Intervention group: In this group, individuals will receive dry needling for 3 weeks and once a week at painful trigger points of cuff muscles. These muscles include Soleus, Quadratus plantae, Flexor digitorum brevis, Flexor hallusic longus, Gastrocnemius and Abductor hallucis.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospitals of Shiraz university of medical sciences
Full name of responsible person
Tahere salehi
Street address
School of Rehabilitation Sciences, Abiverdi 1 St., Chamran Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Email
t_salehi71@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ghasemi Unes
Street address
Floor 7, Center Bilding of Shiraz Univercity of Medical Science, beside Helale Ahmar, Zand street
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir/fa/contact-information/index.html
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ebrahimi samaneh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Abiverdi 1 St., Chamran Blvd., Shiraz, Iran
City
shiraz
Province
Fars
Postal code
1733-71345
Phone
+98 71 3627 1551
Email
EbrahimiS@Sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ebrahimi samaneh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
EbrahimiS@Sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahere salehi
Position
master of physical therapy student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi St. 1, Chamran Blvd., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
t_salehi71@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results will be published as an article in the research international journals
When the data will become available and for how long
In the next one to two years
To whom data/document is available
Only people who ask the information from the main investigator
Under which criteria data/document could be used
With the permission through a written or an oral request
From where data/document is obtainable
School of Rehabilitation Sciences, Shiraz University of Medical Sciences, 1st Abiverdi, Chamran Blv., Miss Tahere salehi, Phone number: 0098 71 36271551
What processes are involved for a request to access data/document
With a written request, they can access the library of Shiraz University of Medical Sciences, School of Rehabilitation Sciences
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