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

Primary Purpose

Cervical Spine Osteophyte

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
PNF group
manual therapy group
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spine Osteophyte focused on measuring PNF, manual therapy, neck pain

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Krakowskie Centrum Rehabilitacji i Ortopedii

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PNF group

Manual therapy group

Arm Description

PNF techniques, patterns, re-education of postural control, once a day 10 days,

traction, joints mobilization, pos-isometric relaxation, once a day 10 days

Outcomes

Primary Outcome Measures

Oswestry scale
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

VAS scale
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.
assessment of the occurrence of vertigo, balance problems,nausea,limited ROM in shoulder joints
There were closed questiones with yes or no answer
ROM evaluation
ROM of cervical spine was evaluated with a measuring tape

Full Information

First Posted
September 19, 2018
Last Updated
September 21, 2018
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT03683602
Brief Title
Effect of Chosen Treatment Methods in Patients With Cervical Spine Osteoarthritis
Acronym
PNF
Official Title
Effect of Chosen Treatment Methods on Pain, ROM, Associated Symptoms and Functioning in Patients With Cervical Spine Osteoarthritis: Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University

4. Oversight

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

5. Study Description

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
Detailed Description
Degenerative changes of cervical spine contribute to pain and decreasing ROM. Cervical pain is the fourth common cause of disability in the United States and it has a significant socio-economic impact worldwide. Pain of cervical spine is one of the leading cause of decreasing quality of life and it requires more attention from medical service providers and researchers. Further sudies are urgently required to better understand prognostic factors and clinical course of neck pain especially in low-middle-income countries as well as ways how to prevent such ailments. Especially office workers run the risk of musculoskeletal system overload due to prolonged sitting position with office equipment not suited to their needs [4,5,6]. The annual incidence of neck pain in industrialised countries varies from 27% to 48% what generates high costs and becomes the key issue. In 50-85% patients suffering from pain of cervical spine the symptoms don't resolve spontaneously and in 47% they may become chronic. Common cause of neck pain is: sedentery lifestyle, office work, difficulty sleeping, obesity, bad posture, depression, frequent use of a computer, female gender. Neck pain is common in office workers and it happens annual in 13-48% of them. As many as 42-69% experienced neck pain in last 12 months and in 34-49% they reported the beginning of neck pain during annual observation. Until now there are no clear conclusions concerning types of exercises to decrease pain and improve function of cervical spine in the proffesion mentioned. Neck pain often becomes chronic and it stays at least 6 months in 10% in man and 17% in women. Considering that neck pain is a problem for the general population it seems appropriate to indicate a treatment which will decrease pain effectively and that can improve functionig in daily living. The goal of this study is to Compare the effect of PNF therapy with manual therapy in improving range of motion, decreasing pain, associated symptoms and improving ADLs in patients with cervical spine osteoarthtitis. The parallel-group, single-centered, double-blind randomized experimental study was conducted in Cracow Rehabilitation and Orthopedic Centre in an outpatient clinic located in Aleja Modrzewiowa 22 in Poland. This medical facility has i.a. Accreditation Certificate, ISO Certificate. Written information was delivered to the Director of the Centre who obtained consent. The Bioethics Commission expressed a positive opinion on conducting the studies No. 71/KBL/OIL/2011 and follows the Declaration of Helsinki for ethical principles for medical research involving humans. Patients admitted to rehabilitation in KCRiO were screened by Physical Medicine and Rehabilitation physician and on the basis of entry criteria they were qualified or excluded. All the patients involved were asked to sign a written informed consent for the participation in the study and filling in baseline assessments.The patients underwent rehabilitation program tailored for cervical osteoarthritis. One group received PNF treatment, the second one manual therapy. The patients were treated individually. Additionally both groups received physical modalities: laser therapy and TENS on cervical spine. Time of treatment was 2 weeks- 10 rehabilitation units 45 minutes each, once a day. Treatment in the Ist group (PNF) included: neck patterns with a technique: Combination of Isotonics upper extremity patterns with a technique: Combination of Isotonics neck patterns with a technique: Hold-Relax scapula patterns with techniques: Stabilizing Reversals and Contract-Relax reeducation of postural control. Treatment used in the IInd group (manual therapy) included: mobilisation of cervicothoracic junction cervical segmental mobilisation (flexion, extension, coupling movement) isometric exercises of cervical spine PIR (post-isometric muscle relaxation) traction of cervical spine received reeducation for postural control Data was collected concerning age, BMI and type of work. After randomisation patients in both groups were blinded with regard to kind of received treatment and the study hipothesis. They received information who would be their physiotherapist. Data collecter was not involved in the trial. Observer collecting data couldn't enter the exercise room while patients were treated and couldn't be prezent during randomization. Contact between a person responsible for randomization process and data collector, as well as between caregivers and data collector was avoided; it was monitored by a Head of Physiotherapy Unit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spine Osteophyte
Keywords
PNF, manual therapy, neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PNF group
Arm Type
Experimental
Arm Description
PNF techniques, patterns, re-education of postural control, once a day 10 days,
Arm Title
Manual therapy group
Arm Type
Active Comparator
Arm Description
traction, joints mobilization, pos-isometric relaxation, once a day 10 days
Intervention Type
Other
Intervention Name(s)
PNF group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
manual therapy group
Intervention Description
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 Measure Information:
Title
Oswestry scale
Description
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.
Time Frame
Change from baseline Oswesstry scale at 2 weeks.
Secondary Outcome Measure Information:
Title
VAS scale
Description
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.
Time Frame
baseline, two weeks, 3 months
Title
assessment of the occurrence of vertigo, balance problems,nausea,limited ROM in shoulder joints
Description
There were closed questiones with yes or no answer
Time Frame
baseline, two weeks, 3 months
Title
ROM evaluation
Description
ROM of cervical spine was evaluated with a measuring tape
Time Frame
baseline, two weeks, 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Maicki, PhD
Organizational Affiliation
Jagiellonian University Colegium Medicum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krakowskie Centrum Rehabilitacji i Ortopedii
City
Krakow
State/Province
Malopolska
ZIP/Postal Code
30-224
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study Protocol, Informed Consent Form, will be made available
IPD Sharing Time Frame
available
IPD Sharing Access Criteria
on email request: tomasz.maicki@uj.edu.pl
Citations:
PubMed Identifier
29536618
Citation
Nazari G, Bobos P, Billis E, MacDermid JC. Cervical flexor muscle training reduces pain, anxiety, and depression levels in patients with chronic neck pain by a clinically important amount: A prospective cohort study. Physiother Res Int. 2018 Jul;23(3):e1712. doi: 10.1002/pri.1712. Epub 2018 Mar 14.
Results Reference
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Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
Lluch E, Arguisuelas MD, Coloma PS, Palma F, Rey A, Falla D. Effects of deep cervical flexor training on pressure pain thresholds over myofascial trigger points in patients with chronic neck pain. J Manipulative Physiol Ther. 2013 Nov-Dec;36(9):604-11. doi: 10.1016/j.jmpt.2013.08.004. Epub 2013 Oct 21.
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Citation
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Effect of Chosen Treatment Methods in Patients With Cervical Spine Osteoarthritis

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