PainNCT01469533
Pressure Pain Thresholds and Basal Electromyographic Activities Following Spinal Mechanical Manipulation
A study testing Spinal mechanical manipulation intervention in people with Pain, run by RenJi Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate if the application of spinal mechanical manipulation on low back region resulted in changes in pressure pain thresholds (PPT) in asymptomatic subjects and the extent of the hypoalgesia; whether it is local, regional or systemic. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Spinal mechanical manipulation intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Oct 2011
- 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
- asymptomatic volunteers
- age from 18 to 60 years
Who cannot join
- aversion to manual contact
- symptoms in the low back or lower extremities
- previous history of spine surgery
- receiving any manual therapy within the past 1 month before the study
- any contraindication to manipulation
- regular use of analgesic or anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Pressure Pain Thresholds and Basal Electromyographic Activities Following Spinal Mechanical Manipulation in Asymptomatic Subjects
The purpose of this study is to investigate if the application of spinal mechanical manipulation on low back region resulted in changes in pressure pain thresholds (PPT) in asymptomatic subjects and the extent of the hypoalgesia; whether it is local, regional or systemic. Simultaneously, the investigators are to further explore the phenomenon of reduced sEMG activity after spinal mechanical manipulation to better understand the immediate effects of mechanical manipulation on low back region.
Read the detailed description
Spinal manipulation (SM) is used by clinicians for the treatment of several chronic pain conditions. The effectiveness of different spinal manipulations targeted at the lumbar spine in patients with low back pain is supported by an increasing number of high-quality randomized clinical trials1and systematic reviews. Although these techniques have shown some effectiveness in clinical practice, most of clinical studies solely investigated the effects of spinal manipulation on overall reports of pain and function and the underlying mechanisms by which manipulation produce clinical effects remain largely unknown.
The neurophysiologic mechanisms by which manipulation inhibits pain, however, are matters of speculation and still under investigation. Proposed hypotheses have suggested that manipulation has the potential to remove the source of mechanical pain or induce stimulus-produced analgesia. Spinal manipulation induces sufficient force to simultaneously activate both superficial and deep somatic mechanoreceptors, proprioceptors, and nociceptors. The effect of this stimulation is a strong afferent segmental barrage of spinal cord sensory neurons, capable of altering the pattern of afferent input to the central nervous system and inhibiting the central transmission of pain. Other suggested mechanisms have been the activation of the endogenous opiate system, the alteration of the chemical mediators or the effects of joint cavitation. An understanding of the mechanism by which manipulations cause a hypoalgesic response is subject to further research and is currently far from complete. A review of the literature found several studies exploring immediate changes in mechanical pain sensitivity provoked by spinal manipulative procedures. Mobilisation/manipulation to the cervical spine has been shown to provide a hypoalgesic effect as measured by pressure pain thresholds (PPTs) in patients suffering from mechanical neck pain and lateral epicondylalgia. A hypoalgesic effect has also been demonstrated following mobilization to peripheral joints in the upper and lower limbs. Mobilizations to the lumbar spine have been shown to produce an immediate and significant widespread hypoalgesic effect in asymptomatic subjects However, Perry et al. that found unilateral mobilizations on the lumbar spine respectively had side specific response.
Besides analgesic effect, it has been presented spinal manipulation can reduce the increased resting muscle tone or spasm, which can be monitored by surface electromyography (sEMG). If the presence of a hypertonic muscle is functionally associated with a spinal dysfunction that is correctable by SM, it would consequently follow that the associated higher EMG level would diminish after appropriate SM. In a descriptive study DeVocht JW et al. found that manipulation induces an immediate change, usually a reduction, in resting EMG level in patients with low back pain. Herzog J reported the observation of a single but very dramatic decrease in resting EMG activity in thoracic musculature within 1 second of SM. One possible segmental mechanism could be that the manipulation may induce a reflex muscle relaxation by modifying proprioceptive group 1 and 2 afferents. However, few randomly controlled trials have directly investigated the effect of spinal mechanical manipulation on basal electromyographic activity (BEA) in asymptomatic subjects.
