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
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
37
37
No
No
empty
2018-10-01, 1397/07/09
2018-10-01 00:00:00
empty
2020-03-01, 1398/12/11
2020-03-01 00:00:00
empty
2020-03-01, 1398/12/11
2020-03-01 00:00:00
empty
to determine actual recruitment start date and actual recruitment end date
to determine actual recruitment start date and actual recruitment end date
empty
مشخص کردن تایخ دقیق ابتدا و انتهای نمونه گیری
مشخص کردن تایخ دقیق ابتدا و انتهای نمونه گیری
Primary outcomes
#1
Before the intervention(baseline) and four weeks
At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up
BeforeAt the intervention(baseline)baseline, after three weeks of intervention, after six weeks of intervention, and four weeksafter a two-week follow-up
قبل از شروع مداخله و هفته چهار
قبل از شروع مداخله، بعد از هفته سوم مداخله، بعد از هفته ششم مداخله و بعد از follow up دو هفته ای
قبل از شروع مداخله، بعد از هفته سوم مداخله، بعد از هفته ششم مداخله و بعد از follow up دو هفته چهارای
#2
Before the intervention(baseline) and four weeks
At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up
BeforeAt the intervention(baseline)baseline, after three weeks of intervention, after six weeks of intervention, and four weeksafter a two-week follow-up
قبل از شروع مداخله و هفته چهار
قبل از شروع مداخله، بعد از هفته سوم مداخله، بعد از هفته ششم مداخله و بعد از follow up دو هفته ای
قبل از شروع مداخله، بعد از هفته سوم مداخله، بعد از هفته ششم مداخله و بعد از follow up دو هفته چهارای
#3
Before the intervention(baseline) and four weeks
At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up
BeforeAt the intervention(baseline)baseline, after three weeks of intervention, after six weeks of intervention, and four weeksafter a two-week follow-up
قبل از شروع مداخله و هفته چهار
قبل از شروع مداخله، بعد از هفته سوم مداخله، بعد از هفته ششم مداخله و بعد از follow up دو هفته ای
قبل از شروع مداخله، بعد از هفته سوم مداخله، بعد از هفته ششم مداخله و بعد از follow up دو هفته چهارای
#4
Before the intervention(baseline) and four weeks
At the baseline, after six weeks of intervention
BeforeAt the intervention(baseline) and fourbaseline, after six weeks of intervention
قبل از شروع مداخله و هفته چهار
قبل از شروع مداخله و بعد از هفته ششم مداخله
قبل از شروع مداخله و بعد از هفته چهارششم مداخله
#5
Before the intervention(baseline) and four weeks
At the baseline, after six weeks of intervention
BeforeAt the intervention(baseline) and fourbaseline, after six weeks of intervention
قبل از شروع مداخله و هفته چهار
قبل از شروع مداخله و بعد از هفته ششم مداخله
قبل از شروع مداخله و بعد از هفته چهارششم مداخله
Secondary outcomes
#1
Before the intervention(baseline) and four weeks
At the baseline, after three weeks of intervention, after six weeks of intervention and after a two-week follow up period
BeforeAt the intervention(baseline)baseline, after three weeks of intervention, after six weeks of intervention and four weeksafter a two-week follow up period
قبل از شروع مداخله و هفته چهار
قبل از شروع مداخله و بعد از هفته سوم مداخله، بعد از هفته ششم مداخله و بعد از follow-p دو هفته ای
قبل از شروع مداخله و بعد از هفته چهارسوم مداخله، بعد از هفته ششم مداخله و بعد از follow-p دو هفته ای
Intervention groups
#1
Intervention group: The intervention group will receive the exercise therapy and the dry needling for four weeks. The exercise therapy consist of the stretching exercise of the plantar fascia; the soleus muscle; the gastrocnemius muscle and the big-toe flexor. The patients do the stretching exercise three times per day; any time ten repetitions; each taking 30 seconds; during four 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 four weeks.
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.
Intervention group: The intervention group will receive the exercise therapy and the dry needling for foursix 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 threetwo times per day; any time tenfifteen repetitions; each taking 30 seconds; during foursix 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 foursix weeks.
