Low Back PainLBP-HVLANCT06399497
Effects of Lumbar Spinal Manipulation in Subjects With Chronic Low Back Pain
A study testing spinal manipulation and simulated manipulation in people with Low Back Pain, run by Universidad de Córdoba at 1 site in Spain.
Trial summary
This study aims to measure the effects of spinal manipulation on Chronic Spinal Pain by assessing Muscle Mechanical Properties (MMPs) using MyotonPRO®, Mechanical Perception Threshold (MPT) using Von Frey monofilaments, and Pressure Pain Threshold (PPT) using an algometer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- spinal manipulation and simulated manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- May 2024to Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with chronic low back pain
Who cannot join
- Spinal trauma or surgery history.
- Spinal congenital deformities.
- Inflammatory or autoimmune disease
- Herniated disc in the segment L5.
- Pregnant women.
- Body Mass Index \> 30kg/m2
- Subjects that have received treatment for low back pain in the seven days prior to the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Physiobalance
Córdoba, 14011
Lourdes García Luque, PhD, z12galul@uco.es
Sandra Alcaraz Clariana, PhD, sandra_fi@hotmail.com
About this study
Official title: Effects of Lumbar Spinal Manipulation on Muscle Mechanical Properties, Pressure Pain Threshold and Mechanical Perception Threshold in Subjects With Chronic Low Back Pain
This study aims to measure the effects of spinal manipulation on Chronic Spinal Pain by assessing Muscle Mechanical Properties (MMPs) using MyotonPRO®, Mechanical Perception Threshold (MPT) using Von Frey monofilaments, and Pressure Pain Threshold (PPT) using an algometer. Participants will be randomly assigned to either spinal manipulation or placebo groups to compare effects on MMPs, MPT, and PPT. Assessments will occur at three time points: baseline, immediately post-intervention (real or simulated), and 24 hours post-intervention. This research targets individuals with chronic spinal pain, providing insights into the potential benefits of spinal manipulation in managing this condition.
- Conditions
- Low Back Pain
- Being tested
- spinal manipulation, simulated manipulation
- Keywords
- Manipulation, Spinal, Muscle Mechanical Properties, Pain Threshold, Perception Threshold
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal manipulationOther
Also called thrust, high-velocity low-amplitude
A high-velocity low-amplitude spinal manipulation at the L5 level will be performance by means of the lumbar roll technique, with the subject in right lateral decubitus.
simulated manipulationOther
Also called placebo intervention
Simulated manipulation intervention, in the same position as in the Intervention Group, performance in right lateral decubitus with the left leg flexed and the left foot resting on the right popliteal fossa. Without stretching the paravertebral tissues, the participant will remain for approximately 20 seconds without receiving manual impulse.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | A physical therapist, with more than 10 years of experience, performs a high-velocity low-amplitude spinal manipulation at the L5 level by means of the lumbar roll technique, performed with the subject in right lateral decubitus. Receives: Other: spinal manipulation |
| Control Group | Placebo comparator | A physical therapist performance a simulated manipulation intervention, for which the same position as in the Intervention Group will be used, in right lateral decubitus with the left leg flexed and the left foot resting on the right popliteal fossa. Without stretching the paravertebral tissues, the participant will remain for approximately 20 seconds without receiving manual impulse. Receives: Other: simulated manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mechanical propierties
The measurements will be performed with the MyotonPro®. The subject will be positioned in prone position with both upper limbs around the body. They will be asked to breathe apnea for five seconds after exhaling to reduce the abdominal influence on the test. Measurements at the lumbar level will be performed by positioning the MyotonPro® probe perpendicular to the muscle belly of the erector spinae, 2.5 cm from the midline of the spinous process of L5. A measurement of the tibialis anterior will assess the effect of the remote manipulation. For this purpose, the subject will be positioned in supine decubitus with the lower limb in extension. A point will be located on the tibialis anterior muscle, three finger traverses from the crest of the tibia in a caudal direction.
