Therapeutic Exercise and Vegan Diet on Pain and Quality of Life

NCT ID: NCT04923022

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2021-08-11

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.

Conditions

Chronic Idiopathic Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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®).

Group Type: EXPERIMENTAL

Vegan Diet

Intervention Type: OTHER

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 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.

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

Group Type: EXPERIMENTAL

Therapeutic exercise

Intervention Type: OTHER

Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.

Control group

Participants in this group will not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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

Therapeutic exercise

Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

KTO Karatay University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Savaş Torlak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

41901325-050.99

Identifier Type: -

Identifier Source: org_study_id