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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 9, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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