Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Isostretching
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, pain, incapacity, life quality, rehabilitation
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
Sites / Locations
- Erika Rosangela Alves Prado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physiotherapy treatment technique
Patients remained on the waiting list
Arm Description
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"
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.
Outcomes
Primary Outcome Measures
Evaluation of isostretching effects in patients with chronic low back pain
Reviewed by analog pain scale. (VAS)
Secondary Outcome Measures
Full Information
NCT ID
NCT01314157
First Posted
March 11, 2011
Last Updated
July 28, 2022
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01314157
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2011 (Actual)
Primary Completion Date
November 30, 2011 (Actual)
Study Completion Date
November 30, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, pain, incapacity, life quality, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy treatment technique
Arm Type
Experimental
Arm Description
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"
Arm Title
Patients remained on the waiting list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Isostretching
Other Intervention Name(s)
Strengthening and stretching exercise during expiration.
Intervention Description
12 interventions (two times per week) for 45 minutes
Primary Outcome Measure Information:
Title
Evaluation of isostretching effects in patients with chronic low back pain
Description
Reviewed by analog pain scale. (VAS)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Rosângela A Prado, Specialist
Organizational Affiliation
Universidade Estadual de Ciências da Saúde de Alagoas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erika Rosangela Alves Prado
City
Maceió
State/Province
Alagoas
ZIP/Postal Code
57051-540
Country
Brazil
12. IPD Sharing Statement
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Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain
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