Chronic Low Back PainNCT04802850
Investigation of Immediate, Short and Long Term Effects of Mulligan Mobilization With Movement Techniques in Nonspesific Chronic Low Back Pain
A study testing Mulligan mobilization with movement in people with Chronic Low Back Pain, run by Suleyman Demirel University.
Trial summary
Introduction: Although the effectiveness of many mobilization methods in chronic low back pain (CLBP) was shown, these effects were not monitored in the long term. The aim of this study was to identify the immediate, short and long-term effects of mulligan mobilization with movement (MWM) in terms of pain, range of… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Mulligan mobilization with movement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Apr 2015
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having 3 months' continuous or intermittent LBP symptoms, without leg pain above the knee
- Pain at VAS > 3/10,
- Back pain increased by active lumbar flexion movement
Who cannot join
- Confirmed nerve root compression
- Neurological symptoms
- Lumbar spine stenosis
- Back surgery history
- Chronic pain syndrome
- LBP from fracture
Show all 12Show fewer
- Infection
- Visceral disease
- Pregnancy
- Major clinical depression
- Cauda equina syndrome
- Significant osteoporosis.
About this study
Official title: Investigation of Immediate, Short and Long Term Effects of Mulligan Mobilization With Movement Techniques in Nonspesific Chronic Low Back Pain: a Randomized Placebo-controlled Trial
Introduction: Although the effectiveness of many mobilization methods in chronic low back pain (CLBP) was shown, these effects were not monitored in the long term. The aim of this study was to identify the immediate, short and long-term effects of mulligan mobilization with movement (MWM) in terms of pain, range of motion (ROM), flexibility, endurance, functionality and disabilities in patients with CLBP. Methods: The study was designed in randomized-placebo controlled with 36 people randomly distributed into 2 groups. Sustained natural apophyseal glide (SNAG) was applied to the lumbar region, straight leg raise (SLR) with traction to the hip, and internal rotational mobilization techniques and home exercise program were applied in Group 1 (n=19); and the same techniques were applied as sham mobilization in Group 2 (n=17). The evaluations were made as post-intervention for immediate effect, and were also made at the 5th week, 3rd month, and 6th months for short and long-term effect. Evaluation was also made for pain in 12th month.
- Conditions
- Chronic Low Back Pain
- Being tested
- Mulligan mobilization with movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan mobilization with movementOther
| Study group | Role | What they receive |
|---|---|---|
| Real MWM | Experimental | Real mobilization with movement Receives: Other: Mulligan mobilization with movement |
| Sham MWM | Sham comparator | sham or placebo mobilization with movement Receives: Other: Mulligan mobilization with movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexibility
Change of lumbar flexibility with sit and reach objective test( cm)
Measured: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Endurance
Change of endurance of lumbar extensors with Sorensen endurance test(sn)
Measured: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Functionality with patient specific function scale
Change of function
Measured: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Disabilities with Oswestry disability index(scale)
Change of disabilities
Measured: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Secondary outcomes (1)
range of motion with goniometer
change of range of motion
Measured: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jan 2013
- Primary completion1 Apr 2014
- Study completion1 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE YAKUT, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802850
- Sponsor's protocol ID
- study1984
- Status last verified
- Mar 2021
- First submitted
- 6 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Immediate, Short and Long Term Effects of Mulligan Mobilization With Movement Techniques in Nonspesific Chronic Low Back Pain: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04802850
- Acronym / sponsor ID
- study1984
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Apr 2014 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 17 Mar 2021 (actual)
- 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.
Introduction: Although the effectiveness of many mobilization methods in chronic low back pain (CLBP) was shown, these effects were not monitored in the long term. The aim of this study was to identify the immediate, short and long-term effects of mulligan mobilization with movement (MWM) in terms of pain, range of motion (ROM), flexibility, endurance, functionality and disabilities in patients with CLBP. Methods: The study was designed in randomized-placebo controlled with 36 people randomly distributed into 2 groups. Sustained natural apophyseal glide (SNAG) was applied to the lumbar region, straight leg raise (SLR) with traction to the hip, and internal rotational mobilization techniques and home exercise program were applied in Group 1 (n=19); and the same techniques were applied as sham mobilization in Group 2 (n=17). The evaluations were made as post-intervention for immediate effect, and were also made at the 5th week, 3rd month, and 6th months for short and long-term effect. Evaluation was also made for pain in 12th month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real MWM | Experimental | Other: Mulligan mobilization with movementReal mobilization with movement |
| Sham MWM | Sham comparator | Other: Mulligan mobilization with movementsham or placebo mobilization with movement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having 3 months' continuous or intermittent LBP symptoms, without leg pain above the knee
- Pain at VAS > 3/10,
- Back pain increased by active lumbar flexion movement
Key exclusion criteria (12 listed)
- Confirmed nerve root compression
- Neurological symptoms
- Lumbar spine stenosis
- Back surgery history
- Chronic pain syndrome
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 |
|---|---|---|
| Mulligan mobilization with movement | Other | Real MWM, Sham MWM |
Primary outcome
Flexibility
Time frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Change of lumbar flexibility with sit and reach objective test( cm)
Endurance
Time frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Change of endurance of lumbar extensors with Sorensen endurance test(sn)
Functionality with patient specific function scale
Time frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Change of function
Disabilities with Oswestry disability index(scale)
Time frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Change of disabilities
1 secondary outcome
range of motion with goniometer
Time frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)-12 months
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 17 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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 Mulligan mobilization with movement in people with Chronic Low Back Pain, run by Suleyman Demirel University.
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 12 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 17 Mar 2021. 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. Some participants in this study may receive a placebo. 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?
Flexibility (time frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)). The study lists 4 primary outcomes in all. 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 17 Mar 2021.