Weakness, MuscleNCT05689723
The Effect of Spinal Manipulation on Hip Extension Strength and Jump Height
A study testing Lumbar manipulation in people with Weakness, Muscle, run by Messiah College.
Trial summary
The purpose of this study is to study the effects of lumbar manipulation on hip extension strength and jump height in healthy subjects. Procedures to be followed: First, the subject will be asked to complete a medical history form. Then they will be instructed on the procedure for strength and jump testing. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Weakness, Muscle
- What is being tested?
- Lumbar manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Oct 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 30
- able to read and write in English and clearly understand the informed consent.
Who cannot join
- currently have low back pain
- pregnant or may be pregnant
- previously diagnosed with spondylolisthesis, a herniated disc, or have signs and symptoms of nerve root compression
- history of spine surgery
- history of cancer, compression fracture, osteoporosis, osteopenia, or a history of systemic, connective tissue, or neurological disease,
- pain with the pre-manipulative hold
- positive findings on medical history form, or physical exam,
- presence of anxiety during the procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Spinal Manipulation on Hip Extension Strength and Jump Height, A Double Blind Randomized Control Trial
The purpose of this study is to study the effects of lumbar manipulation on hip extension strength and jump height in healthy subjects.
Procedures to be followed: First, the subject will be asked to complete a medical history form. Then they will be instructed on the procedure for strength and jump testing. Next, range of motion of the low back will be measured. Then hip strength will be measured using a digital handheld measurement tool. The subject will then be asked to jump as high as they can on a floor mat. The subject will then receive a sealed envelope indicating the intervention they will to receive, either the manipulation or a fake manipulation. Instructions will be provided, and the subject will be positioned on a treatment table to receive the intervention. At this point, they will either receive the manipulation or fake manipulation on the right and left side. An immediate re-test of hip strength will be taken, and the subject will again jump as high as they can on a floor mat. Follow-up measures of these tests will be completed again 20 minutes after the intervention is given.
Read the detailed description
The participant will complete a medical history form and undergo a brief active range of motion screen of the lumbar spine. The participant will complete a hip strength test utilizing the microFET 2 Manual Muscle Tester Hand Held Dynamometer. The participant will then jump as high as they can on the Just Jump System. A sealed envelope indicating the intervention to be received will be given to the participant. An investigator blinded to the pre and post-measures will open the envelope indicating the intervention to be performed. The participant will be blinded to which intervention group they are categorized to. The participant will be positioned on a high-low treatment table to receive the assigned intervention, either intervention 1 (thrust mobilization) or 2 (sham mobilization). The participant will either receive the thrust-mobilization or sham mobilization up to 2 times on the left and right side. An immediate re-test of hip strength will be conducted followed by performing the same three jumps. Follow-up measures at 20 minutes post-intervention will be performed.
Intervention for the Thrust-mobilization Group The intervention group will receive passive spinal rotational grade V mobilization, based on Maitland's approach. The intervention will be performed with the subject in right sidelying and left sidelying. The operator's palpating hand is placed over the L2-3 intervertebral space, and the other hand bends both legs of the participant up to the range at which the L2-3 midposition is found. The participant is then asked to straighten the lower leg and hook the upper leg over it with the upper leg's knee positioned over the side of the plinth. While the lower component is kept still, the participant's trunk is rotated until the hip starts to lift off from the plinth. The bottom hand and uppermost hand rest under a pillow and the chest wall, respectively. With the starting position settled, the operator stands behind the participant, takes up the slack within the spine and then provides a grade V mobilization while stabilizing the uppermost shoulder.
Intervention for the Sham Group Subjects are positioned in right sidelying. The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.
Double Blind: The subjects will not know what intervention they are receiving - same generic script is provided. One Investigator is performing all pre and post-tests without knowledge of intervention, the other investigator is opening the envelope and providing the intervention behind a screen without knowledge of test results. This investigator will record the subjects assigned # and which intervention they received. Investigators will record data on spreadsheet separately.