گروه مداخله: گروه مداخله تمرین درمانی و سوزن زدن خشک را به مدت 4 هفته دریافت می کنند. تمرین درمانی شامل تمرینات کششی فاشیای پلانتار؛ عضله سولئوس؛ گاستروکنمیوس و کشش عضله فلکسور شست می باشد.از بیماران خواسته می شود که هر کدام از تمرینات کششی را سه بار در روز و هر بار 10 تکرار و هر تکرار به مدت 30 ثانیه انجام دهند. سوزدن خشک طبق پروتکلmodified-delphi انجام خواهد شد و به این صورت می باشد که طبق این پروتکل ابتدا عضلاتی که مسئول اصلی درد بیمار هستند شامل عضلات سولئوس؛ کوادراتوس پلنتی؛ فلکسور دیجیتروم برویس و ابداکتور هالوسیس سوزن زده می شوند.گروه مداخله یک بار در هفته به مدت چهار هفته؛ درمان سوزن زدن خشک را دریافت خواهند کرد.
گروه مداخله: گروه مداخله تمرین درمانی و سوزن زدن خشک را به مدت 6هفته دریافت می کنند. تمرین درمانی شامل تمرینات کششی فاشیای پلانتار؛ عضله سولئوس؛ گاستروکنمیوسT کشش عضله فلکسور شست , کشش بر روی static wooden wedgeمی باشد.از بیماران خواسته می شود که هر کدام از تمرینات کششی را دو بار در روز و هر بار 15 تکرار و هر تکرار به مدت 30 ثانیه انجام دهند. سوزدن خشک طبق پروتکلmodified-delphi انجام خواهد شد و به این صورت می باشد که طبق این پروتکل ابتدا عضلاتی که مسئول اصلی درد بیمار هستند شامل عضلات سولئوس؛ کوادراتوس پلنتی؛ فلکسور دیجیتروم برویس و ابداکتور هالوسیس سوزن زده می شوند.گروه مداخله یک بار در هفته به مدت شش هفته؛ درمان سوزن زدن خشک را دریافت خواهند کرد.
گروه مداخله: گروه مداخله تمرین درمانی و سوزن زدن خشک را به مدت 4 هفته6هفته دریافت می کنند. تمرین درمانی شامل تمرینات کششی فاشیای پلانتار؛ عضله سولئوس؛ گاستروکنمیوس وگاستروکنمیوسT کشش عضله فلکسور شست می, کشش بر روی static wooden wedgeمی باشد.از بیماران خواسته می شود که هر کدام از تمرینات کششی را سهدو بار در روز و هر بار 1015 تکرار و هر تکرار به مدت 30 ثانیه انجام دهند. سوزدن خشک طبق پروتکلmodified-delphi انجام خواهد شد و به این صورت می باشد که طبق این پروتکل ابتدا عضلاتی که مسئول اصلی درد بیمار هستند شامل عضلات سولئوس؛ کوادراتوس پلنتی؛ فلکسور دیجیتروم برویس و ابداکتور هالوسیس سوزن زده می شوند.گروه مداخله یک بار در هفته به مدت چهارشش هفته؛ درمان سوزن زدن خشک را دریافت خواهند کرد.
#2
Control group: The control group will receive the exercise therapy for four weeks. The exercise therapy consist of the stretching exercise of the plantar fascia; the soleus muscle; the gastrocnemius muscle and the big-toe flexor. The patients do the stretching exercise three times per day; any time ten repetitions; each taking 30 seconds; during four weeks.
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.
Control group: The control group will receive the exercise therapy for foursix 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 threetwo times per day; any time tenfifteen repetitions; each taking 30 seconds; during foursix weeks.
گروه کنترل: گروه کنترل تمرین درمانی را به مدت 4 هفته دریافت می کنند. تمرین درمانی شامل تمرینات کششی فاشیای پلانتار؛ عضله سولئوس؛ گاستروکنمیوس و کشش عضله فلکسور شست می باشد.از بیماران خواسته می شود که هر کدام از تمرینات کششی را سه بار در روز و هر بار 10 تکرار و هر تکرار به مدت 30 ثانیه انجام دهند.
