Improvement After Physiotherapy for Low Back Pain: The Go... | NCT02168582

Studies
Improvement After Physiotherapy for Low Back Pain: The Good Responders

NCT02168582

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jan 3, 2019Actual

Enrollment

44Actual

Phase

Not provided

Conditions

Low Back Pain

Interventions

physiotherapy as usual in primary care

Countries

Norway

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

Dec 2018

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

May 2014Actual

Primary Completion Date

Mar 9, 2017Actual

Completion Date

Mar 9, 2017Actual

First Submitted Date

Jun 18, 2014

First Submission Date that Met QC Criteria

Jun 18, 2014

First Posted Date

Jun 20, 2014Estimated

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

Jan 2, 2019

Last Update Posted Date

Jan 3, 2019Actual

Name	Class
Trondheim Kommune	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This is an observational study that aims to characterize individual response of patients getting physical therapy for chronic non-specific low back pain.

Participants will be classified based on a questionnaire and motor tests to investigate whether individual improvement after physical therapy may be predicted. These observations may help to decide which should be the preferred treatment offered.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Label	Type	Description	Intervention Names
low back pain			Behavioral: physiotherapy as usual in primary care

Name	Type	Description	Arm Group Labels	Other Names
physiotherapy as usual in primary care	Behavioral		low back pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient-reported disability	questionnaire (Oswestry Disability Index)	1 year

Secondary Outcomes

Measure	Description	Time Frame
self-efficacy	questionnaire and interview	1 year
global perceived effect	questionnaire	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

low back pain
receiving primary care physiotherapy

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Persons seeking primary care physiotherapy because of low back pain.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Siri Forsmo, prof md	Norwegian University of Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Public Health and General Practice		Trondheim			Norway

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities
D011320	Primary Health Care

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation
D003191	Comprehensive Health Care
D010346	Patient Care Management

Browse Leaves

Not provided

Browse Branches

Not provided