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Guidance and Physiotherapy in the treatment of patients with Acute Low Back Pain

Minimal Intervention vs. Physical Therapy in the treatment of patients with Nonspecific Acute Low Back Pain: randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7ffw9k
Enrollment
Unknown
Registered
2020-03-05
Start date
2020-04-01
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

In the Minimum Intervention Group (GM), 123 patients will be submitted to an Orientation Program based on The Back Book (Roland et al, 1996), lasting six weeks, performed at the Spinal Pathology Ambul
- Myofascial release: In all sessions, massage maneuvers for myofascial release will be performed, with deep, superficial and friction sliding techniques, applied to the lumbar paravertebral musculatu
- Superficial Heat: Participants will receive five disposable thermal stickers and will be
Other
E02.779

Sponsors

Universidade Federeal de São Paulo - UNIFESP
Lead Sponsor
Hospital São Paulo
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with acute nonspecific low back pain; both genders; age between 18 and 60 years; who agree to participate in the research and sign the IC.

Exclusion criteria

Exclusion criteria: Patients with a history of previous spine surgery; who have undergone physical treatment for low back pain in the past six months; who present clinical warning signs for the presence of fractures, tumors or infections and for the presence of inflammatory, pelvic and abdominal diseases; patients with the presence of associated neurological symptoms indicative of radiculopathy; patients who have contraindications to the use of anti-inflammatory drugs; pregnant women; illiterate.

Design outcomes

Primary

MeasureTime frame
Functionality, assessed using the Oswestry Disability Index (ODI) Functionality Questionnaire, validated for the Portuguese language, which is used to assess functional capacity in individuals with low back pain and consists of 10 items that represent limitations in activities including personal care, lifting objects, walking, sitting, standing, sleeping, sex life, social life, locomotion and pain intensity; the score ranges from 0 to 100, with higher scores indicating greater disability; the minimal clinically significant difference for ODI is estimated at 6 points for acute low back pain.

Secondary

MeasureTime frame
Kinesiophobia Index, assessed using the Fear Avoidance Beliefs Questionnaire (FABQ), which was developed according to cognitive behavioral models that address fear, beliefs and avoidance behaviors of individuals with low back pain in relation to physical activity and work ; this questionnaire consists of sixteen self-report items, which are divided into two subscales, one of which addresses the fears and beliefs of individuals in relation to work (FABQ - Work), while the other addresses their fears and beliefs in relation to physical activities (FABQ - Phys); each item is graded on a seven-point scale ranging from 0, which means completely disagree, to 6, which means completely agree.;Pain recurrence, assessed through a simple question to the patient regarding recurrences of pain (after the end of the interventions, up to 12 weeks).;Additional medication use, assessed through a simple question to the patient regarding the recurrent use of medication (within the 12-week follow-up period).;Chronification of symptoms, assessed through persistence or not of pain (12 weeks after the beginning of interventions).;Recovery rate, assessed using the Global Lumbar Recovery Scale, which consists of a measure of global recovery with which patients self-classify the degree of recovery from their low back pain; in applying this scale the instruction for the patient is: Assess the extent of recovery from your low back pain on the scale below; the scale is based on the very worst and completely recovered descriptors, which are congruent with the question; comprises 11 points, among which the negative numbers represent the degree of worsening of the condition and the positive numbers represent the degree of improvement; these positive and negative numbers, balanced around a zero point (unchanged) reflect the bipolar nature of the construct, that is, recovery versus worsening.;Pain intensity, assessed using the Numerical Pain Scale (END), which is applied verbally and assesses the lev

Countries

Brazil

Contacts

Public ContactLuciano Castelo

Universidade Federeal de São Paulo - UNIFESP

casteloluciano@hotmail.com5511991317479

Outcome results

None listed

Source: REBEC (via WHO ICTRP)