Chronic Low-back PainNCT05638997
Effects of Different Treatment Methods Applied to Spine in Chronic Non-Spesific Low Back Pain
A study testing Instrument assisted manipulation + Core exercises, Mulligan mobilization with movement + Core exercises and Core exercises in people with Chronic Low-back Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to investigate the effects of instrument assisted manipulation (IAM) and Mulligan mobilization with movement (MWM) on joint range of motion (ROM), pain, proprioception, endurance, back awareness and disability in individuals with chronic non-specific low back pain (CNSLBP). Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Instrument assisted manipulation + Core exercises, Mulligan mobilization with movement + Core exercises and Core exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 30 Jun 2020
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- LBP for at least 3 months
- Diagnosis of non-specific LBP
- 20-55 ages.
Who cannot join
- Red flag symptoms related to LBP
- Neurological findings
- Pain radiating to the leg
- Undergone spinal surgery
- Pathology of the spine (fracture, tumor, spondylolisthesis, spinal stenosis, cauda equina syndrome).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Tokat Province, 60250
About this study
Official title: Effects of Different Treatment Methods Applied to Spine in Chronic Non-Spesific Low Back Pain: A Randomized Controlled Trial
We aimed to investigate the effects of instrument assisted manipulation (IAM) and Mulligan mobilization with movement (MWM) on joint range of motion (ROM), pain, proprioception, endurance, back awareness and disability in individuals with chronic non-specific low back pain (CNSLBP). Fifthy one participants were randomly divided into 3 groups. The first was the Mulligan group, the second was the IAM group, and the third was the core exercise group. Visual Analogue Scale (VAS) was used to assess pain severity. Lumbal flexibility was evaluated with the fingertip-to-floor test. Oswestry disability index (ODI) and Roland Morris Disability Questionnaire (RMDQ) used to evaluate the disability. Fremantle back awareness questionnaire (FBAQ) used to evaluate back awareness. Joint ROM (lumbal flexion, lumbal extension and lumbal lateral flexion) and proprioception (30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position) evaluated with JTECH digital dual inclinometer. McGill core endurance tests were used for core endurance assessment. McGill core endurance assessment consists of 3 tests. These: Flexor endurance test, lateral endurance test and extensor endurance test.
Read the detailed description
IAM and Mulligan MWM interventions were applied 3 days a week for 2 weeks in total 6 sessions. All 3 groups did same core exercise program. The exercise program was done from the baseline for 6 weeks, 3 days a week, for a total of 18 sessions. Outcome measurements were done at baseline, at the end of the 2nd week, and at the end of the 6th week. The researcher who performed the outcome measurements did not know the participant's group. Assessment and treatment were performed by two different researchers with 8 years of professional experience. Visual Analogue Scale (VAS) was used to assess pain severity. Lumbal flexibility was evaluated with the fingertip-to-floor test. Oswestry disability index (ODI) and Roland Morris Disability Questionnaire (RMDQ) used to evaluate the disability. Fremantle back awareness questionnaire (FBAQ) used to evaluate back awareness. Joint ROM (lumbal flexion, lumbal extension and lumbal lateral flexion) and proprioception (30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position) evaluated with JTECH digital dual inclinometer. The measurement of the joint ROM in the lumbal region with the dual inclinometer technique is a reliable method. McGill core endurance tests were used for core endurance assessment. McGill core endurance assessment consists of 3 tests. These: Flexor endurance test, lateral endurance test and extensor endurance test.
