Clinical trial NCT05336500: Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates
Official title: Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates Exercises in Patients With Primary Chronic Low Back Pain: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effectiveness of education to keep the abdomen relaxed versus contracted during Pilates exercises in patients with primary chronic low back pain.

Participants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks. The control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way. Primary outcomes will be pain intensity and disability 12 weeks post randomisation.


Eligibility criteria: Inclusion Criteria:

* Aged from 18 years old;
* Low back pain for more than 3 months;
* Disability level ≥ 4 points on the Roland-Morris Disability Questionnaire (RMDQ);
* Ability to move independently with or without assistance;
* Ability to understand Portuguese enough to be able to fill in the questionnaires.

Exclusion Criteria:

* The main area of pain other than the lumbar spine (eg, nerve root compression or herniated disc with radicular pain, lateral or central stenosis);
* Surgery performed on the lumbar spine.
* Surgery performed on the lower limbs, or abdominal region less than 6 months ago;
* Performing an invasive procedure for pain relief (eg, epidural injection, rhizotomy) in the last 3 months;
* Diagnosis of inflammatory rheumatologic diseases, progressive neurological disease, or viral diseases as the primary cause of pain;
* Scoliosis as the primary cause of pain;
* Unstable heart conditions;
* Presence of red flags such as malignancy/cancer, acute trauma (less than 6 months), infection, spinal cord/cauda equina compression.

Primary outcomes:
measure: Pain intensity
timeFrame: 12 weeks post randomisation
measure: Disability related
timeFrame: 12 weeks post randomisation
Secondary outcomes:
measure: Perception of global improvement
timeFrame: 12 weeks post randomisation
measure: Specific functionality
timeFrame: 12 weeks post randomisation
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Centro Universitário Augusto Motta
Study officials:
References:
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