Effectiveness of Lifestyle Counseling Versus Physical The... | NCT01631344

Studies
Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain

NCT01631344

Sponsor

Assuta Hospital Systems

Status

Completed

Last Update Posted

Jan 10, 2019Actual

Enrollment

220Actual

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

Daily physical activity consultation, Using the "Stage of change" model

Countries

Israel

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

Jan 2019

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

Feb 2011

Primary Completion Date

Jul 2017Actual

Completion Date

Jan 8, 2019Actual

First Submitted Date

Jun 7, 2012

First Submission Date that Met QC Criteria

Jun 28, 2012

First Posted Date

Jun 29, 2012Estimated

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 9, 2019

Last Update Posted Date

Jan 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Background:

Low back pain is the leading cause of disability, affecting the quality of life and work productivity.

It is the most common reason for seek medical help and advice. Low back pain creates huge economical burden worldwide. To date, most ( 90%) of low back pain cases are not clinically defined with no preferred medical treatment

Study objectives:

To prove that consulting using the "Stage of change" model for daily physical activity will lead to long term improvement of pain, disability and well-being parameters of those suffering from chronic low back pain, people age 25-55, when compared to conventional Physical Therapy.
Study hypotheses:

The intervention groups vs. Physical Therapy group will demonstrate that the following parameters will improve after: 3 months, one, two and five years.
1. Pain reduction.
2. Less disability - improvement in daily activities.
3. Better feeling of health and well-being.
4. Increased and better compliance to daily sport activities.
5. BMI reduction.
6. Reduction of cigarette smoking.
7. Reduction of usage of anti-analgesics and anti-inflammatory medications.
8. Reduction in number of visits to Physical Therapy clinics due to low back pain.
Methods:

The present Randomized intervention study that will include 220 healthy individuals, males and females aged 25-55 years old suffering from chronic or recurrent low back pain, with or without radiation to the legs that were referred to Maccabi Healthcare Services Physical Therapy clinics in the Sharon district in Israel.

These individuals will be randomized to one of the following two groups:

Conventional Physical Therapy.
Physical Therapy focused on healthy lifestyle using the "Stage of Change" model.

Non-dependent observer will follow-up on the outcome parameters via phone calls and filling the questionnaire's with the relevant study participants following 3 months, 1 year, 2 and 5 years.

Detailed Description

Not provided

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

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physical Therapy	No Intervention	Conventional Physical Therapy
Daily physical activity consultation, Using Stage of change	Experimental		Other: Daily physical activity consultation, Using the "Stage of change" model

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Daily physical activity consultation, Using the "Stage of change" model	Other	Consultation of daily physical activity is provided, including selection of up to four pain relief exercises

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years		3 months, 1, 2 and 5 years

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline of Pain using the Numerical pain scale at 3 months, 1, 2 and 5 years		3 months, 1, 2 and 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women
Age 25-55 years old
Chronic / recurrent low back pain (over 3 months)
With or without radiation

Exclusion Criteria:

Rheumatoid disease
Tumors
Fibromyalgia
Back surgery
Road / work accidents
Non Hebrew speaking
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yair Shapiro, MD.	Maccabi Healthcare Services, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maccabi Healthcare Services Clinics		Tel Aviv			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29643158	Derived	Canaway A, Pincus T, Underwood M, Shapiro Y, Chodick G, Ben-Ami N. Is an enhanced behaviour change intervention cost-effective compared with physiotherapy for patients with chronic low back pain? Results from a multicentre trial in Israel. BMJ Open. 2018 Apr 10;8(4):e019928. doi: 10.1136/bmjopen-2017-019928.
29587572	Derived

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