Cervical Spine Osteophyte Clinical Trial
Official title:
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
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.
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