Pain ThresholdNCT02828501
Additive Effects of Combined Spinal Manipulations on Pain Pressure Threshold
A study testing Spinal Manipulation in people with Pain Threshold, run by University of South Carolina.
Trial summary
Physical therapists frequently use spinal manipulation therapy (SMT) to treat spinal pain. However, the methods by which SMT exerts its effects are not well understood. The aim of this study is to assess potential changes in pain pressure threshold following both a cervical and lumbar spine manipulation in a single… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Threshold
- What is being tested?
- Spinal Manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Feb 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included in this study, consenting male and female participants must be between the ages of 18 and 60. This age range insures skeletal maturity with a reasonably low prevalence of severe osteoarthritis or osteopenia.
Who cannot join
- The presence of any of the following factors will exclude the participant from this study:
- Currently involved in a worker's compensation claim or in personal injury litigation.
- Currently on, or applying for, permanent or temporary disability due to a medical or mental health condition.
- Currently taking prescription analgesics.
- Activity-limiting pain arising from any site other than listed in the specific entry criteria.
- Additional exclusion criteria include the presence of any of the following conditions as determined by prior medical and/or radiographic examination or initial MRI:
Show all 26Show fewer
- pregnancy or have been pregnant in the last year;
- spinal osteoporosis or osteopenia;
- inflammatory joint disease;
- an infection involving the spine;
- severe arthritis;
- any current (within 5 years) neoplastic condition;
- any history of vertebral fracture with current bony instability or measurable deformity;
- severe lumbar stenosis (defined as an A-P diameter of the thecal sac of less than 5 mm at any level, from mid-sagittal lumbar T2-weighted MRI);
- diagnosis of cervical spinal stenosis
- any abnormalities or compression of the spinal cord, cauda equine, or spinal nerves;
- any upper or lower extremity nerve impairment;
- unstable angina, congestive heart failure, orthopnea, or severe hypertension;
- any history of a surgical procedure to the cervical or thoracic or lumbar spine;
- any surgical procedures to the abdomen, thorax, upper extremities, head or neck in the past 6 months prior to enrollment in the study;
- history of whiplash in the last 6 weeks;
- evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.;
- resting blood pressure greater than 140/90 mmHg at initial intake;
- presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia, or hyperlipidemia;
- current use of any of the following medications: narcotics, opiate-based analgesics, prescribed anticoagulants (this does not include low doses of ASA or NSAIDs), and oral or injected corticosteroids.
- These criteria are designed to exclude individuals for whom spinal manipulation is contraindicated.
About this study
Official title: Additive Effects of Combined Cervical and Lumbar Manipulation on Pain Pressure Threshold in a Single Session
Physical therapists frequently use spinal manipulation therapy (SMT) to treat spinal pain. However, the methods by which SMT exerts its effects are not well understood. The aim of this study is to assess potential changes in pain pressure threshold following both a cervical and lumbar spine manipulation in a single treatment session at sites local and diffuse to the site of manipulation application. This study will also attempt to determine if the order of the cervical and lumbar manipulation application impacts pain pressure threshold changes.
Read the detailed description
The aim of the proposed study is to add to the literature pertaining to the effects of spinal manipulation on PPT. To date, no studies have assessed whether or not there is an additive effect of multiple manipulations during a single treatment session on PPT. The proposed study will assess potential changes in PPT between baseline measurements, following a single cervical or lumbar manipulation, and after the delivery of second spinal manipulation performed on a different segment. The study design will allow for the investigation of possible additive effects, as well as for the effect of the first manipulation to be assessed independently of the second. Order of delivery of the cervical and lumbar manipulation will be randomized among participants to allow investigators to consider the possibility that the order of the manipulations impacts PPT changes.
Research Questions
- Is a single spinal manipulation of either the cervical or lumbar spine associated with an immediate increase in pain pressure threshold either locally or diffusely when compared to a no treatment control?
- What is the effect of a second spinal manipulation at a different segment immediately following the first spinal manipulation on pain pressure threshold?
- Is there a difference based on the order of which spinal manipulation is administered (cervical first, then lumbar; lumbar first, then cervical) on post-intervention local and diffuse pain pressure threshold?
Overview of Research Design This study will be a cross-sectional, single-blinded randomized control trial. This will be a single session, experimental approach in which participants who meet the inclusion/exclusion criteria will be divided into three groups: treatment group 1, treatment group 2, and control group. Group assignment will be performed using randomized concealed allocation. Participants will undergo pain pressure threshold testing using pressure algometry, followed by a cervical manipulation for treatment group 1 and a lumbar manipulation for treatment group 2. The control group will rest quietly for an allotted amount of time. Upon completion of the first intervention, a second pain pressure threshold assessment will be performed. Treatment group 1 will then receive a lumbar manipulation, while treatment group 2 receives a cervical manipulation. The control group will again rest quietly. Following the second intervention, a final pain pressure threshold assessment will be taken. The primary dependent measures will be 1) current pain intensity as reported by a verbal numeric pain rating scale, 2) self-reported stiffness, and 3) pain pressure threshold measured in Newtons.
