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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05769179
Other study ID # 2023/03/03
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 30, 2023
Est. completion date March 30, 2024

Study information

Verified date March 2023
Source Ankara Yildirim Beyazit University
Contact Seyda Toprak Celenay
Phone +90312 906 1000
Email sydtoprak@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study was to compare the effects of different manual therapy approaches on pain, cervical range of motion, balance, functional status and life quality in patients with chronic neck pain.


Description:

Various physiotherapy and rehabilitation methods are applied in the treatment of patients with chronic neck pain. Clinical practice guidelines for individuals with chronic neck pain recommend both manual therapy and exercise therapy among conservative treatments. Manual therapy are methods that can be safely applied to soft tissues and joints. Both manual therapy and exercise applications have been shown to have positive effects on neck pain and function. Some studies in the literature have also shown that manual therapy methods have positive effects on balance. However, no study examining the effects of different manual therapy (classical massage, connective tissue massage, manual joint techniques) approaches applied to individuals with chronic neck pain on pain, cervical range of motion, balance, functional status and quality of life was found in the literature.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date March 30, 2024
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - To be between the ages of 18-65. - To participate in the study voluntarily. - Having a complaint of neck pain for at least 3 months. Exclusion Criteria: - To have undergone cervical spine surgery - Having cervical fracture and/or joint subluxation/dislocation - Severe degenerative arthritis - Having a neurological disease (Parkinson's disease, poliomyelitis, etc.) or an -inflammatory rheumatic disease (ankylosing spondylitis, rheumatoid arthritis, etc.) - Presence of malignancy - Having cord compression and signs - Severe radiculopathy or myelopathy - Positive vertebrobasilar artery test, - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Massage group
Massage group will be applied classic massage and cervical stabilisation exercises 3 days a week for 4 weeks
Connective tissue massage group
Connective tissue massage group will be applied connective tissue massage and cervical stabilisation exercises 3 days a week for 4 weeks
Mobilization group
Mobilization group will be applied cervical mobilization techniques and cervical stabilisation exercises 3 days a week for 4 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity Pain intensity will be assessed with the Visual Analogue Scale (a 100 mm long horizontal line). Patient will be asked to score the pain he/she feels out of 10. The beginning of the figure is "0 "no pain", ending in "10 "there is unbearable pain". change from baseline at 4 weeks
Secondary Pressure Pain Threshold Pressure Pain Threshold will be assessed with a digital algometer device. The device that objectively measures the pain threshold will be used for the evaluation. The probe of the device will be pressed on the trapezius muscle. The first pain threshold felt will be recorded. change from baseline at 4 weeks
Secondary Cervical Range of Motion Cervical range of motion will be evaluated with a goniometer in the sitting position. Neck flexion, extension, right-left lateral flexion and right-left rotation ranges of motion will be recorded change from baseline at 4 weeks
Secondary Balance Balance will be evaluated with the Biodex Balance System Device. The individual is placed on a platform of the device that evaluates the ability to keep the centre of gravity on the support surface. Changes in the centre of gravity of the individual standing on this platform will be recorded with this device in static and dynamic, with eyes open and closed. change from baseline at 4 weeks
Secondary Functional Status Functional Status will be assessed with Neck Disability Index. This index consists of 10 items. Each item was scored from 0 (no disability) to 5 (complete disability). The total score ranged from 0 (no disability) to 50 (total disability). As the score increased, disability increased and as the score decreased, disability decreased. change from baseline at 4 weeks
Secondary Life quality Life quality will be assessed with Short Form-36 questionnaire. The questionnaire consists of 36 items. Scoring is done over 100 points and the scores are between 0 and 100 points for each sub-parameter. "0" is calculated as the worst value and "100" as the best value. change from baseline at 4 weeks
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