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Evaluation of the effect of progressive neuromuscular training alone and combined with trigger point dry needling of peroneal muscles on functional status, postural control, and muscular activity of the lower extremity during jump-landing task in athletes with chronic ankle Instability

Protocol summary

Study aim
Evaluation of the effect of exercise therapy alone and combined with trigger point dry needling of peroneal muscles on muscular activity of the lower extremity during jump-landing task in athletes with chronic ankle Instability.
Design
Randomized, parallel group, placebo controlled trial, on 60 patients. Blocked randomization is used.
Settings and conduct
Control group: Subjects will complete progressive neuromuscular exercise, 2 sessions per week for 6 sequential weeks. Intervention group 1: The subjects will complete the same exercise program as control group.Moreover they will receive dry needling of peroneus longus and peroneus brevis trigger points, 1 session per week for 6 weeks. Intervention group 2: The subjects will complete the same exercise program as control group.Moreover they will receive placebo dry needling of peroneus longus and peroneus brevis trigger points, 1 session per week for 6 weeks.
Participants/Inclusion and exclusion criteria
Regular sport activity in soccer, volleyball or basketball, at least 3 sessions per week, each lasting at least 2 hours. Existing ankle instability according to Cumberland Ankle Instability Tools (CAIT). Clinical presentation of trigger points in peroneal muscles.
Intervention groups
Intervention group 1: exercise therapy plus dry needling Intervention group 2: exercise therapy plus placebo dry needling control group: exercise therapy alone.
Main outcome variables
Amplitude of electromyographic activity of peroneus longus, peroneus brevis, soleus, vastus medialis, gluteus medius, tibialis anterior. Onset time of peroneus longus, peroneus brevis, soleus, vastus medialis, gluteus medius, tibialis anterior.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220408054452N1
Registration date: 2022-05-23, 1401/03/02
Registration timing: prospective

Last update: 2022-05-23, 1401/03/02
Update count: 0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Parsa Salemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1721
Email address
parsa_salemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of progressive neuromuscular training alone and combined with trigger point dry needling of peroneal muscles on functional status, postural control, and muscular activity of the lower extremity during jump-landing task in athletes with chronic ankle Instability
Public title
The effect of dry needling on chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Regular sport activity in soccer, volleyball or basketball, at least 3 sessions per week, each lasting at least 2 hours A history of repeated ankle sprains along with inflammatory symptoms Existing ankle instability according to Cumberland Ankle Instability Tools (CAIT) Clinical presentation of trigger points in peroneal muscles
Exclusion criteria:
A history of musculoskeletal injury in other lower extremity joints within last 3 months leading to at least on day loss of regular activity. A history of the immune system or blood coagulation disorders, vestibular dysfunction, neurological or neurovascular conditions, or convulsion Acute inflammatory symptoms in ankle region
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly allocated to three experimental groups using blocked randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid A'rabi St, Yaman St, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.991

Health conditions studied

1

Description of health condition studied
Chronic Ankle Instability
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle

Primary outcomes

1

Description
Onset time of peroneus longus, peroneus brevis, soleus, vastus medialis, gluteus medius, tibialis anterior
Timepoint
1- Before intervention 2- Immediately after the 1st session of intervention 3- After the last session of intervention 4- Three months after the end of the last session of intervention
Method of measurement
Surface electromyography device (time difference between initial foot-ground contact and onset of electromyographic activity of each muscle)

2

Description
Amplitude of electromyographic activity of peroneus longus, peroneus brevis, soleus, vastus medialis, gluteus medius, tibialis anterior
Timepoint
1- Before intervention 2- Immediately after the 1st session of intervention 3- After the last session of intervention 4- Three months after the end of the last session of intervention
Method of measurement
Surface electromyography device (average amplitude of muscular activity 200 milliseconds before - 200 milliseconds after initial foot-ground contact)

Secondary outcomes

1

Description
Functional status scores
Timepoint
1- Before intervention, 2- After the last intervention session, 3- Three months after the last intervention session
Method of measurement
1- Foot and Ankle Ability Measure (FAAM), 2- Cumberland's Ankle instability index

2

Description
Dynamic postural stability
Timepoint
1- Before intervention, 2- After the last intervention session, 3- Three months after the last intervention session
Method of measurement
Scores of the Star Excursion Balance Test (SEBT)

3

Description
Time of figure of 8 hop test
Timepoint
1- Before intervention, 2- After the last intervention session, 3- Three months after the last intervention session
Method of measurement
Measurement of time for completing figure of 8 hop test

4

Description
Distance in triple hop test
Timepoint
1- Before intervention, 2- After the last intervention session, 3- Three months after the last intervention session
Method of measurement
Measuring distance in triple hop test

5

Description
Static postural control
Timepoint
1- Before intervention, 2- After the last intervention session, 3- Three months after the last intervention session
Method of measurement
Measuring stability indices in Biodex balance test

Intervention groups

1

Description
Intervention group: (1st intervention) subjects will complete progressive neuromuscular exercise, 2 sessions per week for 6 sequential weeks. Each session will last about 30 minutes. The subjects will also receive dry needling of peroneus longus and peroneus brevis trigger points, 1 session per week for 6 weeks.
Category
Rehabilitation

2

Description
Intervention group: (2nd intervention) subjects will complete progressive neuromuscular exercise, 2 sessions per week for 6 sequential weeks. Each session will last about 30 minutes. The subjects will also receive placebo dry needling of peroneus longus and peroneus brevis trigger points, 1 session per week for 6 weeks, while all stages of intervention is similar to real dry needling sessions.
Category
Rehabilitation

3

Description
Control group: Subjects will complete progressive neuromuscular exercise, 2 sessions per week for 6 sequential weeks. Each session will last about 30 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic of faculty of rehabilitation of Shahid Beheshti university of medical sicences
Full name of responsible person
Mohsen Rustaei
Street address
Rehabilitation faculty of Shahid Beheshti university of Medical Sciences, opposit to Bu'ali hospital, Damavand St
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
tavan2020@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Research and technology assistance, Shahid Beheshti university of medical sciences, Yaman St, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Hoseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty of Shahid Beheshti university of medical sciences, Damavand St
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
majid_hoseini@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Hoseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty of Shahid Beheshti university of medical sciences, Damavand St
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
majid_hoseini@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Hoseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty of Shahid Beheshti university of medical sciences, Damavand St
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
majid_hoseini@sbmu.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
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