Clinical trial NCT01314157: Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain
Official title: Evaluation of Isostretching Effects in Patients With Mechanical and Postural
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
pain
incapacity
life quality
rehabilitation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-03-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Alocados de forma cega para o grupo de intervenção: 27 pacientes com diagnóstico de lombalgia crônica realizaram o Isostretching e uso de diclofenaco em caso de dor e grupo controle:27 pacientes com lombalgia crônica sem atividade física com uso apenas de diclofenaco em caso dedor Todos foram submetidos à avaliação inicial (T0), com 20 dias (T20) e com 45 dias (T45), por um avaliador cego. Os pacientes foram instruídos nos dois grupos, pelo médico, a utilizar o diclofenaco de sódio 50mg, a cada oito horas de acordo com a dor.
Primary purpose: TREATMENT

Brief summary: Isostretching is effective in treating chronic back pain to improve pain, quality of life and functional capacity.

Detailed description: Objective: This study investigated the influence of isostretching on patients with chronic low back pain. Methods: It was a randomized, controlled trial with concealed allocation, intention-to-treat analysis, and blind assessment. Fifty-four patients with chronic low back pain were randomized to an experimental group and a control group. The experimental group performed isostretching twice a week for 45 days, while the control group remained on the waiting list for physical therapy. Patients were submitted to evaluations at baseline, after 20 and 45 days of treatment with regard to pain, quality of life, functional capacity, and satisfaction. Results: The experimental group exhibited statistically significant improvements in comparison to the control group with regard to pain (p = .003), functional capacity (p = .026), patient satisfaction (p \< .001), and quality of life as determined by the functional capacity (p = .012), physical aspects (p = .011) and pain (p = .006) subscales of the SF-36. The experimental group used a significantly lesser amount of pain medication than the control group (p = .03). Conclusion: Isostretching was effective in reducing pain and in improving function, patient satisfaction and some aspects of quality of life in patients with chronic low back pain.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with chronic low back pain with pain located between the last rib and the gluteal fold over 12 weeks;
* Mechanical back pain that worsens with exertion and relieved by rest;
* Pain between 3 and 8 cm measured by analog pain scale.

Exclusion Criteria:

* Subjects who presented pain root
* Fibromyalgia
* Severe scoliosis with abnormal alignment of the spine (Cobb angle\> 40); Tumors in the column; Infiltration in the lumbar spine in the last three months; Previous surgery of the spine (patients return to work or process expulsion)
* Have changed or initiated physical activity in the last three months
* Body mass index greater than 30 kg/m2

Primary outcomes:
measure: Evaluation of isostretching effects in patients with chronic low back pain
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Maceió
country: Brazil
facility: Erika Rosangela Alves Prado
state: Alagoas
Study officials:
affiliation: Universidade Estadual de Ciências da Saúde de Alagoas
name: Erika Rosângela A Prado, Specialist
role: PRINCIPAL_INVESTIGATOR
References: