Protocol summary

Study aim
This study aimed to determine the impact of placebo and placebo mentality on the effectiveness of dynamic tape on posture control, the electrical activity of selected muscles, and functional performance in athletes with chronic ankle instability.
Design
A clinical trial, crossover design, double-blind, randomized on 32 patients. A lottery is used for randomization.
Settings and conduct
The study will take place in the sports rehabilitation laboratory at Arak University. The participants will be athletes with chronic ankle instability. They will visit the laboratory on three separate days to perform tests under three different taping expectations.
Participants/Inclusion and exclusion criteria
The inclusion criteria: a history of ankle sprain two or more times; a sensation of fear and instability in ankle function; a score of 24 or lower on the Cumberland Ankle Instability Tool (CAIT ≤ 24); and confirmation of ankle functional instability; no history of using dynamic tape). The exclusion criteria include a history of previous surgery on the lower limb; a history of fracture or acute injury to the musculoskeletal structures or joints of the lower limb (such as sprains, fractures, etc.) within the three months prior to the study.
Intervention groups
We will conduct this study with one group under three different conditions, each with a different intervention: 1. The first intervention involves creating a positive expectation (placebo) about the dynamic tape. 2. The second intervention involves creating a negative expectation (nocebo) about the dynamic tape. 3. The third intervention involves creating a neutral expectation about the dynamic tape. 4. The fourth intervention: the measurement is performed in conditions without taping.
Main outcome variables
Posture control, the electrical activity of selected muscles, and functional performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200204046368N15
Registration date: 2024-06-11, 1403/03/22
Registration timing: prospective

Last update: 2024-06-11, 1403/03/22
Update count: 0
Registration date
2024-06-11, 1403/03/22
Registrant information
Name
Zahra Raeisi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3492
Email address
z_raisi13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-14, 1403/03/25
Expected recruitment end date
2024-08-15, 1403/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of placebo and nocebo in the effectiveness of dynamic tape on the postural control, electrical muscle activity of selected muscles, and the performance of athletes with chronic ankle instability
Public title
positive expectation, negative expectation and taping
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
A history of ankle sprain that requires medical treatment twice or more Feeling of fear and instability of ankle function Obtaining a score less than or equal to 24 from the Cumberland Questionnaire (CAIT≤24) Obtaining a score between -2 and +2 on a five-point Likert scale for individual mentality towards the influence of the taping
Exclusion criteria:
Having a history of previous surgery in the lower limbs Having a history of fractures and acute injuries of the musculoskeletal structure or joints of the lower limbs (such as sprains, fractures, etc.) in the three months leading up to the research led to the loss of at least one day of physical activity. History of using dynamic tape
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are required to visit the sports science laboratory at Arak University on three separate days. Evaluations will be conducted under three conditions: positive mental induction, negative mental induction, and neutral, over three different days (sessions). The lottery is used to determine which criteria will be used to evaluate the tests in each session. At the start of the first session, the subject selects one of three different conditions through a lottery, and the tests are carried out accordingly. In the second session, a draw is conducted between the two remaining conditions. Then, in the third session, the third condition is tested.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants are unaware of the intervention due to their positive, negative, and neutral mental expectations. Additionally, the collected data is provided to the analysts in code form, and they are unaware of the evaluated mentalities.
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University
Street address
Arak University, Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2024-01-31, 1402/11/11
Ethics committee reference number
IR.ARAKU.REC.1402.076

Health conditions studied

1

Description of health condition studied
Ankel instability
ICD-10 code
M25.373
ICD-10 code description
Other instability, unspecified ankle

Primary outcomes

1

Description
Electromyographic activity of muscle
Timepoint
With positive expectation from the dynamic tape, with negative expectation from the dynamic tape, with usual expectation from the dynamic tape
Method of measurement
Electromyography

2

Description
Postural control
Timepoint
With positive expectation from the dynamic tape, with negative expectation from the dynamic tape, with usual expectation from the dynamic tape
Method of measurement
Pedoscan

3

Description
Functional performance
Timepoint
With positive expectation from the dynamic tape, with negative expectation from the dynamic tape, with usual expectation from the dynamic tape
Method of measurement
Functional test

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this condition, dynamic type will be applied on the ankle. The test will be taken with the usual mentality of the person.
Category
Prevention

2

Description
Intervention group 1: In this condition, dynamic type is applied on the ankle and positive mental expectation is induced to the participants.
Category
Placebo

3

Description
Intervention group 2: In this condition, dynamic type is applied on the ankle and negative mental expectation is induced to the participants.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak university
Full name of responsible person
Zahra Raeisi
Street address
Shariati street
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3277 4031
Email
Z_raisi13@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak university
Full name of responsible person
Hamed Safikhani
Street address
Shariati street
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 2000
Email
d-research@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak university
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
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Basij Square, Arak University
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Basij Square, Arak University
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Basij Square, Arak University
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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