Low Back PainCLBPNCT02178202
McKenzie Exercise Vs Harmonic Technique in Chronic Low Back Pain
A study testing McKenzie exercise and Harmonic technique in people with Low Back Pain, run by University of Tehran.
Trial summary
The purpose of this study was to investigate the effects of HT compared with McK exercise on pain and disability in patients with LBP. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- McKenzie exercise and Harmonic technique
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 20 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Had persistent back pain at least eight weeks or during the last year subjects must suffer from LBP at least three times and each time lasted more than a week.
Who cannot join
- Had a history of fracture or surgery in the spine, pelvis and lower extremities through last year
- History of neuromuscular disease
- The referral and radicular pain in the lower extremities and neurological or sensory disturbance in the lower extremities
- Urinary incontinence and pain severity higher that 7 based on visual analogue scale (VAS)
About this study
Official title: Prescription of Two Exercise Therapy Protocols for Treating Chronic Low Back Pain
The purpose of this study was to investigate the effects of HT compared with McK exercise on pain and disability in patients with LBP.
- Conditions
- Low Back Pain
- Being tested
- McKenzie exercise, Harmonic technique
- Keywords
- Harmonic technique, Low Back Pain, McKenzie exercise, Pain, Disability
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McKenzie exerciseBehavioural
First to sixth McKenzie exercises were performed for 5 times/week and 10 treatment sessions totally.
Harmonic techniqueDevice
Lower limb suspension exercise was performed for 5 times/week and 10 treatment sessions totally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahman Sheikhhoseini, University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178202
- Sponsor's protocol ID
- qs-2012-05-05
- Acronym
- CLBP
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription of Two Exercise Therapy Protocols for Treating Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02178202
- Acronym / sponsor ID
- CLBP / qs-2012-05-05
- Conditions
- Low Back Pain
- Keywords
- Harmonic technique, Low Back Pain, McKenzie exercise, Pain, Disability
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of TehranUniversity, hospital or other
- First posted
- 30 Jun 2014 (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.
The purpose of this study was to investigate the effects of HT compared with McK exercise on pain and disability in patients with LBP.
Study design
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Had persistent back pain at least eight weeks or during the last year subjects must suffer from LBP at least three times and each time lasted more than a week.
Key exclusion criteria (4 listed)
- Had a history of fracture or surgery in the spine, pelvis and lower extremities through last year
- History of neuromuscular disease
- The referral and radicular pain in the lower extremities and neurological or sensory disturbance in the lower extremities
- Urinary incontinence and pain severity higher that 7 based on visual analogue scale (VAS)
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 |
|---|---|---|
| McKenzie exerciseFirst to sixth McKenzie exercises were performed for 5 times/week and 10 treatment sessions totally. | Behavioural | – |
| Harmonic techniqueLower limb suspension exercise was performed for 5 times/week and 10 treatment sessions totally | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing McKenzie exercise and Harmonic technique in people with Low Back Pain, run by University of Tehran.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 30 Jun 2014.