- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05074576
The Effect of Mulligan Mobilization Technique (TheEffect)
The Effect of Mulligan Mobilization Technique Application in Addition to Classical Therapies on Pain and Joint Range of Motion People With Neck Pain
Study Overview
Status
Intervention / Treatment
Detailed Description
The study is designed as a single-center, parallel-group, randomized controlled clinical trial in Istanbul Medipol university hospital.
The study will be conducted on 40 volunteers with mechanical neck pain. The patients were randomized into two groups. Groups were determined by randomization method with closed box. A random paper was drawn for the participants included in the study.
Inclusion criterias are being between age of 25-65 years, having neck pain for at least 2 weeks, participants that were diagnosed with MNP by a doctor, having no contraindicated condition for manual treatment. Exclusion criterias were surgical indications and/ or surgery history for cervical region, history of trauma to the cervical region and those with systemic disease, participation of physical therapy and rehabilitation program in the last one year, fibromyalgia, presence of cardiac pacemaker, intra-articular steroid injection in neck joint in the last three months.
In the intervention; Mulligan mobilization technique, electroterapy and active range of motion and stretching exercises carried out in Mulligan group while only electrotherapy agents and exercises are applied as a classical treatment to the control group. Goniometer for the range of motion of the neck (ROM), Visual Analogue Scale (VAS), Neck Pain And Disability Scale (NPDS), Short Form Health Survey (SF-36) will be used for evaluation.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beykoz
-
Istanbul, Beykoz, Turkey, 34820
- Ozge Ozlu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being between age of 25-65 years,
- having neck pain for at least 2 weeks,
- participants that were diagnosed with MNP by a doctor,
- having no contraindicated condition for manual treatment.
Exclusion Criteria:
- surgical indications and/ or surgery history for cervical region,
- history of trauma to the cervical region and those with systemic disease,
- participation of physical therapy and rehabilitation program in the last one year,
- fibromyalgia,
- presence of cardiac pacemaker,
- intra-articular steroid injection in neck joint in the last three months.
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 |
|---|---|
|
Experimental: Mulligan group
In addition to the conventional treatments, Sustained Natural Apophysial Gliding (SNAG) a type of Mulligan mobilization technique is applied.
|
Ultrasound (8minutes, 1.5 w/cm2, pulsed), conventional transcutaneous electrical nerve stimulation (TENS) (20 minutes, 60-120 Hz frequency) and hot pack application (20 minutes) and interferential current (100 rpm) as electrotherapy agents. In addition to the conventional treatments, Sustained Natural Apophysial Gliding (SNAG) a type of Mulligan mobilization technique is applied. Mobilization is performed by giving 15-20 seconds rest between 3 sets of 4-5 repetations. Patients were treated in a sitting position. SNAG technique was applied by the physiotherapist at each on spinal level. Active movement with using passive manual force in the direction of translation or rotation was applied to the cervical vertebrae. At the end range of the joint, overpressure was applied by the patient himself |
|
Other: Control group
Electroterapy agents are applied in the contro group
|
Electroterapy agents are applied in the same conditions with Mulligan Group.
Active neck, shoulder and thoracic region exercises for correction postural misalignment are performed in both groups.
All exercises were done in 3 sets of 10 repetitions.
Stretching exercises of upper part of Trapezius, sternocleidomastoideus and pectoral muscles are done with 10 repetitions and for 15-30 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion
Time Frame: 10 minutes
|
Universal goniometer is used to measure the joint position and joint range of motion measurements based on Kendall and American Association of Orthopedic Surgeons.
The participant is in the sitting position and asked to perform active cervical region flexion, extension, right and left rotation, right and left lateral flexion of the neck movements and performed degrees are recorded.
|
10 minutes
|
|
Pain status
Time Frame: 5 minutes
|
Pain intensity is evaluated with visual analog scale (VAS) in two conditions during activity and resting time.
This method, which is developed to determine the intensity of pain to indicate by numbers.
It begins with the absence of pain (0) on numerical scale and ends the level of unbearable pain
|
5 minutes
|
|
Life quality
Time Frame: 15 minutes
|
Quality of life of the participants are evaluated by Short Form 36 (SF-36).
It is a self-assessment scale developed by Rond Corporation in 1992.
Short Form 36 (SF-36) is a personalized scale that assesses the general health status of the patients with 36 questions, 8 Sub-Items (Physical function, physical role weakness, body pain, general health, vitality, social function, emotional function, mental function).
SF-36 scale is scored from 0 to 100 (0 = worst, 100 = best)
|
15 minutes
|
|
Disability status
Time Frame: 10 minutes
|
The items assess the severity of pain and the relationship between pain, occupational, social, recreational, emotional factors.
It determines the effect of neck pain on disability, functionality and quality of life.
Total score is the sum of the points in each item and ranges from 0 to 100.
High scores indicate that more affected status
|
10 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: OZGE OZLU, Medipol University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ozluozge
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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