Chronic Idiopathic Neck PainNCT04923022
Therapeutic Exercise and Vegan Diet on Pain and Quality of Life
A study testing Vegan Diet and Therapeutic exercise in people with Chronic Idiopathic Neck Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
45 sedentary volunteer female individuals whose age range is between 18-25 years and diagnosed with chronic idiopathic neck pain by a specialist physical therapy doctor will participate in the study. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Idiopathic Neck Pain
- What is being tested?
- Vegan Diet and Therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2021to 11 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals aged 18-25,
- neck pain for at least 3 months,
- VAS score greater than 5
Who cannot join
- using regular analgesic,
- having had neck surgery,
- the presence of neurological or specific problems in the neck (vertebral fracture, inflammation, infection, etc.),
- cortisone use,
- pregnancy,
- serious chronic diseases,
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- those with serious psychiatric disorders
- Individuals who received physical therapy within 3 months
- Antidepressant use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women With Chronic Idiopathic Neck Pain.
45 sedentary volunteer female individuals whose age range is between 18-25 years and diagnosed with chronic idiopathic neck pain by a specialist physical therapy doctor will participate in the study. Participants will be randomly divided into three groups: vegan diet group (n=15), therapeutic exercise group (n=15) and control group (n=15). Participants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®). Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.The aim of this study is to compare the Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women with Chronic Idiopathic Neck Pain.
- Conditions
- Chronic Idiopathic Neck Pain
- Being tested
- Vegan Diet, Therapeutic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan DietOther
Participants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®).
Therapeutic exerciseOther
Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Vegan diet | Experimental | Participants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last for eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®). Receives: Other: Vegan Diet |
| Therapeutic exercise | Experimental | The participants in the therapeutic exercise group will perform the following therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.
1. The patient, sitting in the cervical spine neutral position, performs flexion, extension and rotation of the cervical spine, unloaded and in the maximum possible range of motion.
2. While the patient is in the supine position, she performs passive lateral mobilization to the neck with the help of a physiotherapist.
3. In the supine position, the patient performs isometric neck flexion, lateral flexion and rotation movements against the manual resistance given by the physiotherapist
4. The patient lying on his back does isometric neck extension movement against gravity
5. The patient performs isometric neck flexion, lateral flexion and rotation movements against the elastic band in the sitting position Receives: Other: Therapeutic exercise |
| Control group | No intervention | Participants in this group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Body mass index will be calculated as weight/height2
Measured: 1 minute
Visual Analog Scale (VAS)
Pain intensity was evaluated with the Visual Analogue Scale (VAS). The VAS consists of a 10 cm long horizontal line. 0 means "no pain " and 10 means "unbearable severe pain". Individuals marked the level of corresponding to pain they felt on the 10 cm line, and the values of the marked places were calculated with a 100-millimeter ruler
Measured: 2 minutes
Neck Disability Index (NDI)
This index consists of 10 parts and the each part of index has 6 different answers. In these 10 parts, there are answers about the severity of neck pain, personal care of the individual, lifting, reading, headache, concentration, work life, driving, sleep and leisure activities. It is scored as 0 (no pain and functional limitation) and 5 (the most severe pain and maximum limitation). In the NDI, 0-4 points were stated as no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability and 35 points above complete disability
Measured: 10 minutes
Short Form 36
this questionnaire consists of 36 questions covering eight domains of health and wellbeing corresponding subscales, whichare used to estimate a physical (PCS) and a mental com-ponent score (MCS).The sub-parameters of the test are physical function, physical role difficulty, emotional role difficulty, energy, mental health, social functionality, pain and general health perception. A minimum of 0 and a maximum of 100 points can be obtained from the test. A high scores from the test indicates well-being.
Measured: 15 minutes
Tampa Scale of Kinesiophobia (TSK-17)
The kinesiophobia was evaluated using the Tampa Scale of Kinesiophobia (TSK-17). The validity and reliability of the scale was performed by Yılmaz et al.
