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

NCT01631344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-01-10

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

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

Sponsors & Collaborators

  • Assuta Hospital Systems

    lead OTHER

Principal Investigators

  • Yair Shapiro, MD. · Maccabi Healthcare Services, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2017-07-31
Completion
2019-01-08

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01631344 on ClinicalTrials.gov