Low Back PainNCT01631344
Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain
A study testing Daily physical activity consultation, Using the "Stage of change" model in people with Low Back Pain, run by Assuta Hospital Systems at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Daily physical activity consultation, Using the "Stage of change" model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to 8 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women
- Age 25-55 years old
- Chronic / recurrent low back pain (over 3 months)
- With or without radiation
Who cannot join
- Rheumatoid disease
- Tumors
- Fibromyalgia
- Back surgery
- Road / work accidents
- Non Hebrew speaking
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
Background:
Low back pain is the leading cause of disability, affecting the quality of life and work productivity.
Read more
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.
- Conditions
- Low Back Pain
- Being tested
- Daily physical activity consultation, Using the "Stage of change" model
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily physical activity consultation, Using the "Stage of change" modelOther
Consultation of daily physical activity is provided, including selection of up to four pain relief exercises
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy | No intervention | Conventional Physical Therapy |
| Daily physical activity consultation, Using Stage of change | Experimental | Not described Receives: Other: Daily physical activity consultation, Using the "Stage of change" model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years
Measured: 3 months, 1, 2 and 5 years
Secondary outcomes (1)
Change from baseline of Pain using the Numerical pain scale at 3 months, 1, 2 and 5 years
Measured: 3 months, 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startFeb 2011
- Primary completionJul 2017
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yair Shapiro, MD., Principal investigator, Maccabi Healthcare Services, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631344
- Sponsor's protocol ID
- 2008036
- Status last verified
- Jan 2019
- First submitted
- 7 Jun 2012
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 29643158Ben-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.
PubMed 29587572Ben-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.
PubMed 28142364
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01631344
- Acronym / sponsor ID
- 2008036
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2017 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy | No intervention | –Conventional Physical Therapy |
| Daily physical activity consultation, Using Stage of change | Experimental | Other: Daily physical activity consultation, Using the "Stage of change" model |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women
- Age 25-55 years old
- Chronic / recurrent low back pain (over 3 months)
- With or without radiation
Key exclusion criteria (7 listed)
- Rheumatoid disease
- Tumors
- Fibromyalgia
- Back surgery
- Road / work accidents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily physical activity consultation, Using the "Stage of change" modelConsultation of daily physical activity is provided, including selection of up to four pain relief exercises | Other | Daily physical activity consultation, Using Stage of change |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 29643158Canaway 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.
- Derived from this study: PubMed 29587572Ben-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.
- Derived from this study: PubMed 28142364Ben-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.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yair Shapiro, MD. principal investigator
Maccabi Healthcare Services, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily physical activity consultation, Using the "Stage of change" model in people with Low Back Pain, run by Assuta Hospital Systems at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01631344, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.