- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04794647
The Effects of Manual Therapy on Balance and Cervical Proprioception
The Effects of Manual Therapy Applied to the Cervical Region on Balance and Proprioception in Patients With Nonspesific Neck Pain: A Randomised Placebo Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nonspecific neck pain (NSNP) is one of the most common causes of neck pain and it occurs as a result of postural or mechanical causes without a specific musculoskeletal pathology or injury history. Neck pain leads to a decrease in the activity of the deep cervical muscle which contains a large amount of muscle spindles, with an increase in the activity of the superficial cervical muscle. Depending on the pain, chemical changes occur in the cervical receptors and differentiation in sensitivity of the muscle spindle is observed. These changes in the structures of the cervical region predispose to deterioration in the sense of proprioception, which is an important component of balance. The disruption in proprioceptive abilities causes sensori-motor defects, muscle inhibition, muscle atrophy, and muscle fatigue. Changing cervical afferent information can affect proprioception as well as balance. Both the presence of neck pain and disruptions in the proprioceptive sense may reflect negatively on balance and postural control. In a study comparing patients with neck pain with asymptomatic individuals, increases in postural sway were found in patients with neck pain, and it was stated that the increased sway was associated with the dysfunction of the postural control system.
In the light of these informations, treatment approaches that can positively contribute to proprioception and balance gain importance in patients with NSNP. Although manual therapy is used both to reduce pain, and to increase cervical mobility in patients with NSNP, the number of studies investigating the effects of manual therapy on balance and proprioception is quite insufficient.
It was thought that mobilization applied to the cervical region can improve cervical proprioception and mobility, reduce pain and contribute positively to balance. The purpose of this study is to examine the effect of mobilization applications on the balance and cervical proprioception in patients with NSNP.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zafer Günendi, Prof.
- Phone Number: +90 532 383 91 53
- Email: zafergunendi@yahoo.com
Study Contact Backup
- Name: Nagihan Acet, Phd.
- Phone Number: +90 532 205 26 05
- Email: nagihan.acet@gmail.com
Study Locations
-
-
-
Ankara, Turkey
- Gazi University
-
Ankara, Turkey, 06500
- Gazi University Faculty of Medicine
-
Ankara, Turkey, 06560
- Gazi Univercity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cervical mobilization
'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.
|
A kind of manual therapy tecnique applied to the cervical region
Other Names:
|
Placebo Comparator: placebo mobilization
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: baseline-3rd week
|
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
Time Frame: baseline-3rd week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical mobility
Time Frame: baseline-3rd week
|
Active cervical range of motion was measured with the CROM device (Cervical Range of Motion-Perfomance Attainment Associates, St. Paul, MN, 55117, United States) for each direction (flexion, extension, right and left lateral flexion, right and left rotation).
It is an inclinometer system that utilizes gravity and magnetic effects.
|
baseline-3rd week
|
Cervical pain
Time Frame: baseline-3rd week
|
The visual analog scale (VAS) was used to assess patient's pain intensity.
|
baseline-3rd week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nevin Atalay Güzel, Prof., Gazi Univercity
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: J Manipulative Physiol Ther. 2006 May;29(4):340.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24074710-604.01.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on Cervical mobilization
-
Cairo UniversityCompleted
-
Riphah International UniversityCompleted
-
Noha ElsertyRecruiting
-
Mücahit ÖZTOPPamukkale UniversityCompleted
-
Universidad Europea de MadridCompleted
-
Shenandoah UniversityCompletedMusculoskeletal Neck Pain | Unilateral HeadacheUnited States
-
Loma Linda UniversityCompleted
-
Hacettepe UniversityCompletedIdiopathic Parkinson's DiseaseTurkey
-
University of LahoreRecruiting
-
Youngstown State UniversityFranklin Pierce UniversityCompletedNeck PainUnited States