- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04760366
Fascial-muscular Lengthening Therapy in the Patients With Chronic Low Back Pain.
Effects of Fascial-muscular Lengthening Therapy on Tight Iliopsoas Muscle in the Patients With Chronic Low Back Pain.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fedral,Pakistan
-
Islamabad, Fedral,Pakistan, Pakistan, 440000
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
Patients in this group will receive interventional therapy To perform this technique:
the conventional therapy
|
|
Other: Group B: Conventional treatment
Patients in this group will receive the conventional therapy
|
the conventional therapy
Patients in this group will receive the interventional therapy which will include: Stretching's of iliopsoas muscle which can be done in two positions:
Patients in this group will also receive the conventional therapy which will include:
|
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00766 Najia Zainab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
-
Kirsehir Ahi Evran UniversitesiHacettepe University; Selcuk UniversityRecruitingLow Back Pain, Mechanical | Non Specific Chronic Low Back Pain | Low Back Pain, ChronicTurkey
-
University of BarcelonaHospital Clinic of BarcelonaRecruitingBack Pain | Chronic Low-back Pain | Chronic Low-back Pain (cLBP)Spain
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
Dokuz Eylul UniversityCompletedMindfulness Meditation | Non-specific Chronic Low Back Pain | Chronic Low-back Pain (cLBP)Turkey (Türkiye)
-
Xijing HospitalRecruitingLow Back Pain | Non-specific Chronic Low Back Pain | CLBP - Chronic Low Back Pain | Paraspinal MuscleChina
-
University of FaisalabadNot yet recruiting
-
Rhode Island HospitalRecruitingChronic Pain | Chronic Low-back PainUnited States
-
Marmara UniversityCompletedMechanical Low Back Pain | Chronic Low Back Pain (CLBP)Turkey
Clinical Trials on fascial- muscular lengthening therapy
-
Hasan Kalyoncu UniversityNot yet recruitingExercise | Hand Flexor Tendon | Facial MobilizationTurkey (Türkiye)
-
University of GaziantepRecruitingPostural; Defect | Tension-Type Headache | Proprioceptive Disorders | Pain, Neck | Craniovertebral; SyndromeTurkey
-
Hasan Kalyoncu UniversityCompletedPost Partum | Carpal Tunnel Syndrome (CTS) | Fascial MobilizationTurkey (Türkiye)
-
Riphah International UniversityCompletedAdhesive CapsulitisPakistan
-
Real Fundación Victoria EugeniaCompleted
-
University of SalfordCompletedRespiratory Disease | Long COVIDUnited Kingdom
-
Hacettepe UniversityUnknown
-
Central South UniversityCompleted
-
Riphah International UniversityCompleted
-
University of British ColumbiaNot yet recruitingExercise Therapy