Clinical trial NCT04297527: Effect of Mulligan Mobilization in Chronic Non-Spesific Low Back Pain
Official title: Efficacy of Mulligan Mobilization Technique in Chronic Non-Spesific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Lumbal SNAGs, efficiency
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 55
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* low back pain for at least 3 months
* intensity of pain ranges from 3 to 6 according to VAS

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of Range of Motion from baseline at 3 weeks and from baseline at 6 months
timeFrame: Baseline, 3 weeks,6 months
measure: Change of Spinal Mobility from baseline at 3 weeks and from baseline at 6 months
timeFrame: Baseline, 3 weeks,6 months
measure: Change from Pain Intensity from baseline at 3 weeks and from baseline at 6 months
timeFrame: Baseline, 3 weeks,6 months
Secondary outcomes:
measure: Change from Fear Avoidance Behaviour from baseline at 3 weeks and from baseline at 6 months
timeFrame: Baseline, 3 weeks,6 months
measure: Change from Disability level from baseline at 3 weeks and from baseline at 6 months
timeFrame: Baseline, 3 weeks,6 months
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Denizli State Hospital
Study officials:
affiliation: Pamukkale University
name: Nesrin Yağcı, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Vicenzino 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.
citation: Hussien 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.