Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT01631344|
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : January 10, 2019
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
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Other: Daily physical activity consultation, Using the "Stage of change" model||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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 ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01631344
|Maccabi Healthcare Services Clinics|
|Tel Aviv, Israel|
|Principal Investigator:||Yair Shapiro, MD.||Maccabi Healthcare Services, Israel|