Chronic Low Back PainNCT04760366
Fascial-muscular Lengthening Therapy in the Patients With Chronic Low Back Pain.
A study testing fascial- muscular lengthening therapy, Stretching's of iliopsoas muscle and the conventional therapy in people with Chronic Low Back Pain, run by Riphah International University at 1 site in Pakistan.
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 . Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- fascial- muscular lengthening therapy, Stretching's of iliopsoas muscle and the conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Aug 2020to 20 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- • The study excludes male patients.
- No history of serious underlying pathology, nerve root compromise, structural deformities, genetic spinal disorders or previous spinal surgery
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Islamabad, Fedral,Pakistan, 440000
About this study
Official title: 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 .
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- fascial- muscular lengthening therapy, Stretching's of iliopsoas muscle, the conventional therapy
- Keywords
- FMLT, Chronic LWP, ROM, ODI, NPRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascial- muscular lengthening therapyOther
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 muscleOther
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 therapyOther
the conventional therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A (Experimental) | Experimental | Patients in this group will receive interventional therapy through fascial- muscular lengthening therapy .Patients in this group will also receive the conventional therapy Receives: Other: fascial- muscular lengthening therapy; Other: the conventional therapy |
| Group B: Conventional treatment | Other | Patients in this group will receive the conventional therapy Receives: Other: Stretching's of iliopsoas muscle; Other: the conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6th day
For tight iliopsoas: Thomas Test.
This test is used to test the flexibility of hip flexors.Baseline,6th day
Measured: 6th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start13 Aug 2020
- Primary completion20 Mar 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shafaq Shahid, MSPT-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760366
- Sponsor's protocol ID
- REC/00766 Najia Zainab
- Status last verified
- Sep 2021
- First submitted
- 16 Feb 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fascial-muscular Lengthening Therapy on Tight Iliopsoas Muscle in the Patients With Chronic Low Back Pain.
- ClinicalTrials.gov ID
- NCT04760366
- Acronym / sponsor ID
- REC/00766 Najia Zainab
- Conditions
- Chronic Low Back Pain
- Keywords
- FMLT, Chronic LWP, ROM, ODI, NPRS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Experimental) | Experimental | Other: fascial- muscular lengthening therapy, Other: the conventional therapyPatients in this group will receive interventional therapy through fascial- muscular lengthening therapy .Patients in this group will also receive the conventional therapy |
| Group B: Conventional treatment | Other | Other: Stretching's of iliopsoas muscle, Other: the conventional therapyPatients in this group will receive the conventional therapy |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • The study includes female patients with chronic low back pain.
Key exclusion criteria (2 listed)
- • The study excludes male patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fascial- muscular lengthening therapyPatients 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 | Group A (Experimental) |
| Stretching's of iliopsoas musclePatients 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. | Other | Group B: Conventional treatment |
| the conventional therapythe conventional therapy | Other | Group A (Experimental), Group B: Conventional treatment |
Primary outcome
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
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
For tight iliopsoas: Thomas Test.
Time frame: 6th day
This test is used to test the flexibility of hip flexors.Baseline,6th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shafaq Shahid, MSPT-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fascial- muscular lengthening therapy, Stretching's of iliopsoas muscle and the conventional therapy in people with Chronic Low Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 6th day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.