- Conditions
- Chronic Low-back Pain
- Being tested
- Instrument assisted manipulation + Core exercises, Mulligan mobilization with movement + Core exercises, Core exercises
- Keywords
- Chronic Low Back Pain, Physiotherapy, Mulligan, Instrument Assisted Manipulation, Core Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument assisted manipulation + Core exercisesOther
The effect of Instrument assisted manipulation on chronic non-spesific low back pain
Mulligan mobilization with movement + Core exercisesOther
The effect of Mulligan mobilization with movement on chronic non-spesific low back pain
Core exercisesOther
The effect of core exercises on chronic non-spesific low back pain
| Study group | Role | What they receive |
|---|---|---|
| Instrument Assisted Manipulation Group | Experimental | Instrument Assisted Manipulation + Core exercises Receives: Other: Instrument assisted manipulation + Core exercises |
| Mulligan Mobilization with Movement Group | Experimental | Mulligan Mobilization with Movement + Core exercises Receives: Other: Mulligan mobilization with movement + Core exercises |
| Control group | Active comparator | Core exercises Receives: Other: Core exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline visual analogue scale at 2nd and 6th weeks
Pain assessment. The minimum score of the visual analogue scale is 0, and the maximum score is 10. Higher scores indicate worse outcome.
Measured: Baseline, 2nd week, 6th week
Change from baseline fingertip-to-floor test at 2nd and 6th weeks
Lumbal flexibility
Measured: Baseline, 2nd week, 6th week
Change from baseline joint ROM measurement with digital inclinometer at 2nd and 6th weeks
Lumbal flexion, lumbal extension and lumbal lateral flexion
Measured: Baseline, 2nd week, 6th week
Change from baseline proprioception measurement with digital inclinometer at 2nd and 6th weeks
30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position
Measured: Baseline, 2nd week, 6th week
Change from baseline Oswestry disability index at 2nd and 6th weeks
Disability assessment. The minimum score of the Oswestry disability index is 0, and the maximum score is 50. Higher scores indicate worse outcome.
Measured: Baseline, 2nd week, 6th week
Change from baseline Roland Morris disability questionnaire at 2nd and 6th weeks
Disability assessment. The minimum score of the Roland Morris disability questionnaire is 0, and the maximum score is 24. Higher scores indicate worse outcome.
Measured: Baseline, 2nd week, 6th week
Change from baseline Fremantle back awareness questionnaire at 2nd and 6th weeks
Back awareness assessment. The minimum score of the Fremantle back awareness questionnaire is 0, and the maximum score is 36. Higher scores indicate worse outcome.
Measured: Baseline, 2nd week, 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Aug 2019
- Primary completion28 Feb 2020
- Study completion30 Jun 2020
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
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Erol, Tokat Gaziosmanpasa University
- Investigators
- Erkan Erol, PhD, Principal investigator, Tokat Gaziosmanpaşa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638997
- Sponsor's protocol ID
- GaziosmanpasaU_Erol_01
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Treatment Methods Applied to Spine in Chronic Non-Spesific Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05638997
- Acronym / sponsor ID
- GaziosmanpasaU_Erol_01
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic Low Back Pain, Physiotherapy, Mulligan, Instrument Assisted Manipulation, Core Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Dec 2022 (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.
We aimed to investigate the effects of instrument assisted manipulation (IAM) and Mulligan mobilization with movement (MWM) on joint range of motion (ROM), pain, proprioception, endurance, back awareness and disability in individuals with chronic non-specific low back pain (CNSLBP). Fifthy one participants were randomly divided into 3 groups. The first was the Mulligan group, the second was the IAM group, and the third was the core exercise group. Visual Analogue Scale (VAS) was used to assess pain severity. Lumbal flexibility was evaluated with the fingertip-to-floor test. Oswestry disability index (ODI) and Roland Morris Disability Questionnaire (RMDQ) used to evaluate the disability. Fremantle back awareness questionnaire (FBAQ) used to evaluate back awareness. Joint ROM (lumbal flexion, lumbal extension and lumbal lateral flexion) and proprioception (30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position) evaluated with JTECH digital dual inclinometer. McGill core endurance tests were used for core endurance assessment. McGill core endurance assessment consists of 3 tests. These: Flexor endurance test, lateral endurance test and extensor endurance test.
