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Chronic Low-back PainNCT06078033

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

A study testing Mobilization with movement in people with Chronic Low-back Pain, run by Eleuterio Atanasio Sánchez Romero at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Low-back Pain
What is being tested?
Mobilization with movement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteSpain
Study dates
2 Dec 2023to 20 May 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Radiculopathy
  • Neurological signs, symptoms, or deficit
  • Rheumatic or autoimmune disease
  • Cutaneous disease
  • History of fracture or spinal surgery
  • Pregnancy
Show all 10Show fewer
  • Neuropathic pain
  • Active cancer
  • Spondylolysis/Spondylolisthesis
  • Mild/Severe cognitive impairment which interferes with outcomes measurement

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad Europea de Madrid

    Villaviciosa de Odón, Madrid, 28670

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Mobilization with movement, Sham mobilization with movement
Keywords
Chronic low back pain, Manual therapy, Conditioned Pain Modulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobilization with movementBiological

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

  • Sham mobilization with movementBiological

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

Study groups in NCT06078033
Study groupRoleWhat they receive
Intervention: Mobilization with movement (MWM)ExperimentalThe 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.
Receives: Biological: Mobilization with movement
Control: Sham mobilization with movementSham comparatorPatients 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.
Receives: Biological: Sham mobilization with movement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 minutes

Secondary outcomes (7)

  1. 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.

    Measured: 30 minutes

  2. Body Chart

    Widespread pain was measured with body chart

    Measured: Baseline

  3. Kinesiophobia

    Kinesiophobia was measured with Spanish version of Tampa Scale of Kinesiophobia. Higher scores denotes greater fear of experiencing pain while moving.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. Disability

    Low back pain associated disability was measured with Spanish version of Roland-Morris Disability Questionnaire. Higher scores denotes greater pain-associated disability.

    Measured: Baseline

  7. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2023
  2. Study start2 Dec 2023
  3. Primary completion20 May 2024
  4. Study completion20 May 2024

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06078033
Sponsor's protocol ID
1811202225222
Status last verified
May 2024
First submitted
29 Sep 2023
Last updated
21 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36917046

  • 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.

    PubMed 31408011

  • 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

  • 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.

    PubMed 32049888

  • 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.

    PubMed 31764164

  • 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.

    PubMed 31443625

  • 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.

    PubMed 15976161

Questions about this trial

What is this clinical trial studying?

A study testing Mobilization with movement in people with Chronic Low-back Pain, run by Eleuterio Atanasio Sánchez Romero 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 21 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conditioned pain modulation (time frame: 30 minutes). 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 NCT06078033, which also lists 7 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 21 May 2024.

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