Evaluation of Isostretching Effects in Patients With Mech... | NCT01314157

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

NCT01314157

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Aug 1, 2022Actual

Enrollment

54Actual

Phase

Not Applicable

Conditions

Chronic Low Back Pain

Interventions

Isostretching

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2011Actual

Primary Completion Date

Nov 30, 2011Actual

Completion Date

Nov 30, 2011Actual

First Submitted Date

Mar 11, 2011

First Submission Date that Met QC Criteria

Mar 11, 2011

First Posted Date

Mar 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2022

Last Update Posted Date

Aug 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erika Rosangela Alves Prado, Mestra em Ciências da Saúde Aplicada a Medicina Reumatológica, Federal University of São PauloPrincipal Investigator

Lead Sponsor

Federal University of São PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Isostretching	Other	12 interventions (two times per week) for 45 minutes	Physiotherapy treatment technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of isostretching effects in patients with chronic low back pain	Reviewed by analog pain scale. (VAS)	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erika Rosângela A Prado, Specialist	Universidade Estadual de Ciências da Saúde de Alagoas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erika Rosangela Alves Prado		Maceió	Alagoas	57051-540	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain
D010146	Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

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.

Masking Info

Masking

Double

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.

Who Masked

Care ProviderOutcomes Assessor