Subluxation of Joint of Lumbar SpineNCT02407418
The Effects of Spinal Manipulation on Thigh Muscle Strength
A study testing Spinal Manipulation in people with Subluxation of Joint of Lumbar Spine, run by Grant Sanders.
Trial summary
The purpose of this study was to investigate the effects of chiropractic low back adjustments on thigh muscle strength. Force production was measured during different types of muscle contractions with a device called an isokinetic dynamometer. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Dec 2012
- 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
- Between the ages of 20 to 35 years
- Asymptomatic with regard to low back, pelvic or lower extremity pain
Who cannot join
- Previously received spinal manipulation from a chiropractor or other health care provider
- Contraindications to lumbar spine manipulation (such as fractures, lumbar disc herniation, abdominal aortic aneurysm or cauda equina syndrome)
About this study
Official title: The Effects of Lumbosacral Manipulation on Isokinetic Strength of the Knee Extensors and Flexors
The purpose of this study was to investigate the effects of chiropractic low back adjustments on thigh muscle strength. Force production was measured during different types of muscle contractions with a device called an isokinetic dynamometer. The study included 21 college-aged subjects who did not have any pain and had never received chiropractic treatment with spinal manipulation. During two separate sessions, subjects' thigh muscle forces were recorded while performing maximal muscle contractions on the isokinetic dynamometer. Baseline measurements of muscle force were acquired before either treatment form of spinal manipulation or a sham spinal manipulation, followed by identical muscle force measurements within five and twenty minutes post-treatment.
Read the detailed description
Spinal manipulation is a therapeutic procedure employed by various healthcare practitioners for alleviating acute and chronic musculoskeletal complaints. This form of treatment is also delivered to enhance the performance and augment the rehabilitation of athletes. However, despite research findings alleging the strength-modulating effects of spinal manipulation alongside numerous professional athletes' positive anecdotal claims concerning its results, the physiological processes to explain its effects remain largely unexplained. Therefore, the purpose of this work was to investigate the effects of spinal manipulation in a college-aged sample population.
This study examined the effect of spinal manipulation delivered to the lumbosacral region on concentric force production of the knee extensors and flexors. A randomized, controlled, single-blind repeated measures design was utilized with 21 subjects. Isometric and isokinetic peak torques (Nm) were recorded during two separate session while subjects performed maximal voluntary contractions post-treatment of either spinal manipulation or a sham manipulation.
- Conditions
- Subluxation of Joint of Lumbar Spine
- Being tested
- Spinal Manipulation, Sham Manipulation
- Keywords
- spinal manipulation, muscle strength dynamometer, muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationOther
Side-posture, high-velocity low-amplitude spinal manipulation targeting the lumbar spine and sacroiliac joints
Sham ManipulationOther
A simulated lumbar spine manipulation in which no vertebral contact was made
| Study group | Role | What they receive |
|---|---|---|
| Spinal Manipulation | Active comparator | In a repeated measures, crossover design, all subjects received spinal manipulation during the second or third session. The selection of spinal manipulation or sham was randomized. Receives: Other: Spinal Manipulation |
| Sham Manipulation | Sham comparator | In a repeated measures, crossover design, all subjects received the sham manipulation during the second or third session. The selection of spinal manipulation or sham was randomized. Receives: Other: Sham Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in isometric and isokinetic peak torques compared to baseline
Peak torque measurements were recorded in newton meters (Nm) while subjects performed maximal voluntary contractions of concentric knee extension and flexion during a randomized protocol of isometric and isokinetic contractions, all of which measured with an isokinetic dynamometer
Measured: Baseline peak torque measurements were acquired before either treatment form of lumbosacral manipulation or sham manipulation, followed by identical peak torque measurements recorded within 5 minutes and at 20 minutes post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grant Sanders
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grant Sanders, University of Kentucky
- Investigators
- Grant D Sanders, D.C., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407418
- Sponsor's protocol ID
- 12-0280-F1V
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2015
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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 22289432Pickar JG. Neurophysiological effects of spinal manipulation. Spine J. 2002 Sep-Oct;2(5):357-71. doi: 10.1016/s1529-9430(02)00400-x.
PubMed 14589467Miners AL. Chiropractic treatment and the enhancement of sport performance: a narrative literature review. J Can Chiropr Assoc. 2010 Dec;54(4):210-21.
PubMed 21120012Grindstaff TL, Hertel J, Beazell JR, Magrum EM, Ingersoll CD. Effects of lumbopelvic joint manipulation on quadriceps activation and strength in healthy individuals. Man Ther. 2009 Aug;14(4):415-20. doi: 10.1016/j.math.2008.06.005. Epub 2008 Sep 20.
