PELVIS SyndromeNCT06461507
Comparative Effects of Jandas's Approach With and Without Post Isometric Relaxation Technique
A study testing Janda's Approach in people with PELVIS Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Posterior lower crossed syndrome is a perplexing puzzle of muscular imbalance, manifests as an intricate interplay between weakened glutes and tight flexors. The aim of the study will be to determine the effects of Jandas's approach with and without post-isometric relaxation technique on pain, muscle flexibility, and… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- PELVIS Syndrome
- What is being tested?
- Janda's Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2024to 10 Oct 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age:20-60 years
- Gender: Both males and females
- NPRS (Numerical Pain Rating Scale): < 7
- Positive Finger to Floor Test : > 48cm in males, >50cm for females
- Positive Modified Thomas Test: greater than zero
- Patients with anterior pelvic tilt
Who cannot join
- Preexisting spinal pathology
- Congenital abnormality
- Neurological deficits,
- Recent spinal or lower-limb trauma or surgery
- Spasm of the trunk or lower-limb muscles
- Lower-limb radiculopathy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shafeen medical complex Punjab Pakistan
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Jandas's Approach With and Without Post Isometric Relaxation Technique on Pain, Muscle Flexibility, Functional Disability in Patients With Posterior Lower Crossed Syndrome
Posterior lower crossed syndrome is a perplexing puzzle of muscular imbalance, manifests as an intricate interplay between weakened glutes and tight flexors. The aim of the study will be to determine the effects of Jandas's approach with and without post-isometric relaxation technique on pain, muscle flexibility, and functional disability in patients with the posterior lower crossed syndrome.
Read the detailed description
A Randomized Controlled Trial will be conducted at physical therapy department of Rabia Welfare Hospital Lahore, FMH Physiotherapy Clinic Lahore and Shafaeen Physiotherapy Clinic Lahore through convenient sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with janda's approach and Group B will be treated with combination of post isometric relaxation technique for Illiopsoas and janda's approach at the frequency of 3 sets with 10 repetitions and twice a week. Outcome measures will be conducted through pain,muscle flexibility, pelvic tilt and disability questionnaire after 4 weeks. Data will be analysed using SPSS software version 25.After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or nonparametric test will be used within a group or between two groups.
- Conditions
- PELVIS Syndrome
- Being tested
- Janda's Approach
- Keywords
- disability, pain, flexibility
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Janda's ApproachOther
For Tightened Structures Stretching applied toIliopsoas and Erector spinal muscles (5 repetitions of stretching with 30-s hold for each muscle). For Strengthening of Weakened Structures; Glute bridge and Abdominal crunch(10 repetitions of each).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Muscle Energy Technique (METs) | Experimental | ▪ Apply METs to the iliopsoas muscle by instructing the patient to do hip flexion and resist movement by pushing their leg down towards the table, activating their iliopsoas muscle. (This contraction is known as an isometric contraction). Maintain the isometric contraction for approximately 5-10 seconds, encouraging the patient to exert maximal effort. After the contraction, relax the patient's leg as they exhale, and take the muscle to its new, slightly increased, passive range of motion. Receives: Other: Janda's Approach |
| Group B: Janda's Approach | Active comparator | For tightened structures stretching, use the Iliopsoas stretch and the Erector spinae stretch (5 repetitions of stretching with 30-s hold for each muscle) For Strengthening Weakened Structures: Glute bridge, Abdominal crunch (10 repetitions of each) Receives: Other: Janda's Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale (NPRS)
- Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: upto 4 weeks
Finger to floor test -Muscle flexibility test
- The patient is asked to bend forward and attempt to reach for the floor with their fingertips.
- The physical therapist then measures the distance between the patient's right long finger and the floor using a standard measuring tape
- Ask the client whether pain, stiffness or both limit the movement(Fingertips to floor (FTF) test).
- If the FTF test is limited by pain, the location and pain score out of 10 should be documented.
