Chronic PainNCT04297527
Effect of Mulligan Mobilization in Chronic Non-Spesific Low Back Pain
A study testing Conventional Physiotherapy and Mulligan Mobilization in people with Chronic Pain, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Fifty five participants diagnosed with CNSLBP, will randomized into three groups. Group I (18 subjects) will receive 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week, Group II (19 subjects) will receive 9 sessions of SNAGs, and Group III will receive CPP plus SNAGs. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Conventional Physiotherapy and Mulligan Mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2017to Jul 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- low back pain for at least 3 months
- intensity of pain ranges from 3 to 6 according to VAS
Who cannot join
- undergoing surgical operation in the lumbar region or having a surgical indication having an exercise therapy and / or physical therapy in the last 1 year
- a history of trauma involving lumbar region and systemic and inflammatory disease targeting this region
- corticosteroids consumption for a long time
- being pregnant.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Denizli State Hospital
Denizli, 20040
Merve Bergin Korkmaz, Dr., +905469114635, mbergina@hotmail.com
Şule Şimşek, Pdh.
About this study
Official title: Efficacy of Mulligan Mobilization Technique in Chronic Non-Spesific Low Back Pain
Fifty five participants diagnosed with CNSLBP, will randomized into three groups. Group I (18 subjects) will receive 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week, Group II (19 subjects) will receive 9 sessions of SNAGs, and Group III will receive CPP plus SNAGs. Outcome measures are pain, ROM, spinal mobility, fear avoidance behaviour and function. Measurements will record before, after and 6 month after the end of the treatment.
Read the detailed description
Inclussion criterias are; low back pain for at least 3 months, intensity of pain ranges from 3 to 6 according to VAS. Exclussion criterias are; undergoing surgical operation in the lumbar region or having a surgical indication, having an exercise therapy and / or physical therapy in the last 1 year, a history of trauma involving lumbar region and systemic and inflammatory disease targeting this region, participants using corticosteroids for a long time and being pregnant.Acording to our criterias 55 participants diagnosed with CNSLBP will randomised into three groups. Group 1 will receive Conventional Physiotherapy programme consisting of Hot pack, US and TENS applications. Group II aill receive Lumbar SNAGS consisting of Lumbar Extension SNAGS in prone, SNAGS in lion position and Lumbar flexion SNAGS in sitting, techniques. Group III will receive 9 sessions of SNAGs, and Group III will receive CPP plus SNAGs.Outcome measures are pain, ROM, spinal mobility, fear avoidance behaviour and function. Measurements will record before, after and 6 month after the end of the treatment. All treatment groups were treated with the same researcher. All assessments were made by another blind researcher three times at before, after and 6 month after treatment.
- Conditions
- Chronic Pain
- Being tested
- Conventional Physiotherapy, Mulligan Mobilization
- Keywords
- Lumbal SNAGs, efficiency
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyProcedure or surgery
Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in prone and supported with a pillow under the abdomen, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm² and duration of 5 minute. TENS was applied to the lumbar region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.
Mulligan MobilizationProcedure or surgery
Also called Lumbal SNAGs
Extension SNAGS in prone, SNAGS in lion position and Lumbar flexion SNAGS in sitting, techniques were used. The techniques were applied in 3 sets with 10 repetitions and 60 seconds rest between sets.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy Group | Experimental | Group I (18 subjects) received 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week. Receives: Procedure: Conventional Physiotherapy |
| Mulligan Mobilization Group | Experimental | Mulligan Mobilization was administered 9 sessions (3 days a week, for 3 weeks). . Receives: Procedure: Mulligan Mobilization |
| Conventional Physiotherapy plus Mulligan Mobilization Group | Experimental | Conventional Physiotherapy (15 session) plus Mulligan Mobilization Programme (9 session) were applied in this group. CP were applied 5 days a week and CP+MM 3 days a week for 3 weeks. Receives: Procedure: Conventional Physiotherapy; Procedure: Mulligan Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Range of Motion from baseline at 3 weeks and from baseline at 6 months
ROM is measured by BROM II device during flexion and extension activity.
Measured: Baseline, 3 weeks,6 months
Change of Spinal Mobility from baseline at 3 weeks and from baseline at 6 months
Spinal mobility measured by Schober test.