PubMed 18805726Hillermann B, Gomes AN, Korporaal C, Jackson D. A pilot study comparing the effects of spinal manipulative therapy with those of extra-spinal manipulative therapy on quadriceps muscle strength. J Manipulative Physiol Ther. 2006 Feb;29(2):145-9. doi: 10.1016/j.jmpt.2005.12.003.
PubMed 16461174Suter E, McMorland G, Herzog W, Bray R. Conservative lower back treatment reduces inhibition in knee-extensor muscles: a randomized controlled trial. J Manipulative Physiol Ther. 2000 Feb;23(2):76-80.
PubMed 10714531Suter E, McMorland G, Herzog W, Bray R. Decrease in quadriceps inhibition after sacroiliac joint manipulation in patients with anterior knee pain. J Manipulative Physiol Ther. 1999 Mar-Apr;22(3):149-53. doi: 10.1016/S0161-4754(99)70128-4.
PubMed 10220713Botelho MB, Andrade BB. Effect of cervical spine manipulative therapy on judo athletes' grip strength. J Manipulative Physiol Ther. 2012 Jan;35(1):38-44. doi: 10.1016/j.jmpt.2011.09.005. Epub 2011 Nov 10.
PubMed 22079053Fernandez-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 19028251Paungmali A, Vicenzino B, Smith M. Hypoalgesia induced by elbow manipulation in lateral epicondylalgia does not exhibit tolerance. J Pain. 2003 Oct;4(8):448-54. doi: 10.1067/s1526-5900(03)00731-4.
PubMed 14622665Abbott JH, Patla CE, Jensen RH. The initial effects of an elbow mobilization with movement technique on grip strength in subjects with lateral epicondylalgia. Man Ther. 2001 Aug;6(3):163-9. doi: 10.1054/math.2001.0408.
PubMed 11527456Giggey K, Tepe R. A pilot study to determine the effects of a supine sacroiliac orthopedic blocking procedure on cervical spine extensor isometric strength. J Chiropr Med. 2009 Jun;8(2):56-61. doi: 10.1016/j.jcm.2008.11.002.
PubMed 19646387Keller TS, Colloca CJ. Mechanical force spinal manipulation increases trunk muscle strength assessed by electromyography: a comparative clinical trial. J Manipulative Physiol Ther. 2000 Nov-Dec;23(9):585-95. doi: 10.1067/mmt.2000.110947.
PubMed 11145798Suter E, McMorland G. Decrease in elbow flexor inhibition after cervical spine manipulation in patients with chronic neck pain. Clin Biomech (Bristol). 2002 Aug;17(7):541-4. doi: 10.1016/s0268-0033(02)00025-6.
PubMed 12206946Wang SS, Meadows J. Immediate and carryover changes of C5-6 joint mobilization on shoulder external rotator muscle strength. J Manipulative Physiol Ther. 2010 Feb;33(2):102-8. doi: 10.1016/j.jmpt.2009.12.006.
PubMed 20170775
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lumbosacral Manipulation on Isokinetic Strength of the Knee Extensors and Flexors
- ClinicalTrials.gov ID
- NCT02407418
- Acronym / sponsor ID
- 12-0280-F1V
- Conditions
- Subluxation of Joint of Lumbar Spine
- Keywords
- spinal manipulation, muscle strength dynamometer, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Grant SandersUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Apr 2015 (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 was to investigate the effects of chiropractic low back adjustments on thigh muscle strength. Force production was measured during different types of muscle contractions with a device called an isokinetic dynamometer. The study included 21 college-aged subjects who did not have any pain and had never received chiropractic treatment with spinal manipulation. During two separate sessions, subjects' thigh muscle forces were recorded while performing maximal muscle contractions on the isokinetic dynamometer. Baseline measurements of muscle force were acquired before either treatment form of spinal manipulation or a sham spinal manipulation, followed by identical muscle force measurements within five and twenty minutes post-treatment.
Detailed description
Spinal manipulation is a therapeutic procedure employed by various healthcare practitioners for alleviating acute and chronic musculoskeletal complaints. This form of treatment is also delivered to enhance the performance and augment the rehabilitation of athletes. However, despite research findings alleging the strength-modulating effects of spinal manipulation alongside numerous professional athletes' positive anecdotal claims concerning its results, the physiological processes to explain its effects remain largely unexplained. Therefore, the purpose of this work was to investigate the effects of spinal manipulation in a college-aged sample population.
