Low Back PainNCT06656156
PNF Technique on Iliopsoas and Hamstring Muscle on Chronic Low Back Pain
A study testing Proprioceptive neuromuscular facilitation technique and Conventional treatment in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the study to evaluate the effects of PNF in terms of decreasing low back pain, increasing range of motion and improving flexibility of the hamstrings and iliopsoas. Their association in LBP can be found through studies and my study based on this point will show whether targeting these two muscles would have… Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Proprioceptive neuromuscular facilitation technique and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Aug 2024to 30 Nov 2024
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- chronic NSLBP of more than 3 months (NPRS 3-7)
- positive modified Thomas test (Posterior thigh does not touch table, knee flex >80)
- positive modified SLR (unable to extend knee), SLR (pain >70 degrees)
Who cannot join
- History of abdominal, back, and hip surgery
- Spine and hip fracture
- menstruation at the time of testing.
- Pain and severe joint stiffness of hip and knee
- problems of cardiovascular and respiratory systems
- Physiological problems that cause referred pain at the low back (UTI, kidney problem, tumor, pancreatitis)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah postgraduate Medical centre
Karachi, Sindh, 75510
Aisha a., MS-OMPT
About this study
Official title: Effects of Proprioceptive Neuromuscular Facilitation of Iliopsoas and Hamstring on Patients With Chronic Low Back Pain
The aim of the study to evaluate the effects of PNF in terms of decreasing low back pain, increasing range of motion and improving flexibility of the hamstrings and iliopsoas. Their association in LBP can be found through studies and my study based on this point will show whether targeting these two muscles would have any effect on lumbar back pain.
Read the detailed description
One of the most prevalent, significant, and leading causes of disability in industries is chronic low back pain (CLBP) which also leads to poor quality of life. 50.4% of patients with low back pain reported a history of prolonged unsupported sitting. A study which evaluates muscle tightness in women desk job workers shows 89.83% have Hamstring tightness, whereas 35.59% have Iliopsoas tightness. In today's world majority of jobs require long hours sitting or standing with limited body movements like those involving computers and visual displays, bankers, teachers, industrial workers, architects, and so forth. This sedentary lifestyle has a negative effect on muscles, leads to the shortening which was one of the main contributors to the development of LBP. The iliopsoas, along with other back muscles, is said to play an essential role in stabilizing the pelvis. the shortening of the iliopsoas muscle produced inappropriate loading on the lumbar spine, mostly resulting in greater lumbar lordosis and anterior pelvic tilting thereby acting as a risk factor for low back pain. Patients with LBP also reported shorting of hamstring muscles due to Long-duration sitting.
When treating low back pain, physiotherapy is just as helpful as medication. For acute, chronic, or subacute low back pain, take into consideration the addition of non-pharmacological therapy that has been shown to be beneficial. PNF technique is one of the specific advanced physical exercises.
Joint movement limitation, traction, stretching, and resisted movement are all part of proprioceptive neuromuscular facilitation (PNF). It is effective for restoring ROM, strength, and flexibility to injured or stiff muscles. The PNF Method depends on movement patterns that enhance sensory-motor function. It has been proposed that PNF corrects the distorted impulses generated from muscle proprioceptive receptors. As a result, it lessens discomfort and aims to increase muscle strength.
Proprioceptive neuromuscular facilitation (PNF) is a form of flexibility exercises used to resolve muscle shortening and straining. Studies show that PNF stretching can help individuals with chronic back pain by improving hip range of motion, functional impairment, and pain management. According to a literature review published from 1970 to February 2020, PNF was more effective in helping people suffering with chronic low back pain to relieve their pain and enhance their waist function. A study of India, in 2015 concluded that PNF (modified hold relax) was more effective than ART at increasing hamstring flexibility and reducing pain and impairment. A study conducted in 2017 shows, PNF(CRAC) stretching technique on iliopsoas combined with hamstring stretching is effective to reduce back pain. In just one session, the PNF group had experienced significantly more benefits than the MET group in terms of pain relief, lumbar lordosis reduction, and loosening of the tight iliopsoas. A thesis comparing between PNF exercise and McKenzie method, in which PNF exercise shows better improvement in the low back pain than McKenzie method. another study supports the literature that when treating patients with chronic low back pain, the rhythmic stabilization training technique of proprioceptive neuromuscular facilitation combined with a series of isotonic exercises proved to be beneficial than either technique used alone. Researchers also observed that application of PNF stretching significantly reduces low back pain and dysfunction in patients with chronic low back pain.
