Subluxation of Joint of Lumbar SpineNCT02848456
The Effects of Spinal Manipulation on Central Nervous System Activity Measured by Reflexive Calf Muscle Recruitment
A study testing Spinal Manipulation, Max Voluntary Isometric Contraction and SM+MVIC in people with Subluxation of Joint of Lumbar Spine, run by Grant Sanders at 1 site in United States.
Trial summary
This study investigated the effects of spinal manipulation on central nervous system activity. The presence of postactivation potentiation, an increase in muscular force production following prior muscular contractions, was measured with electromyography and the muscular force production during electrically-induced… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Subluxation of Joint of Lumbar Spine
- What is being tested?
- Spinal Manipulation, Max Voluntary Isometric Contraction and SM+MVIC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2014
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least one year of resistance training experience and current completion of at least three training sessions per week
- Males needed to be able to back squat a minimum load of 1.5 x body weight
- Females needed to be able to back squat 1 x body weight
Who cannot join
- Any pain in the lower back, abdomen or legs and/or surgeries performed in these regions
Trial locations and contacts
1 site in 1 country.
United States1 site
College of Education, Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, KY
Lexington, Kentucky, 40506
About this study
Official title: The Effects of Spinal Manipulative Therapy on Postactivation Potentiation
This study investigated the effects of spinal manipulation on central nervous system activity. The presence of postactivation potentiation, an increase in muscular force production following prior muscular contractions, was measured with electromyography and the muscular force production during electrically-induced calf muscle reflexes. It was hypothesized that significantly greater potentiation would be stimulated by a calf muscle contraction with spinal manipulation delivered immediately beforehand than the potentiation arising from the contraction only.
Read the detailed description
A randomized, controlled, single-blind crossover study design was utilized, and the three independent variables were spinal manipulative therapy (SMT), a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or SMT immediately preceding the MVIC (SMT + MVIC). The treatment order was randomized for each of the three sessions before the tibial nerve Hmax/Mmax stimulation protocol.
Each of the four dependent variables were evoked during the tibial nerve H-reflex stimulation protocol at the conclusion of each session, and included the Hmax/Mmax ratio (%) of the gastrocnemius and soleus muscles and the isometric twitch torque occurring at Hmax and at Mmax. Hmax, the highest H-reflex amplitude, is an indication of the greatest possible reflex activation; as such, it is an estimate of the number of motor neurons a subject is capable of activating in a given state. Further increases in the stimulation intensity cause the subsequent M-wave to reach its highest amplitude, Mmax. Mmax is a compound muscle action potential (CMAP) which represents full muscle activation. Specific to the current investigation, Mmax indicated activation of the total volume of the gastrocnemius/soleus motor neuron (MN) pool.
Given that Hmax is an inference of the number of MNs being recruited, and Mmax constitutes the entire motor neuron pool, the proportion of the entire MN pool capable of being recruited can be estimated with the Hmax/Mmax ratio. The Hmax/Mmax ratio was determined by division of the EMG peak-to-peak amplitudes (mV) evoked at Hmax by the preceding Mmax EMG peak-to-peak amplitudes. Differences in each of the four dependent variables (Hmax/Mmax ratios of the gastrocnemius and soleus and the peak twitch torques evoked at Hmax and Mmax) following each treatment form of SMT, MVIC or SMT+MVIC delivered during the three data collection sessions on three separate days were determined with a two-way (treatment × time point) repeated measures ANOVA. Percent changes from baseline were also calculated for each of the dependent variables, and the same type of ANOVA was used to determine differences in the within-subjects effects of each treatment.