Detailed description
IAM and Mulligan MWM interventions were applied 3 days a week for 2 weeks in total 6 sessions. All 3 groups did same core exercise program. The exercise program was done from the baseline for 6 weeks, 3 days a week, for a total of 18 sessions. Outcome measurements were done at baseline, at the end of the 2nd week, and at the end of the 6th week. The researcher who performed the outcome measurements did not know the participant's group. Assessment and treatment were performed by two different researchers with 8 years of professional experience. Visual Analogue Scale (VAS) was used to assess pain severity. Lumbal flexibility was evaluated with the fingertip-to-floor test. Oswestry disability index (ODI) and Roland Morris Disability Questionnaire (RMDQ) used to evaluate the disability. Fremantle back awareness questionnaire (FBAQ) used to evaluate back awareness. Joint ROM (lumbal flexion, lumbal extension and lumbal lateral flexion) and proprioception (30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position) evaluated with JTECH digital dual inclinometer. The measurement of the joint ROM in the lumbal region with the dual inclinometer technique is a reliable method. McGill core endurance tests were used for core endurance assessment. McGill core endurance assessment consists of 3 tests. These: Flexor endurance test, lateral endurance test and extensor endurance test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Instrument Assisted Manipulation Group | Experimental | Other: Instrument assisted manipulation + Core exercisesInstrument Assisted Manipulation + Core exercises |
| Mulligan Mobilization with Movement Group | Experimental | Other: Mulligan mobilization with movement + Core exercisesMulligan Mobilization with Movement + Core exercises |
| Control group | Active comparator | Other: Core exercisesCore exercises |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- LBP for at least 3 months
- Diagnosis of non-specific LBP
- 20-55 ages.
Key exclusion criteria (5 listed)
- Red flag symptoms related to LBP
- Neurological findings
- Pain radiating to the leg
- Undergone spinal surgery
- Pathology of the spine (fracture, tumor, spondylolisthesis, spinal stenosis, cauda equina 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 |
|---|---|---|
| Instrument assisted manipulation + Core exercisesThe effect of Instrument assisted manipulation on chronic non-spesific low back pain | Other | Instrument Assisted Manipulation Group |
| Mulligan mobilization with movement + Core exercisesThe effect of Mulligan mobilization with movement on chronic non-spesific low back pain | Other | Mulligan Mobilization with Movement Group |
| Core exercisesThe effect of core exercises on chronic non-spesific low back pain | Other | Control group |
Primary outcome
Change from baseline visual analogue scale at 2nd and 6th weeks
Time frame: Baseline, 2nd week, 6th week
Pain assessment. The minimum score of the visual analogue scale is 0, and the maximum score is 10. Higher scores indicate worse outcome.
Change from baseline fingertip-to-floor test at 2nd and 6th weeks
Time frame: Baseline, 2nd week, 6th week
Lumbal flexibility
Change from baseline joint ROM measurement with digital inclinometer at 2nd and 6th weeks
Time frame: Baseline, 2nd week, 6th week
Lumbal flexion, lumbal extension and lumbal lateral flexion
Change from baseline proprioception measurement with digital inclinometer at 2nd and 6th weeks
Time frame: Baseline, 2nd week, 6th week
30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position
Change from baseline Oswestry disability index at 2nd and 6th weeks
Time frame: Baseline, 2nd week, 6th week
Disability assessment. The minimum score of the Oswestry disability index is 0, and the maximum score is 50. Higher scores indicate worse outcome.
Change from baseline Roland Morris disability questionnaire at 2nd and 6th weeks
Time frame: Baseline, 2nd week, 6th week
Disability assessment. The minimum score of the Roland Morris disability questionnaire is 0, and the maximum score is 24. Higher scores indicate worse outcome.
Change from baseline Fremantle back awareness questionnaire at 2nd and 6th weeks
Time frame: Baseline, 2nd week, 6th week
Back awareness assessment. The minimum score of the Fremantle back awareness questionnaire is 0, and the maximum score is 36. Higher scores indicate worse outcome.
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 6 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Erkan Erol, PhD principal investigator
Tokat Gaziosmanpaşa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument assisted manipulation + Core exercises, Mulligan mobilization with movement + Core exercises and Core exercises in people with Chronic Low-back Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 5 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 6 Dec 2022. 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 Turkey (Türkiye). 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 visual analogue scale at 2nd and 6th weeks (time frame: Baseline, 2nd week, 6th week). The study lists 7 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 6 Dec 2022.