In a study they have analyzed the relationship between the iliopsoas and hamstring tightness on LBP. The most powerful and deep hip flexor is the iliopsoas muscle, which is not normally stretched during daily activities. People whose occupations require them to sit for extended periods of time may notice a shortening of these muscles due to adaptation changes. Tightness in that area causes anterior pelvic tilting and hyper-lordosis of the spine, which strain the back muscles and eventually results in low back pain. Muscle flexibility increases and the pelvis retrovert and neutralize when we stretch the iliopsoas. A study found an association between passive hip extension and prolonged sitting/physical inactivity. Results showed there was 6.1° more passive hip extension in the high activity \& minimal sitting group when compared to the low activity \& prolonged sitting group. muscle imbalances due to muscle tension and weakness affects neutral lumbopelvic alignment, among them hamstring extensibility is considered the most important. The tightness in the hamstring causes the adaptive shortening of the muscles leading to posterior pelvic tilt along with the flattening of the lumbar spine which causes pain in the low back. A study concluded that Participants with low back pain had significantly shorter hamstring muscle length than participants without low back pain. Moreover, the hamstring is one of the stabilizers of the pelvic motion in the sagittal plane by controlling the anterior pelvic tilt.
When iliopsoas muscle shortens, the hip joint's biomechanics get disrupted to cause anterior pelvic tilting, according to literature in order to compensate iliopsoas tightness, hamstring contracts to hold the pelvis in its position, which can lead to its tightness because of constant remaining in contracted phase and vice versa. this pathophysiology affects the lumber spine's curvature and causes low back discomfort and exaggeration of subjective symptoms. PNF stretching improves mobility and helps in the healing of injuries by using reflexes to produce deeper stretches that loosen up tight muscles.
The aim of the study to evaluate the effects of PNF in terms of decreasing low back pain, increasing range of motion and improving flexibility of the hamstrings and iliopsoas. Their association in LBP can be found through studies and my study based on this point will show whether targeting these two muscles would have any effect on lumbar back pain. And as there is no published literature available in national evidence on the effects of the PNF technique on either hamstring or iliopsoas tightness, my study bridges the gap and will be a beneficial addition to the literature and also will recommend a cost-effective, easy and harmless treatment that can be implemented as an effective treatment for low-back pain patients.
- Conditions
- Low Back Pain
- Being tested
- Proprioceptive neuromuscular facilitation technique, Conventional treatment
- Keywords
- Low back pain, Proprioceptive neuromuscular facilitation (PNF), Mechanical, Chronic pain, Iliopsoas and hamstring
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive neuromuscular facilitation techniqueOther
Experimental group was given proprioceptive neuromuscular facilitation technique (PNF) along with conventional treatment.
PNF will be applied on iliopsoas and hamstring muscles, 3 repetitions/session with a break of 2 minutes/repetition (10 second isometric Contraction then 10 second stretch)
Treatment contains total 12 sessions (3 times/week for 4 consecutive weeks)
Conventional treatmentOther
Conventional treatment contains tens and hotpack.
Tens Will be applied for 20 minutes and hotpack for 10 minutes
Total 12 sessions (3 times/week for 4 consecutive weeks)
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive neuromuscular facilitation technique | Experimental | Proprioceptive neuromuscular facilitation technique along with conventional treatment Receives: Other: Proprioceptive neuromuscular facilitation technique |
| Conventional treatment | Active comparator | Tens and hotpack Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale( NPRS)
Changes from baseline Numeric pain rating scale starting from 0 to 10 (0-3 categories as mild, 4-6 as moderate and 7-10 as severe) used to assess pain of lumber spine
Measured: 4th week
Secondary outcomes (4)
ROM lumber spine flexion
Changes from baseline ROM (range of motion) of lumber spine flexion will be taken with the help of Goniometer
Measured: 4th week
ROM lumber spine extension
Changes from baseline ROM (range of motion) of lumber spine extension will be taken with the help of Goniometer
Measured: 4th week
ROM lumber spine side bend
Changes from baseline ROM (range of motion) of lumber spine side bend will be taken with the help of Goniometer
Measured: 4th week
ROM lumber spine rotation
Changes from baseline ROM (range of motion) of lumber spine rotation will be taken with the help of Goniometer
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start2 Aug 2024
- Primary completion15 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shamaila yaqub, Ms-ompt, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656156
- Sponsor's protocol ID
- REC/01944 Aisha
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lakkadsha TM, Qureshi MI, Kovela RK, Saifee SS, Lalwani SS. Efficacy of Single Stretching Session of Iliopsoas Using Proprioceptive Neuromuscular Facilitation Versus Muscle Energy Technique on Low Back Pain in Patients With Lumbar Hyper-Lordosis. Cureus. 2022 Aug 12;14(8):e27916. doi: 10.7759/cureus.27916. eCollection 2022 Aug.
PubMed 36110466Gao P, Tang F, Liu W, Mo Y. The effects of proprioceptive neuromuscular facilitation in treating chronic low back pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2022;35(1):21-33. doi: 10.3233/BMR-200306.
