- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07489014
The Effects of Mulligan Joint Mobilization and Instrument-Assisted Soft Tissue Mobilization in Individuals With Neck Pain
Comparison of the Effects of Mulligan Joint Mobilization and Instrument-Assisted Soft Tissue Mobilization on Pain Intensity, Cervical Awareness, and Functionality in Individuals With Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Istanbul Rumeli University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Volunteering to participate in the study
- Being between 18 and 65 years of age
- Having experienced mechanical neck pain for at least 3 months
- Not having any contraindications for manual therapy
Exclusion Criteria:
Receiving a diagnosis of a psychiatric illness
- Having a history of spinal surgery
- Having other musculoskeletal problems that may affect the cervical region (such as scoliosis, shoulder pathologies, thoracic outlet syndrome)
- Having received physiotherapy for neck and back problems within the last year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Mulligan
In line with the Mulligan Concept, natural apophyseal gliding (NAGs) and sustained natural apophyseal gliding (SNAGs) techniques will be applied.
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The treatments will administered 3 days a week for a total of 12 sessions over 4 weeks.
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Active Comparator: Instrumental Soft Tissue Mobilization
In the Instrumental Soft Tissue Mobilization (ITSM) group, participants will undergo bilateral procedures on the upper and middle trapezius muscles, levator scapulae, sternocleidomastoid (SCM), anterior, medius and posterior scalene muscle groups, erector spine, and suboccipital muscles.
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The treatments will administered 3 days a week for a total of 12 sessions over 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Intensity
Time Frame: Baseline and at the end of treatment (week 4)
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Visual Pain Scale.Participants' pain intensity will be assessed using the Visual Analog Scale (VAS).
The Visual Analog Scale is a validated and reliable scale that quantitatively determines the intensity of pain perceived by an individual.
The scale consists of a 10 cm long horizontal or vertical line, with one end of the line defined as "0 = no pain" and the other end as "10 = unbearable pain".
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Baseline and at the end of treatment (week 4)
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Range of motion
Time Frame: Baseline and at the end of treatment (week 4)
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To assess the active range of motion of the cervical joint, the tape measure method described by Hsieh et al. (1986) was used.
This method is reported to be a practical and reliable measurement tool for assessing cervical range of motion in clinical practice.
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Baseline and at the end of treatment (week 4)
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Cervical awareness
Time Frame: Baseline and at the end of treatment (week 4)
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Fremantle Neck Awareness Questionnaire
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Baseline and at the end of treatment (week 4)
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Copenhagen Neck Functional Disability Scale
Time Frame: Baseline and at the end of treatment (week 4)
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Neck Functional Disability is a 15-item questionnaire.
Total score(0-30) indicate higher disability
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Baseline and at the end of treatment (week 4)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Neck flexor endurance
Time Frame: Baseline and at the end of treatment (week 4)
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The test protocol is performed with the individual in a supine position, with knees bent and soles of feet touching the ground (hook position). Individuals are asked to comfortably position their hands on their abdominal area. During the procedure, the physiotherapist places their index and middle fingers overlapping under the participant's head. Participants are first instructed to pull their chin inward and downward (chin-tuck) and, while maintaining this position, to perform active craniocervical flexion, raising their head approximately 2.5 cm above the physiotherapist's fingers. The maximum time participants canmaintain this position without breaking it was recorded in seconds using a stopwatch. |
Baseline and at the end of treatment (week 4)
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SF-36 Quality of life
Time Frame: Baseline and at the end of treatment (week 4)
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The SF-36 does not have a total scoring system; assessment is based on eight sub-dimensions: physical function, physical role difficulty, emotional role difficulty, social function, mental health, energy (vitality), pain, and general health perception.
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Baseline and at the end of treatment (week 4)
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Depression Scale
Time Frame: Baseline and at the end of treatment (week 4)
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Beck Depression Scale is a psychological status-based scale consisting of 21 items developed to assess an individual's recent emotional state.
Each item on the scale is scored between 0 and 3, and the level of depression is determined based on the total score obtained.
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Baseline and at the end of treatment (week 4)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulRumeliU-FTR-ENS-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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