Clinical trial NCT04521244: Lumbar Manipulation in Lumbar Hypomobility
Official title: Immediate Effects of Thrust Versus Non-thrust Lumbar Manipulation on Mobility and Springing Force Tolerance in Lumbar Hypomobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypomotility
Lumbar Spine Instability
Keywords: Lumbar Mobilization
Hypo-mobility
Spinal or segmental stiffness
Lumbar Manipulation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the immediate effects of thrust versus non-thrust lumbar manipulation in individuals with lumbar hypo-mobility on lumbar range of motion and springing force tolerance. A randomized control trial was conducted at Max Rehab and Physical Therapy Centre, Islamabad. The sample size was 18 calculated through open-epi tool but I recruited 60. The participants were divided into two interventional groups each having 30 participants. The study duration was six months. Sampling technique applied was Purposive sampling for recruitment and group randomization using flip coin method. Only 20 to 35 years participants with grade one or two hypo-mobility at lumbar region were included in the study. Tools used in this study are Goniometer, Inclinometers (lumbar Inclinometry using dual inclinometer method),Digital Algometer, Self structured Questionnaire. Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 23.

Detailed description: A systematic and evidence based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines and the key words used were lumbar manipulation, hypo-mobility, spinal stiffness, non-thrust manipulation, lumbar mobilizations, segmentalstiffness.The purpose of the literature review is to find out the pre-existing literature regarding the Lumbar mobilizations and TJM interventions for Lumbar Hypomobility.

In 2019 a systematic review conducted by Aoyagi et al on effectiveness of spinal mobilization stated that there is a moderate to high quality evidence on Spinal mobilizations as effective intervention in low back pain as it decreases pain and improve Range of motion In 2019,a systematic review conducted by Hofstetter et al on Instrumented measurement of spinal stiffness stated that mechanical devices revealed excellent reliability tool to measure Spinal stiffness especially in prone position.

In 2019, a systematic review and meta-analysis conducted by a chi Ngai Lo et al on Spinal manipulation stated that HVLAT is highly effective as an treatment protocol then no intervention or sham manipulation because it improves muscle strength in healthy population

Eligibility criteria: Inclusion Criteria:

* Both Genders
* Participants having Lumbar flexion ≤ 30ᴼ
* Participants having lumbar extension ≤15ᴼ
* Participants having lumbar side bending ≤ 15ᴼ.
* Grade 1 \& 2 hypo-mobility (Stanley Paris Grading System)
* Springing force tolerance measured through Pressure Algometry using Digital
* Algometer whose value can be taken in kg or lb.
* Checklist of Red Flags of TJM Lumbar Spine (Tumor, any bacterial or viral infection like Tuberculosis, UTI which is accompanying any neurological impairments i.e loss of sensations in extremities, Severe Rheumatoid Arthritis,Osteomalacia or Osteoporosis, cervical myelopathy, cord compression,cauda equina syndrome, Bowel and bladder changes, motor vehicle accident or fall, Muscle weakness or atrophy, any history of immunosuppression e.g. steroids, HIV, Abnormal Deep tendon reflexes, Headache, confusion, Abnormal and constant changes in pain pattern, Bilateral or Unilateral Sciatica.)

Exclusion Criteria:

* Participants having normomobility and hypermobility (according to Beighton Score, a score of 4 or more out of 9 indicates generalized hypermobility of the Joints).
* Participants having fracture and lumbar prolapsed intervertebral disc
* Participants having Spondylolisthesis, Lumbar Trauma, any musculoskeletal or cardiorespiratory disorders that affects lumbar spine mobility like (SI, Hip Joint, Thoracic Spine dysfunction)
* Participants who received any therapy for lumbar region past 3 days

Primary outcomes:
measure: Stanley Paris Grading (Self-Structured Questionnaire and Screening Questionnaire)
timeFrame: On Day 1
measure: ROM Lumbar spine ( Flexion)
timeFrame: On Day 1
measure: ROM Lumbar spine (Extension)
timeFrame: On Day 1
measure: ROM Lumbar spine (Side Bending)
timeFrame: On Day 1
Secondary outcomes:
measure: Pressure Pain Threshold (PPT)
timeFrame: On Day 1
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Max Health
state: Fedral
Study officials:
affiliation: Riphah International University
name: Lal Gul Khan, MScPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coulter ID, Crawford C, Hurwitz EL, Vernon H, Khorsan R, Suttorp Booth M, Herman PM. Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis. Spine J. 2018 May;18(5):866-879. doi: 10.1016/j.spinee.2018.01.013. Epub 2018 Jan 31.
citation: Hurwitz EL, Randhawa K, Torres P, Yu H, Verville L, Hartvigsen J, Cote P, Haldeman S. The Global Spine Care Initiative: a systematic review of individual and community-based burden of spinal disorders in rural populations in low- and middle-income communities. Eur Spine J. 2018 Sep;27(Suppl 6):802-815. doi: 10.1007/s00586-017-5393-z. Epub 2017 Dec 27.
citation: Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
citation: Olotu JE, Okon M. Prevalence of Low Back Pain in a Southern Nigerian Population.
citation: Yang K. Outpatient rehabilitation for a patient with chronic low back stiffness. 2019.
citation: Petersson M, Abbott A. Lumbar interspinous pressure pain threshold values for healthy young men and women and the effect of prolonged fully flexed lumbar sitting posture: An observational study. World J Orthop. 2020 Mar 18;11(3):158-166. doi: 10.5312/wjo.v11.i3.158. eCollection 2020 Mar 18.
citation: Page I, Descarreaux M. Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. BMC Musculoskelet Disord. 2019 Jan 18;20(1):29. doi: 10.1186/s12891-019-2408-4.
citation: Aoyagi K, Heller D, Hazlewood D, Sharma N, Dos Santos M. Is spinal mobilization effective for low back pain?: A systematic review. Complement Ther Clin Pract. 2019 Feb;34:51-63. doi: 10.1016/j.ctcp.2018.11.003. Epub 2018 Nov 5. No abstract available.
citation: Hofstetter L, Hausler M, Wirth B, Swanenburg J. Instrumented Measurement of Spinal Stiffness: A Systematic Literature Review of Reliability. J Manipulative Physiol Ther. 2018 Oct;41(8):704-711. doi: 10.1016/j.jmpt.2018.03.002. Epub 2019 Jan 3.
citation: Lo CN, Ng J, Au CK, Lim ECW. The Effectiveness of Spinal Manipulation in Increasing Muscle Strength in Healthy Individuals: A Systematic Review and Meta-Analysis. J Manipulative Physiol Ther. 2019 Feb;42(2):148-158. doi: 10.1016/j.jmpt.2018.10.003.