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

September 21, 2018 updated by: Tomasz Maicki, Jagiellonian University

Effect of Chosen Treatment Methods on Pain, ROM, Associated Symptoms and Functioning in Patients With Cervical Spine Osteoarthritis: Randomised Control Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolska
      • Krakow, Malopolska, Poland, 30-224
        • Krakowskie Centrum Rehabilitacji i Ortopedii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline Oswesstry scale at 2 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Principal Investigator: Tomasz Maicki, PhD, Jagiellonian University Colegium Medicum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 19, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NECK/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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