Spinal mechanical manipulation has been widely used in clinical manual therapy. However, because mechanical thrusts usually produce no cavitations, whether mechanical techniques produce the same hypoalgesic effects and muscle relaxation as manual techniques remains untested. To further elucidate the physiologic mechanisms associated with spinal mechanical manipulation, it is essential to investigate its effects in asymptomatic individuals who do not have any active central sensitization. In fact, recent studies have supported the use of asymptomatic subjects in studies related to neurophysiological mechanisms of spinal manipulations. Further research is therefore required to clarify if there is a hypoalgesic effect or muscle relaxation in response to spinal mechanical manipulation in the lumbar region in asymptomatic subjects.
- Conditions
- Pain
- Being tested
- Spinal mechanical manipulation intervention, Sham manipulation intervention
- Keywords
- Spine, Manipulation, Pain Threshold, Electromyography.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal mechanical manipulation interventionOther
Also called Activator methods maximal setting
Subjects in experimental group are assessed through use of the Activator Methods (AM) assessment protocol. Spinal adjustment of the indicated pelvis, sacrum and lumbar spine is performed through the use of spinal mechanical manipulation. In this study leg length analysis only uses Position #1 and Position #2. Mechanical manipulation is delivered with the Activator Ⅳ Adjusting Instrument (AAI Ⅳ; Activator Methods International, Ltd, Phoenix, AZ) set in the maximal force setting 4, as it is used in routine clinical practice. The Activator Ⅳ delivers a very short duration (<5 ms) force-time impulse with a peak force magnitude of approximately 176N.
Sham manipulation interventionOther
Also called Activator methods zero setting
Subjects in the control group receive a protocol identical to that described above, with the following exception: a sham mechanical thrust is delivered during the AM protocol. The sham procedure is accomplished by setting the expansion control knob on the Activator Ⅱ to the zero (off) position. The expansion control is used to adjust the spring compression and thus the amount of excursion of the instruments' stylus. In the zero position, no excursion of the stylus occurs, although the same clicking sound that the instrument produces during normal use is heard after manual activation of the mechanical trigger.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group receives the real spinal mechanical manipulation. Receives: Other: Spinal mechanical manipulation intervention |
| control group | Sham comparator | The control group receives the sham-manipulation procedure. Receives: Other: Sham manipulation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold assessment
A mechanical pressure algometer (Wagner, Greenwich, CT) is used to measure PPT levels. Participants report to stop the pressure stimulation immediately when the sensation turnes from pressure to pain. The L5-S1 zygapophyseal is chosen as a landmark local to the manipulation. The L5 dermatome is chosen to measure the extent of any hypoalgesic response. The first dorsal interossei in the hand is selected to evaluate if there was a systemic response to the manipulation.
Measured: within 10 minutes immediately after manipulation
Secondary outcomes (1)
Basal electromyographic activity
Basal electromyographic activity (BEA) of paraspinal muscles is measured using a BioGraph@ surface electromyography with Infiniti software Systems version 1.51B (Thought Technology, Montreal, Quebec). Electrodes are 2.25-in (5.72cm) triodes, disposable, and adhesive with Ag/AgCl snaps. The electrodes are placed 30mm from the spinous process of the fourth lumbar vertebra (L4) and 10mm from the spinous process of the fifth cervical vertebra (C5). The signal is selected for 10 seconds.
Measured: within 10 minutes immediately after manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangrui Wang, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469533
- Sponsor's protocol ID
- RenJiH-2011020
- Status last verified
- Nov 2011
- First submitted
- 3 Nov 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Giles LG, Muller R. Chronic spinal pain: a randomized clinical trial comparing medication, acupuncture, and spinal manipulation. Spine (Phila Pa 1976). 2003 Jul 15;28(14):1490-502; discussion 1502-3. doi: 10.1097/00007632-200307150-00003.
PubMed 12865832Lawrence DJ, Meeker W, Branson R, Bronfort G, Cates JR, Haas M, Haneline M, Micozzi M, Updyke W, Mootz R, Triano JJ, Hawk C. Chiropractic management of low back pain and low back-related leg complaints: a literature synthesis. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):659-74. doi: 10.1016/j.jmpt.2008.10.007.
