NCT04794647

Brief Summary

Introduction: Neck pain causes disturbances in both proprioception and balance. The aim of the present study is to determine the effect of mobilization applied to the cervical region on static/dynamic balance and cervical proprioception in patients with nonspecific neck pain (NSNP). Materials and Methods: ... patients were randomly allovated into two groups. Both grups received conventional physiotherapy program (hot pack with transcutaneous electrical nerve stimulation); additionally, the experimental group received mobilization, and the control group received placebo mobilization twice a week for 3 weeks. Before and 3 weeks later, static/dynamic balance, cervical proprioception, cervical mobility and pain were evaluated respectively with Kinesthetic Skill Training System 3000 device, joint position error test, Cervical Joint Range of Motion Device, Visual Analogue Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

January 2, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

March 9, 2021

Last Update Submit

October 30, 2023

Conditions

Keywords

Mobilization, Balance, Pain, Mobility, Joint position sense.

Outcome Measures

Primary Outcomes (2)

  • Balance

    Balance measured with the Kinesthetic Ability Training System 3000 (Med-Fit Systems Inc., Fallbrook, C.A., USA) for static and dynamic balance. The increase in the balance index indicates a deterioration in balance, while the decrease in the index represents an improvement in stability.

    baseline-3rd week

  • Cervical proprioception

    Cervical joint position error test was conducted using the CROM device in transverse plane (right and left rotation). A travel eye mask was used to blindfold the patient. The examiner held the patient's head and moved slowly to the target head position, which is 50% of the maximum cervical range of motion. When patient reached actively the target position that memorized, the difference between the target position and the position obtained was recorded. Each direction of testing was performed three times and the mean error of these trials was used in the analysis.

    baseline-3rd week

Secondary Outcomes (2)

  • Cervical mobility

    baseline-3rd week

  • Cervical pain

    baseline-3rd week

Study Arms (2)

cervical mobilization

EXPERIMENTAL

'Rotation mobilization' was applied to the symptomatic segment / segments after the detailed evaluation (symptom localization tests, cervical region safety tests, joint play tests, pain provocation/alleviation tests) in accordance with the Kaltenborn-Evjenth system in cervical region. Five series of 45-s mobilizations were performed with 15 s of rest. Each patient received 6 treatment sessions over a period of 3 week.

Other: Cervical mobilization

placebo mobilization

PLACEBO COMPARATOR

Placebo mobilization was applied to the cervical region in the same position and the same grip with the mobilization group. The physiotherapist put her hand on a randomly selected faset without any pushing or pulling, The duration of placebo mobilization was the same as the duration of the other group. Each patient received 6 treatment sessions over a period of 3 week.

Other: Placebo mobilization

Interventions

A kind of manual therapy tecnique applied to the cervical region

Also known as: Manual therapy
cervical mobilization

It was applied to the randomly selected cervical faset without any pushing or pulling in the same position and the same grip with cervical mobilization.

placebo mobilization

Eligibility Criteria

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

You may qualify if:

  • to be diagnosed with NSNP by a physiatrist
  • to be in the age range of 18-60 years
  • to have pain affected by neck movements
  • to have restriction of cervical region in at least the last three weeks

You may not qualify if:

  • Neurological or orthopedic disease that may affect balance / proprioception
  • presence of neurological / inflammatory symptoms
  • presence of cervical instability
  • to have trauma / cervical surgery / severe osteoporosis
  • to use of drugs that may affect balance (antidepressants, anticonvulsants, antihistamines, sedatives, betahistine)
  • to have visual / vestibular disorder
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gazi University Faculty of Medicine

Ankara, 06500, Turkey (Türkiye)

Location

Gazi Univercity

Ankara, 06560, Turkey (Türkiye)

Location

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (17)

  • Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.

    PMID: 17369782BACKGROUND
  • Falla DL, Jull GA, Hodges PW. Patients with neck pain demonstrate reduced electromyographic activity of the deep cervical flexor muscles during performance of the craniocervical flexion test. Spine (Phila Pa 1976). 2004 Oct 1;29(19):2108-14. doi: 10.1097/01.brs.0000141170.89317.0e.

    PMID: 15454700BACKGROUND
  • Sahrmann S, Azevedo DC, Dillen LV. Diagnosis and treatment of movement system impairment syndromes. Braz J Phys Ther. 2017 Nov-Dec;21(6):391-399. doi: 10.1016/j.bjpt.2017.08.001. Epub 2017 Sep 27.

