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Therapeutic Exercise and Vegan Diet on Pain and Quality of Life

Primary Purpose

Chronic Idiopathic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vegan Diet
Therapeutic exercise
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Neck Pain

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Vegan diet

Therapeutic exercise

Control group

Arm Description

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®).

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. 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. While the patient is in the supine position, she performs passive lateral mobilization to the neck with the help of a physiotherapist. In the supine position, the patient performs isometric neck flexion, lateral flexion and rotation movements against the manual resistance given by the physiotherapist The patient lying on his back does isometric neck extension movement against gravity The patient performs isometric neck flexion, lateral flexion and rotation movements against the elastic band in the sitting position

Participants in this group will not receive any intervention.

Outcomes

Primary Outcome Measures

Body Mass Index
Body mass index will be calculated as weight/height2
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
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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2021
Last Updated
August 13, 2021
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT04923022
Brief Title
Therapeutic Exercise and Vegan Diet on Pain and Quality of Life
Official Title
The Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women With Chronic Idiopathic Neck Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
August 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KTO Karatay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vegan diet
Arm Type
Experimental
Arm Description
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®).
Arm Title
Therapeutic exercise
Arm Type
Experimental
Arm Description
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. 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. While the patient is in the supine position, she performs passive lateral mobilization to the neck with the help of a physiotherapist. In the supine position, the patient performs isometric neck flexion, lateral flexion and rotation movements against the manual resistance given by the physiotherapist The patient lying on his back does isometric neck extension movement against gravity The patient performs isometric neck flexion, lateral flexion and rotation movements against the elastic band in the sitting position
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in this group will not receive any intervention.
Intervention Type
Other
Intervention Name(s)
Vegan Diet
Intervention Description
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®).
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention Description
Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.
Primary Outcome Measure Information:
Title
Body Mass Index
Description
Body mass index will be calculated as weight/height2
Time Frame
1 minute
Title
Visual Analog Scale (VAS)
Description
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
Time Frame
2 minutes
Title
Neck Disability Index (NDI)
Description
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
Time Frame
10 minutes
Title
Short Form 36
Description
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.
Time Frame
15 minutes
Title
Tampa Scale of Kinesiophobia (TSK-17)
Description
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.
Time Frame
15 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
KTO Karatay University
City
Konya
State/Province
Karatay
Country
Turkey

12. IPD Sharing Statement

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