IRCT | Evaluation the effect of exercise therapy and perineural electrical dry needling on the severity, frequency and disability of patients with cervicogenic headache: a randomized clinical trial.

Protocol summary

Study aim: Determination the effect of exercise therapy and perineural electrical dry needling on the severity, frequency and disability of patients with cervicogenic headache
Design: Clinical trial with control group, double-blind, randomized on 26 patients. The rand function of Excel software was used for randomization.
Settings and conduct: After obtaining informed consent, all participants will be randomly assigned to two intervention and control groups if they meet the inclusion criteria. This study is conducted in the sports medicine department of Sinai Hospital. The patients in both the control and intervention groups are not aware of the type of intervention that will be performed for them, and all the study steps for these two groups are conducted in separate sessions. the evaluator is also unaware of the intervention on the two groups.
Participants/Inclusion and exclusion criteria: The participants in this research include 26 patients with cervicogenic headache who, according to laboratory, clinical or imaging evidence, have evidence of a neck disorder causing headache, and if the patient is unable to complete the therapy and acupuncture exercise sessions or suffers an injury during the study or any disorder, will be removed from the study.
Intervention groups: The intended intervention consists of 8 sessions of 20-30 minutes of perineural electrical dry needling with a frequency of 50 Hz and home exercises during 6 weeks. Exercises are done 5 days a week, 3 times a day and at home. In the control group, exercises are prescribed.
Main outcome variables: Headache intensity; drugs used; duration of each headache attack; location of headache; Frequency and changes in headache characteristics are assessed. Also, the degree of disability; The headache impact test and the global rating of change score after acupuncture sessions and sports exercises.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20240315061292N1

Registration date: 2024-05-05, 1403/02/16

Registration timing: prospective

Last update: 2024-05-05, 1403/02/16

Update count: 0
Registration date: 2024-05-05, 1403/02/16

Registrant information: Name

Marzieh Mahmoudi Zarandi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 921 496 7615

Email address

m-mahmoudiz@razi.tums.ac.ir

Recruitment status: recruiting
Funding source

Expected recruitment start date: 2024-06-21, 1403/04/01
Expected recruitment end date: 2025-06-22, 1404/04/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluation the effect of exercise therapy and perineural electrical dry needling on the severity, frequency and disability of patients with cervicogenic headache: a randomized clinical trial.

Public title: Evaluation the effect of exercise therapy and perineural electrical dry needling on the severity, frequency and disability of patients with cervicogenic headache: a randomized clinical trial.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

The presence of laboratory, clinical and/or imaging evidence of a neck disorder, known to be able to cause headache. A headache that has at least 2 of the following 4 criteria: A) Headache in the temporal region that is related to the presence of neck disorders. B) Headache that improves in parallel with the improvement of the neck disorder. C) Cervical range of motion Is reduced and headache made worse by provocative manoeuvres. D) Headache is abolished following cervical diagnostic anaesthetic blockade. There is no other diagnosis for headache. Definitive diagnosis of cervicogenic headache by a neurologist based on HIS criteria. Absence of orthopedic disorders and diseases such as cervical discopathy that prevent exercises. The patient has not participated in a regular exercise program or physical therapy during the last 4 weeks. The patient has not been treated with corticosteroids (injection or oral) in the last 2 weeks.

Exclusion criteria:

The patient suffers an injury or any disorder during the study that prevents him or her from performing and continuing exercises and acupuncture. The patient is unable to complete acupuncture sessions. The patient's unwillingness to complete the exercise program and acupuncture sessions. Follow-up through the logbook has missed 30% of the exercises. A history of bleeding disorders or the use of anticoagulant drugs Suffering from psychiatric disorders
Age: No age limit
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Outcome assessor

Sample size

Target sample size: 26

Randomization (investigator's opinion)

Randomized

Randomization description

After meeting the inclusion criteria for entering the study, the patients will be randomly placed in one of two groups A or B using the block randomization method using a sealed envelope. Consecutive but equal times, they enter the intervention and control group.

Blinding (investigator's opinion)

Double blinded

Blinding description

In this study, the patients in both the control and intervention groups are not aware of the type of intervention that will be performed for them, and all study steps for these two groups are conducted in separate sessions. Also, the evaluator is not aware of the intervention on the two groups.