- Conditions
- Weakness, Muscle
- Being tested
- Lumbar manipulation, Sham Manipulation
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar manipulationProcedure or surgery
Left and right sidelyiing gaping high velocity low amplitude thrust mobilization
Sham ManipulationProcedure or surgery
The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.
| Study group | Role | What they receive |
|---|---|---|
| Manipulation | Experimental | Left and right sidelyiing gaping high velocity low amplitude thrust mobilization Receives: Procedure: Lumbar manipulation |
| Sham Manipulation | Sham comparator | The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying. Receives: Procedure: Sham Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hip extension strength
microFET 2 Manual Muscle Tester Hand Held Dynamometer
Measured: immediately post instervention and 20 minutes post
Secondary outcomes (1)
Change in jump height
Just Jump System
Measured: immediately post instervention and 20 minutes post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Weakness, MuscleStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Messiah College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689723
- Sponsor's protocol ID
- Bergmann
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sueki DG, Cleland JA, Wainner RS. A regional interdependence model of musculoskeletal dysfunction: research, mechanisms, and clinical implications. J Man Manip Ther. 2013 May;21(2):90-102. doi: 10.1179/2042618612Y.0000000027.
PubMed 24421619Wainner RS, Whitman JM, Cleland JA, Flynn TW. Regional interdependence: a musculoskeletal examination model whose time has come. J Orthop Sports Phys Ther. 2007 Nov;37(11):658-60. doi: 10.2519/jospt.2007.0110. No abstract available.
PubMed 18057674Mintken PE, McDevitt AW, Cleland JA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Michener LA. Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):617-28. doi: 10.2519/jospt.2016.6319.
PubMed 27477473McDevitt A, Young J, Mintken P, Cleland J. Regional interdependence and manual therapy directed at the thoracic spine. J Man Manip Ther. 2015 Jul;23(3):139-46. doi: 10.1179/2042618615Y.0000000005.
PubMed 26309384Bergman GJ, Winter JC, van Tulder MW, Meyboom-de Jong B, Postema K, van der Heijden GJ. Manipulative therapy in addition to usual medical care accelerates recovery of shoulder complaints at higher costs: economic outcomes of a randomized trial. BMC Musculoskelet Disord. 2010 Sep 6;11:200. doi: 10.1186/1471-2474-11-200.
PubMed 20819223Stupar M, Cote P, French MR, Hawker GA. The association between low back pain and osteoarthritis of the hip and knee: a population-based cohort study. J Manipulative Physiol Ther. 2010 Jun;33(5):349-54. doi: 10.1016/j.jmpt.2010.05.008.
PubMed 20605553Pickar JG. Neurophysiological effects of spinal manipulation. Spine J. 2002 Sep-Oct;2(5):357-71. doi: 10.1016/s1529-9430(02)00400-x.
PubMed 14589467Espi-Lopez GV, Arnal-Gomez A, Balasch-Bernat M, Ingles M. Effectiveness of Manual Therapy Combined With Physical Therapy in Treatment of Patellofemoral Pain Syndrome: Systematic Review. J Chiropr Med. 2017 Jun;16(2):139-146. doi: 10.1016/j.jcm.2016.10.003. Epub 2016 Nov 22.
PubMed 28559754Grindstaff 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 18805726Grindstaff TL, Hertel J, Beazell JR, Magrum EM, Kerrigan DC, Fan X, Ingersoll CD. Lumbopelvic joint manipulation and quadriceps activation of people with patellofemoral pain syndrome. J Athl Train. 2012 Jan-Feb;47(1):24-31. doi: 10.4085/1062-6050-47.1.24.
PubMed 22488227Sanders GD, Nitz AJ, Abel MG, Symons TB, Shapiro R, Black WS, Yates JW. Effects of Lumbosacral Manipulation on Isokinetic Strength of the Knee Extensors and Flexors in Healthy Subjects: A Randomized, Controlled, Single-Blind Crossover Trial. J Chiropr Med. 2015 Dec;14(4):240-8. doi: 10.1016/j.jcm.2015.08.002. Epub 2015 Nov 6.
PubMed 26793035Yuen TS, Lam PY, Lau MY, Siu WL, Yu KM, Lo CN, Ng J. Changes in Lower Limb Strength and Function Following Lumbar Spinal Mobilization. J Manipulative Physiol Ther. 2017 Oct;40(8):587-596. doi: 10.1016/j.jmpt.2017.07.003.