There is a 4-point likert scoring in the scale. The total score ranges between 17 and 68. A high value on the TSK-17 indicates a high degree of kinesiophobia and a cut-off score was developed by Vlaeyen et al., where a score of 37 or over is considered a high score.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start15 May 2021
- Primary completion25 Jun 2021
- Study completion11 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Savaş Torlak, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923022
- Sponsor's protocol ID
- 41901325-050.99
- Status last verified
- Aug 2021
- First submitted
- 2 Jun 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women With Chronic Idiopathic Neck Pain.
- ClinicalTrials.gov ID
- NCT04923022
- Acronym / sponsor ID
- 41901325-050.99
- Conditions
- Chronic Idiopathic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
45 sedentary volunteer female individuals whose age range is between 18-25 years and diagnosed with chronic idiopathic neck pain by a specialist physical therapy doctor will participate in the study. Participants will be randomly divided into three groups: vegan diet group (n=15), therapeutic exercise group (n=15) and control group (n=15). Participants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®). Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.The aim of this study is to compare the Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women with Chronic Idiopathic Neck Pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vegan diet | Experimental | Other: Vegan DietParticipants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last for eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®). |
| Therapeutic exercise | Experimental | Other: Therapeutic exerciseThe participants in the therapeutic exercise group will perform the following therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist. 1. The patient, sitting in the cervical spine neutral position, performs flexion, extension and rotation of the cervical spine, unloaded and in the maximum possible range of motion. 2. While the patient is in the supine position, she performs passive lateral mobilization to the neck with the help of a physiotherapist. 3. In the supine position, the patient performs isometric neck flexion, lateral flexion and rotation movements against the manual resistance given by the physiotherapist 4. The patient lying on his back does isometric neck extension movement against gravity 5. The patient performs isometric neck flexion, lateral flexion and rotation movements against the elastic band in the sitting position |
| Control group | No intervention | –Participants in this group will not receive any intervention. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals aged 18-25,
- neck pain for at least 3 months,
- VAS score greater than 5
Key exclusion criteria (9 listed)
- using regular analgesic,
- having had neck surgery,
- the presence of neurological or specific problems in the neck (vertebral fracture, inflammation, infection, etc.),
- cortisone use,
- pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegan DietParticipants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®). | Other | Vegan diet |
| Therapeutic exerciseIndividuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist. | Other | Therapeutic exercise |
Primary outcome
Body Mass Index
Time frame: 1 minute
Body mass index will be calculated as weight/height2
Visual Analog Scale (VAS)
Time frame: 2 minutes
Pain intensity was evaluated with the Visual Analogue Scale (VAS). The VAS consists of a 10 cm long horizontal line. 0 means "no pain " and 10 means "unbearable severe pain". Individuals marked the level of corresponding to pain they felt on the 10 cm line, and the values of the marked places were calculated with a 100-millimeter ruler
Neck Disability Index (NDI)
Time frame: 10 minutes
This index consists of 10 parts and the each part of index has 6 different answers. In these 10 parts, there are answers about the severity of neck pain, personal care of the individual, lifting, reading, headache, concentration, work life, driving, sleep and leisure activities. It is scored as 0 (no pain and functional limitation) and 5 (the most severe pain and maximum limitation). In the NDI, 0-4 points were stated as no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability and 35 points above complete disability
Short Form 36
Time frame: 15 minutes
this questionnaire consists of 36 questions covering eight domains of health and wellbeing corresponding subscales, whichare used to estimate a physical (PCS) and a mental com-ponent score (MCS).The sub-parameters of the test are physical function, physical role difficulty, emotional role difficulty, energy, mental health, social functionality, pain and general health perception. A minimum of 0 and a maximum of 100 points can be obtained from the test. A high scores from the test indicates well-being.
Tampa Scale of Kinesiophobia (TSK-17)
Time frame: 15 minutes
The kinesiophobia was evaluated using the Tampa Scale of Kinesiophobia (TSK-17). The validity and reliability of the scale was performed by Yılmaz et al. There is a 4-point likert scoring in the scale. The total score ranges between 17 and 68. A high value on the TSK-17 indicates a high degree of kinesiophobia and a cut-off score was developed by Vlaeyen et al., where a score of 37 or over is considered a high score.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegan Diet and Therapeutic exercise in people with Chronic Idiopathic Neck Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 1 minute). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.