NCT05496699

Brief Summary

Non-specific neck pain (NSBA) is defined as pain in the posterior and lateral parts of the neck in the absence of neurological and specific pathologies (fracture, infection, inflammation, etc.) between the superior nuchael line and the 1st thoracic vertebra. The lifetime neck pain rate is approximately 12-70%; Neck pain is the reason for admission in approximately 25% of applications to outpatient clinics of the Physical Medicine and Rehabilitation Clinic. Neck pain is the most common spinal problem after low back pain, and it is defined as nonspecific neck pain due to its multifactorial etiology. Many conservative treatment methods are used in the treatment of NSBA. These include medical treatments, exercise, massage, acupuncture, neural therapy and physical therapy modalities. The basis of Mulligan's theory is based on a positional error that develops secondarily, causing misplacement of the joint. With the Mulligan mobilization technique, the joint is displaced to normal and positional error is corrected. Restoration of motion is aimed by repositioning the bone. The main indication in this technique is increased pain, stiffness and weakness in movement. The Mulligan mobilization technique is performed by asking for active movement while maintaining a manually applied joint shift. Painless movement is aimed at the joint. According to the general principles of Mulligan treatment, all techniques are applied in a way that does not cause pain and creates an effect that will eliminate the pain in a short time after the application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

February 7, 2022

Last Update Submit

August 10, 2022

Conditions

Keywords

neck painexercisemanuel therapyphysiotherapy

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale

    A visual analog scale will be used to assess participants' degree of neck pain before and after treatment. It will be created by marking the instantaneous pain according to the levels on a scale with the visual analog scale. The pain felt by the person will be marked as "0: no pain", "10: I feel very severe pain". Scoring will be made from the parts marked on the plane over the points given by the person. The validity and reliability study of the scale was done by Price et al. made by The scale was adapted to Turkish by A. Aydın et al.

    First week

  • Neck Disability Index

    In order to evaluate neck functionality, Vernon et al. Developed by Turkish version study Aslan et al. made by The Neck Disability Questionnaire includes a total of 10 questions such as pain, personal care, concentration, working, driving, and sleeping. Each question will be scored between 0-5 points. The survey will be evaluated out of a maximum of 50 points. 0 points means no restrictions, 50 points means full apology. 0-4 points will be considered as no disability, 5-14 points as mild disability, 14-24 points as moderate disability, 25-34 points as severe disability and 35 and above as complete disability.

    First week

Secondary Outcomes (4)

  • Evaluation of Muscle Strength

    First week

  • Tampa Kinesiophobia Scale

    First week

  • Fremantle Neck Awareness Questionnaire

    First week

  • Corbin Posture Analysis

    First week

Study Arms (2)

mckenzie group

EXPERIMENTAL

Mckenzie exercise protocol will be applied to the participants in this group. It will be applied to the participants for 4 weeks and 5 days a week for 30 minutes. The exercise program will be performed by the patient under the supervision of a physiotherapist.

Behavioral: Mckenzie Exercises

mullgian group

EXPERIMENTAL

Mulligan exercise protocol will be applied to the participants in this group. It will be applied to the participants for 4 weeks and 5 days a week for 30 minutes. The exercise program will be performed by the patient under the supervision of a physiotherapist.

Behavioral: Mulligan Exercise

Interventions

1. Cervical Retraction Exercise in Sitting Position The participant sits on the chair, puts the second and third fingers on his chin and pushes his head posteriorly and inferiorly. 2. Cervical Rotation Exercise in Sitting Position 3. Cervical Retraction Exercise in Supine Position 4. Cervical Rotation Exercise in Supine Position The participant turns his head to the right and left, respectively, while taking his head back in the supine position with his head out of the bed. 5. Cervical Lateral Flexion Exercise 6. Cervical Flexion Exercise in Sitting Position

mckenzie group

The exercises to be applied are listed below. 1- C1-C2 Self Mobilization Slip is applied for natural apophyseal cervical right rotation. The belt is put on level C1. At the same time, the participant actively pulls the belt and turns his head to the right. To facilitate the rotation of the belt in C1, pressure is applied to the belt in the same direction as C2 and rotation of the head towards the restricted side is requested. It waits like this for 3 seconds. These movements are done in the painless range.

mullgian group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with neck pain of unknown origin for more than 3 months
  • Individuals between the ages of 18-45
  • Non-smokers
  • Individuals who have the ability to understand and apply Turkish written and verbal instructions

You may not qualify if:

  • Individuals with a history of neck injury, micro or macro trauma,
  • Individuals with tumors in and around the spinal cord,
  • Individuals who have undergone surgery from the neck and shoulder region,
  • Individuals with positive Vertebrobacillary Artery Test,
  • Female individuals who are pregnant, individuals receiving hormone therapy,
  • Individuals with neurological disease,
  • Individuals with neuropathic pain due to neurological and systemic disorders,
  • Patients with any loss of function in the upper extremities due to musculoskeletal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstinye University

Istanbul, 16360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Burcu Pamukçu

    Istinye University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 group, intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

August 11, 2022

Study Start

April 1, 2022

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations