NCT04643028

Brief Summary

The aim of our study is to compare the efficiency of Mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. The results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Status
unknown

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

November 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 22, 2020

Last Update Submit

November 22, 2020

Conditions

Outcome Measures

Primary Outcomes (7)

  • Pain Intensity

    Pain intensity will be evaluated with the Visual Analogue Scale. The Visual Analogue Scale is a horizontal scale in the range of 0-10 cm, where 0 is the lowest pain and 10 the highest pain. The patient will be asked to mark the pain felt in the neck area on this line and the point marked will be measured with a ruler and recorded in cm.

    5 minutes

  • Neck Disability

    Neck Disability will be measured by Neck Disability Index. The Neck Disability Index is a frequently used scale to evaluate the level of disability due to neck pain. It consists of 10 items and 6 options under each item. Options are scored between 0-5 points. An increasing score indicates a higher level of disability.

    5 minutes

  • Cervical Range of Motion

    Cervical Range of Motion will be assessed by Baseline Bubble Inclinometer as degree of flexion-extension, rotation and lateral flexion and will be recorded.

    5 minutes

  • Head Posture

    Head posture will be evaluated using the craniovertebral angle. The decrease in the craniovertebral angle indicates an increased anterior head posture.

    5 minutes

  • Proprioception

    The "joint position sense error test" defined by Revel et al. Will be used to evaluate cervical proprioception.

    5 minutes

  • Muscle Endurance

    "Cervical Deep Flexor Muscle Endurance Test" will be used.

    3 minutes

  • Neck Awareness

    The Fremantle Neck Awareness Questionnaire, which consists of few and short questions, does not take time, is easy to access, evaluates neck perception, attention and proprioceptive awareness, will be used. An increase in the score obtained from the questionnaire indicates a decrease in neck awareness.

    5 minutes

Study Arms (3)

Home exercise

OTHER

The exercise program will include active normal joint movements in the cervical region, postural exercises, strengthening exercises for the scapular retractor muscles, and stretching exercises for the pectoral muscles, levator scapula and upper part of the trapezius and breathing/relaxation exercises.

Other: Home exercise

Mulligan mobilization

OTHER

Mulligan mobilization will be applied to this group in addition to the exercises in the home exercise group. In painless directions, each session will be applied in 3 sets, a set of 10 repetitions. Sixty seconds of rest will be given between sets.

Other: Mulligan mobilization

Cervical stabilization

OTHER

In addition to the exercises in the home exercise group, this group will be given cervical stabilization training that focuses on the deep neck muscles.

Other: Cervical stabilization

Interventions

Exercise program will include active normal joint movements in the cervical region, postural exercises, strengthening exercises for the scapular retractor muscles, and stretching exercises for the pectoral muscles, levator scapula and upper part of the trapezius and breathing/relaxation exercises.

Home exercise

Mulligan mobilization: Mulligan mobilization will be applied to this group in addition to the exercises in the home exercise group. In painless directions, each session will be applied in 3 sets, a set of 10 repetitions.Sixty seconds of rest will be given between sets.

Mulligan mobilization

Cervical stabilization group: In addition to the exercises in the home exercise group, this group will be given cervical stabilization training that focuses on the deep neck muscles.

Cervical stabilization

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having neck pain lasting more than 3 months
  • Expressing neck pain at least 3,5/10 points and above on a Visual Analog Scale
  • Being 18-65 years old
  • Agree to participate in the study
  • Having obtained 5/50 points and above in Neck Disability Index

You may not qualify if:

  • Having had spinal surgery
  • Other musculoskeletal problems that may affect the cervical region such as impingement, thoracic outlet and scoliosis.
  • Having a diagnosed psychiatric illness
  • Having benefited from physiotherapy and / or another treatment method due to spinal pain problem in the last 1 year.
  • The presence of specific pathological conditions such as malignant condition, fracture, systemic rheumatoid disease.
  • Any health problem that may prevent the application of evaluations and / or treatment other than those mentioned above.
  • Difficulty in communication at a level that prevents the application of evaluations and / or treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Emine Aslan Telci, Professor

    Professor

    STUDY DIRECTOR

Central Study Contacts

Serbay Şekeröz, MSc

CONTACT

Emine Aslan Telci, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The evaluator who made the outcome measurements will not have any information about the group of participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 22, 2020

First Posted

November 24, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

July 1, 2022

Last Updated

November 24, 2020

Record last verified: 2020-11