Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain
NCT ID: NCT01631344
Last Updated: 2019-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2011-02-28
2019-01-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Physical Therapy
Conventional Physical Therapy
No interventions assigned to this group
Daily physical activity consultation, Using Stage of change
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Age 25-55 years old
* Chronic / recurrent low back pain (over 3 months)
* With or without radiation
Exclusion Criteria
* Tumors
* Fibromyalgia
* Back surgery
* Road / work accidents
* Non Hebrew speaking
* Pregnancy
25 Years
55 Years
ALL
No
Sponsors
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Assuta Hospital Systems
OTHER
Responsible Party
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Principal Investigators
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Yair Shapiro, MD.
Role: PRINCIPAL_INVESTIGATOR
Maccabi Healthcare Services, Israel
Locations
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Maccabi Healthcare Services Clinics
Tel Aviv, , Israel
Countries
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References
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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.
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.
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.
Other Identifiers
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2008036
Identifier Type: -
Identifier Source: org_study_id
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