Clinical trial NCT06078033: Efficacy of Mobilization With Movement on Conditioned Pain Modulation in Chronic Low Back Pain Patients
Official title: Efficacy of Mobilization With Movement on Conditioned Pain Modulation in Chronic Low Back Pain Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic low back pain
Manual therapy
Conditioned Pain Modulation
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with chronic low back pain may have altered endogenous mechanisms, which can be evaluated with conditioned modulation paradigms. Mobilization with movement has demonstrated improvements in endogenous analgesic mechanisms in conditions such as knee osteoarthritis or lateral epicondylalgia. However, its effects have not yet been studied in patients with chronic low back pain. The objective of this randomized clinical trial is to evaluate the efficacy of mobilization with movement compared to placebo on endogenous mechanisms in patients with chronic low back pain.

Detailed description: Low back pain is the leading cause of disability worldwide, and chronic low back pain (CLBP) has a prevalence of 2-25%, 80% of which are classified as non-specific low back pain because the causal factors have not yet been determined. Although different mechanisms can be attributed to the chronification of pain, a frequent denominator is the amplification of nociceptive transmission or decreased inhibition of nociceptive stimuli in the peripheral and/or central nervous system.

To assess inhibitory pathways, conditioned pain modulation (CPM) paradigms are commonly used in humans. They are based on the idea that a noxious stimulus applied to one part of the body can inhibit pain elsewhere by activating the descending inhibitory system.

When CPM is evaluated in patients with chronic low back pain, contradictory results are found, with studies reporting an alteration of pain modulation mechanisms and others not.

Different studies found that manual therapy can improve CPM compared to sham in patients with chronic musculoskeletal pain, such as lateral epicondylalgia or knee osteoarthritis. However, its effects in patients with chronic low back pain have not yet been studied.

Therefore, the aim of this study was to investigate the effect of mobilization with motion on CPM in patients with chronic musculoskeletal pain.

Eligibility criteria: Inclusion Criteria:

* Adults with chronic low back pain (\>3 months of pain duration)
* 2 or more on a scale of 0 to 10.

Exclusion Criteria:

* Radiculopathy
* Neurological signs, symptoms, or deficit
* Rheumatic or autoimmune disease
* Cutaneous disease
* History of fracture or spinal surgery
* Pregnancy
* Neuropathic pain
* Active cancer
* Spondylolysis/Spondylolisthesis
* Mild/Severe cognitive impairment which interferes with outcomes measurement

Primary outcomes:
measure: Conditioned pain modulation
timeFrame: 30 minutes
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: 30 minutes
measure: Body Chart
timeFrame: Baseline
measure: Kinesiophobia
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
measure: Anxiety
timeFrame: Baseline
measure: Disability
timeFrame: Baseline
measure: Quality of life (QoL)
timeFrame: Baseline
Other outcomes:
Locations:
city: Villaviciosa De Odón
country: Spain
facility: Universidad Europea de Madrid
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Oliver Martínez, PhDc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez-Pozas O, Sanchez-Romero EA, Beltran-Alacreu H, Arribas-Romano A, Cuenca-Martinez F, Villafane JH, Fernandez-Carnero J. Effects of Orthopedic Manual Therapy on Pain Sensitization in Patients With Chronic Musculoskeletal Pain: An Umbrella Review With Meta-Meta-analysis. Am J Phys Med Rehabil. 2023 Oct 1;102(10):879-885. doi: 10.1097/PHM.0000000000002239. Epub 2023 Mar 14.
citation: Aoyagi K, He J, Nicol AL, Clauw DJ, Kluding PM, Jernigan S, Sharma NK. A Subgroup of Chronic Low Back Pain Patients With Central Sensitization. Clin J Pain. 2019 Nov;35(11):869-879. doi: 10.1097/AJP.0000000000000755.
citation: Sánchez-Romero EA, González-Zamorano Y, Arribas-Romano A, Martínez-Pozas O, Fernández Espinar E, Pedersini P, Villafañe JH, Alonso Pérez JL, Fernández-Carnero J. Efficacy of Manual Therapy on Facilitatory Nociception and Endogenous Pain Modulation in Older Adults with Knee Osteoarthritis: A Case Series. Applied Sciences. 2021; 11(4):1895. https://doi.org/10.3390/app11041895
citation: McPhee ME, Vaegter HB, Graven-Nielsen T. Alterations in pronociceptive and antinociceptive mechanisms in patients with low back pain: a systematic review with meta-analysis. Pain. 2020 Mar;161(3):464-475. doi: 10.1097/j.pain.0000000000001737.
citation: Neelapala YVR, Bhagat M, Frey-Law L. Conditioned Pain Modulation in Chronic Low Back Pain: A Systematic Review of Literature. Clin J Pain. 2020 Feb;36(2):135-141. doi: 10.1097/AJP.0000000000000778.
citation: den Bandt HL, Paulis WD, Beckwee D, Ickmans K, Nijs J, Voogt L. Pain Mechanisms in Low Back Pain: A Systematic Review With Meta-analysis of Mechanical Quantitative Sensory Testing Outcomes in People With Nonspecific Low Back Pain. J Orthop Sports Phys Ther. 2019 Oct;49(10):698-715. doi: 10.2519/jospt.2019.8876. Epub 2019 Aug 23.
citation: Bisset L, Paungmali A, Vicenzino B, Beller E. A systematic review and meta-analysis of clinical trials on physical interventions for lateral epicondylalgia. Br J Sports Med. 2005 Jul;39(7):411-22; discussion 411-22. doi: 10.1136/bjsm.2004.016170.