Fascial-muscular Lengthening Therapy in the Patients With Chronic Low Back Pain.

September 17, 2021 updated by: Riphah International University

Effects of Fascial-muscular Lengthening Therapy on Tight Iliopsoas Muscle in the Patients With Chronic Low Back Pain.

The purpose of this study is to assess and evaluate tight iliopsoas muscle in patients with chronic low back pain and to increase hip flexor flexibility in the patients with chronic low back pain by using the technique of manual fascial-muscular lengthening therapy .

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

Chronic low back pain is one of the the most prevalent complaint in the patients. Low back pain is affecting the population socially and economically, and it is also a leading public health problem, being the very common reason for absentees from work . Living with chronic low back pain leads to not only physiological but also psychological modifications. Low back pain is associated with many biomechanical factors that must not be ignored because in some cases mechanical loading results in acute disc prolapse and can also cause low back pain

The iliopsoas muscle is the primary and the most strongest hip flexor and it plays vital role in the stability of the lumbar spine for axial compression but it has very little movement function on the lumbar spine. Like other postural muscles it functions as stabilizer, and for spinal stability iliopsoas activity is essential although iliopsoas can only produce minimum movements in the sagittal plane. It is assumed that muscle weakness and other structural factors can cause low back pain and activity limitation. As the psoas muscle is the postural muscles so it also has tendency to become tight Psoas muscle tightness is responsible for causing back pain by inhibiting the lumbar and SI-joint range of motion but in the literature there is more focus on hamstring tightness rather than on iliopsoas tightness .The psoas muscle should not be ignored when evaluating and treating low back pain. because iliopsoas muscle tightness can also manifest low back pain, giving the symptoms of lumbosacral region pain, contralateral gluteal region pain and radiating pain in contralateral leg.

There has been a lot of procedures which are used to increase muscle flexibility of tight hip flexors e.g. Active and passive stretching , manual fascial-muscular lengthening therapy , a form of Active Release Technique, proprioceptive neuromuscular facilitation soft tissue mobilization and strengthening of psoas muscle.

Stretching programmers are often part of Physical Therapy treatment plan to increase muscle flexibility. A study done on Passive versus active stretching of hip flexor muscles in subjects with limited hip extension. concluded that active and passive stretching of tight hip flexors will increase the flexibility of hip flexors and range of motion in patient with low back pain

A study on "Low Back Pain with Psoas Tightness" in 2012 and concluded that the low back pain begins when there's irritation in the psoas muscle and he used soft tissue mobilization techniques and strengthening program of hip flexors to treat chronic low back pain which resulted in diminished back pain.

A study on The clinical and biomechanical effects of fascial- muscular lengthening therapy on tight hip flexor patients with and without low back pain in 2014 and concluded that by using fascial-muscular lengthening therapy there was a reduction in low back pain. There was increase in the range of passive hip extension and there was also significant decrease in iliopsoas tightness in the patients with or without low back pain.

A study on Immediate effect of application of the pressure technique to the psoas major on lumbar lordosis in 2018 in which mechanical pressure, which is similar to fascial-muscular lengthening therapy, was applied to the psoas major muscle and concluded that pressure technique reduced psoas major stiffness along with reducing lumbar extension on every segment.

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.
76

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,Pakistan
      • Islamabad, Fedral,Pakistan, Pakistan, 440000
        • Riphah International University

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

21 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • • The study includes female patients with chronic low back pain.

    • The study includes patients from the age group of 25 years and 45.
    • The study includes patients with low back pain for more than 3 months.
    • The study includes patients with chronic bilateral tight hip flexors which will assessed through Thomas Test
    • Pain in flexion bias

Exclusion Criteria:

  • • The study excludes male patients.

    • No history of serious underlying pathology, nerve root compromise, structural deformities, genetic spinal disorders or previous spinal surgery

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: Single

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: Group A (Experimental)
Patients in this group will receive interventional therapy through fascial- muscular lengthening therapy .Patients in this group will also receive the conventional therapy
Other: fascial- muscular lengthening therapy

Patients in this group will receive interventional therapy

To perform this technique:

  1. Have the patient in side lying position
  2. Hip is maximally flexed to shorten the iliopsoas muscle.
  3. Therapist fingers should be on to the targeted area.
  4. Apply gentle pressure in upward direction.
  5. While maintain the pressure, stretch the muscle by moving the hip in extension through full ROM.

  6. Therapist will maintain the pressure in opposing direction. This is considered as one pass. This technique is performed bilaterally. Patients in this group will also receive the conventional therapy which will include:

    • Hot pack for 15 minutes.
    • Myofascial release of iliopsoas.
    • TENS for 15 minutes.
Other: the conventional therapy
the conventional therapy
Other: Group B: Conventional treatment
Patients in this group will receive the conventional therapy
Other: the conventional therapy
the conventional therapy
Other: Stretching's of iliopsoas muscle

Patients in this group will receive the interventional therapy which will include:

Stretching's of iliopsoas muscle which can be done in two positions:

  1. modified lunge position.
  2. The prone stretch.

Patients in this group will also receive the conventional therapy which will include:

  • Hot pack for 15 minutes.
  • Myofascial release of iliopsoas
  • TENS for 15 minutes.

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
Numeric Pain Rating Scale (NPRS)
Time Frame: 6th day
This scale will be used for assessing low back pain before and after treatment.0 no pain 1-4 mild pain 5-7 moderate and 8-10 sever pain. Baseline,6th day
6th day
For disability: Oswestry Disability Index (ODI)
Time Frame: 6th day
Tool used to assess disability related to pain in individuals with acute, sub-acute, or chronic LBP. The total score of ODI range from 0 (no disability) to 100 (maximum disability). The ODI score is recommended as a back pain-specific measure of disability. Reliability with ICC= 0.85 and validity=0.77 Baseline,6th day
6th day
For tight iliopsoas: Thomas Test.
Time Frame: 6th day
This test is used to test the flexibility of hip flexors.Baseline,6th day
6th day

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

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.
August 13, 2020

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.
March 20, 2021

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.
March 20, 2021

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).
February 16, 2021

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.
February 17, 2021

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.
February 18, 2021

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.
September 23, 2021

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.
September 17, 2021

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.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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/00766 Najia Zainab

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

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.

Clinical Trials on Chronic Low Back Pain

Clinical Trials on fascial- muscular lengthening therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings