Low Back PainNCT01794962
"Cognitive Functional Therapy" vs. Manual Therapy for Non-specific Low Back Pain
A study testing Cognitive functional therapy and manual therapy and exercises in people with Low Back Pain, run by Spine Centre of Southern Denmark at 1 site in Denmark.
Trial summary
This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients receive a specific diagnosis, leaving the majority of patients diagnosed with non specific low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Cognitive functional therapy and manual therapy and exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Mar 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be between 18 - 65 years old and have, with a history of low back pain more than three months.
- The primary pain area from T12- to the gluteal folds. Low back pain must be provoked by movements and/or physical activities. Average pain intensity in the last two weeks must be al least: 4/10 on Pain numerical rating scale Participants must have adequate comprehension and expressing the Danish language.
- Participants must be classified as having a "flexion pattern".
Who cannot join
- Participants must not have been sick listed for more than 4 months; have an acute exacerbation of LBP, surgery of low limb within last 4 months or hip or knee osteoarthritis limiting loading of knee and hip flexion.
- Follow medical conditions are also excluding participants:
- A history of spinal surgery Radicular pain (disc prolapse or foraminal stenosis): non painful symptoms in leg, clinical signs of altered nerve conduction) Spinal stenosis A previous history psychiatric disease Current pregnancy Widespread non-specific pain (for filling criteria for fibromyalgia) Imaging confirming spondylolisthesis
- Other diseases:
- Rheumatoid arthritis ankylosing spondylitis neurologic disease infection cancer previous history of osteoporosis The patient can´t be classified as having a flexion pattern Lack of compliance during the intervention: if a patient fails to turn up for more than one appointment with out prior notice.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Classification Based "Cognitive Functional Therapy" vs. Manual Therapy for a Subgroup of Patients With Chronic NSLBP, Classified as Having a "Flexion Pattern"
This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients receive a specific diagnosis, leaving the majority of patients diagnosed with non specific low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP. This pilot study will compare manual therapy (manipulation and soft tissue treatment)and exercises to a classification based biopsychosocial intervention (a cognitive/functional approach) as described by Peter O'Sullivan, on a subgroup called "flexion pattern"
This pilot study has three specific aims:
Read more
(i) To determine the mean and standard deviation on the numerical rating scale of participants in this setting who have a motor control flexion pattern, so that sample size calculations for a fully powered randomized controlled trial could be performed.
(ii) To test the logistical and practical procedures that will be required to perform a fully powered randomized controlled trial using these two treatments.
(iii) To gain a preliminary estimate of any difference in the effect of these two treatments, so as to determine if the results of a fully powered randomized controlled trial might be clinically important and therefore worthwhile undertaking
Read the detailed description
This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients receive a specific diagnosis, leaving the majority of patients diagnosed with non specific low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP.This project will recruit patients , classified with a "flexion pattern" according to the classification system proposed by Peter O´Sullivan. When classified with a flexion pattern the patients will be randomized into either of two treatment arms. Manual therapy (manipulation and soft tissue treatment)and exercises by a chiropractor or to a classification based biopsychosocial intervention done by a physiotherapist, (a cognitive/functional approach) as described by Peter O'Sullivan
This pilot study has three specific aims:
(i) To determine the mean and standard deviation on the numerical rating scale of participants in this setting who have a motor control flexion pattern, so that sample size calculations for a fully powered randomized controlled trial could be performed.
(ii) To test the logistical and practical procedures that will be required to perform a fully powered randomized controlled trial using these two treatments.
(iii) To gain a preliminary estimate of any difference in the effect of these two treatments, so as to determine if the results of a fully powered randomized controlled trial might be clinically important and therefore worthwhile undertaking
- Conditions
- Low Back Pain
- Being tested
- Cognitive functional therapy, manual therapy and exercises
- Keywords
- Classification, LBP, Cognitive functional therapy, Manual Therapy
- 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.
Cognitive functional therapyOther
The intervention is directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.
manual therapy and exercisesOther
Patients in this group will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis primarily and is designed to be consistent with best current manual therapy practice.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy and exercises | Experimental | Manual therapy treatment: spinal manipulation, Soft tissue treatment, muscle energy techniques. Exercises: stabilisation exercises, Mckenzie exercises and general muscle exercises. Receives: Other: manual therapy and exercises |
| Cognitive Functional Therapy | Experimental | An in depth interview, including investigating the patients beliefs on back pain, fear towards movement, anxiety and distress, using reflecting questions. The physical part consists of specific and functional exercises related to the patients functional complaints.And general physical activity for 30 mins 3-4 times weekly. Receives: Other: Cognitive functional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity(numerical rating scale)
Pain intensity Numerical Rating Scale, as pain is the primary reason for patients to seek care. Numerical Rating Scales have shown to have reliability, validity and responsiveness to change at a best practise standard.