Measured: From enrollment to the end of treatment at 24 hours
Secondary outcomes (2)
Pressure pain threshold
An Algometer Commander™ JTECH will be used. Prior to the measurements, the subject will be familiarized with the evaluation by taking three measurements in the tenar region of the hand. During this phase, the subject will be asked to indicate, with eyes closed, the moment in which he perceives the painful sensation. The test will consist of a combination of three measurements administered to each muscle, with an interval between measurements of 3 to 5 seconds. The pressure stimulation will be applied with an algometer, gradually increasing the pressure by 0.5 kg per second until the subject manifests pain. The mean pressure at which the subject manifested pain will be calculated from these three measurements. The algometer will be placed perpendicular to the muscle bellies, and the subject will maintain the same position as in the measurement of the muscle mechanical propierties. The evaluation locations will be the L5 spinal Level and the tibialis anterior (bilaterally)
Measured: From enrollment to the end of treatment at 24 hours
Mechanical perception threshold
It will be evaluated by means of Von Frey monofilaments, which will be applied perpendicularly to the cutaneous surface, with ascending diameter consecutively until the patient reports tactile perception. Prior to the measurements, the subject will be familiarized with the evaluation by taking three measurements in the tenar region of the hand. During this phase, the subject will be asked to indicate, with eyes closed, the moment in which he perceives the pressure sensation. The evaluation sites will be the same as in the MMPs: L5 level. Anterior tibial (bilaterally).
Measured: From enrollment to the end of treatment at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (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 Low Back PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lourdes García Luque, Universidad de Córdoba
- Investigators
- Lourdes García Luque, PhD, Principal investigator, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399497
- Sponsor's protocol ID
- 5874
- Acronym
- LBP-HVLA
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have decided to first present the data in different forums and journals before making the database available
Publications
Trierweiler J, Gottert DN, Gehlen G. Evaluation of mechanical allodynia in an animal immobilization model using the von frey method. J Manipulative Physiol Ther. 2012 Jan;35(1):18-25. doi: 10.1016/j.jmpt.2011.09.007. Epub 2011 Nov 4.
PubMed 22054875Tracey EH, Greene AJ, Doty RL. Optimizing reliability and sensitivity of Semmes-Weinstein monofilaments for establishing point tactile thresholds. Physiol Behav. 2012 Feb 28;105(4):982-6. doi: 10.1016/j.physbeh.2011.11.002. Epub 2011 Nov 11.
PubMed 22100625Keizer D, van Wijhe M, Post WJ, Wierda JM. Quantifying allodynia in patients suffering from unilateral neuropathic pain using von frey monofilaments. Clin J Pain. 2007 Jan;23(1):85-90. doi: 10.1097/01.ajp.0000210950.01503.72.
PubMed 17277649Garcia-Perez-Juana D, Fernandez-de-Las-Penas C, Arias-Buria JL, Cleland JA, Plaza-Manzano G, Ortega-Santiago R. Changes in Cervicocephalic Kinesthetic Sensibility, Widespread Pressure Pain Sensitivity, and Neck Pain After Cervical Thrust Manipulation in Patients With Chronic Mechanical Neck Pain: A Randomized Clinical Trial. J Manipulative Physiol Ther. 2018 Sep;41(7):551-560. doi: 10.1016/j.jmpt.2018.02.004.
PubMed 30442354Nogueira N, Oliveira-Campelo N, Lopes A, Torres R, Sousa ASP, Ribeiro F. The Acute Effects of Manual and Instrument-Assisted Cervical Spine Manipulation on Pressure Pain Threshold, Pressure Pain Perception, and Muscle-Related Variables in Asymptomatic Subjects: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2020 Mar-Apr;43(3):179-188. doi: 10.1016/j.jmpt.2019.05.007.
