The purpose of this research is to investigate the effect of six weeks of stretching exercise and release of the myofascia of the gastrocnemius muscle and plantar fascia on pain intensity, range of motion and functional disability of the neck in people with non-specific chronic neck pain.
Design
Randomized trial with two parallel groups of 16 people without blinding
Settings and conduct
First, the call to participate in the research was made, then the people were examined by a doctor and divided into two random groups, then the interventions were carried out virtually (at the person's home) under the supervision of the researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Men and women between 30 and 40 years old
Absence of any fracture, dislocation and disc herniation in the neck area
Absence of any chronic pain in other parts of the body such as back, knee
Lack of invasive and minimally invasive treatments such as discotomy and fusion, laser and injections
Not getting migraines and the resulting headaches, and then not using migraine medications
No use of psychoactive drugs
Having non-specific chronic neck pain for more than 3 months
Willingness to participate in research and sign informed consent
Having a pain intensity of more than 4 on the visual analog scale
Exclusion criteria :
People who had acute pain for less than 3 months
People who had a history of surgery
People who for any reason were not able to attend training sessions on time
Intervention groups
intervention group:
Perform an exercise protocol that releases the individual's fascia along with selective stretching exercises
control group:
No practice
Main outcome variables
Range of motion and neck pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200209046422N2
Registration date:2024-07-03, 1403/04/13
Registration timing:retrospective
Last update:2024-07-03, 1403/04/13
Update count:0
Registration date
2024-07-03, 1403/04/13
Registrant information
Name
َAmirhossein Barati
Name of organization / entity
Shahid beheshti
Country
Iran (Islamic Republic of)
Phone
+98 21 2248 3343
Email address
ah_barati@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
2022-02-20, 1400/12/01
Actual recruitment end date
2022-07-23, 1401/05/01
Trial completion date
2023-06-22, 1402/04/01
Scientific title
The effect of six weeks of stretching exercise with self-myofascial release of gastrocnemius and plantar fascia on non-specific chronic neck pain
Public title
The effect of six weeks of stretching exercise with self-myofascial release of gastrocnemius and plantar fascia on non-specific chronic neck pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
- Men and women between 30 and 40 years old
- Absence of any fracture, dislocation and disc herniation in the neck area
Absence of any chronic pain in other parts of the body such as back, knee
Absence of invasive and minimally invasive treatments such as discotomy and fusion, laser and injections
Not taking neuropsychiatric drugs
Not getting migraines and headaches caused by it, and then not using migraine medicines
Having non-specific chronic neck pain for more than 3 months
Having a pain intensity of more than 4 on the visual analog scale
Willingness to participate in the research and sign the informed consent
Exclusion criteria:
People who had acute pain for less than 3 months
People who had a history of surgery
People who for any reason were not able to attend training sessions on time
Age
From 30 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying the people to participate in the research, a simple randomization method was used. In such a way that the selection of participants was completely based on chance and probability and every participant had the same chance to enter the sample. The main factor for us was that each participant had an equal chance of being placed in each group. Then, with the lottery method, the names of the people were written on paper and placed in a container, and someone other than the researchers randomly picked the names, and the names that were the first to leave the intervention group and the rest of the control group. In the randomization process, the researchers had no involvement and this work was done by an uninformed person.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of institute of Physical Education
The range of motion of the neck in the sagittal plane including neck flexion and extension
Timepoint
First, the range of motion of the neck was measured before exercises and interventions, and then it was measured again after 6 weeks of exercise.
Method of measurement
First, the subjects were asked to sit comfortably on a chair without a back so that the soles of the feet are on the floor and the palms are on the legs. How to correctly perform flexion (moving the neck forward) and extension (opening the neck backward) was explained to the subject, and after the examiner was placed next to the subject and adopted a suitable position for his head (a position in which the hypothetical line between the base of the nostrils and the soft ear is parallel to the ground), the range of motion of the subjects' necks in the sagittal plane was measured and recorded by the examiner using a goniometer. For this purpose, the axis of the goniometer was placed on the soft part of the ear and one of the arms of the goniometer, which was considered as a fixed arm, was placed perpendicular to the ground, and the other arm of the goniometer, which was a movable arm, was placed on the base of the nose, and then the degree of bending The stretching and opening of the subject's neck was accurately measured and recorded
2
Description
Pain measurement
Timepoint
Just before the interventions and 6 weeks after the interventions
Method of measurement
The neck pain severity questionnaire (VAS) was provided to the subjects and they were asked to complete these questionnaires according to their problem with the utmost accuracy and honesty and then provide them to the examiner.
3
Description
The level of functional disability of people with non-specific chronic neck pain
Timepoint
Just before the interventions and 6 weeks after the interventions
Method of measurement
The central outcome measure index questionnaire in patients with chronic neck pain (COMI-Neck) was given to the subjects and they were asked to complete these questionnaires according to their problem with utmost accuracy and honesty and then given to the examiner.
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: included a 45-minute exercise program, first the person performed warm-up exercises for 10 minutes, then specialized exercises that included releasing the muscles of the back of the leg and plantar fascia using a massage ball and foam roller, as well as The static stretching of this muscle group with the help of a band was in a sitting position for 30 minutes, finally cooling down which lasted for 5 minutes.
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
We intend to present the results of this study in the form of an article with a description of entry and exit criteria, how it works and variables, statistics and general results.
When the data will become available and for how long
1year
To whom data/document is available
Researchers and journals if needed
Under which criteria data/document could be used
In magazines if needed
From where data/document is obtainable
Shahid Beheshti University/ Amir Hossien Barati
What processes are involved for a request to access data/document