Low Back PainNCT00939107
The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain
A study testing spinal manipulation and McKenzie exercises in people with Low Back Pain, run by Back and Rehabilitation Center, Copenhagen at 1 site in Denmark.
Trial summary
Introduction: The McKenzie method as well as spinal manipulation is commonly used for the treatment of low back pain throughout the western world. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- spinal manipulation and McKenzie exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2003to Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 60 years of age
- suffering from low back pain (LBP) with or without leg pain for a period of more than 6 weeks
- able to speak and understand the Danish language
- with a presentation of clinical signs of disc-related symptoms.
Who cannot join
- positive non-organic signs
- serious pathology suspected based on physical examination and/or magnetic resonance imaging
- application for disability pension or pending litigation
- pregnancy
- comorbidity
- recent back surgery
- problems with communication
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Back and Rehabilitation Center Copengagen
Copenhagen, Copenhagen OE, 2100
About this study
Official title: The Effect of the McKenzie Method as Compared With That of Manipulation When Applied Adjunctive to Information and Advice for Patients With Clinical Signs of Disc-related Chronic Low Back Pain: Randomized Controlled Trial.
Introduction:
The McKenzie method as well as spinal manipulation is commonly used for the treatment of low back pain throughout the western world. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of persistent symptoms originating from a diskus in the low back.
Read more
Methods:
After clinical screening 350 patients with or without leg pain who presented with centralization of symptoms or signs of disc herniation were randomized to the McKenzie group or the manipulation group. The outcome measures, Roland Morris Disability Questionnaire, 11 point numerical pain scale, 6 point global perceived change scale, and quality of life (Short Form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.
Read the detailed description
In 1998, Cherkin et al. published a study showing no difference between outcomes following the McKenzie method, chiropractic manipulation, or the provision of an educational booklet for the treatment of patients with acute non-specific low back pain. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of disc-related symptoms for duration of more than 6 Weeks.
- Conditions
- Low Back Pain
- Being tested
- spinal manipulation, McKenzie exercises
- Keywords
- low back pain, Intervertebral disc, McKenzie, Physical Therapy, Spinal manipulation, Chiropractics, Patient education, Exercise therapy, Random allocation
- 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.
spinal manipulationProcedure or surgery
Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care
McKenzie exercisesProcedure or surgery
McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
| Study group | Role | What they receive |
|---|---|---|
| McKenzie exercises | Experimental | McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy Receives: Procedure: McKenzie exercises |
| Spinal manipulation | Active comparator | Spinal manipulation in combination with information of clinical findings and advice about back care Receives: Procedure: spinal manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).
Measured: two months after treatment
Number of Patients With Treatment Success
Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points)
Measured: Two months posttreatment
Secondary outcomes (4)
Pain
The back and leg pain questionnaire included three separate 11 point box scales comprising the following items: Low Back Pain (LBP) at the moment, the worst LBP within the past two weeks, and the average level of LBP within the last two weeks. These summed to a total score ranging from 0 points (no back or leg pain at all) to 60 points (worst possible back and leg pain on all items).
Measured: twelve months posttreatment
Number of Patients on Sick Leave
Measured by self-report of beeing on sick leave at the moment because of LBP
Measured: twelve months posttreatment
Quality of Life
Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)
Measured: twelve months posttreatment
Cost Effectiveness
Measured: twelve months posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startSep 2003
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Back and Rehabilitation Center, Copenhagen
- Sponsor type
- Other government
- Collaborators
- The Danish Rheumatism Association, The Danish Physiotherapy Organization., Foundation for Chiropractic Research and Post Graduate Education, The Danish Institute for Mechanical Diagnosis and Therapy.
