Neck PainNCT03085355
Evaluation of the Effect of the OMT Exercises Education for Pain in Participants With Cervical Pain
A study testing Exercises and PNE and Osteopathic manipulative treatment in people with Neck Pain and Pain, Neck, run by Instituto Brasileiro de Osteopatia at 1 site in Brazil.
Trial summary
The purpose of this randomized pragmatic clinical trial is to assess the effectiveness of the association of the osteopathic manipulative treatment in individuals with chronic non-specific neck pain who receive a exercice program and pain neurocience education. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Neck Pain, Pain, Neck
- What is being tested?
- Exercises and PNE and Osteopathic manipulative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2017to 1 Dec 2018
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of chronic neck pain does not specify that persists for more than 3 months
- Pain at least 3 points on 0-10 numeric pain rating and at least 14% disability on Neck Disability Index
Who cannot join
- individuals who report inflammatory previous surgery, spondylolisthesis, spinal stenosis, herniated disc, radiculopathy, fracture and musculoskeletal degenerative diseases. , Cancer, neurological diseases, pregnancy. They will be excluded participants who received some form of manipulative treatment in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of the Association of the Osteopathic Manipulative Treatment to Exercises, Education for Pain in Participants With Cervical Pain - Pragmatic Clinical Trial Randomized
The purpose of this randomized pragmatic clinical trial is to assess the effectiveness of the association of the osteopathic manipulative treatment in individuals with chronic non-specific neck pain who receive a exercice program and pain neurocience education.
Read the detailed description
The purpose of this study is to determine whether osteopathic manipulative treatment associated exercises and pain neurocience education improves pain and function in individuals with chronic non-specific neck pain
Design: a randomized single blind controlled pragmatic trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise and and pain neurocience education (n=20) or 2) exercise alone and pain neurocience education (n=20). Participants will receive 8 treatments during 4 weeks. Clinical outcomes will be obtained at 1 week, four weeks and 24 weeks after end of treatment.
Methods:
The primary outcome will be pain measured by 11-point numerical pain rating scale. The secondary outcome will be disability measured by the Neck Disability Index, range of motion measured by Cervical Range of Motion device, Pressure pain threshold measured by electronic algometer, global perceived effect, Pain Self-Efficacy Questionnaire and pain catastrophizing scale
- Conditions
- Neck Pain, Pain, Neck
- Being tested
- Exercises and PNE, Osteopathic manipulative treatment
- Keywords
- 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.
Exercises and PNEProcedure or surgery
Exercise for stretching and strength for neck muscles and pain neuroscience education
Osteopathic manipulative treatmentProcedure or surgery
Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education
| Study group | Role | What they receive |
|---|---|---|
| Exercises and PNE | Active comparator | Individuals with neck pain will receive a exercises program and pain neuroscience education. Participants will receive treatments during 4 weeks, 1 treatment per week Receives: Procedure: Exercises and PNE |
| Osteopathic manipulative treatment | Experimental | Individuals with neck pain in this group will also receive a exercises program and pain neuroscience education and the participants will receive treatments during 4 weeks, 1 treatment per week associated with Osteopathic Manipulative Treatment (OMT) Receives: Procedure: Osteopathic manipulative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
measured by numeric rating scale
Measured: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary outcomes (8)
Functionality and disability
measured by Neck Disability Scale
Measured: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Range of motion
measured by CROM device
Measured: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Pressure pain threshold
measured by electronic algometer
Measured: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Global perceived effect
measured by global perceived rating scale
Measured: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Self-efficacy
measured by The Pain Self-Efficacy Questionnaire
Measured: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Catastrophizing
measure by pain catastrophizing scale
Measured: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
kinesiophobia
measure by TAMPA scale
Measured: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
McGuill
measure by Mcguill scale
Measured: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Brasileiro de Osteopatia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Groisman, PT, DO, MSc, Instituto Brasileiro de Osteopatia
- Investigators
- sandro Groisman, Principal investigator, UFCSPA Federal University of Health Science of Porto AlegreGeraldo Jotz, Phd, Study director, UFCSPA Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085355
- Sponsor's protocol ID
- 003
- Status last verified
- Nov 2019
- First submitted
- 19 Mar 2017
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of the Association of the Osteopathic Manipulative Treatment to Exercises, Education for Pain in Participants With Cervical Pain - Pragmatic Clinical Trial Randomized
- ClinicalTrials.gov ID
- NCT03085355
- Acronym / sponsor ID
- 003
- Conditions
- Neck Pain, Pain, Neck
- Keywords
- neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Instituto Brasileiro de OsteopatiaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 21 Mar 2017 (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.
