Nonspecific Chronic Neck PainNCT01947231
GPR vs Manual PT for Chronic Neck Pain
A study testing Global Postural Re-education and Standard manual physical therapy in people with Nonspecific Chronic Neck Pain, run by University of Bologna at 1 site in Italy.
Trial summary
Effective treatment for nonspecific chronic neck pain is a clinical challenge. Patients will be randomized into two groups to compare the outcomes of Global Postural Re-education (GPR) with standard manual physical therapy on with respect to pain, function, kinesiophobia, range of motion, perceived effect, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nonspecific Chronic Neck Pain
- What is being tested?
- Global Postural Re-education and Standard manual physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Nov 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -nonspecific neck pain lasting at least 3 months
Who cannot join
- acute or subacute cervical pain
- specific or known cause of pain
- central or peripheral neurological signs
- systemic pathology
- rheumatologic pathology
- neuromuscular pathology
Show all 9Show fewer
- cognitive impairment
- surgical intervention in the last 6 months prior to study
- physical therapy treatment in the last 6 months prior to study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Global Postural Re-education vs. Standard Manual Physical Therapy for Non-specific Chronic Neck Pain With Cross-over
Effective treatment for nonspecific chronic neck pain is a clinical challenge. Patients will be randomized into two groups to compare the outcomes of Global Postural Re-education (GPR) with standard manual physical therapy on with respect to pain, function, kinesiophobia, range of motion, perceived effect, and satisfaction.
Read the detailed description
These study will use two groups: one to receive GPR which is a systematic method of addressing musculoskeletal pain and related functional deficits and the other to receive "usual care" manual PT which will be individualized to the patient's condition. Usual care will include techniques commonly used in clinical practice selected by the physical therapist after initial examination. After nine weeks of treatment, baseline measures will be re-evaluated. After conclusion of the first phase of the study, patients who were randomized to the "usual care" group will cross-over and receive GPR.
- Conditions
- Nonspecific Chronic Neck Pain
- Being tested
- Global Postural Re-education, Standard manual physical therapy
- Keywords
- neck pain, chronic, Global Postural Re-education, manual therapy, physical therapy
- Medical subject headings
- Neck Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Postural Re-educationOther
Global Postural Re-education is a physical therapy method comprising a series of gentle active movements, implemented by the therapist using manual contacts and verbal commands, to promote postural symmetry.
Standard manual physical therapyOther
Standard manual physical therapy in this study involves a combination of exercises, pompage (gentle manual techniques of distraction and articulation of a joint), anterior-posterior mobilizations as described by Maitland, and massage that have been selected to meet the needs of each individual patient.
| Study group | Role | What they receive |
|---|---|---|
| Global Postural Re-education | Experimental | Global Postural Re-education is delivered in a single treatment session each week for nine weeks. Receives: Other: Global Postural Re-education |
| Standard manual physical therapy | Active comparator | Standard manual physical therapy is delivered in a single treatment session each week for 9 weeks. Receives: Other: Standard manual physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The investigators assessed this outcome with a Visual Analogue Scale (VAS).
Measured: 9 weeks after start of intervention
Cervical Functional Limitations
The investigators assessed this outcome with the Neck Disability Index.
Measured: 9 weeks after start of intervention
Secondary outcomes (4)
Kinesiophobia
The investigators assessed this outcome with the Tampa Scale of Kinesiophobia.
Measured: 9 weeks after start of intervention
Cervical Range of Motion
The investigators assessed this outcome with the CROM-Deluxe which is an inclinometer that is placed on the subject's head to measure cervical range of motion.
Measured: 9 weeks after start of intervention
Self-reported Global Effect of the Intervention
The investigators assessed this outcome with a Global Perceived Effect scale which measures the subject's self-reported improvement or deterioration following the intervention.
Measured: 9 weeks after start of intervention
Patient Satisfaction
The investigators assessed this outcome with the Physical Therapy Patient Satisfaction Questionnaire - Italian Version which has established psychometric properties.
Measured: 9 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonspecific Chronic Neck PainStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, paolo pillastrini, University of Bologna
- Investigators
- Paolo Pillastrini, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947231
- Sponsor's protocol ID
- 2436/2013
- Status last verified
- Jan 2017
- First submitted
- 3 Sep 2013
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Global Postural Re-education vs. Standard Manual Physical Therapy for Non-specific Chronic Neck Pain With Cross-over
- ClinicalTrials.gov ID
- NCT01947231
- Acronym / sponsor ID
- 2436/2013
- Conditions
- Nonspecific Chronic Neck Pain
- Keywords
- neck pain, chronic, Global Postural Re-education, manual therapy, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Sep 2013 (estimated)
- 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.
Effective treatment for nonspecific chronic neck pain is a clinical challenge. Patients will be randomized into two groups to compare the outcomes of Global Postural Re-education (GPR) with standard manual physical therapy on with respect to pain, function, kinesiophobia, range of motion, perceived effect, and satisfaction.
Detailed description
These study will use two groups: one to receive GPR which is a systematic method of addressing musculoskeletal pain and related functional deficits and the other to receive "usual care" manual PT which will be individualized to the patient's condition. Usual care will include techniques commonly used in clinical practice selected by the physical therapist after initial examination. After nine weeks of treatment, baseline measures will be re-evaluated. After conclusion of the first phase of the study, patients who were randomized to the "usual care" group will cross-over and receive GPR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Global Postural Re-education | Experimental | Other: Global Postural Re-educationGlobal Postural Re-education is delivered in a single treatment session each week for nine weeks. |
| Standard manual physical therapy | Active comparator | Other: Standard manual physical therapyStandard manual physical therapy is delivered in a single treatment session each week for 9 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -nonspecific neck pain lasting at least 3 months
Key exclusion criteria (9 listed)
- acute or subacute cervical pain
- specific or known cause of pain
- central or peripheral neurological signs
- systemic pathology
- rheumatologic pathology
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 |
|---|---|---|
| Global Postural Re-educationGlobal Postural Re-education is a physical therapy method comprising a series of gentle active movements, implemented by the therapist using manual contacts and verbal commands, to promote postural symmetry. | Other | Global Postural Re-education |
| Standard manual physical therapyStandard manual physical therapy in this study involves a combination of exercises, pompage (gentle manual techniques of distraction and articulation of a joint), anterior-posterior mobilizations as described by Maitland, and massage that have been selected to meet the needs of each individual patient. | Other | Standard manual physical therapy |
Primary outcome
Pain
Time frame: 9 weeks after start of intervention
The investigators assessed this outcome with a Visual Analogue Scale (VAS).
Cervical Functional Limitations
Time frame: 9 weeks after start of intervention
The investigators assessed this outcome with the Neck Disability Index.
4 secondary outcomes
Kinesiophobia
Time frame: 9 weeks after start of intervention
Cervical Range of Motion
Time frame: 9 weeks after start of intervention
Self-reported Global Effect of the Intervention
Time frame: 9 weeks after start of intervention
Patient Satisfaction
Time frame: 9 weeks after start of intervention
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 31 Jan 2017.
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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.
Paolo Pillastrini principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global Postural Re-education and Standard manual physical therapy in people with Nonspecific Chronic Neck Pain, run by University of Bologna at 1 site in Italy.
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 1 inclusion and 9 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 31 Jan 2017. 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 Italy. 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?
Pain (time frame: 9 weeks after start of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2017.