- Conditions
- Subluxation of Joint of Lumbar Spine
- Being tested
- Spinal Manipulation, Max Voluntary Isometric Contraction, SM+MVIC
- Keywords
- Manipulation, Spinal, H-Reflex, Muscle Contraction, Muscle Strength Dynamometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationProcedure or surgery
Manual, side-posture, high-velocity low-amplitude spinal manipulation targeting the lower lumbar spine and sacroiliac joints
Max Voluntary Isometric ContractionProcedure or surgery
A 10 second plantar flexion maximal voluntary isometric contraction
SM+MVICProcedure or surgery
The spinal manipulation immediately preceding the maximal voluntary isometric contraction
| Study group | Role | What they receive |
|---|---|---|
| Spinal Manipulation SM | Active comparator | In a repeated measures, crossover design, all subjects received one of three randomized treatments during three separate sessions: SM; a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or the manipulation immediately preceding the contraction (SM+MVIC). Receives: Procedure: Spinal Manipulation |
| Max Voluntary Isometric Contraction MVIC | Active comparator | In a repeated measures, crossover design, all subjects received one of three randomized treatments during three separate sessions: SM; a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or the manipulation immediately preceding the contraction (SM+MVIC). Receives: Procedure: Max Voluntary Isometric Contraction |
| SM+MVIC | Active comparator | In a repeated measures, crossover design, all subjects received one of three randomized treatments during three separate sessions: SM; a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or the manipulation immediately preceding the contraction (SM+MVIC). Receives: Procedure: SM+MVIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in H-reflex amplitudes of the gastrocnemius and soleus muscles compared to baseline
Peak-to-peak EMG amplitudes (mV) at Hmax of the gastrocnemius and soleus were recorded before and immediately following the three separate treatments
Measured: Data were collected at 17 time points during a 20-minute tibial nerve electrical stimulation protocol post-treatment: 20 seconds, 40 seconds, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 14:00, 16:00, 18:00 and 20:00 minutes
Changes in isometric twitch torques of the gastrocnemius and soleus muscles compared to baseline
Twitch torques (Nm) of the gastrocnemius and soleus at Mmax were recorded before and immediately following the three separate treatments
Measured: Data were collected at 17 time points during a 20-minute tibial nerve electrical stimulation protocol post-treatment: 10 seconds, 30 seconds, 50 seconds, 1:30, 2:30, 3:30, 4:30, 5:30, 6:30, 7:30, 8:30, 9:30, 11:00, 13:00, 15:00, 17:00 and 19:00 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Subluxation of Joint of Lumbar SpineStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grant Sanders
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Sponsor-investigator, Grant Sanders, University of Kentucky
- Investigators
- Grant D Sanders, D.C., Ph.D., Principal investigator, College of Education, Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, KYJames W Yates, Ph.D., Study chair, College of Education, Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, KY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848456
- Sponsor's protocol ID
- 14-0507-F6A
- Status last verified
- Apr 2017
- First submitted
- 13 Jul 2016
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Shared data include the subjects' reflexive EMG amplitudes and peak torques of the gastrocnemius and soleus during the Hoffmann Reflex electrical stimulation protocol at the conclusion of each data collection session. These raw data are available in Appendix K of the PI's dissertation, which may be obtained at http://uknowledge.uky.edu/khp\_etds/27/
Publications
Hurwitz EL. Epidemiology: spinal manipulation utilization. J Electromyogr Kinesiol. 2012 Oct;22(5):648-54. doi: 10.1016/j.jelekin.2012.01.006. Epub 2012 Jan 29.
PubMed 22289432Michaleff ZA, Lin CW, Maher CG, van Tulder MW. Spinal manipulation epidemiology: systematic review of cost effectiveness studies. J Electromyogr Kinesiol. 2012 Oct;22(5):655-62. doi: 10.1016/j.jelekin.2012.02.011. Epub 2012 Mar 18.
PubMed 22429823Goertz CM, Long CR, Hondras MA, Petri R, Delgado R, Lawrence DJ, Owens EF, Meeker WC. Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study. Spine (Phila Pa 1976). 2013 Apr 15;38(8):627-34. doi: 10.1097/BRS.0b013e31827733e7.
PubMed 23060056Goertz CM, Pohlman KA, Vining RD, Brantingham JW, Long CR. Patient-centered outcomes of high-velocity, low-amplitude spinal manipulation for low back pain: a systematic review. J Electromyogr Kinesiol. 2012 Oct;22(5):670-91. doi: 10.1016/j.jelekin.2012.03.006. Epub 2012 Apr 24.
PubMed 22534288von Heymann WJ, Schloemer P, Timm J, Muehlbauer B. Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo. Spine (Phila Pa 1976). 2013 Apr 1;38(7):540-8. doi: 10.1097/BRS.0b013e318275d09c.
PubMed 23026869Boline PD, Kassak K, Bronfort G, Nelson C, Anderson AV. Spinal manipulation vs. amitriptyline for the treatment of chronic tension-type headaches: a randomized clinical trial. J Manipulative Physiol Ther. 1995 Mar-Apr;18(3):148-54.
