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Effect of Chosen Treatment Methods in Patients With Cervical Spine Osteoarthritis (PNF)

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ClinicalTrials.gov Identifier: NCT03683602
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Tomasz Maicki, Jagiellonian University

Brief Summary:

Abstract Objective: To compare effect of PNF therapy with manual therapy on pain, associated symptoms, range of motion and functioning in patients with cervical spine osteoarthritis.

Design: Parallel group, single-center, double-blinded randomized controlled trial.

Setting: Outpatient clinic in hospital KCRiO. Subject: Eligible patients were female adults with chronic pain of cervical spine due to osteoarthritis of vertebral body and intervertebral disc confirmed by X-ray.

Interventions: Group I (PNF group) was treated according to PNF concept, while Group II according to manual therapy (manual therapy group). Both groups received 10 days of treatment, 45 minutes each day.

Main measures: Primary outcomes measures were Oswestry scale and range of motion (ROM). Secondary outcomes measures were subjective evaluation of cervical pain according to VAS scale and associated symptoms (headache, vertigo, ROM of shoulder joints, balance). For each scale results were measured at baseline, after two weeks of intervention and after a three-month follow-up period without therapy.

Keywords: neck pain, PNF, manual therapy


Condition or disease Intervention/treatment Phase
Cervical Spine Osteophyte Other: PNF group Other: manual therapy group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Chosen Treatment Methods on Pain, ROM, Associated Symptoms and Functioning in Patients With Cervical Spine Osteoarthritis: Randomised Control Trial
Actual Study Start Date : January 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PNF group
PNF techniques, patterns, re-education of postural control, once a day 10 days,
Other: PNF group
PNF is used in treatment of musculoskeletal pain of cervical and lumbar spine. Proprioceptive neuromuscular facilitation is a rehabilitation concept widely used by physiotherapists in many countries, in which stimulation of central nervous system is to achieve the highest possible functional level

Active Comparator: Manual therapy group
traction, joints mobilization, pos-isometric relaxation, once a day 10 days
Other: manual therapy group

Manual therapy is used for an assessment and treatment of joint and soft tissues.

The basic therapeutic tool is mobilisation. In the study joint mobilisation according to Kaltenborn-Evjenth Manual Therapy was used. The joint were mobilised with low velocity passive movements in the whole or end range. Spinal manipulation wasn`t used. Liter Exelby reports that manual therapy with joints mobilisation was quite effective in improvement of functional movements and decreasing of pain.





Primary Outcome Measures :
  1. Oswestry scale [ Time Frame: Change from baseline Oswesstry scale at 2 weeks. ]
    Oswestry Disability Index (ODI) can be used for evaluation both cervical and lumbar spine. It is the most common method used for disability evaluation of patients with neck pain. It consits of questiones which evaluate how the pain limits activities. There are 10 questiones concerning ADLs.


Secondary Outcome Measures :
  1. VAS scale [ Time Frame: baseline, two weeks, 3 months ]
    One of the most commonly used scale for pain evaluation is Visual Analogue Scale (VAS). It is easy to use, it doesn`t require any verbal or reading abilities and it`s comprehensive enough. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left side.

  2. assessment of the occurrence of vertigo, balance problems,nausea,limited ROM in shoulder joints [ Time Frame: baseline, two weeks, 3 months ]
    There were closed questiones with yes or no answer

  3. ROM evaluation [ Time Frame: baseline, two weeks, 3 months ]
    ROM of cervical spine was evaluated with a measuring tape



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • age 45-65,
  • female gender,
  • cervical pain due to osteoarthritis of vertebral body and intervertebral disc confirmed by X-ray,
  • chronic pain lasting more than 13 weeks, verbal contact,
  • intact cognitive functions and voluntary consent for the study.

Exclusion criteria

  • birth or aquired deficits,
  • cervical spine injury,
  • osteoporosis,
  • cervical spine instability,
  • myelopathy,
  • signs of nerve root compression of C1-C8, such as paresis, muscle loss, hyporeflexia, use of analgesics,
  • anti-inflammatory drugs or myorelaxants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683602


Locations
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Poland
Krakowskie Centrum Rehabilitacji i Ortopedii
Krakow, Malopolska, Poland, 30-224
Sponsors and Collaborators
Jagiellonian University
Investigators
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Principal Investigator: Tomasz Maicki, PhD Jagiellonian University Colegium Medicum

Publications of Results:

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Responsible Party: Tomasz Maicki, PhD, Jagiellonian University
ClinicalTrials.gov Identifier: NCT03683602     History of Changes
Other Study ID Numbers: NECK/2018
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study Protocol, Informed Consent Form, will be made available
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: available
Access Criteria: on email request: tomasz.maicki@uj.edu.pl

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tomasz Maicki, Jagiellonian University:
PNF, manual therapy, neck pain

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Spine
Spondylarthritis
Osteophyte
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spondylitis
Spinal Diseases
Bone Diseases
Exostoses
Hyperostosis