PubMed 32951766Lohr C, Braumann KM, Reer R, Schroeder J, Schmidt T. Reliability of tensiomyography and myotonometry in detecting mechanical and contractile characteristics of the lumbar erector spinae in healthy volunteers. Eur J Appl Physiol. 2018 Jul;118(7):1349-1359. doi: 10.1007/s00421-018-3867-2. Epub 2018 Apr 20.
PubMed 29679246Dellalana LE, Chen F, Vain A, Gandelman JS, Poldemaa M, Chen H, Tkaczyk ER. Reproducibility of the durometer and myoton devices for skin stiffness measurement in healthy subjects. Skin Res Technol. 2019 May;25(3):289-293. doi: 10.1111/srt.12646. Epub 2018 Nov 10.
PubMed 30414198Kurashina W, Iijima Y, Sasanuma H, Saito T, Takeshita K. Evaluation of muscle stiffness in adhesive capsulitis with Myoton PRO. JSES Int. 2022 Sep 17;7(1):25-29. doi: 10.1016/j.jseint.2022.08.017. eCollection 2023 Jan.
PubMed 36820433Wu Z, Zhu Y, Xu W, Liang J, Guan Y, Xu X. Analysis of Biomechanical Properties of the Lumbar Extensor Myofascia in Elderly Patients with Chronic Low Back Pain and That in Healthy People. Biomed Res Int. 2020 Feb 18;2020:7649157. doi: 10.1155/2020/7649157. eCollection 2020.
PubMed 32149135Ilahi S, T Masi A, White A, Devos A, Henderson J, Nair K. Quantified biomechanical properties of lower lumbar myofascia in younger adults with chronic idiopathic low back pain and matched healthy controls. Clin Biomech (Bristol). 2020 Mar;73:78-85. doi: 10.1016/j.clinbiomech.2019.12.026. Epub 2020 Jan 2.
PubMed 31954272Dorron SL, Losco BE, Drummond PD, Walker BF. Effect of lumbar spinal manipulation on local and remote pressure pain threshold and pinprick sensitivity in asymptomatic individuals: a randomised trial. Chiropr Man Therap. 2016 Dec 5;24:47. doi: 10.1186/s12998-016-0128-5. eCollection 2016.
PubMed 27980726Jun P, Page I, Vette A, Kawchuk G. Potential mechanisms for lumbar spinal stiffness change following spinal manipulative therapy: a scoping review. Chiropr Man Therap. 2020 Mar 23;28(1):15. doi: 10.1186/s12998-020-00304-x.
PubMed 32293493Page I, Descarreaux M. Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. BMC Musculoskelet Disord. 2019 Jan 18;20(1):29. doi: 10.1186/s12891-019-2408-4.
PubMed 30658622Fagundes Loss J, de Souza da Silva L, Ferreira Miranda I, Groisman S, Santiago Wagner Neto E, Souza C, Tarrago Candotti C. Immediate effects of a lumbar spine manipulation on pain sensitivity and postural control in individuals with nonspecific low back pain: a randomized controlled trial. Chiropr Man Therap. 2020 Jun 3;28(1):25. doi: 10.1186/s12998-020-00316-7.
PubMed 32487243
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lumbar Spinal Manipulation on Muscle Mechanical Properties, Pressure Pain Threshold and Mechanical Perception Threshold in Subjects With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06399497
- Acronym / sponsor ID
- LBP-HVLA / 5874
- Conditions
- Low Back Pain
- Keywords
- Manipulation, Spinal, Muscle Mechanical Properties, Pain Threshold, Perception Threshold
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Universidad de CórdobaUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 May 2024 (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.
