Efficacy of Mobilization With Movement on Conditioned Pain Modulation in Chronic Low Back Pain Patients

Chronic Low-back Pain Clinical Trial

Official title:

Efficacy of Mobilization With Movement on Conditioned Pain Modulation in Chronic Low Back Pain Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06078033
• Other study ID #: 1811202225222
• Status: Completed
• Phase: N/A
• Start date: December 2, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: May 2024
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Biological:
• Mobilization with movement
Sustained neutral apophyseal glide (SNAG) mobilization with movement applied to targeted vertebra while patients performed their painful movement.
• Sham mobilization with movement
Manual contact (without any pressure) applied to targeted vertebra while patients performed their painful movement.

Locations

Country	Name	City	State
Spain	Universidad Europea de Madrid	Villaviciosa De Odón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Eleuterio Atanasio Sánchez Romero

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View 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. — View 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 The — View 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 Wi — View 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. — View 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. — View 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 Olde

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conditioned pain modulation	Conditioned pain modulation of low back, measured on interspace between L5 and S1. Pressure pain threshold (PPT) was used as test stimulus while ischemic pain (using cuff) was used as conditioning stimulus. CPM effect were calculated as the differences between the PPT values with and without the conditioning stimulus.	30 minutes
Secondary	Pressure pain threshold	Pressure pain thresholds (PPT), measured on interspace between L5 and S1. PPT were measured with an algometer placed and applied perpendicular to the skin. Pressure was gradually increased at a rate of 1kg/sec over the targeted location until patient indicated verbally that the sensation became painful. Measurements were taken two times at the location with 30 seconds rest interval between each measurement. The mean of the two measurements for targeted location was calculated for statistical analysis.	30 minutes
Secondary	Body Chart	Widespread pain was measured with body chart	Baseline
Secondary	Kinesiophobia	Kinesiophobia was measured with Spanish version of Tampa Scale of Kinesiophobia. Higher scores denotes greater fear of experiencing pain while moving.	Baseline
Secondary	Depression	Depressive symptoms were measured with Spanish version of Beck Inventory II. 0-13 normal scores; 14-19 mild; 20-28 moderate; 29-63 severe depression.	Baseline
Secondary	Anxiety	Anxiety was measured with Spanish version of State-trait Anxiety Inventory (STAI). Scores of 20-37 indicate no or low anxiety; 38-44 moderate anxiety; 45-80 high anxiety.	Baseline
Secondary	Disability	Low back pain associated disability was measured with Spanish version of Roland-Morris Disability Questionnaire. Higher scores denotes greater pain-associated disability.	Baseline
Secondary	Quality of life (QoL)	QoL was measured with Spanish version of EuroQol 5-Dimensions. Quality of life visual analogue scale consist of a scale from 0 (worse quality of life) to 100 (best quality of life). Additionally, quality of life index may be summarised by a series of five sentences, one for each dimension and stating the level within that dimension; or a label consisting of five ordinal numbers, one for each dimension (by convention, in the order these appear in the questionnaire), defining the severity level, where 1 means no problems.	Baseline