Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain

NCT01314157 | Completed DMC

• 1 other identifier: 1-Prado
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Low Back Pain

Keywords

low back pain; pain; incapacity; life quality; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Evaluation of isostretching effects in patients with chronic low back pain

  Reviewed by analog pain scale. (VAS)

  1 month

Study Arms (2)

Physiotherapy treatment technique

EXPERIMENTAL

Randomized clinical trial controlling and using at the time of allocation, toss with sealed envelopes, sealed and opaque. The study group will be dealt with "technical isostretching"

Other: Isostretching

Patients remained on the waiting list

NO INTERVENTION

Randomized clinical trial controlling and using at the time of allocation, toss with sealed envelopes, sealed and opaque. The study group will be dealt with control group.

Interventions

Isostretching OTHER

12 interventions (two times per week) for 45 minutes

Also known as: Strengthening and stretching exercise during expiration.

Physiotherapy treatment technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Erika Rosangela Alves Prado

Maceió, Alagoas, 57051-540, Brazil

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erika Rosângela A Prado, Specialist

  Universidade Estadual de Ciências da Saúde de Alagoas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Os pacientes selecionados foram alocados de forma aleatória através da lista de randomização gerada por computador, foram confeccionados envelopes lacrados e opacos utilizados para manter o segredo de alocação. Todos foram submetidos à avaliação inicial (T0), com 20 dias (T20) e com 45 dias (T45), por um avaliador cego.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mestra em Ciências da Saúde Aplicada a Medicina Reumatológica

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 14, 2011
• Study Start: March 1, 2011
• Primary Completion: November 30, 2011
• Study Completion: November 30, 2011
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

BR (1)