PubMed 7790794Nelson CF, Bronfort G, Evans R, Boline P, Goldsmith C, Anderson AV. The efficacy of spinal manipulation, amitriptyline and the combination of both therapies for the prophylaxis of migraine headache. J Manipulative Physiol Ther. 1998 Oct;21(8):511-9.
PubMed 9798179Burton AK, Tillotson KM, Cleary J. Single-blind randomised controlled trial of chemonucleolysis and manipulation in the treatment of symptomatic lumbar disc herniation. Eur Spine J. 2000 Jun;9(3):202-7. doi: 10.1007/s005869900113.
PubMed 10905437Haas M, Sharma R, Stano M. Cost-effectiveness of medical and chiropractic care for acute and chronic low back pain. J Manipulative Physiol Ther. 2005 Oct;28(8):555-63. doi: 10.1016/j.jmpt.2005.08.006.
PubMed 16226622Korthals-de Bos IB, Hoving JL, van Tulder MW, Rutten-van Molken MP, Ader HJ, de Vet HC, Koes BW, Vondeling H, Bouter LM. Cost effectiveness of physiotherapy, manual therapy, and general practitioner care for neck pain: economic evaluation alongside a randomised controlled trial. BMJ. 2003 Apr 26;326(7395):911. doi: 10.1136/bmj.326.7395.911.
PubMed 12714472Gunnar Brolinson P, McGinley SM, Kerger S. Osteopathic manipulative medicine and the athlete. Curr Sports Med Rep. 2008 Feb;7(1):49-56. doi: 10.1097/01.CSMR.0000308664.13278.a7.
PubMed 18296946Julian C, Hoskins W, Vitiello AL. Sports chiropractic management at the World Ice Hockey Championships. Chiropr Osteopat. 2010 Dec 3;18:32. doi: 10.1186/1746-1340-18-32.
PubMed 21129212Nook DD, Nook BC. A report of the 2009 World Games injury surveillance of individuals who voluntarily used the International Federation of Sports Chiropractic delegation. J Manipulative Physiol Ther. 2011 Jan;34(1):54-61. doi: 10.1016/j.jmpt.2010.11.003.
PubMed 21237408Uchacz GP. 2010 olympic winter games chiropractic: the making of history. J Can Chiropr Assoc. 2010 Mar;54(1):14-6. No abstract available.
PubMed 20195421Miners AL. Chiropractic treatment and the enhancement of sport performance: a narrative literature review. J Can Chiropr Assoc. 2010 Dec;54(4):210-21.
PubMed 21120012
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Spinal Manipulative Therapy on Postactivation Potentiation
- ClinicalTrials.gov ID
- NCT02848456
- Acronym / sponsor ID
- 14-0507-F6A
- Conditions
- Subluxation of Joint of Lumbar Spine
- Keywords
- Manipulation, Spinal, H-Reflex, Muscle Contraction, Muscle Strength Dynamometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Grant SandersUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 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.
This study investigated the effects of spinal manipulation on central nervous system activity. The presence of postactivation potentiation, an increase in muscular force production following prior muscular contractions, was measured with electromyography and the muscular force production during electrically-induced calf muscle reflexes. It was hypothesized that significantly greater potentiation would be stimulated by a calf muscle contraction with spinal manipulation delivered immediately beforehand than the potentiation arising from the contraction only.
Detailed description
A randomized, controlled, single-blind crossover study design was utilized, and the three independent variables were spinal manipulative therapy (SMT), a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or SMT immediately preceding the MVIC (SMT + MVIC). The treatment order was randomized for each of the three sessions before the tibial nerve Hmax/Mmax stimulation protocol.
Each of the four dependent variables were evoked during the tibial nerve H-reflex stimulation protocol at the conclusion of each session, and included the Hmax/Mmax ratio (%) of the gastrocnemius and soleus muscles and the isometric twitch torque occurring at Hmax and at Mmax. Hmax, the highest H-reflex amplitude, is an indication of the greatest possible reflex activation; as such, it is an estimate of the number of motor neurons a subject is capable of activating in a given state. Further increases in the stimulation intensity cause the subsequent M-wave to reach its highest amplitude, Mmax. Mmax is a compound muscle action potential (CMAP) which represents full muscle activation. Specific to the current investigation, Mmax indicated activation of the total volume of the gastrocnemius/soleus motor neuron (MN) pool.
Given that Hmax is an inference of the number of MNs being recruited, and Mmax constitutes the entire motor neuron pool, the proportion of the entire MN pool capable of being recruited can be estimated with the Hmax/Mmax ratio. The Hmax/Mmax ratio was determined by division of the EMG peak-to-peak amplitudes (mV) evoked at Hmax by the preceding Mmax EMG peak-to-peak amplitudes. Differences in each of the four dependent variables (Hmax/Mmax ratios of the gastrocnemius and soleus and the peak twitch torques evoked at Hmax and Mmax) following each treatment form of SMT, MVIC or SMT+MVIC delivered during the three data collection sessions on three separate days were determined with a two-way (treatment × time point) repeated measures ANOVA. Percent changes from baseline were also calculated for each of the dependent variables, and the same type of ANOVA was used to determine differences in the within-subjects effects of each treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spinal Manipulation SM | Active comparator | Procedure: Spinal ManipulationIn a repeated measures, crossover design, all subjects received one of three randomized treatments during three separate sessions: SM; a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or the manipulation immediately preceding the contraction (SM+MVIC). |
| Max Voluntary Isometric Contraction MVIC | Active comparator | Procedure: Max Voluntary Isometric ContractionIn a repeated measures, crossover design, all subjects received one of three randomized treatments during three separate sessions: SM; a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or the manipulation immediately preceding the contraction (SM+MVIC). |
| SM+MVIC | Active comparator | Procedure: SM+MVICIn a repeated measures, crossover design, all subjects received one of three randomized treatments during three separate sessions: SM; a 10 second plantar flexion maximal voluntary isometric contraction (MVIC) or the manipulation immediately preceding the contraction (SM+MVIC). |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- At least one year of resistance training experience and current completion of at least three training sessions per week
- Males needed to be able to back squat a minimum load of 1.5 x body weight
- Females needed to be able to back squat 1 x body weight
Key exclusion criteria (1 listed)
- Any pain in the lower back, abdomen or legs and/or surgeries performed in these regions
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 ManipulationManual, side-posture, high-velocity low-amplitude spinal manipulation targeting the lower lumbar spine and sacroiliac joints | Procedure or surgery | Spinal Manipulation SM |
| Max Voluntary Isometric ContractionA 10 second plantar flexion maximal voluntary isometric contraction | Procedure or surgery | Max Voluntary Isometric Contraction MVIC |
| SM+MVICThe spinal manipulation immediately preceding the maximal voluntary isometric contraction | Procedure or surgery | SM+MVIC |
Primary outcome
Changes in H-reflex amplitudes of the gastrocnemius and soleus muscles compared to baseline
Time frame: Data were collected at 17 time points during a 20-minute tibial nerve electrical stimulation protocol post-treatment: 20 seconds, 40 seconds, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 14:00, 16:00, 18:00 and 20:00 minutes
Peak-to-peak EMG amplitudes (mV) at Hmax of the gastrocnemius and soleus were recorded before and immediately following the three separate treatments
Changes in isometric twitch torques of the gastrocnemius and soleus muscles compared to baseline
Time frame: Data were collected at 17 time points during a 20-minute tibial nerve electrical stimulation protocol post-treatment: 10 seconds, 30 seconds, 50 seconds, 1:30, 2:30, 3:30, 4:30, 5:30, 6:30, 7:30, 8:30, 9:30, 11:00, 13:00, 15:00, 17:00 and 19:00 minutes
Twitch torques (Nm) of the gastrocnemius and soleus at Mmax were recorded before and immediately following the three separate treatments
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 19 Apr 2017.
- Background: PubMed 22289432Hurwitz EL. Epidemiology: spinal manipulation utilization. J Electromyogr Kinesiol. 2012 Oct;22(5):648-54. doi: 10.1016/j.jelekin.2012.01.006. Epub 2012 Jan 29.
- Background: PubMed 22429823Michaleff ZA, Lin CW, Maher CG, van Tulder MW. Spinal manipulation epidemiology: systematic review of cost effectiveness studies. J Electromyogr Kinesiol. 2012 Oct;22(5):655-62. doi: 10.1016/j.jelekin.2012.02.011. Epub 2012 Mar 18.