- If the FTF test is 0 cm or the patient is able to place their palms to the floor with no pain, a different outcome measure should be considered.
Measured: upto 4 weeks
Modified Thomas Test- Muscle flexibility test
- Have the patient lie supine on a firm surface, with their legs straight.
- Place your hand under the patient's lower back to maintain a neutral spine.
- Slowly flex the patient's hip, bringing their knee towards their chest, until their thigh is perpendicular to the table.
- Assist the patient in flexing their hip further, keeping their knee bent at a 90-degree angle.
- Measure the angle between the patient's thigh and the table using a goniometer or inclinometer.
- Compare the measurement to the normal range (usually around 15-20 degrees) to determine if there is a restriction in iliopsoas flexibility.
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start30 Jun 2024
- Primary completion30 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PELVIS SyndromeStudies 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, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nimra Azhar, MSPT*, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461507
- Sponsor's protocol ID
- REC/RCR & AHS/23/0194 Nimra
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Key J. 'The core': understanding it, and retraining its dysfunction. J Bodyw Mov Ther. 2013 Oct;17(4):541-59. doi: 10.1016/j.jbmt.2013.03.012. Epub 2013 Jun 28.
PubMed 24139017Roberts JM, Wilson K. Effect of stretching duration on active and passive range of motion in the lower extremity. Br J Sports Med. 1999 Aug;33(4):259-63. doi: 10.1136/bjsm.33.4.259.
PubMed 10450481Kale, S. S. and S. Gijare (2019).
Ishida H, Hirose R, Watanabe S. Comparison of changes in the contraction of the lateral abdominal muscles between the abdominal drawing-in maneuver and breathe held at the maximum expiratory level. Man Ther. 2012 Oct;17(5):427-31. doi: 10.1016/j.math.2012.04.006. Epub 2012 May 16.
PubMed 22595657Esakowitz, A. (2014). The effect of muscle energy technique versus chiropractic adjustive therapy in the treatment of chronic low back pain with lower cross syndrome, University of Johannesburg (South Africa).
Janda, V. (1987).
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Jandas's Approach With and Without Post Isometric Relaxation Technique on Pain, Muscle Flexibility, Functional Disability in Patients With Posterior Lower Crossed Syndrome
- ClinicalTrials.gov ID
- NCT06461507
- Acronym / sponsor ID
- REC/RCR & AHS/23/0194 Nimra
- Conditions
- PELVIS Syndrome
- Keywords
- disability, pain, flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 17 Jun 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.
Posterior lower crossed syndrome is a perplexing puzzle of muscular imbalance, manifests as an intricate interplay between weakened glutes and tight flexors. The aim of the study will be to determine the effects of Jandas's approach with and without post-isometric relaxation technique on pain, muscle flexibility, and functional disability in patients with the posterior lower crossed syndrome.
