Effect of Mulligan Mobilization in Chronic Non-Spesific Low Back Pain

Chronic Pain Clinical Trial

Official title:

Efficacy of Mulligan Mobilization Technique in Chronic Non-Spesific Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297527
• Other study ID #: 15.11.2016/20
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: July 2020

Study information

• Verified date: May 2020
• Source: Pamukkale University
• Contact: Sule SIMSEK, Dr.
• Phone: +9005058099914
• Email: suleserefsimsek[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Procedure:
• Conventional Physiotherapy
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 Mobilization
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.

Locations

Country	Name	City	State
Turkey	Denizli State Hospital	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. Epub 2006 Sep 7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 3 weeks,6 months
Primary	Change of Spinal Mobility from baseline at 3 weeks and from baseline at 6 months	Spinal mobility measured by Schober test.	Baseline, 3 weeks,6 months
Primary	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.	Baseline, 3 weeks,6 months
Secondary	Change from Fear Avoidance Behaviour from baseline at 3 weeks and from baseline at 6 months	It is measured by Fear Avoidance Behaviour Questionnaire-Turkish.The total score ranges from 0 to 96. Maximum score indicates increased fear avoidanve behaviour	Baseline, 3 weeks,6 months
Secondary	Change from Disability level from baseline at 3 weeks and from baseline at 6 months	It is measured by measured by Rolland Morris Disability Questionnaire-Turkish.Total score ranked from 0 to 24. Increased score represents disability in functional activities	Baseline, 3 weeks,6 months