Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04760366
Other study ID # REC/00766 Najia Zainab
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 13, 2020
Est. completion date March 20, 2021

Study information

Verified date September 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date March 20, 2021
Est. primary completion date March 20, 2021
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
fascial- muscular lengthening therapy
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.
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: 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.
the conventional therapy
the conventional therapy

Locations

Country Name City State
Pakistan Riphah International University Islamabad Fedral,Pakistan

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6th day
Primary 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 6th day
Primary For tight iliopsoas: Thomas Test. This test is used to test the flexibility of hip flexors.Baseline,6th day 6th day
See also
  Status Clinical Trial Phase
Completed NCT03243084 - Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy N/A
Suspended NCT04735185 - Stem Cells vs. Steroids for Discogenic Back Pain N/A
Completed NCT03162952 - RAND Center of Excellence for the Study of Appropriateness of Care in CAM
Completed NCT03240146 - Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain N/A
Completed NCT05282589 - Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients N/A
Completed NCT03637998 - Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain N/A
Recruiting NCT02289170 - Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100) N/A
Active, not recruiting NCT01944163 - The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain N/A
Completed NCT02231554 - Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial N/A
Recruiting NCT02063503 - Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients N/A
Completed NCT01704677 - Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT01177241 - Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids N/A
Completed NCT01490905 - A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain Phase 4
Completed NCT01177254 - Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions N/A
Completed NCT01177280 - Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes N/A
Completed NCT00984815 - Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment Phase 3
Completed NCT00763321 - Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) Phase 3
Completed NCT00761150 - Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) Phase 3
Completed NCT00767806 - A Study for Patient With Chronic Low Back Pain Phase 3