PubMed 19028250Boal RW, Gillette RG. Central neuronal plasticity, low back pain and spinal manipulative therapy. J Manipulative Physiol Ther. 2004 Jun;27(5):314-26. doi: 10.1016/j.jmpt.2004.04.005.
PubMed 15195039Cramer G, Budgell B, Henderson C, Khalsa P, Pickar J. Basic science research related to chiropractic spinal adjusting: the state of the art and recommendations revisited. J Manipulative Physiol Ther. 2006 Nov-Dec;29(9):726-61. doi: 10.1016/j.jmpt.2006.09.003.
PubMed 17142166Vernon H. Qualitative review of studies of manipulation-induced hypoalgesia. J Manipulative Physiol Ther. 2000 Feb;23(2):134-8. doi: 10.1016/s0161-4754(00)90084-8.
PubMed 10714544de Camargo VM, Alburquerque-Sendin F, Berzin F, Stefanelli VC, de Souza DP, Fernandez-de-las-Penas C. Immediate effects on electromyographic activity and pressure pain thresholds after a cervical manipulation in mechanical neck pain: a randomized controlled trial. J Manipulative Physiol Ther. 2011 May;34(4):211-20. doi: 10.1016/j.jmpt.2011.02.002. Epub 2011 Mar 21.
PubMed 21621722Fernandez-Carnero J, Fernandez-de-las-Penas C, Cleland JA. Immediate hypoalgesic and motor effects after a single cervical spine manipulation in subjects with lateral epicondylalgia. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):675-81. doi: 10.1016/j.jmpt.2008.10.005.
PubMed 19028251DeVocht JW, Pickar JG, Wilder DG. Spinal manipulation alters electromyographic activity of paraspinal muscles: a descriptive study. J Manipulative Physiol Ther. 2005 Sep;28(7):465-71. doi: 10.1016/j.jmpt.2005.07.002.
PubMed 16182019Fernandez-de-Las-Penas C, Alonso-Blanco C, Cleland JA, Rodriguez-Blanco C, Alburquerque-Sendin F. Changes in pressure pain thresholds over C5-C6 zygapophyseal joint after a cervicothoracic junction manipulation in healthy subjects. J Manipulative Physiol Ther. 2008 Jun;31(5):332-7. doi: 10.1016/j.jmpt.2008.04.006.
PubMed 18558274
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pressure Pain Thresholds and Basal Electromyographic Activities Following Spinal Mechanical Manipulation in Asymptomatic Subjects
- ClinicalTrials.gov ID
- NCT01469533
- Acronym / sponsor ID
- RenJiH-2011020
- Conditions
- Pain
- Keywords
- Spine, Manipulation, Pain Threshold, Electromyography.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Nov 2011 (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 investigate if the application of spinal mechanical manipulation on low back region resulted in changes in pressure pain thresholds (PPT) in asymptomatic subjects and the extent of the hypoalgesia; whether it is local, regional or systemic. Simultaneously, the investigators are to further explore the phenomenon of reduced sEMG activity after spinal mechanical manipulation to better understand the immediate effects of mechanical manipulation on low back region.
Detailed description
Spinal manipulation (SM) is used by clinicians for the treatment of several chronic pain conditions. The effectiveness of different spinal manipulations targeted at the lumbar spine in patients with low back pain is supported by an increasing number of high-quality randomized clinical trials1and systematic reviews. Although these techniques have shown some effectiveness in clinical practice, most of clinical studies solely investigated the effects of spinal manipulation on overall reports of pain and function and the underlying mechanisms by which manipulation produce clinical effects remain largely unknown.