- Conditions
- Pain Threshold
- Being tested
- Spinal Manipulation
- Keywords
- Pain Threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationProcedure or surgery
A spinal manipulation is a high velocity, low amplitude thrust through a physiological barrier in order to elicit a cavitation.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar manipulation group | Experimental | Spinal Manipulation Receives: Procedure: Spinal Manipulation |
| Cervical manipulation group | Experimental | Spinal Manipulation Receives: Procedure: Spinal Manipulation |
| Control group | No intervention | This group will receive a 2 minute supine rest between measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure-Pain Threshold as assessed by a pressure algometer
Measured: Two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ThresholdStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Jordon, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828501
- Sponsor's protocol ID
- Pro00043661
- Status last verified
- Apr 2019
- First submitted
- 22 Jun 2016
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jordon MK, Beattie PF, D'Urso S, Scriven S. Spinal manipulation does not affect pressure pain thresholds in the absence of neuromodulators: a randomized controlled trial. J Man Manip Ther. 2017 Sep;25(4):172-181. doi: 10.1080/10669817.2016.1230352. Epub 2016 Sep 12.
PubMed 28912629
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effects of Combined Cervical and Lumbar Manipulation on Pain Pressure Threshold in a Single Session
- ClinicalTrials.gov ID
- NCT02828501
- Acronym / sponsor ID
- Pro00043661
- Conditions
- Pain Threshold
- Keywords
- Pain Threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Jul 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.
Physical therapists frequently use spinal manipulation therapy (SMT) to treat spinal pain. However, the methods by which SMT exerts its effects are not well understood. The aim of this study is to assess potential changes in pain pressure threshold following both a cervical and lumbar spine manipulation in a single treatment session at sites local and diffuse to the site of manipulation application. This study will also attempt to determine if the order of the cervical and lumbar manipulation application impacts pain pressure threshold changes.
Detailed description
The aim of the proposed study is to add to the literature pertaining to the effects of spinal manipulation on PPT. To date, no studies have assessed whether or not there is an additive effect of multiple manipulations during a single treatment session on PPT. The proposed study will assess potential changes in PPT between baseline measurements, following a single cervical or lumbar manipulation, and after the delivery of second spinal manipulation performed on a different segment. The study design will allow for the investigation of possible additive effects, as well as for the effect of the first manipulation to be assessed independently of the second. Order of delivery of the cervical and lumbar manipulation will be randomized among participants to allow investigators to consider the possibility that the order of the manipulations impacts PPT changes.
Research Questions
- Is a single spinal manipulation of either the cervical or lumbar spine associated with an immediate increase in pain pressure threshold either locally or diffusely when compared to a no treatment control?
- What is the effect of a second spinal manipulation at a different segment immediately following the first spinal manipulation on pain pressure threshold?
- Is there a difference based on the order of which spinal manipulation is administered (cervical first, then lumbar; lumbar first, then cervical) on post-intervention local and diffuse pain pressure threshold?
Overview of Research Design This study will be a cross-sectional, single-blinded randomized control trial. This will be a single session, experimental approach in which participants who meet the inclusion/exclusion criteria will be divided into three groups: treatment group 1, treatment group 2, and control group. Group assignment will be performed using randomized concealed allocation. Participants will undergo pain pressure threshold testing using pressure algometry, followed by a cervical manipulation for treatment group 1 and a lumbar manipulation for treatment group 2. The control group will rest quietly for an allotted amount of time. Upon completion of the first intervention, a second pain pressure threshold assessment will be performed. Treatment group 1 will then receive a lumbar manipulation, while treatment group 2 receives a cervical manipulation. The control group will again rest quietly. Following the second intervention, a final pain pressure threshold assessment will be taken. The primary dependent measures will be 1) current pain intensity as reported by a verbal numeric pain rating scale, 2) self-reported stiffness, and 3) pain pressure threshold measured in Newtons.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumbar manipulation group | Experimental | Procedure: Spinal ManipulationSpinal Manipulation |
| Cervical manipulation group | Experimental | Procedure: Spinal ManipulationSpinal Manipulation |
| Control group | No intervention | –This group will receive a 2 minute supine rest between measurements |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be included in this study, consenting male and female participants must be between the ages of 18 and 60. This age range insures skeletal maturity with a reasonably low prevalence of severe osteoarthritis or osteopenia.
Key exclusion criteria (26 listed)
- The presence of any of the following factors will exclude the participant from this study:
- Additional exclusion criteria include the presence of any of the following conditions as determined by prior medical and/or radiographic examination or initial MRI:
- pregnancy or have been pregnant in the last year;
- spinal osteoporosis or osteopenia;
- inflammatory joint disease;
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 |
|---|---|---|
| Spinal ManipulationA spinal manipulation is a high velocity, low amplitude thrust through a physiological barrier in order to elicit a cavitation. | Procedure or surgery | Cervical manipulation group, Lumbar manipulation group |
Primary outcome
Pressure-Pain Threshold as assessed by a pressure algometer
Time frame: Two minutes
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 30 Apr 2019.
- Derived from this study: PubMed 28912629Jordon MK, Beattie PF, D'Urso S, Scriven S. Spinal manipulation does not affect pressure pain thresholds in the absence of neuromodulators: a randomized controlled trial. J Man Manip Ther. 2017 Sep;25(4):172-181. doi: 10.1080/10669817.2016.1230352. Epub 2016 Sep 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation in people with Pain Threshold, run by University of South Carolina.
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 26 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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Pressure-Pain Threshold as assessed by a pressure algometer (time frame: Two minutes). 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 NCT02828501, which also lists 1 linked publication.
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 30 Apr 2019.