Neck PainNCT02051478
Thoracic Manipulation and Mobilization for Neck Pain
A study testing Thoracic mobilization and Thoracic manipulation in people with Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The purpose of this randomized clinical trial was to examine the widespread effects of thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain sensitivity and neck pain intensity in patients with chronic mechanical neck pain. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Thoracic mobilization and Thoracic manipulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to Jun 2013
- 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
- mechanical idiopathic neck pain
- bilateral pain symptoms
- chronic pain (>3 months of duration)
Who cannot join
- whiplash injury
- previous spine surgery
- diagnosis of cervical radiculopathy or myelopathy
- diagnosis of fibromyalgia
- having undergone any physical therapy intervention in the previous year
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CHANGES IN PRESSURE PAIN SENSITIVITY AND NECK PAIN AFTER THORACIC THRUST MANIPULATION OR NON-THRUST MOBILIZATION IN PATIENTS WITH MECHANICAL NECK PAIN
The purpose of this randomized clinical trial was to examine the widespread effects of thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain sensitivity and neck pain intensity in patients with chronic mechanical neck pain.
- Conditions
- Neck Pain
- Being tested
- Thoracic mobilization, Thoracic manipulation
- Keywords
- manipulation, mobilization, spine, pressure 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.
Thoracic mobilizationOther
Patients will receive 20 seconds bouts of grade III-IV of central posterior-anterior (PA) non-thrust mobilization from T3 to T6 spinous process as described by Maitland et al for an overall intervention time of approximately 2 minutes
Thoracic manipulationOther
A high-velocity, end range, anterior-posterior thrust applied through the elbows to the mid-thoracic spine will be applied
| Study group | Role | What they receive |
|---|---|---|
| Thoracic manipulation | Experimental | A high-velocity, end range, anterior-posterior thrust applied through the elbows to the mid-thoracic spine will be applied. Receives: Other: Thoracic manipulation |
| Thoracic mobilization | Active comparator | Patients will receive 20 seconds bouts of grade III-IV of central posterior-anterior (PA) non-thrust mobilization from T3 to T6 spinous process as described by Maitland et al for an overall intervention time of approximately 2 minutes Receives: Other: Thoracic mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pressure pain thresholds
The amount of pressure applied for the pressure sensation to first change to pain will be assessed with an electronic algometer (Somedic AB, Farsta, Sweden) over the C5-C6 zygapophyseal joint, second metacarpal and tibialis anterior muscle
Measured: Change between baseline and 1o minutes immediate after the intervention
Secondary outcomes (1)
Change in Neck pain intensity
Participants will rate the intensity of their neck pain at rest on an 11-point numerical pain rate scale (NPRS, 0: no pain, 10: maximum pain)
Measured: Change between baseline and 1o minutes immediate after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startSep 2012
- Primary completionJun 2013
- Study completionJun 2013
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- Jaime Salom.Moreno, PT, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051478
- Sponsor's protocol ID
- URJC2012/11
- Status last verified
- Jan 2014
- First submitted
- 28 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHANGES IN PRESSURE PAIN SENSITIVITY AND NECK PAIN AFTER THORACIC THRUST MANIPULATION OR NON-THRUST MOBILIZATION IN PATIENTS WITH MECHANICAL NECK PAIN
- ClinicalTrials.gov ID
- NCT02051478
- Acronym / sponsor ID
- URJC2012/11
- Conditions
- Neck Pain
- Keywords
- manipulation, mobilization, spine, pressure pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 Jan 2014 (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 randomized clinical trial was to examine the widespread effects of thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain sensitivity and neck pain intensity in patients with chronic mechanical neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic manipulation | Experimental | Other: Thoracic manipulationA high-velocity, end range, anterior-posterior thrust applied through the elbows to the mid-thoracic spine will be applied. |
| Thoracic mobilization | Active comparator | Other: Thoracic mobilizationPatients will receive 20 seconds bouts of grade III-IV of central posterior-anterior (PA) non-thrust mobilization from T3 to T6 spinous process as described by Maitland et al for an overall intervention time of approximately 2 minutes |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mechanical idiopathic neck pain
- bilateral pain symptoms
- chronic pain (>3 months of duration)
Key exclusion criteria (6 listed)
- whiplash injury
- previous spine surgery
- diagnosis of cervical radiculopathy or myelopathy
- diagnosis of fibromyalgia
- having undergone any physical therapy intervention in the previous year
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 |
|---|---|---|
| Thoracic mobilizationPatients will receive 20 seconds bouts of grade III-IV of central posterior-anterior (PA) non-thrust mobilization from T3 to T6 spinous process as described by Maitland et al for an overall intervention time of approximately 2 minutes | Other | Thoracic mobilization |
| Thoracic manipulationA high-velocity, end range, anterior-posterior thrust applied through the elbows to the mid-thoracic spine will be applied | Other | Thoracic manipulation |
Primary outcome
Change in Pressure pain thresholds
Time frame: Change between baseline and 1o minutes immediate after the intervention
The amount of pressure applied for the pressure sensation to first change to pain will be assessed with an electronic algometer (Somedic AB, Farsta, Sweden) over the C5-C6 zygapophyseal joint, second metacarpal and tibialis anterior muscle
1 secondary outcome
Change in Neck pain intensity
Time frame: Change between baseline and 1o minutes immediate after the 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 2014.
Related trials for Neck Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Ameliorated Pap Tests and Cervical Cancer Screening Participation
Cervical Cancer Screening, Cervical Cancer Screening Methods
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Not yet recruiting
Effects of Mobilization With and Without Suboccipital Muscle Release on Pain, Range of Motion, and Disability in Mechanical Neck Pain
Mechanical Neck Pain
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
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.
Jaime Salom.Moreno, PT, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic mobilization and Thoracic manipulation in people with Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 3 inclusion and 6 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 2014. 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 Spain. 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?
Change in Pressure pain thresholds (time frame: Change between baseline and 1o minutes immediate after the intervention). 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 2014.