گروه کنترل: گروه کنترل تمرین درمانی را به مدت 6 هفته دریافت می کنند. تمرین درمانی شامل تمرینات کششی فاشیای پلانتار؛ عضله سولئوس؛ گاستروکنمیوس و کشش عضله فلکسور شست و کشش بر روی static wooden wedge می باشد.از بیماران خواسته می شود که هر کدام از تمرینات کششی را دو بار در روز و هر بار 15 تکرار و هر تکرار به مدت 30 ثانیه انجام دهند.
گروه کنترل: گروه کنترل تمرین درمانی را به مدت 46 هفته دریافت می کنند. تمرین درمانی شامل تمرینات کششی فاشیای پلانتار؛ عضله سولئوس؛ گاستروکنمیوس و کشش عضله فلکسور شست و کشش بر روی static wooden wedge می باشد.از بیماران خواسته می شود که هر کدام از تمرینات کششی را سهدو بار در روز و هر بار 1015 تکرار و هر تکرار به مدت 30 ثانیه انجام دهند.
Protocol summary
Study aim
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
Design
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.
Settings and conduct
Place of study: Musculoskeletal sonography laboratory of physiotherapy of Faculty of Rehabilitation of Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
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
Intervention groups
The intervention group: will receive exercise therapy and dry needling for four weeks.
The control group: will receive exercise therapy for four weeks.
Main outcome variables
Pain; quality of life; foot function; thickness of the plantar fascia; echogenicity of the plantar fascia
General information
Reason for update
to determine actual recruitment start date and actual recruitment end date
Acronym
IRCT registration information
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
Registration date
2018-09-14, 1397/06/23
Registrant information
Name
Saman Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 8468
Email address
salehis@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-07, 1397/06/16
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
2018-10-01, 1397/07/09
Actual recruitment end date
2020-03-01, 1398/12/11
Trial completion date
2020-03-01, 1398/12/11
Scientific title
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
Public title
The effectiveness of dry needling and exercise therapy vs. exercise therapy alone on foot function in patients with heel pain
Purpose
Treatment
Inclusion/Exclusion criteria
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
Ethics committee of Tehran University of Medical Science
Street address
Department of research and technology of Tehran University of Medical Sciences; Keshavarz Blvd; Ghods St
City
Tehran
Province
Tehran
Postal code
3439123900
Approval date
2018-05-25, 1397/03/04
Ethics committee reference number
IR.TUMS.VCR.REC.1397.231
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
At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up
Method of measurement
Visual analog scale
2
Description
Quality of life
Timepoint
At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up
Method of measurement
Short-form36(SF-36) questionnaire
3
Description
Foot function
Timepoint
At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up
Method of measurement
Foot and Ankle Ability Measure questionnaire (FAAM) and Foot and ankle outcome score (FAOS)
4
Description
Thickness of the plantar fascia
Timepoint
At the baseline, after six weeks of intervention
Method of measurement
Ultrasonography
5
Description
Echogenicity of the plantar fascia
Timepoint
At the baseline, after six weeks of intervention
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Foot range of motion
Timepoint
At the baseline, after three weeks of intervention, after six weeks of intervention and after a two-week follow up period
Method of measurement
Goniometer
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Saman Salehi
Street address
Hasan Abad Square; Imam Khomeini Ave
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
salehis@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraiyan
Street address
Department of research and technology of Tehran University of Medical Sciences; Keshavarz Blvd; Ghods St
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8163 3685
Email
salehis@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Saman Salehi
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation of Tehran University of Medical Science; Piche Shemiran; Enghelab street
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7752 8468
Email
salehis@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azade Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation of Tehran University of Medical Science; Piche Shemiran; Enghelab street
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7752 8468
Email
shadmehr@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saman Salehi
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Health Technology Assessment
Street address
School of rehabilitation of Tehran University of Medical Science; Piche Shemiran; Enghelab street
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7752 8468
Email
salehis@razi.tums.ac.ir
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The original data is shared in thesis format.
When the data will become available and for how long
After defense of thesis, the original data is shared in thesis format.
To whom data/document is available
Academic researchers, physiotherapists
Under which criteria data/document could be used
In order to use clinical results, the original data is shared in thesis format.
From where data/document is obtainable
Library of the faculty of rehabilitation of Tehran University of Medical Sciences
What processes are involved for a request to access data/document
Referral to library of the faculty of rehabilitation of Tehran University of Medical Sciences