Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain
NCT ID: NCT04940715
Last Updated: 2021-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
54 participants
INTERVENTIONAL
2021-09-30
2022-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Mobilization With Movement on Conditioned Pain Modulation in Chronic Low Back Pain Patients
NCT06078033
Effects of Lumbar Spinal Manipulation in Subjects With Chronic Low Back Pain
NCT06399497
Manipulative Therapy Techniques to Treat Chronic Low Back Pain
NCT01796496
Does Low Back Position Matters in Manual Therapy Treatment
NCT04664348
Mechanisms of Chiropractic Spinal Manipulation for Chronic Low Back Pain
NCT05162924
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Aim #1: The main objective of this study is to determine the efficacy of two manual therapy approaches (passive joint mobilization and mobilization with movement) on pain (measured with Visual Analogue Scale) and pain processing (measured with pressure pain threshold, temporal summation and conditioned pain modulation) in patients with chronic low back pain and see its results on short, medium and long term.
Aim #2: The secondary objective is to compare the effect of both manual therapy techniques with an inactive control group in terms of pain and pain processing.
Aim #3: Determine the efficacy of manual therapy on intervention groups on psychological outcomes as catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale of Kinesiophobia) and depression (Beck Depressive Inventory) and compare them with control group.
Methodology Research Design: Randomized, longitudinal, experimental, prospective, parallel and double-blind study with patients with chronic low back pain.
Participants: Adults between 18-65 years old residing Comunidad de Madrid, all of whom were recruited personally for the study. All patients will read the information sheet explaining what the study will consist, as well as the informed consent form, which they will sign voluntarily beforehand.
Sample Size: The sample size will be calculated by means of the "Gpower 3.0.18" computer program.
Randomization: Randomization will be done through the GraphPad software (GraphPad Software, Inc CA 92037 USA). Patients who meet the inclusion criteria and have none of the exclusion criteria will be entered into the study and the sample will be randomized to obtain three groups in opaque and sealed envelopes: A (passive joint mobilization), B (mobilization with movement) and C (control group).
Masking: The double-blind criteria are met, in which the subjects participating in the study will not know the group to which they were assigned, as well as the physiotherapist in charge of collecting the outcomes data.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Passive joint mobilization
Patients lay down on a prone position, with their hands around the body and neck placed comfortable. The therapist performed a postero-anterior joint mobilization using Maitland's technique, applying pressure to spinous process of targeted vertebra (the one who reproduces patient's symptoms).
Passive joint mobilization
Dosage: 5 sets of 2 minutes with 30 seconds of rest were applied, with a strong force (\>50% of maximum therapist strength), according to patient's irritability and severity.
Mobilization with movement
Patients perform their painful movement (flexion, extension…). If pain wasn't reproduced, a combination of movements will be performed (flexion + rotation…). The most painful vertebral level was assessed too with passive accessory vertebral movements. Afterwards, with the patient on a seated position on a stretcher with feet supported and a belt around the waist, the therapist performed a sustained glide on the targeted vertebra (spinous process) with the force and direction that relieved pain to the lowest level.
Mobilization with movement
Dosage: 3 sets of 10 repetitions were performed, with 1-2 minutes of rest between sets.
Control group
Patients were measured at baseline and then were placed on "wait list" until the end of the study. At this time, they were measured again.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Passive joint mobilization
Dosage: 5 sets of 2 minutes with 30 seconds of rest were applied, with a strong force (\>50% of maximum therapist strength), according to patient's irritability and severity.
Mobilization with movement
Dosage: 3 sets of 10 repetitions were performed, with 1-2 minutes of rest between sets.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pain lasting 6 months or more
* Pain measure of 2 or more on a 0 to 10 scale
* Age between 18-65 years old
* Haven't received physical therapy during last month
Exclusion Criteria
* Neurological signs, symptoms or deficit
* Rheumatic/autoimmune/systemic disease
* History of fracture, trauma or previous spinal surgery
* Pregnancy
* Disc herniation
* Neuropathic pain
* Active cancer
* Spondylolysis/Spondylolisthesis
* Cognitive impairment
* Long-term opioid intake
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Rey Juan Carlos
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Josue Fernandez Carnero
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Oliver Martínez Pozas, PhD candidate
Role: PRINCIPAL_INVESTIGATOR
Universidad Rey Juan Carlos (Madrid)
Eleuterio A. Sánchez Romero, PhD
Role: STUDY_DIRECTOR
Universidad Europea de Madrid (Madrid)
Josué Fernández Carnero, PhD
Role: STUDY_DIRECTOR
Universidad Rey Juan Carlos (Madrid)
Héctor Beltrán Alacreu, PhD
Role: STUDY_DIRECTOR
Universidad de Castilla La-Mancha (Toledo)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Alkhawajah HA, Alshami AM. The effect of mobilization with movement on pain and function in patients with knee osteoarthritis: a randomized double-blind controlled trial. BMC Musculoskelet Disord. 2019 Oct 18;20(1):452. doi: 10.1186/s12891-019-2841-4.
Lascurain-Aguirrebena I, Newham D, Critchley DJ. Mechanism of Action of Spinal Mobilizations: A Systematic Review. Spine (Phila Pa 1976). 2016 Jan;41(2):159-72. doi: 10.1097/BRS.0000000000001151.
Aspinall SL, Jacques A, Leboeuf-Yde C, Etherington SJ, Walker BF. No difference in pressure pain threshold and temporal summation after lumbar spinal manipulation compared to sham: A randomised controlled trial in adults with low back pain. Musculoskelet Sci Pract. 2019 Oct;43:18-25. doi: 10.1016/j.msksp.2019.05.011. Epub 2019 May 31.
Arribas-Romano A, Fernandez-Carnero J, Molina-Rueda F, Angulo-Diaz-Parreno S, Navarro-Santana MJ. Efficacy of Physical Therapy on Nociceptive Pain Processing Alterations in Patients with Chronic Musculoskeletal Pain: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2502-2517. doi: 10.1093/pm/pnz366.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1003202108421
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.