Cervical Spine OsteophytePNFNCT03683602
Effect of Chosen Treatment Methods in Patients With Cervical Spine Osteoarthritis
A study testing PNF group and manual therapy group in people with Cervical Spine Osteophyte, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Spine Osteophyte
- What is being tested?
- PNF group and manual therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Krakowskie Centrum Rehabilitacji i Ortopedii
Krakow, Malopolska, 30-224
About this study
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.
Read more
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
Read the 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.
- Conditions
- Cervical Spine Osteophyte
- Being tested
- PNF group, manual therapy group
- Keywords
- PNF, manual therapy, neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF groupOther
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
manual therapy groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PNF group | Experimental | PNF techniques, patterns, re-education of postural control, once a day 10 days, Receives: Other: PNF group |
| Manual therapy group | Active comparator | traction, joints mobilization, pos-isometric relaxation, once a day 10 days Receives: Other: manual therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline Oswesstry scale at 2 weeks.
Secondary outcomes (3)
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.
Measured: baseline, two weeks, 3 months
assessment of the occurrence of vertigo, balance problems,nausea,limited ROM in shoulder joints
There were closed questiones with yes or no answer
Measured: baseline, two weeks, 3 months
ROM evaluation
ROM of cervical spine was evaluated with a measuring tape
Measured: baseline, two weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study startJan 2011
- Primary completionApr 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cervical Spine OsteophyteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Maicki, Jagiellonian University
- Investigators
- Tomasz Maicki, PhD, Principal investigator, Jagiellonian University Colegium Medicum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683602
- Sponsor's protocol ID
- NECK/2018
- Acronym
- PNF
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Informed Consent Form, will be made available
Publications
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.
PubMed 29536618Malik AA, Robinson S, Khan WS, Dillon B, Lovell ME. Assessment of Range of Movement, Pain and Disability Following a Whiplash Injury. Open Orthop J. 2017 Jul 19;11:541-545. doi: 10.2174/1874325001711010541. eCollection 2017.
PubMed 28839498Vincent K, Maigne JY, Fischhoff C, Lanlo O, Dagenais S. Systematic review of manual therapies for nonspecific neck pain. Joint Bone Spine. 2013 Oct;80(5):508-15. doi: 10.1016/j.jbspin.2012.10.006. Epub 2012 Nov 16.
PubMed 23165183de Koning CH, van den Heuvel SP, Staal JB, Smits-Engelsman BC, Hendriks EJ. Clinimetric evaluation of active range of motion measures in patients with non-specific neck pain: a systematic review. Eur Spine J. 2008 Jul;17(7):905-21. doi: 10.1007/s00586-008-0656-3. Epub 2008 Apr 22.
PubMed 18427843Ylinen J, Kautiainen H, Wiren K, Hakkinen A. Stretching exercises vs manual therapy in treatment of chronic neck pain: a randomized, controlled cross-over trial. J Rehabil Med. 2007 Mar;39(2):126-32. doi: 10.2340/16501977-0015.
PubMed 17351694Cunha AC, Burke TN, Franca FJ, Marques AP. Effect of global posture reeducation and of static stretching on pain, range of motion, and quality of life in women with chronic neck pain: a randomized clinical trial. Clinics (Sao Paulo). 2008 Dec;63(6):763-70. doi: 10.1590/s1807-59322008000600010.
PubMed 19060998Lluch 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.
PubMed 24152997Falla D, O'Leary S, Farina D, Jull G. Association between intensity of pain and impairment in onset and activation of the deep cervical flexors in patients with persistent neck pain. Clin J Pain. 2011 May;27(4):309-14. doi: 10.1097/AJP.0b013e31820212cf.
PubMed 21178596Cleland JA, Childs JD, Fritz JM, Whitman JM, Eberhart SL. Development of a clinical prediction rule for guiding treatment of a subgroup of patients with neck pain: use of thoracic spine manipulation, exercise, and patient education. Phys Ther. 2007 Jan;87(1):9-23. doi: 10.2522/ptj.20060155. Epub 2006 Dec 1.
