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Clinical Trials/NCT01631344
NCT01631344
Completed
Not Applicable

Intervention Study to Examine the Effectiveness of Lifestyle Counseling Using the "Stage of Change" Model Versus Conventional Physical Therapy on Chronic Low Back Pain

Assuta Hospital Systems1 site in 1 country220 target enrollmentFebruary 2011
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Assuta Hospital Systems
Enrollment
220
Locations
1
Primary Endpoint
Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years
Status
Completed
Last Updated
7 years ago

Overview

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

  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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
January 8, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Assuta Hospital Systems
Responsible Party
Sponsor

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
  • Fibromyalgia
  • Back surgery
  • Road / work accidents
  • Non Hebrew speaking
  • Pregnancy

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Study Sites (1)

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