Lumbar Manipulation in Lumbar Hypomobility

Study Overview
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Brief Summary
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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
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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

Official Title
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Immediate Effects of Thrust Versus Non-thrust Lumbar Manipulation on Mobility and Springing Force Tolerance in Lumbar Hypomobility

Conditions
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Hypomotility, Lumbar Spine Instability

Intervention / Treatment
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* Other: Thrust joint lumbar manipulation
* Other: Lumbar mobilization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrust joint lumbar manipulation<br>Thrust joint lumbar manipulation (Lumbar rotation manipulation) ,Moist Hot pack | Other: Thrust joint lumbar manipulation<br>* Moist Hot pack of 14/15' over lumbar region for 15 mins. Hydro collator Temperature according to standardized hot pack is 40-45οC.Bilateral Thrust Manipulation of Lumbar Spine from L1-L5 Baseline Algometer for springing force tolerance and Lumbar Inclinometry using dual inclinometer for lumbar flexion, extension and goniometer for lumbar side bending.These pre and post intervention values were mentioned in questionnaire. The participants were administered with thrust and non-thrust manipulation of the lumbar spine and data was collected again immediately after the interventions without any delay.<br>|
| Active Comparator: Lumbar mobilization<br>Lumbar mobilization (Stretch rotation mobilization), Moist Hot pack | Other: Lumbar mobilization<br>* Moist Hot pack of 14/15' from L1 where ribcage ends up to the region of gluteal folds for 15 mins. Non Thrust Manipulation for 30 seconds Using Kaltenborn grade 3 (Stretch rotation mobilization).Baseline Algometer for springing force tolerance and Lumbar Inclinometry using dual inclinometerfor lumbar flexion, extension and goniometer for lumbar side bending. These pre and post intervention values were mentioned in questionnaire. The participants were administered with thrust and non-thrust manipulation of the lumbar spine and data was collected again immediately after the interventions without any delay.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stanley Paris Grading (Self-Structured Questionnaire and Screening Questionnaire) | It is 0-6 PIVM Grading system for manual grading of Rotatoric Movement.From 0-2 grades considered as Hypo-mobility. Grade 1 is considerable decreased movement and grade 2 is slight decreased movement at the lumbar region.As per my inclusion criteria, participants with grade 1 & 2 hypo-mobility were included.On the basis of screening questionnaire, lumbar hypo-mobility was diagnosed by Stanley Paris grading system and after taking demographics in self-structured questionnaire, pre and post intervention values were mentioned in the Questionnaire.0 grade is no movement (ankylosis or fused) while 6 grade is complete instability. | On Day 1 | 
| ROM Lumbar spine ( Flexion) | Participants having lumbar flexion ≤ 30° were recruited.Changes from the Baseline ROM (range of Motion) of Lumbar flexion was taken with the Help of Inclinometers. Standard normative value for lumbar range for flexion is 40-60°. | On Day 1 | 
| ROM Lumbar spine (Extension) | Participants having lumbar extension ≤ 15° were recruited. Changes from the Baseline ROM (range of Motion) of Lumbar extension was taken with the Help of Inclinometers. Standard normative value for lumbar range of extension is 20-35°. | On Day 1 | 
| ROM Lumbar spine (Side Bending) | Participants having side bending ≤ 15° were recruited.Changes from the Baseline ROM (range of Motion) of Lumbar side bending was taken with the Help of Goniometer. Standard normative value for lumbar range of side bending is 15-20°. | On Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Threshold (PPT) | Changes from Baseline Pressure Pain Threshold (PPT) were taken with the help of digital algometer.which measures springing force tolerance in kg or lb. | On Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Mobilization, Hypo-mobility, Spinal or segmental stiffness, Lumbar Manipulation