This study aims to measure the effects of spinal manipulation on Chronic Spinal Pain by assessing Muscle Mechanical Properties (MMPs) using MyotonPRO®, Mechanical Perception Threshold (MPT) using Von Frey monofilaments, and Pressure Pain Threshold (PPT) using an algometer. Participants will be randomly assigned to either spinal manipulation or placebo groups to compare effects on MMPs, MPT, and PPT. Assessments will occur at three time points: baseline, immediately post-intervention (real or simulated), and 24 hours post-intervention. This research targets individuals with chronic spinal pain, providing insights into the potential benefits of spinal manipulation in managing this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: spinal manipulationA physical therapist, with more than 10 years of experience, performs a high-velocity low-amplitude spinal manipulation at the L5 level by means of the lumbar roll technique, performed with the subject in right lateral decubitus. |
| Control Group | Placebo comparator | Other: simulated manipulationA physical therapist performance a simulated manipulation intervention, for which the same position as in the Intervention Group will be used, in right lateral decubitus with the left leg flexed and the left foot resting on the right popliteal fossa. Without stretching the paravertebral tissues, the participant will remain for approximately 20 seconds without receiving manual impulse. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject with chronic low back pain
Key exclusion criteria (7 listed)
- Spinal trauma or surgery history.
- Spinal congenital deformities.
- Inflammatory or autoimmune disease
- Herniated disc in the segment L5.
- Pregnant women.
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 manipulationAlso: thrust, high-velocity low-amplitudeA high-velocity low-amplitude spinal manipulation at the L5 level will be performance by means of the lumbar roll technique, with the subject in right lateral decubitus. | Other | Intervention Group |
| simulated manipulationAlso: placebo interventionSimulated manipulation intervention, in the same position as in the Intervention Group, performance in right lateral decubitus with the left leg flexed and the left foot resting on the right popliteal fossa. Without stretching the paravertebral tissues, the participant will remain for approximately 20 seconds without receiving manual impulse. | Other | Control Group |
Primary outcome
Muscle mechanical propierties
Time frame: From enrollment to the end of treatment at 24 hours
The measurements will be performed with the MyotonPro®. The subject will be positioned in prone position with both upper limbs around the body. They will be asked to breathe apnea for five seconds after exhaling to reduce the abdominal influence on the test. Measurements at the lumbar level will be performed by positioning the MyotonPro® probe perpendicular to the muscle belly of the erector spinae, 2.5 cm from the midline of the spinous process of L5. A measurement of the tibialis anterior will assess the effect of the remote manipulation. For this purpose, the subject will be positioned in supine decubitus with the lower limb in extension. A point will be located on the tibialis anterior muscle, three finger traverses from the crest of the tibia in a caudal direction.
2 secondary outcomes
Pressure pain threshold
Time frame: From enrollment to the end of treatment at 24 hours
Mechanical perception threshold
Time frame: From enrollment to the end of treatment at 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 22054875Trierweiler J, Gottert DN, Gehlen G. Evaluation of mechanical allodynia in an animal immobilization model using the von frey method. J Manipulative Physiol Ther. 2012 Jan;35(1):18-25. doi: 10.1016/j.jmpt.2011.09.007. Epub 2011 Nov 4.
- Background: PubMed 22100625Tracey EH, Greene AJ, Doty RL. Optimizing reliability and sensitivity of Semmes-Weinstein monofilaments for establishing point tactile thresholds. Physiol Behav. 2012 Feb 28;105(4):982-6. doi: 10.1016/j.physbeh.2011.11.002. Epub 2011 Nov 11.
- Background: PubMed 17277649Keizer D, van Wijhe M, Post WJ, Wierda JM. Quantifying allodynia in patients suffering from unilateral neuropathic pain using von frey monofilaments. Clin J Pain. 2007 Jan;23(1):85-90. doi: 10.1097/01.ajp.0000210950.01503.72.