Placebo

Not used

Assignment

Factorial

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committee of Sina Hospital - Tehran University of Medical Sciences

Street address

Sports Medicine Department, Sina Hospital, Hassan Abad Square, Imam Khomeini Street

City

Tehran

Province

Tehran

Postal code

1136746911
Approval date: 2023-05-06, 1402/02/16
Ethics committee reference number: IR.TUMS.SINAHOSPITAL.REC.1402.018

Health conditions studied

1

Description of health condition studied: Cervicogenic headache
ICD-10 code: G44.8
ICD-10 code description: Headache associated with sexual activity

Primary outcomes

1

Description: Pain intensity based on the Numerical Pain Rating Scale (NPRS)
Timepoint: At the beginning of the study and after 6 weeks
Method of measurement: The Numerical Pain Rating Scale (NPRS)

Secondary outcomes

1

Description: Patient's disability
Timepoint: At the beginning of the study and after 6 weeks
Method of measurement: The Neck Disability Index (NDI)

2

Description: Pain intensity
Timepoint: At the beginning of the study and after 6 weeks
Method of measurement: Headache Impact Test (HIT-6): This test consists of 6 questions and shows the impact of headache on the patient's life. For each question, a score between 6 and 13 is considered.

3

Description: The Global Rating of Change Score (GROC)
Timepoint: At the beginning of the study and after 6 weeks
Method of measurement: This questionnaire measures the overall changes in recovery and can include values from negative 7 to positive 7.

Intervention groups

1

Description: Intervention group: The intended intervention consists of 8 sessions of 20-30 minutes of dry needling with perineural electrical stimulation with a frequency of 50 Hz and home exercises during 6 weeks. These exercises in both groups include neck and periscapular exercises. The exercises are performed 5 days a week, 3 times a day and at home. The patients are instructed to stop the exercises and inform the researcher if the symptoms worsen and the pain worsens more than 3.10 NPRS. In addition to the exercises, the intervention group is treated with dry needling with perineural electrical stimulation. Acupuncture is performed on the trigger points that are performed by the doctor during the initial examination. These points can be located in the occipital, paraspinal, periscapular and trapezius muscle areas. Acupuncture sessions are done 2 days a week with an at least one day between two sessions. After each session, the patient is asked about the regular exercise, and if necessary, retraining and correction of movements is done. All patients are trained about sports exercises in person, and in order to prevent forgetting and perform them correctly, exercises are presented to patients in the form of a logbook with pictures and explanations.
Category: Treatment - Other

2

Description: Control group: In the control group, exercises are prescribed. These exercises are performed at least 5 days a week, 3 times a day and at home. Patients in the control group are regularly followed up by phone once every two weeks, in order to motivate and check the performance of exercises. Explanations and pictures related to sports exercises are attached in the form of a training logbook.
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Sina Hospital

Full name of responsible person

Marzieh Mahmoudi Zarandi

Street address

Sports Medicine Department, Sina Hospital, Hassan Abad Square, Imam Khomeini Street

City

Tehran

Province

Tehran

Postal code

1136746911

Phone

+98 21 6634 8500

Email

m.m.z.of۷sky@gmail.com

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Ali Akbari Sari

Street address

Research and Technology Vice-Chancellor, 6th floor, Central Organization of the University, corner of Quds St., Keshavarz Blvd

City

Tehran

Province

Tehran

Postal code

1417653761

Phone

+98 21 8163 3685

Email

vcr@sina.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

Marzieh Mahmoudi Zarandi

Position

resident

Latest degree

Medical doctor

Other areas of specialty/work

Sport Medicine

Street address

Sports Medicine Department, Sina Hospital, Hassan Abad Square, Imam Khomeini Street

City

Tehran

Province

Tehran

Postal code

1136746911

Phone

+98 21 6634 8500

Email

m-mahmoudiz@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Maryam Abolhasani

Position

Associate Professor

Latest degree

Specialist

Other areas of specialty/work

Sport Medicine

Street address

Sports Medicine Department, Sina Hospital, Hassan Abad Square, Imam Khomeini Street

City

Tehran

Province

Tehran

Postal code

1136746911

Phone

+98 21 6634 8500

Email

dr_m_abolhasani@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Marzieh Mahmoudi Zarandi

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

Sport Medicine

Street address

Sports Medicine Department, Sina Hospital, Hassan Abad Square, Imam Khomeini Street

City

Tehran

Province

Tehran

Postal code

1136746911

Phone

+98 921 496 7615

Fax

Email

m-mahmoudiz@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: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long: The access period starts 3 months after the results are published.
To whom data/document is available: The data will be available to researchers working in academic and scientific institutions or people who are also engaged in industry and can apply to receive them.
Under which criteria data/document could be used: The use of data for other scientific researches is permitted by mentioning the source.
From where data/document is obtainable: m.m.z.of7sky@gmail.com
What processes are involved for a request to access data/document: At first, the researcher sends an e-mail stating the request to the mentioned e-mail address, and then after a maximum of 1 month, the investigation is done and the documents are sent to the e-mail address of the researcher.
Comments

Evaluation the effect of exercise therapy and perineural electrical dry needling on the severity, frequency and disability of patients with cervicogenic headache: a randomized clinical trial.