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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01631344
Enrollment
220
Registered
2012-06-29
Start date
2011-02-28
Completion date
2019-01-08
Last updated
2019-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

OTHERDaily 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

Sponsors

Assuta Hospital Systems
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years3 months, 1, 2 and 5 years

Secondary

MeasureTime frame
Change from baseline of Pain using the Numerical pain scale at 3 months, 1, 2 and 5 years3 months, 1, 2 and 5 years

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026