Measured: 12 months FU
Secondary outcomes (1)
Ronald Morris Questionaire
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2018
- Study completionMar 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kasper Ussing, Msc, Principal investigator, Spine Centre of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794962
- Sponsor's protocol ID
- KU2012
- Status last verified
- Mar 2018
- First submitted
- 27 Jan 2013
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification Based "Cognitive Functional Therapy" vs. Manual Therapy for a Subgroup of Patients With Chronic NSLBP, Classified as Having a "Flexion Pattern"
- ClinicalTrials.gov ID
- NCT01794962
- Acronym / sponsor ID
- KU2012
- Conditions
- Low Back Pain
- Keywords
- Classification, LBP, Cognitive functional therapy, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 20 Feb 2013 (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.
This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients receive a specific diagnosis, leaving the majority of patients diagnosed with non specific low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP. This pilot study will compare manual therapy (manipulation and soft tissue treatment)and exercises to a classification based biopsychosocial intervention (a cognitive/functional approach) as described by Peter O'Sullivan, on a subgroup called "flexion pattern"
This pilot study has three specific aims:
(i) To determine the mean and standard deviation on the numerical rating scale of participants in this setting who have a motor control flexion pattern, so that sample size calculations for a fully powered randomized controlled trial could be performed.
(ii) To test the logistical and practical procedures that will be required to perform a fully powered randomized controlled trial using these two treatments.
(iii) To gain a preliminary estimate of any difference in the effect of these two treatments, so as to determine if the results of a fully powered randomized controlled trial might be clinically important and therefore worthwhile undertaking
Detailed description
This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients receive a specific diagnosis, leaving the majority of patients diagnosed with non specific low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP.This project will recruit patients , classified with a "flexion pattern" according to the classification system proposed by Peter O´Sullivan. When classified with a flexion pattern the patients will be randomized into either of two treatment arms. Manual therapy (manipulation and soft tissue treatment)and exercises by a chiropractor or to a classification based biopsychosocial intervention done by a physiotherapist, (a cognitive/functional approach) as described by Peter O'Sullivan
This pilot study has three specific aims:
(i) To determine the mean and standard deviation on the numerical rating scale of participants in this setting who have a motor control flexion pattern, so that sample size calculations for a fully powered randomized controlled trial could be performed.
(ii) To test the logistical and practical procedures that will be required to perform a fully powered randomized controlled trial using these two treatments.
(iii) To gain a preliminary estimate of any difference in the effect of these two treatments, so as to determine if the results of a fully powered randomized controlled trial might be clinically important and therefore worthwhile undertaking
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy and exercises | Experimental | Other: manual therapy and exercisesManual therapy treatment: spinal manipulation, Soft tissue treatment, muscle energy techniques. Exercises: stabilisation exercises, Mckenzie exercises and general muscle exercises. |
| Cognitive Functional Therapy | Experimental | Other: Cognitive functional therapyAn in depth interview, including investigating the patients beliefs on back pain, fear towards movement, anxiety and distress, using reflecting questions. The physical part consists of specific and functional exercises related to the patients functional complaints.And general physical activity for 30 mins 3-4 times weekly. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be between 18 - 65 years old and have, with a history of low back pain more than three months.
- The primary pain area from T12- to the gluteal folds. Low back pain must be provoked by movements and/or physical activities. Average pain intensity in the last two weeks must be al least: 4/10 on Pain numerical rating scale Participants must have adequate comprehension and expressing the Danish language.
- Participants must be classified as having a "flexion pattern".
Key exclusion criteria (6 listed)
- Participants must not have been sick listed for more than 4 months; have an acute exacerbation of LBP, surgery of low limb within last 4 months or hip or knee osteoarthritis limiting loading of knee and hip flexion.
- A history of spinal surgery Radicular pain (disc prolapse or foraminal stenosis): non painful symptoms in leg, clinical signs of altered nerve conduction) Spinal stenosis A previous history psychiatric disease Current pregnancy Widespread non-specific pain (for filling criteria for fibromyalgia) Imaging confirming spondylolisthesis
- Rheumatoid arthritis ankylosing spondylitis neurologic disease infection cancer previous history of osteoporosis The patient can´t be classified as having a flexion pattern Lack of compliance during the intervention: if a patient fails to turn up for more than one appointment with out prior notice.
- -
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 |
|---|---|---|
| Cognitive functional therapyThe intervention is directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder. | Other | Cognitive Functional Therapy |
| manual therapy and exercisesPatients in this group will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis primarily and is designed to be consistent with best current manual therapy practice. | Other | Manual therapy and exercises |
Primary outcome
Pain Intensity(numerical rating scale)
Time frame: 12 months FU
Pain intensity Numerical Rating Scale, as pain is the primary reason for patients to seek care. Numerical Rating Scales have shown to have reliability, validity and responsiveness to change at a best practise standard.
1 secondary outcome
Ronald Morris Questionaire
Time frame: 12 months follow up
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
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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.
Kasper Ussing, Msc principal investigator
Spine Centre of Southern 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 Cognitive functional therapy and manual therapy and exercises in people with Low Back Pain, run by Spine Centre of Southern Denmark 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Mar 2018. 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?
The study was stopped early. 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.
What does the primary outcome measure?
Pain Intensity(numerical rating scale) (time frame: 12 months FU). It is what the study was designed to measure, not a finding.
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 8 Mar 2018.