- Background: PubMed 30442354Garcia-Perez-Juana D, Fernandez-de-Las-Penas C, Arias-Buria JL, Cleland JA, Plaza-Manzano G, Ortega-Santiago R. Changes in Cervicocephalic Kinesthetic Sensibility, Widespread Pressure Pain Sensitivity, and Neck Pain After Cervical Thrust Manipulation in Patients With Chronic Mechanical Neck Pain: A Randomized Clinical Trial. J Manipulative Physiol Ther. 2018 Sep;41(7):551-560. doi: 10.1016/j.jmpt.2018.02.004.
- Background: PubMed 32951766Nogueira N, Oliveira-Campelo N, Lopes A, Torres R, Sousa ASP, Ribeiro F. The Acute Effects of Manual and Instrument-Assisted Cervical Spine Manipulation on Pressure Pain Threshold, Pressure Pain Perception, and Muscle-Related Variables in Asymptomatic Subjects: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2020 Mar-Apr;43(3):179-188. doi: 10.1016/j.jmpt.2019.05.007.
- Background: PubMed 29679246Lohr C, Braumann KM, Reer R, Schroeder J, Schmidt T. Reliability of tensiomyography and myotonometry in detecting mechanical and contractile characteristics of the lumbar erector spinae in healthy volunteers. Eur J Appl Physiol. 2018 Jul;118(7):1349-1359. doi: 10.1007/s00421-018-3867-2. Epub 2018 Apr 20.
- Background: PubMed 30414198Dellalana LE, Chen F, Vain A, Gandelman JS, Poldemaa M, Chen H, Tkaczyk ER. Reproducibility of the durometer and myoton devices for skin stiffness measurement in healthy subjects. Skin Res Technol. 2019 May;25(3):289-293. doi: 10.1111/srt.12646. Epub 2018 Nov 10.
- Background: PubMed 36820433Kurashina W, Iijima Y, Sasanuma H, Saito T, Takeshita K. Evaluation of muscle stiffness in adhesive capsulitis with Myoton PRO. JSES Int. 2022 Sep 17;7(1):25-29. doi: 10.1016/j.jseint.2022.08.017. eCollection 2023 Jan.
- Background: PubMed 32149135Wu Z, Zhu Y, Xu W, Liang J, Guan Y, Xu X. Analysis of Biomechanical Properties of the Lumbar Extensor Myofascia in Elderly Patients with Chronic Low Back Pain and That in Healthy People. Biomed Res Int. 2020 Feb 18;2020:7649157. doi: 10.1155/2020/7649157. eCollection 2020.
- Background: PubMed 31954272Ilahi S, T Masi A, White A, Devos A, Henderson J, Nair K. Quantified biomechanical properties of lower lumbar myofascia in younger adults with chronic idiopathic low back pain and matched healthy controls. Clin Biomech (Bristol). 2020 Mar;73:78-85. doi: 10.1016/j.clinbiomech.2019.12.026. Epub 2020 Jan 2.
- Background: PubMed 27980726Dorron SL, Losco BE, Drummond PD, Walker BF. Effect of lumbar spinal manipulation on local and remote pressure pain threshold and pinprick sensitivity in asymptomatic individuals: a randomised trial. Chiropr Man Therap. 2016 Dec 5;24:47. doi: 10.1186/s12998-016-0128-5. eCollection 2016.
- Background: PubMed 32293493Jun P, Page I, Vette A, Kawchuk G. Potential mechanisms for lumbar spinal stiffness change following spinal manipulative therapy: a scoping review. Chiropr Man Therap. 2020 Mar 23;28(1):15. doi: 10.1186/s12998-020-00304-x.
- Individual participant dataSharing planned: Undecided. The investigators have decided to first present the data in different forums and journals before making the database available
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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.
Lourdes García Luque, PhD principal investigator
Universidad de Córdoba
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 and simulated manipulation in people with Low Back Pain, run by Universidad de Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 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 6 May 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lourdes García Luque, PhD (0034+ 627366324, z12galul@uco.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mechanical propierties (time frame: From enrollment to the end of treatment at 24 hours). 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 NCT06399497, 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 6 May 2024.