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The Effect of Mulligan Mobilization Technique (TheEffect)

Primary Purpose

Orthopedic Disorder of Spine, Manual Therapy, Physical Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mulligan group
Control group
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder of Spine focused on measuring Mulligan Mobilization, Mechanical Neck Pain

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ozge Ozlu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mulligan group

Control group

Arm Description

In addition to the conventional treatments, Sustained Natural Apophysial Gliding (SNAG) a type of Mulligan mobilization technique is applied.

Electroterapy agents are applied in the contro group

Outcomes

Primary Outcome Measures

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.
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
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)
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

Secondary Outcome Measures

Full Information

First Posted
September 29, 2021
Last Updated
September 29, 2021
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05074576
Brief Title
The Effect of Mulligan Mobilization Technique
Acronym
TheEffect
Official Title
The Effect of Mulligan Mobilization Technique Application in Addition to Classical Therapies on Pain and Joint Range of Motion People With Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
October 15, 2021 (Anticipated)
Study Completion Date
November 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder of Spine, Manual Therapy, Physical Therapy
Keywords
Mulligan Mobilization, Mechanical Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are blind for allocation and outcomes measures.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mulligan group
Arm Type
Experimental
Arm Description
In addition to the conventional treatments, Sustained Natural Apophysial Gliding (SNAG) a type of Mulligan mobilization technique is applied.
Arm Title
Control group
Arm Type
Other
Arm Description
Electroterapy agents are applied in the contro group
Intervention Type
Other
Intervention Name(s)
Mulligan group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Range of Motion
Description
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.
Time Frame
10 minutes
Title
Pain status
Description
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
Time Frame
5 minutes
Title
Life quality
Description
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)
Time Frame
15 minutes
Title
Disability status
Description
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
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OZGE OZLU
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ozge Ozlu
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34820
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
When I will publish this manuscript in a journal, I would share the results of individual participant data of this study with other researchers.
Citations:
PubMed Identifier
25264016
Citation
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.
Results Reference
result

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The Effect of Mulligan Mobilization Technique

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