Measured: Baseline, 3 weeks,6 months
Change from Pain Intensity from baseline at 3 weeks and from baseline at 6 months
Pain intensity during flexion and extension activity in lumbar region is measured by Numeric pain scale in which "0" shows No pain while "10" shows worst pain.
Measured: Baseline, 3 weeks,6 months
Secondary outcomes (2)
Change from Fear Avoidance Behaviour from baseline at 3 weeks and from baseline at 6 months
It ıs measured by Fear Avoidance Behaviour Questionnaire-Turkish.The total score ranges from 0 to 96. Maximum score indicates increased fear avoidanve behaviour
Measured: Baseline, 3 weeks,6 months
Change from Disability level from baseline at 3 weeks and from baseline at 6 months
It ıs measured by measured by Rolland Morris Disability Questionnaire-Turkish.Total score ranked from 0 to 24. İncreased score represents disability in functional activities
Measured: Baseline, 3 weeks,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start14 Jun 2017
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şule, Pamukkale University
- Investigators
- Nesrin Yağcı, Prof. Dr., Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297527
- Sponsor's protocol ID
- 15.11.2016/20
- Status last verified
- May 2020
- First submitted
- 24 Feb 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because there is no web site to share my data
Publications
Hidalgo B, Pitance L, Hall T, Detrembleur C, Nielens H. Short-term effects of Mulligan mobilization with movement on pain, disability, and kinematic spinal movements in patients with nonspecific low back pain: a randomized placebo-controlled trial. J Manipulative Physiol Ther. 2015 Jul-Aug;38(6):365-74. doi: 10.1016/j.jmpt.2015.06.013. Epub 2015 Jul 26.
PubMed 26215900Vicenzino B, Paungmali A, Teys P. Mulligan's mobilization-with-movement, positional faults and pain relief: current concepts from a critical review of literature. Man Ther. 2007 May;12(2):98-108. doi: 10.1016/j.math.2006.07.012. Epub 2006 Sep 7.
PubMed 16959529Hussien HM, Abdel-Raoof NA, Kattabei OM, Ahmed HH. Effect of Mulligan Concept Lumbar SNAG on Chronic Nonspecific Low Back Pain. J Chiropr Med. 2017 Jun;16(2):94-102. doi: 10.1016/j.jcm.2017.01.003. Epub 2017 Mar 30.
PubMed 28559749
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mulligan Mobilization Technique in Chronic Non-Spesific Low Back Pain
- ClinicalTrials.gov ID
- NCT04297527
- Acronym / sponsor ID
- 15.11.2016/20
- Conditions
- Chronic Pain
- Keywords
- Lumbal SNAGs, efficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 5 Mar 2020 (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.
Fifty five participants diagnosed with CNSLBP, will randomized into three groups. Group I (18 subjects) will receive 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week, Group II (19 subjects) will receive 9 sessions of SNAGs, and Group III will receive CPP plus SNAGs. Outcome measures are pain, ROM, spinal mobility, fear avoidance behaviour and function. Measurements will record before, after and 6 month after the end of the treatment.
Detailed description
Inclussion criterias are; low back pain for at least 3 months, intensity of pain ranges from 3 to 6 according to VAS. Exclussion criterias are; undergoing surgical operation in the lumbar region or having a surgical indication, having an exercise therapy and / or physical therapy in the last 1 year, a history of trauma involving lumbar region and systemic and inflammatory disease targeting this region, participants using corticosteroids for a long time and being pregnant.Acording to our criterias 55 participants diagnosed with CNSLBP will randomised into three groups. Group 1 will receive Conventional Physiotherapy programme consisting of Hot pack, US and TENS applications. Group II aill receive Lumbar SNAGS consisting of Lumbar Extension SNAGS in prone, SNAGS in lion position and Lumbar flexion SNAGS in sitting, techniques. Group III will receive 9 sessions of SNAGs, and Group III will receive CPP plus SNAGs.Outcome measures are pain, ROM, spinal mobility, fear avoidance behaviour and function. Measurements will record before, after and 6 month after the end of the treatment. All treatment groups were treated with the same researcher. All assessments were made by another blind researcher three times at before, after and 6 month after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy Group | Experimental | Procedure: Conventional PhysiotherapyGroup I (18 subjects) received 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week. |
| Mulligan Mobilization Group | Experimental | Procedure: Mulligan MobilizationMulligan Mobilization was administered 9 sessions (3 days a week, for 3 weeks). . |
| Conventional Physiotherapy plus Mulligan Mobilization Group | Experimental | Procedure: Conventional Physiotherapy, Procedure: Mulligan MobilizationConventional Physiotherapy (15 session) plus Mulligan Mobilization Programme (9 session) were applied in this group. CP were applied 5 days a week and CP+MM 3 days a week for 3 weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- low back pain for at least 3 months
- intensity of pain ranges from 3 to 6 according to VAS
Key exclusion criteria (4 listed)
- undergoing surgical operation in the lumbar region or having a surgical indication having an exercise therapy and / or physical therapy in the last 1 year
- a history of trauma involving lumbar region and systemic and inflammatory disease targeting this region
- corticosteroids consumption for a long time
- being pregnant.