The purpose of this randomized pragmatic clinical trial is to assess the effectiveness of the association of the osteopathic manipulative treatment in individuals with chronic non-specific neck pain who receive a exercice program and pain neurocience education.
Detailed description
The purpose of this study is to determine whether osteopathic manipulative treatment associated exercises and pain neurocience education improves pain and function in individuals with chronic non-specific neck pain
Design: a randomized single blind controlled pragmatic trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise and and pain neurocience education (n=20) or 2) exercise alone and pain neurocience education (n=20). Participants will receive 8 treatments during 4 weeks. Clinical outcomes will be obtained at 1 week, four weeks and 24 weeks after end of treatment.
Methods:
The primary outcome will be pain measured by 11-point numerical pain rating scale. The secondary outcome will be disability measured by the Neck Disability Index, range of motion measured by Cervical Range of Motion device, Pressure pain threshold measured by electronic algometer, global perceived effect, Pain Self-Efficacy Questionnaire and pain catastrophizing scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercises and PNE | Active comparator | Procedure: Exercises and PNEIndividuals with neck pain will receive a exercises program and pain neuroscience education. Participants will receive treatments during 4 weeks, 1 treatment per week |
| Osteopathic manipulative treatment | Experimental | Procedure: Osteopathic manipulative treatmentIndividuals with neck pain in this group will also receive a exercises program and pain neuroscience education and the participants will receive treatments during 4 weeks, 1 treatment per week associated with Osteopathic Manipulative Treatment (OMT) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptoms of chronic neck pain does not specify that persists for more than 3 months
- Pain at least 3 points on 0-10 numeric pain rating and at least 14% disability on Neck Disability Index
Key exclusion criteria (1 listed)
- individuals who report inflammatory previous surgery, spondylolisthesis, spinal stenosis, herniated disc, radiculopathy, fracture and musculoskeletal degenerative diseases. , Cancer, neurological diseases, pregnancy. They will be excluded participants who received some form of manipulative treatment in the last three months.
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 |
|---|---|---|
| Exercises and PNEExercise for stretching and strength for neck muscles and pain neuroscience education | Procedure or surgery | Exercises and PNE |
| Osteopathic manipulative treatmentOsteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education | Procedure or surgery | Osteopathic manipulative treatment |
Primary outcome
Pain intensity
Time frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
measured by numeric rating scale
8 secondary outcomes
Functionality and disability
Time frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Range of motion
Time frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Pressure pain threshold
Time frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Global perceived effect
Time frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Self-efficacy
Time frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Catastrophizing
Time frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
kinesiophobia
Time frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
McGuill
Time frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
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 5 Nov 2019.
- Individual participant dataSharing planned: No
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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.
sandro Groisman principal investigator
UFCSPA Federal University of Health Science of Porto Alegre
Geraldo Jotz, Phd study director
UFCSPA Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises and PNE and Osteopathic manipulative treatment in people with Neck Pain and Pain, Neck, run by Instituto Brasileiro de Osteopatia at 1 site in Brazil.
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 2 inclusion and 1 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 5 Nov 2019. 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 Brazil. 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 intensity (time frame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment). 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 5 Nov 2019.