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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01314157

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Low Back Pain	Other: Isostretching	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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:

Double (Care Provider, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

Evaluation of Isostretching Effects in Patients With Mechanical and Postural

Actual Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Nov 30, 2011

Actual Study Completion Date :

Nov 30, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physiotherapy treatment technique 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 12 interventions (two times per week) for 45 minutes Other Names: Strengthening and stretching exercise during expiration.
No Intervention: Patients remained on the waiting list 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.

Arm

Intervention/Treatment

Experimental: Physiotherapy treatment technique

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

12 interventions (two times per week) for 45 minutes

Other Names:

Strengthening and stretching exercise during expiration.

No Intervention: Patients remained on the waiting list

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.

Outcome Measures

Primary Outcome Measures

Evaluation of isostretching effects in patients with chronic low back pain [1 month]
Reviewed by analog pain scale. (VAS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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