- Background: PubMed 23060056Goertz CM, Long CR, Hondras MA, Petri R, Delgado R, Lawrence DJ, Owens EF, Meeker WC. Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study. Spine (Phila Pa 1976). 2013 Apr 15;38(8):627-34. doi: 10.1097/BRS.0b013e31827733e7.
- Background: PubMed 22534288Goertz CM, Pohlman KA, Vining RD, Brantingham JW, Long CR. Patient-centered outcomes of high-velocity, low-amplitude spinal manipulation for low back pain: a systematic review. J Electromyogr Kinesiol. 2012 Oct;22(5):670-91. doi: 10.1016/j.jelekin.2012.03.006. Epub 2012 Apr 24.
- Background: PubMed 23026869von Heymann WJ, Schloemer P, Timm J, Muehlbauer B. Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo. Spine (Phila Pa 1976). 2013 Apr 1;38(7):540-8. doi: 10.1097/BRS.0b013e318275d09c.
- Background: PubMed 7790794Boline PD, Kassak K, Bronfort G, Nelson C, Anderson AV. Spinal manipulation vs. amitriptyline for the treatment of chronic tension-type headaches: a randomized clinical trial. J Manipulative Physiol Ther. 1995 Mar-Apr;18(3):148-54.
- Background: PubMed 9798179Nelson CF, Bronfort G, Evans R, Boline P, Goldsmith C, Anderson AV. The efficacy of spinal manipulation, amitriptyline and the combination of both therapies for the prophylaxis of migraine headache. J Manipulative Physiol Ther. 1998 Oct;21(8):511-9.
- Background: PubMed 10905437Burton AK, Tillotson KM, Cleary J. Single-blind randomised controlled trial of chemonucleolysis and manipulation in the treatment of symptomatic lumbar disc herniation. Eur Spine J. 2000 Jun;9(3):202-7. doi: 10.1007/s005869900113.
- Background: PubMed 16226622Haas M, Sharma R, Stano M. Cost-effectiveness of medical and chiropractic care for acute and chronic low back pain. J Manipulative Physiol Ther. 2005 Oct;28(8):555-63. doi: 10.1016/j.jmpt.2005.08.006.
- Background: PubMed 12714472Korthals-de Bos IB, Hoving JL, van Tulder MW, Rutten-van Molken MP, Ader HJ, de Vet HC, Koes BW, Vondeling H, Bouter LM. Cost effectiveness of physiotherapy, manual therapy, and general practitioner care for neck pain: economic evaluation alongside a randomised controlled trial. BMJ. 2003 Apr 26;326(7395):911. doi: 10.1136/bmj.326.7395.911.
- Background: PubMed 18296946Gunnar Brolinson P, McGinley SM, Kerger S. Osteopathic manipulative medicine and the athlete. Curr Sports Med Rep. 2008 Feb;7(1):49-56. doi: 10.1097/01.CSMR.0000308664.13278.a7.
- Background: PubMed 21129212Julian C, Hoskins W, Vitiello AL. Sports chiropractic management at the World Ice Hockey Championships. Chiropr Osteopat. 2010 Dec 3;18:32. doi: 10.1186/1746-1340-18-32.
- Individual participant dataSharing planned: Yes. Shared data include the subjects' reflexive EMG amplitudes and peak torques of the gastrocnemius and soleus during the Hoffmann Reflex electrical stimulation protocol at the conclusion of each data collection session. These raw data are available in Appendix K of the PI's dissertation, which may be obtained at http://uknowledge.uky.edu/khp_etds/27/
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.
Grant D Sanders, D.C., Ph.D. principal investigator
College of Education, Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, KY
James W Yates, Ph.D. study chair
College of Education, Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, KY
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 Manipulation, Max Voluntary Isometric Contraction and SM+MVIC in people with Subluxation of Joint of Lumbar Spine, run by Grant Sanders at 1 site in United States.
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 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 19 Apr 2017. 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 United States. 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?
Changes in H-reflex amplitudes of the gastrocnemius and soleus muscles compared to baseline (time frame: Data were collected at 17 time points during a 20-minute tibial nerve electrical stimulation protocol post-treatment: 20 seconds, 40 seconds, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 14:00, 16:00, 18:00 and 20:00 minutes). The study lists 2 primary outcomes in all. 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 NCT02848456, which also lists 48 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 19 Apr 2017.