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Effects of Osteopathic Manual Treatment in Patients with Chronic Low Back Pain

Effects of Osteopathic Manual Treatment protocols in patients with chronic Low Back Pain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5rq9bd8
Enrollment
Unknown
Registered
2024-03-02
Start date
2023-04-17
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low back pain

Interventions

This is a 5-arm, double blind and randomized controlled clinical trial that assess the effect of osteopathic treatment protocols in individuals with chronic low back pain. After baseline assessment, t
Group 2 – functional, cranial and visceral manual manipulations (n=36)
Group 3 – myofascial manual techniques and neural mobilization (n=36)
Group 4 – individualized pragmatic osteopathic protocol (n=36) and Group 5 – pain education (n=36). All protocols will be applied once a week for 06 weeks by blinded clinicians about pain classificati

Sponsors

Escola de Osteopatia de Madrid
Lead Sponsor
Escola de Osteopatia de Madrid
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Subjects with lombar pain for at least 03 months, most days

Exclusion criteria

Exclusion criteria: Severe osteoporosis; progressive neurological disease; scoliosis above 30°; reumathic diseases; Laségue positive above 35°; previous lumbar surgery; patient using experimental treatments; patients undergoing another manipulative treatment out of this study; cancer; pregnancy

Design outcomes

Primary

MeasureTime frame
Pain reduction is expected, assessed using the Visual Analog Scale (VAS), that is composed of a score from 0 to 10 points, with 0 representing total absence of pain and 10 representing the 'maximum pain' tolerable by the patient. ;An increase in the pressure pain threshold is expected, assessed by algometry, whose pressure pain will be assessed using an algometer in units of kg, at points located in the superior trapezius and anterior tibialis muscles on the dominant side. The greater the quantity in kg, the greater the tolerance to pressure pain.;It is expected that the participant will have better pain modulation, represented by an increase in the pressure pain threshold in algometry associated with a decrease in the EAVD score after submerging the hand in ice water at the end of the interventions. This modulation will be assessed using the Cold Pressor Test (CPT), where the test will be carried out to record the average of 3 measurements of the pressure pain threshold and the EAVD based on the pressure exerted on the algometry points will also be recorded. Then, the patient will submerge the non-dominant hand in a container with ice water for 2 minutes so that another algometry test can be carried out immediately.;A reduction in neuropathic pain is expected, assessed by applying the questionnaire (DN4) consisting of 10 items, with 7 items related to symptoms and 3 items related to the physical examination. One point is added for each positive response and zero points for each negative response. The cutoff point is 4 points, with subjects scoring equal to or greater than 4 points considered to have neuropathic pain. A reduction in the score is expected after the completion of interventions.;An increase in pain tolerance is expected in temporal summation, assessed using a 300g monofilament aesthesiometer will be used to perform 3 stimuli with a 5-second interval between them on the paravertebral muscle at the L3 level on the dominant side, and the VAS (Visual Analo

Secondary

MeasureTime frame
A reduction in the intensity of catastrophic thinking is expected, assessed using the Pain Catastrophizing Scale (B-PCS), in which the subject assigns a rating from 0 to 4 (minimal, mild, moderate, intense, and very intense, respectively) to 13 statements that describe different thoughts and feelings that may be present when the subject is in pain.

Countries

Brazil

Contacts

Public ContactRogério Queiroz

Escola de Osteopatia de Madrid

rogerio.queiroz@osteopatiamadrid.com.br+5519981112319

Outcome results

None listed

Source: REBEC (via WHO ICTRP)