- Investigators
- Tom Petersen, PT,PhD, Principal investigator, Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939107
- Sponsor's protocol ID
- KF-01-057/03
- Status last verified
- Nov 2009
- First submitted
- 13 Jul 2009
- Last updated
- 19 Nov 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Petersen T, Christensen R, Juhl C. Predicting a clinically important outcome in patients with low back pain following McKenzie therapy or spinal manipulation: a stratified analysis in a randomized controlled trial. BMC Musculoskelet Disord. 2015 Apr 1;16:74. doi: 10.1186/s12891-015-0526-1.
PubMed 25887046
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the McKenzie Method as Compared With That of Manipulation When Applied Adjunctive to Information and Advice for Patients With Clinical Signs of Disc-related Chronic Low Back Pain: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00939107
- Acronym / sponsor ID
- KF-01-057/03
- Conditions
- Low Back Pain
- Keywords
- low back pain, Intervertebral disc, McKenzie, Physical Therapy, Spinal manipulation, Chiropractics, Patient education, Exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Back and Rehabilitation Center, CopenhagenOther government
- Collaborators
- The Danish Rheumatism Association, The Danish Physiotherapy Organization., Foundation for Chiropractic Research and Post Graduate Education, The Danish Institute for Mechanical Diagnosis and Therapy.
- Study start
- Sep 2003
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Posted 19 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction:
The McKenzie method as well as spinal manipulation is commonly used for the treatment of low back pain throughout the western world. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of persistent symptoms originating from a diskus in the low back.
Methods:
After clinical screening 350 patients with or without leg pain who presented with centralization of symptoms or signs of disc herniation were randomized to the McKenzie group or the manipulation group. The outcome measures, Roland Morris Disability Questionnaire, 11 point numerical pain scale, 6 point global perceived change scale, and quality of life (Short Form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.
Detailed description
In 1998, Cherkin et al. published a study showing no difference between outcomes following the McKenzie method, chiropractic manipulation, or the provision of an educational booklet for the treatment of patients with acute non-specific low back pain. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of disc-related symptoms for duration of more than 6 Weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McKenzie exercises | Experimental | Procedure: McKenzie exercisesMcKenzie exercises according to the principles of Mechanical Diagnosis and Therapy |
| Spinal manipulation | Active comparator | Procedure: spinal manipulationSpinal manipulation in combination with information of clinical findings and advice about back care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 60 years of age
- suffering from low back pain (LBP) with or without leg pain for a period of more than 6 weeks
- able to speak and understand the Danish language
- with a presentation of clinical signs of disc-related symptoms.
Key exclusion criteria (7 listed)
- positive non-organic signs
- serious pathology suspected based on physical examination and/or magnetic resonance imaging
- application for disability pension or pending litigation
- pregnancy
- comorbidity
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 |
|---|---|---|
| spinal manipulationSpinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care | Procedure or surgery | Spinal manipulation |
| McKenzie exercisesMcKenzie exercises according to the principles of Mechanical Diagnosis and Therapy | Procedure or surgery | McKenzie exercises |
Primary outcome
Disability
Time frame: two months after treatment
Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).
Number of Patients With Treatment Success
Time frame: Two months posttreatment
Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points)
4 secondary outcomes
Pain
Time frame: twelve months posttreatment
Number of Patients on Sick Leave
Time frame: twelve months posttreatment
Quality of Life
Time frame: twelve months posttreatment
Cost Effectiveness
Time frame: twelve months posttreatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25887046Petersen T, Christensen R, Juhl C. Predicting a clinically important outcome in patients with low back pain following McKenzie therapy or spinal manipulation: a stratified analysis in a randomized controlled trial. BMC Musculoskelet Disord. 2015 Apr 1;16:74. doi: 10.1186/s12891-015-0526-1.
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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.
Tom Petersen, PT,PhD principal investigator
Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal manipulation and McKenzie exercises in people with Low Back Pain, run by Back and Rehabilitation Center, Copenhagen at 1 site in Denmark.
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 19 Nov 2009. 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disability (time frame: two months after treatment). The study lists 2 primary outcomes in all. 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 NCT00939107, which also lists 1 linked publication.
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 19 Nov 2009.