Lumbar Manipulation in Lumbar Hypomobility

November 10, 2020 updated by: Riphah International University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Fedral
      • Islamabad, Fedral, Pakistan, 44000
        • Max Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thrust joint lumbar manipulation
Thrust joint lumbar manipulation (Lumbar rotation manipulation) ,Moist Hot pack
Other: Thrust joint lumbar manipulation
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.
Active Comparator: Lumbar mobilization
Lumbar mobilization (Stretch rotation mobilization), Moist Hot pack
Other: Lumbar mobilization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stanley Paris Grading (Self-Structured Questionnaire and Screening Questionnaire)
Time Frame: On Day 1
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)
Time Frame: On Day 1
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)
Time Frame: On Day 1
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)
Time Frame: On Day 1
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)
Time Frame: On Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

November 9, 2020

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC/00695 Saba Nawaz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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