NCT05074576

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

October 12, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

September 29, 2021

Last Update Submit

September 29, 2021

Conditions

Keywords

Mulligan MobilizationMechanical Neck Pain

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Mulligan group

EXPERIMENTAL

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

Other: Mulligan group

Control group

OTHER

Electroterapy agents are applied in the contro group

Other: Control group

Interventions

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

Mulligan 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.

Control group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozge Ozlu

Istanbul, Beykoz, 34820, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • Ozlu O, Sahin M. The effect of mulligan mobilization technique application in addition to conventional physiotherapy on pain and joint range of motion in people with neck pain. J Bodyw Mov Ther. 2024 Jul;39:225-230. doi: 10.1016/j.jbmt.2024.02.009. Epub 2024 Mar 5.

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • OZGE OZLU

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blind for allocation and outcomes measures.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PT

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

August 15, 2020

Primary Completion

October 15, 2021

Study Completion

November 15, 2021

Last Updated

October 12, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

When I will publish this manuscript in a journal, I would share the results of individual participant data of this study with other researchers.

Locations