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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
fascial- muscular lengthening therapy
Stretching's of iliopsoas muscle
the conventional therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring FMLT, Chronic LWP, ROM, ODI, NPRS

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A (Experimental)

Group B: Conventional treatment

Arm Description

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 the conventional therapy

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
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
For disability: Oswestry Disability Index (ODI)
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
For tight iliopsoas: Thomas Test.
This test is used to test the flexibility of hip flexors.Baseline,6th day

Secondary Outcome Measures

Full Information

First Posted
February 16, 2021
Last Updated
September 17, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04760366
Brief Title
Fascial-muscular Lengthening Therapy in the Patients With Chronic Low Back Pain.
Official Title
Effects of Fascial-muscular Lengthening Therapy on Tight Iliopsoas Muscle in the Patients With Chronic Low Back Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
FMLT, Chronic LWP, ROM, ODI, NPRS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Experimental)
Arm Type
Experimental
Arm Description
Patients in this group will receive interventional therapy through fascial- muscular lengthening therapy .Patients in this group will also receive the conventional therapy
Arm Title
Group B: Conventional treatment
Arm Type
Other
Arm Description
Patients in this group will receive the conventional therapy
Intervention Type
Other
Intervention Name(s)
fascial- muscular lengthening therapy
Intervention Description
Patients in this group will receive interventional therapy To perform this technique: Have the patient in side lying position Hip is maximally flexed to shorten the iliopsoas muscle. Therapist fingers should be on to the targeted area. Apply gentle pressure in upward direction. While maintain the pressure, stretch the muscle by moving the hip in extension through full ROM. 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.
Intervention Type
Other
Intervention Name(s)
Stretching's of iliopsoas muscle
Intervention Description
Patients in this group will receive the interventional therapy which will include: Stretching's of iliopsoas muscle which can be done in two positions: modified lunge position. 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.
Intervention Type
Other
Intervention Name(s)
the conventional therapy
Intervention Description
the conventional therapy
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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
Time Frame
6th day
Title
For disability: Oswestry Disability Index (ODI)
Description
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
Time Frame
6th day
Title
For tight iliopsoas: Thomas Test.
Description
This test is used to test the flexibility of hip flexors.Baseline,6th day
Time Frame
6th day

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
• The study includes female patients with chronic low back pain
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shafaq Shahid, MSPT-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Fedral,Pakistan
ZIP/Postal Code
440000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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