Effects of Lumbar Spinal Manipulation in Subjects With Chronic Low Back Pain

NCT06399497 | Not Yet Recruiting

• 1 other identifier: 5874
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Manipulation, Spinal; Muscle Mechanical Properties; Pain Threshold; Perception Threshold

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 24 hours

Secondary Outcomes (2)

• Pressure pain threshold

  From enrollment to the end of treatment at 24 hours

• Mechanical perception threshold

  From enrollment to the end of treatment at 24 hours

Study Arms (2)

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.

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.

Other: simulated manipulation

Interventions

spinal manipulation OTHER

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.

Also known as: thrust, high-velocity low-amplitude

Intervention Group

simulated manipulation OTHER

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.

Also known as: placebo intervention

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with chronic low back pain

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Córdoba: lead

Study Sites (1)

Physiobalance

Córdoba, 14011, Spain

Location

Related Publications (14)

• 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.

  PMID: 22054875 BACKGROUND

• Tracey 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.

  PMID: 22100625 BACKGROUND

• Keizer 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.

  PMID: 17277649 BACKGROUND

• Garcia-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.

  PMID: 30442354 BACKGROUND

• Nogueira 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.

  PMID: 32951766 BACKGROUND

• Lohr 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.

  PMID: 29679246 BACKGROUND

• Dellalana 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.

  PMID: 30414198 BACKGROUND

• Kurashina 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.

  PMID: 36820433 BACKGROUND

• Wu 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.

  PMID: 32149135 BACKGROUND

• Ilahi 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.

  PMID: 31954272 BACKGROUND

• Dorron 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.

  PMID: 27980726 BACKGROUND

• Jun 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.

  PMID: 32293493 BACKGROUND

• Page 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.

  PMID: 30658622 BACKGROUND

• Fagundes 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.

  PMID: 32487243 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal; Heimlich Maneuver

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation; Emergency Treatment

Study Officials

• Lourdes García Luque, PhD

  Universidad de Córdoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lourdes García Luque, PhD

CONTACT

0034+ 627366324; z12galul@uco.es

Sandra Alcaraz Clariana, PhD

CONTACT

0034+ 625434043; sandra_fi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be blinded to the intervention assigned to each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

ES (1)