PubMed 34250930Cejudo A, Centenera-Centenera JM, Santonja-Medina F. The Potential Role of Hamstring Extensibility on Sagittal Pelvic Tilt, Sagittal Spinal Curves and Recurrent Low Back Pain in Team Sports Players: A Gender Perspective Analysis. Int J Environ Res Public Health. 2021 Aug 16;18(16):8654. doi: 10.3390/ijerph18168654.
PubMed 34444402
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Neuromuscular Facilitation of Iliopsoas and Hamstring on Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06656156
- Acronym / sponsor ID
- REC/01944 Aisha
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Proprioceptive neuromuscular facilitation (PNF), Mechanical, Chronic pain, Iliopsoas and hamstring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 24 Oct 2024 (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 aim of the study to evaluate the effects of PNF in terms of decreasing low back pain, increasing range of motion and improving flexibility of the hamstrings and iliopsoas. Their association in LBP can be found through studies and my study based on this point will show whether targeting these two muscles would have any effect on lumbar back pain.
Detailed description
One of the most prevalent, significant, and leading causes of disability in industries is chronic low back pain (CLBP) which also leads to poor quality of life. 50.4% of patients with low back pain reported a history of prolonged unsupported sitting. A study which evaluates muscle tightness in women desk job workers shows 89.83% have Hamstring tightness, whereas 35.59% have Iliopsoas tightness. In today's world majority of jobs require long hours sitting or standing with limited body movements like those involving computers and visual displays, bankers, teachers, industrial workers, architects, and so forth. This sedentary lifestyle has a negative effect on muscles, leads to the shortening which was one of the main contributors to the development of LBP. The iliopsoas, along with other back muscles, is said to play an essential role in stabilizing the pelvis. the shortening of the iliopsoas muscle produced inappropriate loading on the lumbar spine, mostly resulting in greater lumbar lordosis and anterior pelvic tilting thereby acting as a risk factor for low back pain. Patients with LBP also reported shorting of hamstring muscles due to Long-duration sitting.
When treating low back pain, physiotherapy is just as helpful as medication. For acute, chronic, or subacute low back pain, take into consideration the addition of non-pharmacological therapy that has been shown to be beneficial. PNF technique is one of the specific advanced physical exercises.
Joint movement limitation, traction, stretching, and resisted movement are all part of proprioceptive neuromuscular facilitation (PNF). It is effective for restoring ROM, strength, and flexibility to injured or stiff muscles. The PNF Method depends on movement patterns that enhance sensory-motor function. It has been proposed that PNF corrects the distorted impulses generated from muscle proprioceptive receptors. As a result, it lessens discomfort and aims to increase muscle strength.
Proprioceptive neuromuscular facilitation (PNF) is a form of flexibility exercises used to resolve muscle shortening and straining. Studies show that PNF stretching can help individuals with chronic back pain by improving hip range of motion, functional impairment, and pain management. According to a literature review published from 1970 to February 2020, PNF was more effective in helping people suffering with chronic low back pain to relieve their pain and enhance their waist function. A study of India, in 2015 concluded that PNF (modified hold relax) was more effective than ART at increasing hamstring flexibility and reducing pain and impairment. A study conducted in 2017 shows, PNF(CRAC) stretching technique on iliopsoas combined with hamstring stretching is effective to reduce back pain. In just one session, the PNF group had experienced significantly more benefits than the MET group in terms of pain relief, lumbar lordosis reduction, and loosening of the tight iliopsoas. A thesis comparing between PNF exercise and McKenzie method, in which PNF exercise shows better improvement in the low back pain than McKenzie method. another study supports the literature that when treating patients with chronic low back pain, the rhythmic stabilization training technique of proprioceptive neuromuscular facilitation combined with a series of isotonic exercises proved to be beneficial than either technique used alone. Researchers also observed that application of PNF stretching significantly reduces low back pain and dysfunction in patients with chronic low back pain.
In a study they have analyzed the relationship between the iliopsoas and hamstring tightness on LBP. The most powerful and deep hip flexor is the iliopsoas muscle, which is not normally stretched during daily activities. People whose occupations require them to sit for extended periods of time may notice a shortening of these muscles due to adaptation changes. Tightness in that area causes anterior pelvic tilting and hyper-lordosis of the spine, which strain the back muscles and eventually results in low back pain. Muscle flexibility increases and the pelvis retrovert and neutralize when we stretch the iliopsoas. A study found an association between passive hip extension and prolonged sitting/physical inactivity. Results showed there was 6.1° more passive hip extension in the high activity \& minimal sitting group when compared to the low activity \& prolonged sitting group. muscle imbalances due to muscle tension and weakness affects neutral lumbopelvic alignment, among them hamstring extensibility is considered the most important. The tightness in the hamstring causes the adaptive shortening of the muscles leading to posterior pelvic tilt along with the flattening of the lumbar spine which causes pain in the low back. A study concluded that Participants with low back pain had significantly shorter hamstring muscle length than participants without low back pain. Moreover, the hamstring is one of the stabilizers of the pelvic motion in the sagittal plane by controlling the anterior pelvic tilt.
