Comparison of the Efficiency of Manual Therapy and Exercise in People With Mechanical Neck Pain
1 other identifier
interventional
60
1 country
1
Brief Summary
Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology underlying the complaints. Most of the MNP cases are due to muscular or paraspinal soft tissue problems and show improvement in the first 6 weeks with conservative treatment methods. Various manual therapy techniques and various exercises are reported to have positive effects on neck pain. However, the isolated effects of these techniques in people with MNP are not fully known. Therefore, the aim of this study is to determine the effects of two different treatment programs in which the manual therapy technique and the exercise program are applied in individuals with MNP. In addition, comparing the effect of the treatment program in which manual therapy and exercise program are applied together with the isolated effects of these techniques is another aim.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2021
CompletedFirst Posted
Study publicly available on registry
December 13, 2021
CompletedStudy Start
First participant enrolled
December 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2022
CompletedMay 26, 2023
May 1, 2023
4 months
November 13, 2021
May 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neck Disability Index
The neck function of the patients will be evaluated with the Neck Disability Index. The disability levels of the participants due to neck pain will be evaluated with the 'Neck Disability Index' . This scale consists of 10 items including pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleep status and leisure activities. Each item was scored from 0 (no disability) to 5 (complete disability).
6 weeks
Pain intensity
Pain intensity of the patients at rest, during activity and at night was assessed using the Visual Analog Scale (VAS). In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.
6 weeks
Secondary Outcomes (4)
Range of Motion (ROM)
6 weeks
Pain Pressure Threshold (PPT)
6 weeks l
36-Item Short Form Survey (SF-36)
6 weeks
Patient satisfaction level
At the end of 6-weeks
Study Arms (3)
Exercise Group
EXPERIMENTALExercise Program only
Manual Therapy Group
ACTIVE COMPARATORManual Therapy only
Manual Therapy and Exercise Group
ACTIVE COMPARATORManual Therapy + exercise program
Interventions
Manual Therapy: High velocity-low amplitude technique
Eligibility Criteria
You may qualify if:
- Diagnosed with MNP
- Decrease in cervical region ROM
- Ability to adapt to verbal, written and visual instructions
You may not qualify if:
- Spine surgery history
- Neurological neck pain in the cervical region
- Presence of tumor in the cervical region
- Blood coagulation disorders
- Vertebrobasilar artery insufficiency
- Cervical region trauma history
- Communicative/mental problems that prevent participation in treatment
- Inflammatory rheumatological diseases affecting the cervical region
- Physiotherapy and rehabilitation treatments for neck pain in the last 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tuğba Akgüllerlead
Study Sites (1)
Istanbul University-Cerrahpasa
Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yıldız Analay Akbaba, PhD
Istabul University-Cerrahpasa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
November 13, 2021
First Posted
December 13, 2021
Study Start
December 13, 2021
Primary Completion
April 19, 2022
Study Completion
April 19, 2022
Last Updated
May 26, 2023
Record last verified: 2023-05