The neurophysiologic mechanisms by which manipulation inhibits pain, however, are matters of speculation and still under investigation. Proposed hypotheses have suggested that manipulation has the potential to remove the source of mechanical pain or induce stimulus-produced analgesia. Spinal manipulation induces sufficient force to simultaneously activate both superficial and deep somatic mechanoreceptors, proprioceptors, and nociceptors. The effect of this stimulation is a strong afferent segmental barrage of spinal cord sensory neurons, capable of altering the pattern of afferent input to the central nervous system and inhibiting the central transmission of pain. Other suggested mechanisms have been the activation of the endogenous opiate system, the alteration of the chemical mediators or the effects of joint cavitation. An understanding of the mechanism by which manipulations cause a hypoalgesic response is subject to further research and is currently far from complete. A review of the literature found several studies exploring immediate changes in mechanical pain sensitivity provoked by spinal manipulative procedures. Mobilisation/manipulation to the cervical spine has been shown to provide a hypoalgesic effect as measured by pressure pain thresholds (PPTs) in patients suffering from mechanical neck pain and lateral epicondylalgia. A hypoalgesic effect has also been demonstrated following mobilization to peripheral joints in the upper and lower limbs. Mobilizations to the lumbar spine have been shown to produce an immediate and significant widespread hypoalgesic effect in asymptomatic subjects However, Perry et al. that found unilateral mobilizations on the lumbar spine respectively had side specific response.
Besides analgesic effect, it has been presented spinal manipulation can reduce the increased resting muscle tone or spasm, which can be monitored by surface electromyography (sEMG). If the presence of a hypertonic muscle is functionally associated with a spinal dysfunction that is correctable by SM, it would consequently follow that the associated higher EMG level would diminish after appropriate SM. In a descriptive study DeVocht JW et al. found that manipulation induces an immediate change, usually a reduction, in resting EMG level in patients with low back pain. Herzog J reported the observation of a single but very dramatic decrease in resting EMG activity in thoracic musculature within 1 second of SM. One possible segmental mechanism could be that the manipulation may induce a reflex muscle relaxation by modifying proprioceptive group 1 and 2 afferents. However, few randomly controlled trials have directly investigated the effect of spinal mechanical manipulation on basal electromyographic activity (BEA) in asymptomatic subjects.
Spinal mechanical manipulation has been widely used in clinical manual therapy. However, because mechanical thrusts usually produce no cavitations, whether mechanical techniques produce the same hypoalgesic effects and muscle relaxation as manual techniques remains untested. To further elucidate the physiologic mechanisms associated with spinal mechanical manipulation, it is essential to investigate its effects in asymptomatic individuals who do not have any active central sensitization. In fact, recent studies have supported the use of asymptomatic subjects in studies related to neurophysiological mechanisms of spinal manipulations. Further research is therefore required to clarify if there is a hypoalgesic effect or muscle relaxation in response to spinal mechanical manipulation in the lumbar region in asymptomatic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Spinal mechanical manipulation interventionThe experimental group receives the real spinal mechanical manipulation. |
| control group | Sham comparator | Other: Sham manipulation interventionThe control group receives the sham-manipulation procedure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- asymptomatic volunteers
- age from 18 to 60 years
Key exclusion criteria (6 listed)
- aversion to manual contact
- symptoms in the low back or lower extremities
- previous history of spine surgery
- receiving any manual therapy within the past 1 month before the study
- any contraindication to manipulation
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 mechanical manipulation interventionAlso: Activator methods maximal settingSubjects in experimental group are assessed through use of the Activator Methods (AM) assessment protocol. Spinal adjustment of the indicated pelvis, sacrum and lumbar spine is performed through the use of spinal mechanical manipulation. In this study leg length analysis only uses Position #1 and Position #2. Mechanical manipulation is delivered with the Activator Ⅳ Adjusting Instrument (AAI Ⅳ; Activator Methods International, Ltd, Phoenix, AZ) set in the maximal force setting 4, as it is used in routine clinical practice. The Activator Ⅳ delivers a very short duration (<5 ms) force-time impulse with a peak force magnitude of approximately 176N. | Other | experimental group |
| Sham manipulation interventionAlso: Activator methods zero settingSubjects in the control group receive a protocol identical to that described above, with the following exception: a sham mechanical thrust is delivered during the AM protocol. The sham procedure is accomplished by setting the expansion control knob on the Activator Ⅱ to the zero (off) position. The expansion control is used to adjust the spring compression and thus the amount of excursion of the instruments' stylus. In the zero position, no excursion of the stylus occurs, although the same clicking sound that the instrument produces during normal use is heard after manual activation of the mechanical trigger. | Other | control group |
Primary outcome
Pressure pain threshold assessment
Time frame: within 10 minutes immediately after manipulation
A mechanical pressure algometer (Wagner, Greenwich, CT) is used to measure PPT levels. Participants report to stop the pressure stimulation immediately when the sensation turnes from pressure to pain. The L5-S1 zygapophyseal is chosen as a landmark local to the manipulation. The L5 dermatome is chosen to measure the extent of any hypoalgesic response. The first dorsal interossei in the hand is selected to evaluate if there was a systemic response to the manipulation.
