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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05074576
Other study ID # ozluozge
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 15, 2020
Est. completion date November 15, 2021

Study information

Verified date September 2021
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the effect of the Mulligan mobilization technique on pain intensity and range of motion individuals with neck pain. The patients were randomized into two groups. Group 1 is the Mulligan Mobilization group and the second group is the control group.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date November 15, 2021
Est. primary completion date October 15, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Mulligan group
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
Control 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.

Locations

Country Name City State
Turkey Ozge Ozlu Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Ganesh GS, Mohanty P, Pattnaik M, Mishra C. Effectiveness of mobilization therapy and exercises in mechanical neck pain. Physiother Theory Pract. 2015 Feb;31(2):99-106. doi: 10.3109/09593985.2014.963904. Epub 2014 Sep 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Range of Motion 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
Primary Pain status 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
Primary Life quality 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
Primary Disability status 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
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