Therapeutic Exercise and Vegan Diet on Pain and Quality of Life

NCT04923022 | Completed

• 1 other identifier: 41901325-050.99
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Body Mass Index

  Body mass index will be calculated as weight/height2

  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

  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

  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.

  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.

  15 minutes

Study Arms (3)

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®).

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

Other: Therapeutic exercise

Control group

NO INTERVENTION

Participants in this group will not receive any intervention.

Interventions

Vegan Diet 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®).

Vegan diet

Therapeutic exercise OTHER

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

Therapeutic exercise

Eligibility Criteria

• Age: 18 Years - 25 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged 18-25,
• neck pain for at least 3 months,
• VAS score greater than 5

You may not qualify if:

• 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

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Diet, Vegan; Exercise Therapy

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 11, 2021
• Study Start: May 15, 2021
• Primary Completion: June 25, 2021
• Study Completion: August 11, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

TU (1)