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 |
|---|---|---|
| Conventional PhysiotherapyConventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in prone and supported with a pillow under the abdomen, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm² and duration of 5 minute. TENS was applied to the lumbar region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes. | Procedure or surgery | Conventional Physiotherapy Group, Conventional Physiotherapy plus Mulligan Mobilization Group |
| Mulligan MobilizationAlso: Lumbal SNAGsExtension SNAGS in prone, SNAGS in lion position and Lumbar flexion SNAGS in sitting, techniques were used. The techniques were applied in 3 sets with 10 repetitions and 60 seconds rest between sets. | Procedure or surgery | Conventional Physiotherapy plus Mulligan Mobilization Group, Mulligan Mobilization Group |
Primary outcome
Change of Range of Motion from baseline at 3 weeks and from baseline at 6 months
Time frame: Baseline, 3 weeks,6 months
ROM is measured by BROM II device during flexion and extension activity.
Change of Spinal Mobility from baseline at 3 weeks and from baseline at 6 months
Time frame: Baseline, 3 weeks,6 months
Spinal mobility measured by Schober test.
Change from Pain Intensity from baseline at 3 weeks and from baseline at 6 months
Time frame: Baseline, 3 weeks,6 months
Pain intensity during flexion and extension activity in lumbar region is measured by Numeric pain scale in which "0" shows No pain while "10" shows worst pain.
2 secondary outcomes
Change from Fear Avoidance Behaviour from baseline at 3 weeks and from baseline at 6 months
Time frame: Baseline, 3 weeks,6 months
Change from Disability level from baseline at 3 weeks and from baseline at 6 months
Time frame: Baseline, 3 weeks,6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Background: PubMed 26215900Hidalgo B, Pitance L, Hall T, Detrembleur C, Nielens H. Short-term effects of Mulligan mobilization with movement on pain, disability, and kinematic spinal movements in patients with nonspecific low back pain: a randomized placebo-controlled trial. J Manipulative Physiol Ther. 2015 Jul-Aug;38(6):365-74. doi: 10.1016/j.jmpt.2015.06.013. Epub 2015 Jul 26.
- Background: PubMed 16959529Vicenzino B, Paungmali A, Teys P. Mulligan's mobilization-with-movement, positional faults and pain relief: current concepts from a critical review of literature. Man Ther. 2007 May;12(2):98-108. doi: 10.1016/j.math.2006.07.012. Epub 2006 Sep 7.
- Background: PubMed 28559749Hussien HM, Abdel-Raoof NA, Kattabei OM, Ahmed HH. Effect of Mulligan Concept Lumbar SNAG on Chronic Nonspecific Low Back Pain. J Chiropr Med. 2017 Jun;16(2):94-102. doi: 10.1016/j.jcm.2017.01.003. Epub 2017 Mar 30.
- Individual participant dataSharing planned: No. Because there is no web site to share my data
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Nesrin Yağcı, Prof. Dr. study director
Pamukkale 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 Conventional Physiotherapy and Mulligan Mobilization in people with Chronic Pain, run by Pamukkale 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 2 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 5 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şule ŞİMŞEK, Dr. (+9005058099914, suleserefsimsek@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Range of Motion from baseline at 3 weeks and from baseline at 6 months (time frame: Baseline, 3 weeks,6 months). The study lists 3 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 NCT04297527, which also lists 3 linked publications.
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 5 May 2020.