Neck PainNCT02956863
The Effect of Osteopathic Treatment in Pain and Functionality Individuals With Chronic Neck Pain
A study testing Osteopathic manipulative treatment and Exercises in people with Neck Pain, run by Instituto Brasileiro de Osteopatia at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Osteopathic manipulative treatment and Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2016to Sep 2017
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptoms of chronic neck pain does not specify that persists for more than 3 months
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: The Effect of Osteopathic Manipulative Treatment in Pain and Functionality Individuals With Nonspecific Chronic Neck Pain: Randomized Clinical Trial
The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain
Read the detailed description
The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain Design: a randomized single blind placebo controlled trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise (n=20) or 2) exercise alone (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.
- Conditions
- Neck Pain
- Being tested
- Osteopathic manipulative treatment, Exercises
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatmentProcedure or surgery
Osteopathic manipulative treatment delivered on pragmatic way.
ExercisesProcedure or surgery
Exercise for stretching and strength for neck muscles
| Study group | Role | What they receive |
|---|---|---|
| Exercises | Active comparator | Individuals with neck pain will receive a exercises program. Participants will receive treatments during 4 weeks, 1 treatments per week. Receives: Procedure: Exercises |
| Osteopathic manipulative treatment | Experimental | Individuals with neck pain in this group will also receive a exercises program and the participants will receive treatments during 4 weeks, 1 treatments 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: 30 days after end treatment
Secondary outcomes (3)
range of motion
measured by CROM device
Measured: 30 days after end treatment
Pressure pain threshold
measured by electronic algometer
Measured: 30 days after end treatment
functionality and disability
measured by Neck Disability Scale
Measured: 30 days after end treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017
- Study completionSep 2017
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
- 40 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, MS, Principal investigator, IBO Brazilian Osteopathic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956863
- Sponsor's protocol ID
- 002
- Status last verified
- Feb 2018
- First submitted
- 3 Nov 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathic Manipulative Treatment in Pain and Functionality Individuals With Nonspecific Chronic Neck Pain: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02956863
- Acronym / sponsor ID
- 002
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Brasileiro de OsteopatiaUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Nov 2016 (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.
The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain
Detailed description
The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain Design: a randomized single blind placebo controlled trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise (n=20) or 2) exercise alone (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercises | Active comparator | Procedure: ExercisesIndividuals with neck pain will receive a exercises program. Participants will receive treatments during 4 weeks, 1 treatments per week. |
| Osteopathic manipulative treatment | Experimental | Procedure: Osteopathic manipulative treatmentIndividuals with neck pain in this group will also receive a exercises program and the participants will receive treatments during 4 weeks, 1 treatments per week associated with Osteopathic Manipulative Treatment (OMT) |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Symptoms of chronic neck pain does not specify that persists for more than 3 months
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 |
|---|---|---|
| Osteopathic manipulative treatmentOsteopathic manipulative treatment delivered on pragmatic way. | Procedure or surgery | Osteopathic manipulative treatment |
| ExercisesExercise for stretching and strength for neck muscles | Procedure or surgery | Exercises |
Primary outcome
Pain intensity
Time frame: 30 days after end treatment
measured by numeric rating scale
3 secondary outcomes
range of motion
Time frame: 30 days after end treatment
Pressure pain threshold
Time frame: 30 days after end treatment
functionality and disability
Time frame: 30 days after end 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 22 Feb 2018.
- 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, MS principal investigator
IBO Brazilian Osteopathic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulative treatment and Exercises in people with Neck Pain, 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 1 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 22 Feb 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 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: 30 days after end 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 22 Feb 2018.