NCT04297527

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

February 24, 2020

Last Update Submit

May 2, 2020

Conditions

Keywords

Lumbal SNAGs, efficiency

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Change from Fear Avoidance Behaviour from baseline at 3 weeks and from baseline at 6 months

    Baseline, 3 weeks,6 months

  • Change from Disability level from baseline at 3 weeks and from baseline at 6 months

    Baseline, 3 weeks,6 months

Study Arms (3)

Conventional Physiotherapy Group

EXPERIMENTAL

Group I (18 subjects) received 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week.

Procedure: Conventional Physiotherapy

Mulligan Mobilization Group

EXPERIMENTAL

Mulligan Mobilization was administered 9 sessions (3 days a week, for 3 weeks). .

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.

Procedure: Conventional PhysiotherapyProcedure: Mulligan Mobilization

Interventions

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.

Conventional Physiotherapy GroupConventional Physiotherapy plus Mulligan Mobilization Group

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.

Also known as: Lumbal SNAGs
Conventional Physiotherapy plus Mulligan Mobilization GroupMulligan Mobilization Group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denizli State Hospital

Denizli, 20040, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 26215900BACKGROUND
  • 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.

    PMID: 16959529BACKGROUND
  • 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.

    PMID: 28559749BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nesrin Yağcı, Prof. Dr.

    Pamukkale University

    STUDY DIRECTOR

Central Study Contacts

Şule ŞİMŞEK, Dr.

CONTACT

Merve Bergin Korkmaz, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
All assessments were made by another blind researcher three times at before, after and 6 month after treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 24, 2020

First Posted

March 5, 2020

Study Start

June 14, 2017

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Because there is no web site to share my data

Locations