Protocol summary
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Study aim
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The effectiveness of dry needling and exercise therapy vs. exercise therapy alone on pain, foot function, quality of life, thickness and echogenicity of the plantar fascia in patients with plantar fasciitis
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Design
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The present study is a randomized control trial,with parallel group and double blind. Participants in the study are divided into two intervention and control groups based on randomized block design. The control group will receive exercise therapy for four weeks. The intervention group will receive exercise therapy and dry needling for four weeks. The sample size is 60.
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Settings and conduct
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Place of study: Musculoskeletal sonography laboratory of physiotherapy of Faculty of Rehabilitation of Tehran University of Medical Sciences.
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Participants/Inclusion and exclusion criteria
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inclusion criteria: individuals with plantar fasciitis (PF), age between 20-45 years
exclusion criteria: History of direct trauma to the heel; the presence of systemic inflammatory disorders; low back pain caused by disc herniation; the presence of Tarsal tunnel syndrome(TTS); history of fracture in foot and ankle; use aid of support for walking; the presence of contraindication for dryneedling, women who are pregnant; treatment for plantar heel pain in the previous 4 weeks; unwillingness to participate in the study
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Intervention groups
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The intervention group: will receive exercise therapy and dry needling for four weeks.
The control group: will receive exercise therapy for four weeks.
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Main outcome variables
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Pain; quality of life; foot function; thickness of the plantar fascia; echogenicity of the plantar fascia
General information
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Reason for update
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to determine actual recruitment start date and actual recruitment end date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180107038257N1
Registration date:
2018-09-14, 1397/06/23
Registration timing:
prospective
Last update:
2021-04-22, 1400/02/02
Update count:
1
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Registration date
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2018-09-14, 1397/06/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-07, 1397/06/16
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Expected recruitment end date
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2019-01-19, 1397/10/29
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Actual recruitment start date
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2018-10-01, 1397/07/09
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Actual recruitment end date
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2020-03-01, 1398/12/11
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Trial completion date
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2020-03-01, 1398/12/11
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Scientific title
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The effectiveness of dry needling and exercise therapy vs. exercise therapy alone on pain, foot function, quality of life, thickness and echogenicity of the plantar fascia in patients with plantar fasciitis
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Public title
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The effectiveness of dry needling and exercise therapy vs. exercise therapy alone on foot function in patients with heel pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
individuals with plantar fasciitis
age between 20-45 years
Exclusion criteria:
History of direct trauma to the heel
The presence of systemic inflammatory disorders
Low back pain caused by disc herniation
The presence of Tarsal tunnel syndrome(TTS)
History of fracture in foot and ankle
Use aid of support for walking
The presence of contraindication for dryneedling
Women who are pregnant
Treatment for plantar heel pain in the previous 4 weeks
Unwillingness to participate in the study
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Age
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From 20 years old to 45 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
37
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: randomized block design, block size:4, ratio 1:1
Randomization tool: software
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-25, 1397/03/04
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Ethics committee reference number
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IR.TUMS.VCR.REC.1397.231
Health conditions studied
1
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Description of health condition studied
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plantar fasciitis
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ICD-10 code
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M72.2
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ICD-10 code description
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Plantar fascial fibromatosis
Primary outcomes
1
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Description
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Pain
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Timepoint
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At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up
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Method of measurement
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Visual analog scale
2
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Description
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Quality of life
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Timepoint
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At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up
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Method of measurement
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Short-form36(SF-36) questionnaire
3
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Description
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Foot function
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Timepoint
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At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up
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Method of measurement
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Foot and Ankle Ability Measure questionnaire (FAAM) and Foot and ankle outcome score (FAOS)
4
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Description
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Thickness of the plantar fascia
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Timepoint
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At the baseline, after six weeks of intervention
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Method of measurement
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Ultrasonography
5
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Description
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Echogenicity of the plantar fascia
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Timepoint
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At the baseline, after six weeks of intervention
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Method of measurement
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Ultrasonography
Secondary outcomes
1
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Description
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Foot range of motion
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Timepoint
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At the baseline, after three weeks of intervention, after six weeks of intervention and after a two-week follow up period
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Method of measurement
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Goniometer
Intervention groups
1
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Description
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Intervention group: The intervention group will receive the exercise therapy and the dry needling for six weeks. The exercise therapy consist of the stretching exercise of the plantar fascia; the soleus muscle; the gastrocnemius muscle and the big-toe flexor and stretching on the static wooden wedge. The patients do the stretching exercise two times per day; any time fifteen repetitions; each taking 30 seconds; during six weeks. Dry needling is done according to the modified-delphi protocol. According to the protocol, the muscles that are primarily responsible for the pain including: the soleus; the quadratus plantae; the flexor digitorum brevis and the abductor hallucis. The intervention group will receive the dry needling once a week; during six weeks.
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Category
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Rehabilitation
2
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Description
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Control group: The control group will receive the exercise therapy for six weeks. The exercise therapy consist of the stretching exercise of the plantar fascia; the soleus muscle; the gastrocnemius muscle and the big-toe flexor and stretching on the static wooden wedge . The patients do the stretching exercise two times per day; any time fifteen repetitions; each taking 30 seconds; during six weeks.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The original data is shared in thesis format.
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When the data will become available and for how long
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After defense of thesis, the original data is shared in thesis format.
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To whom data/document is available
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Academic researchers, physiotherapists
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Under which criteria data/document could be used
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In order to use clinical results, the original data is shared in thesis format.
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From where data/document is obtainable
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Library of the faculty of rehabilitation of Tehran University of Medical Sciences
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What processes are involved for a request to access data/document
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Referral to library of the faculty of rehabilitation of Tehran University of Medical Sciences
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Comments
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