Detailed description
A Randomized Controlled Trial will be conducted at physical therapy department of Rabia Welfare Hospital Lahore, FMH Physiotherapy Clinic Lahore and Shafaeen Physiotherapy Clinic Lahore through convenient sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with janda's approach and Group B will be treated with combination of post isometric relaxation technique for Illiopsoas and janda's approach at the frequency of 3 sets with 10 repetitions and twice a week. Outcome measures will be conducted through pain,muscle flexibility, pelvic tilt and disability questionnaire after 4 weeks. Data will be analysed using SPSS software version 25.After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or nonparametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Muscle Energy Technique (METs) | Experimental | Other: Janda's Approach▪ Apply METs to the iliopsoas muscle by instructing the patient to do hip flexion and resist movement by pushing their leg down towards the table, activating their iliopsoas muscle. (This contraction is known as an isometric contraction). Maintain the isometric contraction for approximately 5-10 seconds, encouraging the patient to exert maximal effort. After the contraction, relax the patient's leg as they exhale, and take the muscle to its new, slightly increased, passive range of motion. |
| Group B: Janda's Approach | Active comparator | Other: Janda's ApproachFor tightened structures stretching, use the Iliopsoas stretch and the Erector spinae stretch (5 repetitions of stretching with 30-s hold for each muscle) For Strengthening Weakened Structures: Glute bridge, Abdominal crunch (10 repetitions of each) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age:20-60 years
- Gender: Both males and females
- NPRS (Numerical Pain Rating Scale): < 7
- Positive Finger to Floor Test : > 48cm in males, >50cm for females
- Positive Modified Thomas Test: greater than zero
Key exclusion criteria (7 listed)
- Preexisting spinal pathology
- Congenital abnormality
- Neurological deficits,
- Recent spinal or lower-limb trauma or surgery
- Spasm of the trunk or lower-limb muscles
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 |
|---|---|---|
| Janda's ApproachFor Tightened Structures Stretching applied toIliopsoas and Erector spinal muscles (5 repetitions of stretching with 30-s hold for each muscle). For Strengthening of Weakened Structures; Glute bridge and Abdominal crunch(10 repetitions of each). | Other | Group A: Muscle Energy Technique (METs), Group B: Janda's Approach |
Primary outcome
Numerical pain rating scale (NPRS)
Time frame: upto 4 weeks
o Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain. The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Finger to floor test -Muscle flexibility test
Time frame: upto 4 weeks
* The patient is asked to bend forward and attempt to reach for the floor with their fingertips. * The physical therapist then measures the distance between the patient's right long finger and the floor using a standard measuring tape * Ask the client whether pain, stiffness or both limit the movement(Fingertips to floor (FTF) test). * If the FTF test is limited by pain, the location and pain score out of 10 should be documented. * If the FTF test is 0 cm or the patient is able to place their palms to the floor with no pain, a different outcome measure should be considered.
Modified Thomas Test- Muscle flexibility test
Time frame: upto 4 weeks
* Have the patient lie supine on a firm surface, with their legs straight. * Place your hand under the patient's lower back to maintain a neutral spine. * Slowly flex the patient's hip, bringing their knee towards their chest, until their thigh is perpendicular to the table. * Assist the patient in flexing their hip further, keeping their knee bent at a 90-degree angle. * Measure the angle between the patient's thigh and the table using a goniometer or inclinometer. * Compare the measurement to the normal range (usually around 15-20 degrees) to determine if there is a restriction in iliopsoas flexibility.
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 15 Oct 2024.
- Background: PubMed 24139017Key J. 'The core': understanding it, and retraining its dysfunction. J Bodyw Mov Ther. 2013 Oct;17(4):541-59. doi: 10.1016/j.jbmt.2013.03.012. Epub 2013 Jun 28.
- Background: PubMed 10450481Roberts JM, Wilson K. Effect of stretching duration on active and passive range of motion in the lower extremity. Br J Sports Med. 1999 Aug;33(4):259-63. doi: 10.1136/bjsm.33.4.259.
- BackgroundKale, S. S. and S. Gijare (2019).
- Background: PubMed 22595657Ishida H, Hirose R, Watanabe S. Comparison of changes in the contraction of the lateral abdominal muscles between the abdominal drawing-in maneuver and breathe held at the maximum expiratory level. Man Ther. 2012 Oct;17(5):427-31. doi: 10.1016/j.math.2012.04.006. Epub 2012 May 16.
- BackgroundEsakowitz, A. (2014). The effect of muscle energy technique versus chiropractic adjustive therapy in the treatment of chronic low back pain with lower cross syndrome, University of Johannesburg (South Africa).
- BackgroundJanda, V. (1987).
- 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.
Nimra Azhar, MSPT* principal investigator
Riphah International University,Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Janda's Approach in people with PELVIS Syndrome, 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 6 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: finished, as of the sponsor's last update on 15 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?
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?
Numerical pain rating scale (NPRS) (time frame: upto 4 weeks). 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?
On the ClinicalTrials.gov record for NCT06461507, which also lists 6 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 15 Oct 2024.