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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01631344
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
Assuta Hospital Systems

Brief Summary:


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

  1. 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.

  2. 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.
  3. 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:

  1. Conventional Physical Therapy.
  2. 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Daily physical activity consultation, Using the "Stage of change" model Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2011
Actual Primary Completion Date : July 2017
Actual Study Completion Date : January 8, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Physical Therapy
Conventional Physical Therapy
Experimental: Daily physical activity consultation, Using Stage of change Other: Daily physical activity consultation, Using the "Stage of change" model
Consultation of daily physical activity is provided, including selection of up to four pain relief exercises

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01631344

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Maccabi Healthcare Services Clinics
Tel Aviv, Israel
Sponsors and Collaborators
Assuta Hospital Systems
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Principal Investigator: Yair Shapiro, MD. Maccabi Healthcare Services, Israel
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Assuta Hospital Systems Identifier: NCT01631344    
Other Study ID Numbers: 2008036
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations