- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04923022
Therapeutic Exercise and Vegan Diet on Pain and Quality of Life
The Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women With Chronic Idiopathic Neck Pain.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karatay
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Konya, Karatay, Turkey
- KTO Karatay University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals aged 18-25,
- neck pain for at least 3 months,
- VAS score greater than 5
Exclusion Criteria:
- 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,
- those with serious psychiatric disorders
- Individuals who received physical therapy within 3 months
- Antidepressant use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Vegan diet
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®).
|
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®).
|
EXPERIMENTAL: Therapeutic exercise
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.
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Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.
|
NO_INTERVENTION: Control group
Participants in this group will not receive any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: 1 minute
|
Body mass index will be calculated as weight/height2
|
1 minute
|
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
|
2 minutes
|
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
|
10 minutes
|
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.
|
15 minutes
|
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. |
15 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41901325-050.99
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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