- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01631344
Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain
Intervention Study to Examine the Effectiveness of Lifestyle Counseling Using the "Stage of Change" Model Versus Conventional Physical Therapy on Chronic Low Back Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tel Aviv, Israel
- Maccabi Healthcare Services Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Physical Therapy
Conventional Physical Therapy
|
|
Experimental: Daily physical activity consultation, Using Stage of change
|
Consultation of daily physical activity is provided, including selection of up to four pain relief exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months, 1, 2 and 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months, 1, 2 and 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yair Shapiro, MD., Maccabi Healthcare Services, Israel
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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