When iliopsoas muscle shortens, the hip joint's biomechanics get disrupted to cause anterior pelvic tilting, according to literature in order to compensate iliopsoas tightness, hamstring contracts to hold the pelvis in its position, which can lead to its tightness because of constant remaining in contracted phase and vice versa. this pathophysiology affects the lumber spine's curvature and causes low back discomfort and exaggeration of subjective symptoms. PNF stretching improves mobility and helps in the healing of injuries by using reflexes to produce deeper stretches that loosen up tight muscles.
The aim of the study to evaluate the effects of PNF in terms of decreasing low back pain, increasing range of motion and improving flexibility of the hamstrings and iliopsoas. Their association in LBP can be found through studies and my study based on this point will show whether targeting these two muscles would have any effect on lumbar back pain. And as there is no published literature available in national evidence on the effects of the PNF technique on either hamstring or iliopsoas tightness, my study bridges the gap and will be a beneficial addition to the literature and also will recommend a cost-effective, easy and harmless treatment that can be implemented as an effective treatment for low-back pain patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive neuromuscular facilitation technique | Experimental | Other: Proprioceptive neuromuscular facilitation techniqueProprioceptive neuromuscular facilitation technique along with conventional treatment |
| Conventional treatment | Active comparator | Other: Conventional treatmentTens and hotpack |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- chronic NSLBP of more than 3 months (NPRS 3-7)
- positive modified Thomas test (Posterior thigh does not touch table, knee flex >80)
- positive modified SLR (unable to extend knee), SLR (pain >70 degrees)
Key exclusion criteria (7 listed)
- History of abdominal, back, and hip surgery
- Spine and hip fracture
- menstruation at the time of testing.
- Pain and severe joint stiffness of hip and knee
- problems of cardiovascular and respiratory systems
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 |
|---|---|---|
| Proprioceptive neuromuscular facilitation techniqueExperimental group was given proprioceptive neuromuscular facilitation technique (PNF) along with conventional treatment. PNF will be applied on iliopsoas and hamstring muscles, 3 repetitions/session with a break of 2 minutes/repetition (10 second isometric Contraction then 10 second stretch) Treatment contains total 12 sessions (3 times/week for 4 consecutive weeks) | Other | Proprioceptive neuromuscular facilitation technique |
| Conventional treatmentConventional treatment contains tens and hotpack. Tens Will be applied for 20 minutes and hotpack for 10 minutes Total 12 sessions (3 times/week for 4 consecutive weeks) | Other | Conventional treatment |
Primary outcome
Numeric pain rating scale( NPRS)
Time frame: 4th week
Changes from baseline Numeric pain rating scale starting from 0 to 10 (0-3 categories as mild, 4-6 as moderate and 7-10 as severe) used to assess pain of lumber spine
4 secondary outcomes
ROM lumber spine flexion
Time frame: 4th week
ROM lumber spine extension
Time frame: 4th week
ROM lumber spine side bend
Time frame: 4th week
ROM lumber spine rotation
Time frame: 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 36110466Lakkadsha TM, Qureshi MI, Kovela RK, Saifee SS, Lalwani SS. Efficacy of Single Stretching Session of Iliopsoas Using Proprioceptive Neuromuscular Facilitation Versus Muscle Energy Technique on Low Back Pain in Patients With Lumbar Hyper-Lordosis. Cureus. 2022 Aug 12;14(8):e27916. doi: 10.7759/cureus.27916. eCollection 2022 Aug.
- Background: PubMed 34250930Gao P, Tang F, Liu W, Mo Y. The effects of proprioceptive neuromuscular facilitation in treating chronic low back pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2022;35(1):21-33. doi: 10.3233/BMR-200306.
- Background: PubMed 34444402Cejudo A, Centenera-Centenera JM, Santonja-Medina F. The Potential Role of Hamstring Extensibility on Sagittal Pelvic Tilt, Sagittal Spinal Curves and Recurrent Low Back Pain in Team Sports Players: A Gender Perspective Analysis. Int J Environ Res Public Health. 2021 Aug 16;18(16):8654. doi: 10.3390/ijerph18168654.
- Individual participant dataSharing planned: No
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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.
shamaila yaqub, Ms-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 Proprioceptive neuromuscular facilitation technique and Conventional treatment in people with 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale( NPRS) (time frame: 4th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06656156, which also lists 3 linked publications.
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 24 Oct 2024.