The Effect of Muscular Endurance on Disability Level and Participation in Life
Primary Purpose
Neck Pain
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
Sponsored by

About this trial
This is an interventional treatment trial for Neck Pain focused on measuring non specific neck pain, endurance, disability, participation, pain
Eligibility Criteria
Inclusion Criteria:
- Voluntary consent to participate in the study
- Clinical diagnosis of non spesific neck pain
Exclusion Criteria:
- There is physical/mental problem that may prevent exercise
Sites / Locations
- Suleyman Demirel University Education and Training HospitalRecruiting
- Suleyman Demirel UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
exercise
routine
Arm Description
In addition to routine treatment: Postural evenness Chin tuck exercise Range of motion exercises for all angles of the cervical joint Neck isometric exercises Cervical stabilization exercises (with ball) Stretching exercises of pectoralis, latissimus dorsi, trapezius upper part, levator scapula, rhomboid and scalene muscles
only routine treatment
Outcomes
Primary Outcome Measures
KEELE ASSESMENT OF PARTICIPATION
participation in life: 15 items total; min:0; max:11; 1-11:participation restriction in at least
one activity. Mobility; Self-Care; Domestic Life; Interpersonal Interactions and Relationships; Major Life Areas; Community Social & Civic life
Mean response for each question was reported, with a lower score indicating better perceived participation; question scores range from 1 to 5
Northwick Park Neck Pain Questionnaire
the neck pain and the consequent patient disabilities: The neck pain score is the sum of the points scored for the first nine questions.
Question 9 (about the driving) is not applicable if the patient doesn't drive a car in good health.
• If the nine questions are answered: NPQ percentage = ((neck pain score) / 36) x 100%.
• If the first eight questions are answered: NPQ percentage = ((neck pain score) / 32) x 100%. The higher the percentage, the greater the disability and the pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05259358
Brief Title
The Effect of Muscular Endurance on Disability Level and Participation in Life
Official Title
The Effect of Muscular Endurance on Disability Level and Participation in Life in Non-specific Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
September 20, 2022 (Anticipated)
Study Completion Date
December 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Non-specific neck pain (NSBA), which is one of the most common causes of neck pain in the literature, occurs as a result of a postural or mechanical cause without a specific pathology or injury to the musculoskeletal system. NSBA causes an increase in superficial cervical muscle activity, and a decrease in deep cervical muscle activity, which contains a large amount of muscle spindles. Patients with chronic neck pain face functional limitations in many ways. Evaluation of disability as a result of loss of functions related to neck pain is necessary to cope with neck pain. In the ICF activity and participation section due to neck pain, it is stated that the daily life activities of the person are limited due to neck pain, both at work and at home, and with this, the level of disability of the person increases. Loss of endurance, on the other hand, appears as a physical marker in the development of chronic neck pain due to the effect of muscle functions in patients who have problems in the neck region, according to ICF.
Detailed Description
Patients with non-specific neck pain who volunteered to participate in the study and who met the inclusion criteria of the study will be included in the study after signing the voluntary consent form. First of all, the demographic and clinical characteristics of the patients will be questioned with the evaluation form. The personal information of the patients (gender, height, weight, smoking, etc.) and clinical status (pain type, pain intensity, muscle endurance measurements) will be recorded by the physiotherapist in the evaluation form. In addition to the evaluation form, the Northwick Park Neck Pain Questionnaire will evaluate the patients' neck disability, while the Keele Participation Evaluation will evaluate their level of participation in life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
non specific neck pain, endurance, disability, participation, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients included in the treatment group had 10 sessions postural smoothness, Chin tuck exercises, Range of motion exercises at all angles of the cervical joint, Neck isometric exercises, Cervical stabilization exercises (with ball), Pectoralis, latissimus dorsi, trapezoidal upper part, rhomboid and scalene muscle stretching exercises will be done face-to-face with a physiotherapist. At the end of 10 sessions of face-to-face training, the patients will perform the same exercises at home for 1 month. The patients will not given any exercises in the control group. Measurements and evaluations of the patients in both groups will be made twice that is before and after the treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise
Arm Type
Active Comparator
Arm Description
In addition to routine treatment:
Postural evenness
Chin tuck exercise
Range of motion exercises for all angles of the cervical joint
Neck isometric exercises
Cervical stabilization exercises (with ball)
Stretching exercises of pectoralis, latissimus dorsi, trapezius upper part, levator scapula, rhomboid and scalene muscles
Arm Title
routine
Arm Type
No Intervention
Arm Description
only routine treatment
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
exercises that increase muscular endurance
Primary Outcome Measure Information:
Title
KEELE ASSESMENT OF PARTICIPATION
Description
participation in life: 15 items total; min:0; max:11; 1-11:participation restriction in at least
one activity. Mobility; Self-Care; Domestic Life; Interpersonal Interactions and Relationships; Major Life Areas; Community Social & Civic life
Mean response for each question was reported, with a lower score indicating better perceived participation; question scores range from 1 to 5
Time Frame
change in participation in life in one month
Title
Northwick Park Neck Pain Questionnaire
Description
the neck pain and the consequent patient disabilities: The neck pain score is the sum of the points scored for the first nine questions.
Question 9 (about the driving) is not applicable if the patient doesn't drive a car in good health.
• If the nine questions are answered: NPQ percentage = ((neck pain score) / 36) x 100%.
• If the first eight questions are answered: NPQ percentage = ((neck pain score) / 32) x 100%. The higher the percentage, the greater the disability and the pain.
Time Frame
change in disability level in one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntary consent to participate in the study
Clinical diagnosis of non spesific neck pain
Exclusion Criteria:
There is physical/mental problem that may prevent exercise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burcu Ozuberk, Asist Prof
Phone
0 (288) 214 54 13
Ext
1215
Email
burcuozuberk@klu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mine A Deniz, PT, PhD
Organizational Affiliation
Suleyman Demirel University
Official's Role
Study Director
Facility Information:
Facility Name
Suleyman Demirel University Education and Training Hospital
City
Isparta
State/Province
East Campus
ZIP/Postal Code
32260
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mine A Deniz, PT, PhD
Phone
02462112000
Ext
2145
Email
minedeniz@sdu.edu.tr
Facility Name
Suleyman Demirel University
City
Isparta
State/Province
East Campus
ZIP/Postal Code
32260
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mine A Deniz
Phone
02462112000
Email
minedeniz@sdu.edu.tr
12. IPD Sharing Statement
Learn more about this trial
The Effect of Muscular Endurance on Disability Level and Participation in Life
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