NCT03782584

Brief Summary

The aim of this study is to investigate the effects of modified pilates exercises on neck pain, deep neck flexor muscles edurance, joint position sense and functionality in patients with chronic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
Last Updated

November 23, 2020

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

March 19, 2018

Last Update Submit

November 20, 2020

Conditions

Neck Pain

Keywords

exercisepilatesmodified pilateschronic neck pain

Outcome Measures

Primary Outcomes (6)

  • Pain Evaluation

    This test will be measured by Visual Analog Scale (VAS) score. VAS has 10-centimeter line corresponding to the amount of pain they experienced. "0" means "no pain" and "10" means "pain as bad as possible".

    6 weeks

  • Neck Disability Index

    Neck disability index is a survey that has 10 different sections including Pain intensity, personal care, weight lifting, reading, headache, concentration, work, driving, sleeping and resting activitie.

    6 weeks

  • Posture Evaluation

    Sagital plan photographs of the people will be taken and head and shoulder posture will be evaluated.

    6 weeks

  • Neck Range Of Motion

    Range of motion will be measured by cervical range of motion device (CROM device)

    6 weeks

  • Deep Neck Flexor Endurance

    Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.

    6 weeks

  • Neck Position Sense

    Joint position error of 6-direction (flexion, extension, right-left lateral flexion and right-left rotation) will be measured by cervical range of motion device (CROM device).

    6 weeks

Study Arms (2)

Modified Pilates Exercise Group

EXPERIMENTAL

they will be involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week.

Other: modified pilates exercise

Control Group

OTHER

they will be given daily life advises to prevent neck pain

Other: daily life advises

Interventions

modified pilates exerciseOTHER

modified exercises from original pilates exercises.

Also known as: daily routine advises
Modified Pilates Exercise Group
daily life advisesOTHER

they will be given daily life advises to prevent neck pain

Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having neck pain more than 3 months
  • No physical therapy in last year
  • No background with pilates exercises
  • Being able to understand Turkish, treatment and evaluations.
  • Being able to complete all the evaluations and treatment

You may not qualify if:

  • Fracture or surgery background with shoulder, cervical area or other extremities.
  • Any systemic musculoskeletal diseases
  • Existing chest deformities or scoliosis
  • Cervical hernia, neuropathy or whiplash.
  • Pregnancy
  • Having pain above 7 in VAS
  • Any other pain that could prevent people from doing exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir University of Economics

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • Sahiner Picak G, Yesilyaprak SS. Effects of clinical pilates exercises in patients with chronic nonspecific neck pain: a randomized clinical trial. Ir J Med Sci. 2023 Jun;192(3):1205-1214. doi: 10.1007/s11845-022-03101-y. Epub 2022 Jul 20.

    PMID: 35857170DERIVED

MeSH Terms

Conditions

Neck PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • sevgi sevi yeşilyaprak, PHD

    9 eylül university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 19, 2018

First Posted

December 20, 2018

Study Start

April 1, 2018

Primary Completion

August 30, 2018

Study Completion

November 30, 2018

Last Updated

November 23, 2020

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)