1 secondary outcome
Basal electromyographic activity
Time frame: within 10 minutes immediately after manipulation
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 10 Nov 2011.
- Background: PubMed 12865832Giles LG, Muller R. Chronic spinal pain: a randomized clinical trial comparing medication, acupuncture, and spinal manipulation. Spine (Phila Pa 1976). 2003 Jul 15;28(14):1490-502; discussion 1502-3. doi: 10.1097/00007632-200307150-00003.
- Background: PubMed 19028250Lawrence DJ, Meeker W, Branson R, Bronfort G, Cates JR, Haas M, Haneline M, Micozzi M, Updyke W, Mootz R, Triano JJ, Hawk C. Chiropractic management of low back pain and low back-related leg complaints: a literature synthesis. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):659-74. doi: 10.1016/j.jmpt.2008.10.007.
- Background: PubMed 15195039Boal RW, Gillette RG. Central neuronal plasticity, low back pain and spinal manipulative therapy. J Manipulative Physiol Ther. 2004 Jun;27(5):314-26. doi: 10.1016/j.jmpt.2004.04.005.
- Background: PubMed 17142166Cramer G, Budgell B, Henderson C, Khalsa P, Pickar J. Basic science research related to chiropractic spinal adjusting: the state of the art and recommendations revisited. J Manipulative Physiol Ther. 2006 Nov-Dec;29(9):726-61. doi: 10.1016/j.jmpt.2006.09.003.
- Background: PubMed 10714544Vernon H. Qualitative review of studies of manipulation-induced hypoalgesia. J Manipulative Physiol Ther. 2000 Feb;23(2):134-8. doi: 10.1016/s0161-4754(00)90084-8.
- Background: PubMed 21621722de Camargo VM, Alburquerque-Sendin F, Berzin F, Stefanelli VC, de Souza DP, Fernandez-de-las-Penas C. Immediate effects on electromyographic activity and pressure pain thresholds after a cervical manipulation in mechanical neck pain: a randomized controlled trial. J Manipulative Physiol Ther. 2011 May;34(4):211-20. doi: 10.1016/j.jmpt.2011.02.002. Epub 2011 Mar 21.
- Background: PubMed 19028251Fernandez-Carnero J, Fernandez-de-las-Penas C, Cleland JA. Immediate hypoalgesic and motor effects after a single cervical spine manipulation in subjects with lateral epicondylalgia. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):675-81. doi: 10.1016/j.jmpt.2008.10.005.
- Background: PubMed 16182019DeVocht JW, Pickar JG, Wilder DG. Spinal manipulation alters electromyographic activity of paraspinal muscles: a descriptive study. J Manipulative Physiol Ther. 2005 Sep;28(7):465-71. doi: 10.1016/j.jmpt.2005.07.002.
- Background: PubMed 18558274Fernandez-de-Las-Penas C, Alonso-Blanco C, Cleland JA, Rodriguez-Blanco C, Alburquerque-Sendin F. Changes in pressure pain thresholds over C5-C6 zygapophyseal joint after a cervicothoracic junction manipulation in healthy subjects. J Manipulative Physiol Ther. 2008 Jun;31(5):332-7. doi: 10.1016/j.jmpt.2008.04.006.
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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.
Xiangrui Wang study director
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal mechanical manipulation intervention in people with Pain, run by RenJi Hospital at 1 site in China.
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 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 10 Nov 2011. 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 China. 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. Some participants in this study may receive a placebo. 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 assessment (time frame: within 10 minutes immediately after manipulation). 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 NCT01469533, which also lists 9 linked publications.
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 10 Nov 2011.