PubMed 17142640Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
PubMed 11719741
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chosen Treatment Methods on Pain, ROM, Associated Symptoms and Functioning in Patients With Cervical Spine Osteoarthritis: Randomised Control Trial
- ClinicalTrials.gov ID
- NCT03683602
- Acronym / sponsor ID
- PNF / NECK/2018
- Conditions
- Cervical Spine Osteophyte
- Keywords
- PNF, manual therapy, neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF group | Experimental | Other: PNF groupPNF techniques, patterns, re-education of postural control, once a day 10 days, |
| Manual therapy group | Active comparator | Other: manual therapy grouptraction, joints mobilization, pos-isometric relaxation, once a day 10 days |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- birth or aquired deficits,
- cervical spine injury,
- osteoporosis,
- cervical spine instability,
- myelopathy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNF groupPNF 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 | Other | PNF group |
| manual therapy groupManual 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. | Other | Manual therapy group |
Primary outcome
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.
3 secondary outcomes
VAS scale
Time frame: 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
ROM evaluation
Time frame: baseline, two weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Results publication: PubMed 29536618Nazari 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 publication: PubMed 28839498Malik AA, Robinson S, Khan WS, Dillon B, Lovell ME. Assessment of Range of Movement, Pain and Disability Following a Whiplash Injury. Open Orthop J. 2017 Jul 19;11:541-545. doi: 10.2174/1874325001711010541. eCollection 2017.
- Results publication: PubMed 23165183Vincent K, Maigne JY, Fischhoff C, Lanlo O, Dagenais S. Systematic review of manual therapies for nonspecific neck pain. Joint Bone Spine. 2013 Oct;80(5):508-15. doi: 10.1016/j.jbspin.2012.10.006. Epub 2012 Nov 16.
- Results publication: PubMed 18427843de Koning CH, van den Heuvel SP, Staal JB, Smits-Engelsman BC, Hendriks EJ. Clinimetric evaluation of active range of motion measures in patients with non-specific neck pain: a systematic review. Eur Spine J. 2008 Jul;17(7):905-21. doi: 10.1007/s00586-008-0656-3. Epub 2008 Apr 22.
- Results publication: PubMed 17351694Ylinen J, Kautiainen H, Wiren K, Hakkinen A. Stretching exercises vs manual therapy in treatment of chronic neck pain: a randomized, controlled cross-over trial. J Rehabil Med. 2007 Mar;39(2):126-32. doi: 10.2340/16501977-0015.
- Results publication: PubMed 19060998Cunha AC, Burke TN, Franca FJ, Marques AP. Effect of global posture reeducation and of static stretching on pain, range of motion, and quality of life in women with chronic neck pain: a randomized clinical trial. Clinics (Sao Paulo). 2008 Dec;63(6):763-70. doi: 10.1590/s1807-59322008000600010.
- Results publication: PubMed 24152997Lluch 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.
- Results publication: PubMed 21178596Falla D, O'Leary S, Farina D, Jull G. Association between intensity of pain and impairment in onset and activation of the deep cervical flexors in patients with persistent neck pain. Clin J Pain. 2011 May;27(4):309-14. doi: 10.1097/AJP.0b013e31820212cf.
- Results publication: PubMed 17142640Cleland JA, Childs JD, Fritz JM, Whitman JM, Eberhart SL. Development of a clinical prediction rule for guiding treatment of a subgroup of patients with neck pain: use of thoracic spine manipulation, exercise, and patient education. Phys Ther. 2007 Jan;87(1):9-23. doi: 10.2522/ptj.20060155. Epub 2006 Dec 1.
- Results publication: PubMed 11719741Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
- Individual participant dataSharing planned: Yes. Study Protocol, Informed Consent Form, will be made available
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Maicki, PhD principal investigator
Jagiellonian University Colegium Medicum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF group and manual therapy group in people with Cervical Spine Osteophyte, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry scale (time frame: Change from baseline Oswesstry scale at 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683602, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.