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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Daily physical activity consultation, Using the "Stage of change" model
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maccabi Healthcare Services Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Physical Therapy

Daily physical activity consultation, Using Stage of change

Arm Description

Conventional Physical Therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2012
Last Updated
January 9, 2019
Sponsor
Assuta Hospital Systems
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1. Study Identification

Unique Protocol Identification Number
NCT01631344
Brief Title
Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain
Official Title
Intervention Study to Examine the Effectiveness of Lifestyle Counseling Using the "Stage of Change" Model Versus Conventional Physical Therapy on Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
January 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assuta Hospital Systems

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. Pain reduction. Less disability - improvement in daily activities. Better feeling of health and well-being. Increased and better compliance to daily sport activities. BMI reduction. Reduction of cigarette smoking. Reduction of usage of anti-analgesics and anti-inflammatory medications. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy
Arm Type
No Intervention
Arm Description
Conventional Physical Therapy
Arm Title
Daily physical activity consultation, Using Stage of change
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Daily physical activity consultation, Using the "Stage of change" model
Intervention Description
Consultation of daily physical activity is provided, including selection of up to four pain relief exercises
Primary Outcome Measure Information:
Title
Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years
Time Frame
3 months, 1, 2 and 5 years
Secondary Outcome Measure Information:
Title
Change from baseline of Pain using the Numerical pain scale at 3 months, 1, 2 and 5 years
Time Frame
3 months, 1, 2 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Shapiro, MD.
Organizational Affiliation
Maccabi Healthcare Services, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maccabi Healthcare Services Clinics
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29643158
Citation
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.
Results Reference
derived
PubMed Identifier
29587572
Citation
Ben-Ami N, Shapiro Y, Pincus T. Outcomes in Distressed Patients With Chronic Low Back Pain: Subgroup Analysis of a Clinical Trial. J Orthop Sports Phys Ther. 2018 Jun;48(6):491-495. doi: 10.2519/jospt.2018.7670. Epub 2018 Mar 27.
Results Reference
derived
PubMed Identifier
28142364
Citation
Ben-Ami N, Chodick G, Mirovsky Y, Pincus T, Shapiro Y. Increasing Recreational Physical Activity in Patients With Chronic Low Back Pain: A Pragmatic Controlled Clinical Trial. J Orthop Sports Phys Ther. 2017 Feb;47(2):57-66. doi: 10.2519/jospt.2017.7057.
Results Reference
derived

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

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