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

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Daily physical activity consultation, Using the Stage of change model


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Physical Therapy<br>Conventional Physical Therapy | |
| Experimental: Daily physical activity consultation, Using Stage of change<br> | Other: Daily physical activity consultation, Using the Stage of change model<br>* Consultation of daily physical activity is provided, including selection of up to four pain relief exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 |