PubMed 29187310Botelho MB, Alvarenga BAP, Molina N, Ribas M, Baptista AF. Spinal Manipulative Therapy and Sports Performance Enhancement: A Systematic Review. J Manipulative Physiol Ther. 2017 Sep;40(7):535-543. doi: 10.1016/j.jmpt.2017.03.014.
PubMed 29191288Sandell J, Palmgren PJ, Bjorndahl L. Effect of chiropractic treatment on hip extension ability and running velocity among young male running athletes. J Chiropr Med. 2008 Jun;7(2):39-47. doi: 10.1016/j.jcme.2008.02.003.
PubMed 19674719
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spinal Manipulation on Hip Extension Strength and Jump Height, A Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05689723
- Acronym / sponsor ID
- Bergmann
- Conditions
- Weakness, Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Messiah CollegeUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 19 Jan 2023 (actual)
- 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 study the effects of lumbar manipulation on hip extension strength and jump height in healthy subjects.
Procedures to be followed: First, the subject will be asked to complete a medical history form. Then they will be instructed on the procedure for strength and jump testing. Next, range of motion of the low back will be measured. Then hip strength will be measured using a digital handheld measurement tool. The subject will then be asked to jump as high as they can on a floor mat. The subject will then receive a sealed envelope indicating the intervention they will to receive, either the manipulation or a fake manipulation. Instructions will be provided, and the subject will be positioned on a treatment table to receive the intervention. At this point, they will either receive the manipulation or fake manipulation on the right and left side. An immediate re-test of hip strength will be taken, and the subject will again jump as high as they can on a floor mat. Follow-up measures of these tests will be completed again 20 minutes after the intervention is given.
Detailed description
The participant will complete a medical history form and undergo a brief active range of motion screen of the lumbar spine. The participant will complete a hip strength test utilizing the microFET 2 Manual Muscle Tester Hand Held Dynamometer. The participant will then jump as high as they can on the Just Jump System. A sealed envelope indicating the intervention to be received will be given to the participant. An investigator blinded to the pre and post-measures will open the envelope indicating the intervention to be performed. The participant will be blinded to which intervention group they are categorized to. The participant will be positioned on a high-low treatment table to receive the assigned intervention, either intervention 1 (thrust mobilization) or 2 (sham mobilization). The participant will either receive the thrust-mobilization or sham mobilization up to 2 times on the left and right side. An immediate re-test of hip strength will be conducted followed by performing the same three jumps. Follow-up measures at 20 minutes post-intervention will be performed.
Intervention for the Thrust-mobilization Group The intervention group will receive passive spinal rotational grade V mobilization, based on Maitland's approach. The intervention will be performed with the subject in right sidelying and left sidelying. The operator's palpating hand is placed over the L2-3 intervertebral space, and the other hand bends both legs of the participant up to the range at which the L2-3 midposition is found. The participant is then asked to straighten the lower leg and hook the upper leg over it with the upper leg's knee positioned over the side of the plinth. While the lower component is kept still, the participant's trunk is rotated until the hip starts to lift off from the plinth. The bottom hand and uppermost hand rest under a pillow and the chest wall, respectively. With the starting position settled, the operator stands behind the participant, takes up the slack within the spine and then provides a grade V mobilization while stabilizing the uppermost shoulder.
Intervention for the Sham Group Subjects are positioned in right sidelying. The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.
Double Blind: The subjects will not know what intervention they are receiving - same generic script is provided. One Investigator is performing all pre and post-tests without knowledge of intervention, the other investigator is opening the envelope and providing the intervention behind a screen without knowledge of test results. This investigator will record the subjects assigned # and which intervention they received. Investigators will record data on spreadsheet separately.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulation | Experimental | Procedure: Lumbar manipulationLeft and right sidelyiing gaping high velocity low amplitude thrust mobilization |
| Sham Manipulation | Sham comparator | Procedure: Sham ManipulationThe experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the ages of 18 and 30
- able to read and write in English and clearly understand the informed consent.
Key exclusion criteria (8 listed)
- currently have low back pain
- pregnant or may be pregnant
- previously diagnosed with spondylolisthesis, a herniated disc, or have signs and symptoms of nerve root compression
- history of spine surgery
- history of cancer, compression fracture, osteoporosis, osteopenia, or a history of systemic, connective tissue, or neurological 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 |
|---|---|---|
| Lumbar manipulationLeft and right sidelyiing gaping high velocity low amplitude thrust mobilization | Procedure or surgery | Manipulation |
| Sham ManipulationThe experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying. | Procedure or surgery | Sham Manipulation |
Primary outcome
Change in hip extension strength
Time frame: immediately post instervention and 20 minutes post
microFET 2 Manual Muscle Tester Hand Held Dynamometer
1 secondary outcome
Change in jump height
Time frame: immediately post instervention and 20 minutes post
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 24421619Sueki DG, Cleland JA, Wainner RS. A regional interdependence model of musculoskeletal dysfunction: research, mechanisms, and clinical implications. J Man Manip Ther. 2013 May;21(2):90-102. doi: 10.1179/2042618612Y.0000000027.
- Background: PubMed 18057674Wainner RS, Whitman JM, Cleland JA, Flynn TW. Regional interdependence: a musculoskeletal examination model whose time has come. J Orthop Sports Phys Ther. 2007 Nov;37(11):658-60. doi: 10.2519/jospt.2007.0110. No abstract available.
- Background: PubMed 27477473Mintken PE, McDevitt AW, Cleland JA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Michener LA. Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):617-28. doi: 10.2519/jospt.2016.6319.
- Background: PubMed 26309384McDevitt A, Young J, Mintken P, Cleland J. Regional interdependence and manual therapy directed at the thoracic spine. J Man Manip Ther. 2015 Jul;23(3):139-46. doi: 10.1179/2042618615Y.0000000005.
- Background: PubMed 20819223Bergman GJ, Winter JC, van Tulder MW, Meyboom-de Jong B, Postema K, van der Heijden GJ. Manipulative therapy in addition to usual medical care accelerates recovery of shoulder complaints at higher costs: economic outcomes of a randomized trial. BMC Musculoskelet Disord. 2010 Sep 6;11:200. doi: 10.1186/1471-2474-11-200.
- Background: PubMed 20605553Stupar M, Cote P, French MR, Hawker GA. The association between low back pain and osteoarthritis of the hip and knee: a population-based cohort study. J Manipulative Physiol Ther. 2010 Jun;33(5):349-54. doi: 10.1016/j.jmpt.2010.05.008.
- 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 28559754Espi-Lopez GV, Arnal-Gomez A, Balasch-Bernat M, Ingles M. Effectiveness of Manual Therapy Combined With Physical Therapy in Treatment of Patellofemoral Pain Syndrome: Systematic Review. J Chiropr Med. 2017 Jun;16(2):139-146. doi: 10.1016/j.jcm.2016.10.003. Epub 2016 Nov 22.
- 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 22488227Grindstaff TL, Hertel J, Beazell JR, Magrum EM, Kerrigan DC, Fan X, Ingersoll CD. Lumbopelvic joint manipulation and quadriceps activation of people with patellofemoral pain syndrome. J Athl Train. 2012 Jan-Feb;47(1):24-31. doi: 10.4085/1062-6050-47.1.24.
- Background: PubMed 26793035Sanders GD, Nitz AJ, Abel MG, Symons TB, Shapiro R, Black WS, Yates JW. Effects of Lumbosacral Manipulation on Isokinetic Strength of the Knee Extensors and Flexors in Healthy Subjects: A Randomized, Controlled, Single-Blind Crossover Trial. J Chiropr Med. 2015 Dec;14(4):240-8. doi: 10.1016/j.jcm.2015.08.002. Epub 2015 Nov 6.
- Background: PubMed 29187310Yuen TS, Lam PY, Lau MY, Siu WL, Yu KM, Lo CN, Ng J. Changes in Lower Limb Strength and Function Following Lumbar Spinal Mobilization. J Manipulative Physiol Ther. 2017 Oct;40(8):587-596. doi: 10.1016/j.jmpt.2017.07.003.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar manipulation in people with Weakness, Muscle, run by Messiah College.
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 8 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: status not confirmed, as of the sponsor's last update on 19 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl Bergmann, ScD (717-796-1800 ext. 3339, kbergmann@messiah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hip extension strength (time frame: immediately post instervention and 20 minutes post). 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 NCT05689723, which also lists 14 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 Jan 2023.