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

NCT ID: NCT06078033

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-02

Study Completion Date

2024-05-20

Brief Summary

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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

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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.

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Randomization was conducted by single randomization. Allocation of the selected patients to different groups (A, intervention; B, placebo) was implemented by opaque envelopes. The randomization was performed by personnel not involved in the trial, such as clinics receptionist. The personnel placed the random characters into sealed opaque envelopes and provided the group allocation to patients. The envelopes were opened only by the manual therapist, without letting the patient know to which group they were assigned to. Additionally, outcomes assessor was blinded to which group patients were assigned to.

Study Groups

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Intervention: Mobilization with movement (MWM)

The MWM technique was performed by asking patients to perform their painful movement (flexion, extension…). If pain was not reproduced, a combination of movements (flexion + rotation…) was performed. The most painful vertebral level was also evaluated with passive accessory vertebral movements. Then, with the patient in a seated position on a stretcher with the feet supported and a belt around the waist, the therapist performed a sustained glide over the targeted vertebra (spinous process) with the force and direction that relieved pain to the lowest level and asked the patient to perform his previous painful movement, as described by Mulligan. Three sets of 10 repetitions were performed, with 1-2 minutes rest between sets.

Group Type EXPERIMENTAL

Mobilization with movement

Intervention Type BIOLOGICAL

Sustained neutral apophyseal glide (SNAG) mobilization with movement applied to targeted vertebra while patients performed their painful movement.

Control: Sham mobilization with movement

Patients allocated to sham group received same evaluation and treatment process. However, only manual contact was performed over the spinous process of the targeted vertebra, without the sustained glide and without applying any force. Three sets of 10 repetitions were performed, with 1-2 minutes rest between sets.

Group Type SHAM_COMPARATOR

Sham mobilization with movement

Intervention Type BIOLOGICAL

Manual contact (without any pressure) applied to targeted vertebra while patients performed their painful movement.

Interventions

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Mobilization with movement

Sustained neutral apophyseal glide (SNAG) mobilization with movement applied to targeted vertebra while patients performed their painful movement.

Intervention Type BIOLOGICAL

Sham mobilization with movement

Manual contact (without any pressure) applied to targeted vertebra while patients performed their painful movement.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eleuterio Atanasio Sánchez Romero

OTHER

Sponsor Role lead

Responsible Party

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Eleuterio Atanasio Sánchez Romero

PhD, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Oliver Martínez, PhDc

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Madrid

Locations

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Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 36917046 (View on PubMed)

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.

Reference Type RESULT
PMID: 31408011 (View on PubMed)

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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 32049888 (View on PubMed)

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.

Reference Type RESULT
PMID: 31764164 (View on PubMed)

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.

Reference Type RESULT
PMID: 31443625 (View on PubMed)

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.

Reference Type RESULT
PMID: 15976161 (View on PubMed)

Other Identifiers

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1811202225222

Identifier Type: -

Identifier Source: org_study_id

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