This study examined the effect of spinal manipulation delivered to the lumbosacral region on concentric force production of the knee extensors and flexors. A randomized, controlled, single-blind repeated measures design was utilized with 21 subjects. Isometric and isokinetic peak torques (Nm) were recorded during two separate session while subjects performed maximal voluntary contractions post-treatment of either spinal manipulation or a sham manipulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Manipulation | Active comparator | Other: Spinal ManipulationIn a repeated measures, crossover design, all subjects received spinal manipulation during the second or third session. The selection of spinal manipulation or sham was randomized. |
| Sham Manipulation | Sham comparator | Other: Sham ManipulationIn a repeated measures, crossover design, all subjects received the sham manipulation during the second or third session. The selection of spinal manipulation or sham was randomized. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the ages of 20 to 35 years
- Asymptomatic with regard to low back, pelvic or lower extremity pain
Key exclusion criteria (2 listed)
- Previously received spinal manipulation from a chiropractor or other health care provider
- Contraindications to lumbar spine manipulation (such as fractures, lumbar disc herniation, abdominal aortic aneurysm or cauda equina syndrome)
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 ManipulationSide-posture, high-velocity low-amplitude spinal manipulation targeting the lumbar spine and sacroiliac joints | Other | Spinal Manipulation |
| Sham ManipulationA simulated lumbar spine manipulation in which no vertebral contact was made | Other | Sham Manipulation |
Primary outcome
Changes in isometric and isokinetic peak torques compared to baseline
Time frame: Baseline peak torque measurements were acquired before either treatment form of lumbosacral manipulation or sham manipulation, followed by identical peak torque measurements recorded within 5 minutes and at 20 minutes post-treatment
Peak torque measurements were recorded in newton meters (Nm) while subjects performed maximal voluntary contractions of concentric knee extension and flexion during a randomized protocol of isometric and isokinetic contractions, all of which measured with an isokinetic dynamometer
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 3 Apr 2015.
- 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 14589467Pickar JG. Neurophysiological effects of spinal manipulation. Spine J. 2002 Sep-Oct;2(5):357-71. doi: 10.1016/s1529-9430(02)00400-x.
- Background: PubMed 21120012Miners AL. Chiropractic treatment and the enhancement of sport performance: a narrative literature review. J Can Chiropr Assoc. 2010 Dec;54(4):210-21.
- Background: PubMed 18805726Grindstaff TL, Hertel J, Beazell JR, Magrum EM, Ingersoll CD. Effects of lumbopelvic joint manipulation on quadriceps activation and strength in healthy individuals. Man Ther. 2009 Aug;14(4):415-20. doi: 10.1016/j.math.2008.06.005. Epub 2008 Sep 20.
- Background: PubMed 16461174Hillermann B, Gomes AN, Korporaal C, Jackson D. A pilot study comparing the effects of spinal manipulative therapy with those of extra-spinal manipulative therapy on quadriceps muscle strength. J Manipulative Physiol Ther. 2006 Feb;29(2):145-9. doi: 10.1016/j.jmpt.2005.12.003.
- Background: PubMed 10714531Suter E, McMorland G, Herzog W, Bray R. Conservative lower back treatment reduces inhibition in knee-extensor muscles: a randomized controlled trial. J Manipulative Physiol Ther. 2000 Feb;23(2):76-80.
- Background: PubMed 10220713Suter E, McMorland G, Herzog W, Bray R. Decrease in quadriceps inhibition after sacroiliac joint manipulation in patients with anterior knee pain. J Manipulative Physiol Ther. 1999 Mar-Apr;22(3):149-53. doi: 10.1016/S0161-4754(99)70128-4.
- Background: PubMed 22079053Botelho MB, Andrade BB. Effect of cervical spine manipulative therapy on judo athletes' grip strength. J Manipulative Physiol Ther. 2012 Jan;35(1):38-44. doi: 10.1016/j.jmpt.2011.09.005. Epub 2011 Nov 10.
- 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 14622665Paungmali A, Vicenzino B, Smith M. Hypoalgesia induced by elbow manipulation in lateral epicondylalgia does not exhibit tolerance. J Pain. 2003 Oct;4(8):448-54. doi: 10.1067/s1526-5900(03)00731-4.
- Background: PubMed 11527456Abbott JH, Patla CE, Jensen RH. The initial effects of an elbow mobilization with movement technique on grip strength in subjects with lateral epicondylalgia. Man Ther. 2001 Aug;6(3):163-9. doi: 10.1054/math.2001.0408.
- Background: PubMed 19646387Giggey K, Tepe R. A pilot study to determine the effects of a supine sacroiliac orthopedic blocking procedure on cervical spine extensor isometric strength. J Chiropr Med. 2009 Jun;8(2):56-61. doi: 10.1016/j.jcm.2008.11.002.
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. principal investigator
University of Kentucky
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation in people with Subluxation of Joint of Lumbar Spine, run by Grant Sanders.
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 2 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 3 Apr 2015. 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. 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?
Changes in isometric and isokinetic peak torques compared to baseline (time frame: Baseline peak torque measurements were acquired before either treatment form of lumbosacral manipulation or sham manipulation, followed by identical peak torque measurements recorded within 5 minutes and at 20 minutes post-treatment). 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 NCT02407418, which also lists 41 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 3 Apr 2015.