    PMID: 29097026BACKGROUND
  • Duray M, Simsek S, Altug F, Cavlak U. Effect of proprioceptive training on balance in patients with chronic neck pain. Agri. 2018 Jul;30(3):130-137. doi: 10.5505/agri.2018.61214.

    PMID: 30028479BACKGROUND
  • Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008 Feb;13(1):2-11. doi: 10.1016/j.math.2007.06.003. Epub 2007 Aug 16.

    PMID: 17702636BACKGROUND
  • Ruhe A, Fejer R, Walker B. Altered postural sway in patients suffering from non-specific neck pain and whiplash associated disorder - A systematic review of the literature. Chiropr Man Therap. 2011 May 24;19(1):13. doi: 10.1186/2045-709X-19-13.

    PMID: 21609469BACKGROUND
  • Voogt L, de Vries J, Meeus M, Struyf F, Meuffels D, Nijs J. Analgesic effects of manual therapy in patients with musculoskeletal pain: a systematic review. Man Ther. 2015 Apr;20(2):250-6. doi: 10.1016/j.math.2014.09.001. Epub 2014 Sep 19.

    PMID: 25282440BACKGROUND
  • Jun P, Page I, Vette A, Kawchuk G. Potential mechanisms for lumbar spinal stiffness change following spinal manipulative therapy: a scoping review. Chiropr Man Therap. 2020 Mar 23;28(1):15. doi: 10.1186/s12998-020-00304-x.

    PMID: 32293493BACKGROUND
  • Lee KS, Lee JH. Effect of maitland mobilization in cervical and thoracic spine and therapeutic exercise on functional impairment in individuals with chronic neck pain. J Phys Ther Sci. 2017 Mar;29(3):531-535. doi: 10.1589/jpts.29.531. Epub 2017 Mar 22.

    PMID: 28356648BACKGROUND
  • Fisher AR, Bacon CJ, Mannion JVH. The effect of cervical spine manipulation on postural sway in patients with nonspecific neck pain. J Manipulative Physiol Ther. 2015 Jan;38(1):65-73. doi: 10.1016/j.jmpt.2014.10.014. Epub 2014 Nov 18.

    PMID: 25467613BACKGROUND
  • Beinert K, Lutz B, Zieglgansberger W, Diers M. Seeing the site of treatment improves habitual pain but not cervical joint position sense immediately after manual therapy in chronic neck pain patients. Eur J Pain. 2019 Jan;23(1):117-123. doi: 10.1002/ejp.1290. Epub 2018 Aug 13.

    PMID: 29999203BACKGROUND
  • Palmgren PJ, Sandstrom PJ, Lundqvist FJ, Heikkila H. Improvement after chiropractic care in cervicocephalic kinesthetic sensibility and subjective pain intensity in patients with nontraumatic chronic neck pain. J Manipulative Physiol Ther. 2006 Feb;29(2):100-6. doi: 10.1016/j.jmpt.2005.12.002.

    PMID: 16461168BACKGROUND
  • Heikkila H, Johansson M, Wenngren BI. Effects of acupuncture, cervical manipulation and NSAID therapy on dizziness and impaired head repositioning of suspected cervical origin: a pilot study. Man Ther. 2000 Aug;5(3):151-7. doi: 10.1054/math.2000.0357.

    PMID: 11034885BACKGROUND
  • Law EY, Chiu TT. Measurement of cervical range of motion (CROM) by electronic CROM goniometer: a test of reliability and validity. J Back Musculoskelet Rehabil. 2013;26(2):141-8. doi: 10.3233/BMR-2012-00358.

    PMID: 23640315BACKGROUND
  • Reddy RS, Tedla JS, Dixit S, Abohashrh M. Cervical proprioception and its relationship with neck pain intensity in subjects with cervical spondylosis. BMC Musculoskelet Disord. 2019 Oct 15;20(1):447. doi: 10.1186/s12891-019-2846-z.

    PMID: 31615495BACKGROUND
  • Mancini M, Horak FB. The relevance of clinical balance assessment tools to differentiate balance deficits. Eur J Phys Rehabil Med. 2010 Jun;46(2):239-48.

    PMID: 20485226BACKGROUND
  • Huskisson EC, Jones J, Scott PJ. Application of visual-analogue scales to the measurement of functional capacity. Rheumatol Rehabil. 1976 Aug;15(3):185-7. doi: 10.1093/rheumatology/15.3.185.

    PMID: 968347BACKGROUND

MeSH Terms

Conditions

Neck PainPain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Nevin Atalay Güzel, Prof.

    Gazi Univercity

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, controlled and double blind clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

January 2, 2020

Primary Completion

January 2, 2021

Study Completion

January 2, 2021

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations