HyperlordosisNCT05460949
William Training Versus Hold Relax Stretching of Iliopsoas Muscle
A study testing HOLD RELAX STRETCHING OF ILIOPSOAS and WILLIAM'S PROTOCOL in people with Hyperlordosis, run by Riphah International University at 1 site in Pakistan.
Trial summary
Hyper lordosis is a condition in which there is an excessive spine curvature in the lower back. Hyper lordosis is a very common symptom. It occurs in high-income, middle-income, and low-income countries and all age groups from children to the elderly population Only a small proportion of people have a well understood… Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Hyperlordosis
- What is being tested?
- HOLD RELAX STRETCHING OF ILIOPSOAS and WILLIAM'S PROTOCOL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to Sep 2022
- 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 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21-40 years
- Hyperlordosis Angle
- Females having increased lordotic curve
- Pain perceived anywhere in the region of lumbar spine from L1 to l5.
- Limitation of lumbar spine range of motion.
Who cannot join
- Any red flags including tumors, fractures.
- Spinal canal stenosis
- Rheumatoid arthritis
- Osteoporosis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Hospital
Lahore, Punjab Province, 54660
Hafiza Mehjabeen, PP-Dpt, 03026577666, hafiza.mehjabeen@riphah.edu.pk
Faiza Mubeen, MS-WHPT
About this study
Official title: Effects of William Training Versus Hold Relax Stretching of Iliopsoas Muscle in Females With Hyperlordosis
Hyper lordosis is a condition in which there is an excessive spine curvature in the lower back. Hyper lordosis is a very common symptom. It occurs in high-income, middle-income, and low-income countries and all age groups from children to the elderly population Only a small proportion of people have a well understood pathological cause-eg, a vertebral fracture, malignancy, or infection. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greatest risk of reporting low back pain.Hyper lordosis creates a characteristic C-shaped curve in the lower back, or lumbar region, where the spine curves inward just above the buttocks. It often occurs as a result of poor posture or a lack of exercise. Hyperlordosis can cause muscle tightening and stiffness in the lower back. It can also damage the spine and soft tissues in the lumbar region. Hyperlordosis leads to excessive curvature of the spine in the lower back, causing the abdomen and buttocks to appear more prominent in profile view. People with hyperlordosis may experience mild to severe lower back pain, which may worsen with movement.
Various conservative treatments are used to treat hyperlordosis and low back pain due to hyperlordosis. Most commonly used are the manual therapy techniques that employ William's protocol and hold relax stretching of iliopsoas muscle at lumbar spine. This study will be randomized control trial used to compare the effects of William protocol and hold relax stretching of iliopsoas muscle in subjects with hyperlordosis and low back pain. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre assessment will be done using LUMBAR SPINE QUESTIONNAIRE as subjective measurements and NPRS as objective measurements. Subjects in one group will be treated using William's protocol and the other one will be treated with hold relax stretching of iliopsoas muscle. Each subject will receive 08 treatment sessions with 02 treatment sessions per week. Post treatment reading for NPRS and lumbar spine questionnaire will be recorded after every week.
Read the detailed description
Hyper lordosis is a condition in which there is an excessive spine curvature in the lower back. Hyper lordosis is a very common symptom. It occurs in high-income, middle-income, and low-income countries and all age groups from children to the elderly population Only a small proportion of people have a well understood pathological cause-eg, a vertebral fracture, malignancy, or infection. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greatest risk of reporting low back pain.Hyper lordosis creates a characteristic C-shaped curve in the lower back, or lumbar region, where the spine curves inward just above the buttocks. It often occurs as a result of poor posture or a lack of exercise. Hyperlordosis can cause muscle tightening and stiffness in the lower back. It can also damage the spine and soft tissues in the lumbar region. Hyperlordosis leads to excessive curvature of the spine in the lower back, causing the abdomen and buttocks to appear more prominent in profile view. People with hyperlordosis may experience mild to severe lower back pain, which may worsen with movement.
Various conservative treatments are used to treat hyperlordosis and low back pain due to hyperlordosis. Most commonly used are the manual therapy techniques that employ William's protocol and hold relax stretching of iliopsoas muscle at lumbar spine. This study will be randomized control trial used to compare the effects of William protocol and hold relax stretching of iliopsoas muscle in subjects with hyperlordosis and low back pain. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre assessment will be done using LUMBAR SPINE QUESTIONNAIRE as subjective measurements and NPRS as objective measurements. Subjects in one group will be treated using William's protocol and the other one will be treated with hold relax stretching of iliopsoas muscle. Each subject will receive 08 treatment sessions with 02 treatment sessions per week. Post treatment reading for NPRS and lumbar spine questionnaire will be recorded after every week.Various conservative treatments are used to treat hyperlordosis and low back pain due to hyperlordosis. Most commonly used are the manual therapy techniques that employ William's protocol and hold relax stretching of iliopsoas muscle at lumbar spine. This study will be randomized control trial used to compare the effects of William protocol and hold relax stretching of iliopsoas muscle in subjects with hyperlordosis and low back pain. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre assessment will be done using LUMBAR SPINE QUESTIONNAIRE as subjective measurements and NPRS as objective measurements. Subjects in one group will be treated using William's protocol and the other one will be treated with hold relax stretching of iliopsoas muscle. Each subject will receive 08 treatment sessions with 02 treatment sessions per week. Post treatment reading for NPRS and lumbar spine questionnaire will be recorded after every week.
- Conditions
- Hyperlordosis
- Being tested
- HOLD RELAX STRETCHING OF ILIOPSOAS, WILLIAM'S PROTOCOL
- Medical subject headings
- Swayback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOLD RELAX STRETCHING OF ILIOPSOASOther
10 second isometric contraction of iliopsoas muscle (HR), 10-second rest, 20 second static stretch, 5 repetitions.
- The stretching exercise was performed 2 times a week for 8 weeks. 10 second isometric contraction of iliopsoas muscle (HR), 10-second rest, 20 second static stretch, 5 repetitions.
The stretching exercise was performed 2 times a week for 8 weeks.
WILLIAM'S PROTOCOLOther
Pelvic tilt Single Knee to chest Double knee to chest Partial sit-up Hamstring stretch Hip Flexor stretch Squat Each group performed special trainings for 8 weeks, 2 sessions per week; each session took about 1 hour. Duration of each exercise was 8 to 10 seconds in each set. Protocols were started with 1 set of 10 repetitions at starting baseline and by improving performance and patients' compatibility with trainings, all eventually finished with 3 sets of 20 repetitions at the end of protocols.
| Study group | Role | What they receive |
|---|---|---|
| HOLD RELAX STRETCHING OF ILIOPSOAS | Experimental | 10-second isometric contraction of iliopsoas muscle (HR), 10-second rest, 20-second static stretch, 5 repetitions.
The stretching exercise was performed 2 times a week for 8 weeks. Receives: Other: HOLD RELAX STRETCHING OF ILIOPSOAS |
| • WILLIAM'S PROTOCOL | Experimental | * Pelvic tilt
* Single Knee to chest
* Double knee to chest
* Partial sit-up
* Hamstring stretch
* Hip Flexor stretch
* Squat
* Each group performed special trainings for 8 weeks, 2 sessions per week; each session took about 1 hour. Duration of each exercise was 8 to 10 seconds in each set. Protocols were started with 1 set of 10 repetitions at starting baseline and by improving performance and patients' compatibility with trainings, all eventually finished with 3 sets of 20 repetitions at the end of protocols. Receives: Other: WILLIAM'S PROTOCOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment
The NRS for pain is a unidimensional measure of pain intensity in adults including those with chronic pain due to rheumatic diseases. Although various iterations exist, the most commonly used is the 11-item NRS
Measured: 8 weeks
lordatic angle
2- Flexicurve ruler: The angle of lumbar lordosis will be measured with a flexible ruler. The subject remained in the normal standing posture while lordatic angle was measured
Measured: 8 weeks
low back pain
3- Lumbar spine questionnaire (LSQ): It is used for the assessment of low back pain. It contains various items and patients will be asked relevant questions and answers will be noted and written
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jan 2022
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlordosisStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Mehjabeen, MSWHPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460949
- Sponsor's protocol ID
- REC/RCR&AHS/22/0520
- Status last verified
- Sep 2022
- First submitted
- 14 Jul 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of William Training Versus Hold Relax Stretching of Iliopsoas Muscle in Females With Hyperlordosis
- ClinicalTrials.gov ID
- NCT05460949
- Acronym / sponsor ID
- REC/RCR&AHS/22/0520
- Conditions
- Hyperlordosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 15 Jul 2022 (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.
Hyper lordosis is a condition in which there is an excessive spine curvature in the lower back. Hyper lordosis is a very common symptom. It occurs in high-income, middle-income, and low-income countries and all age groups from children to the elderly population Only a small proportion of people have a well understood pathological cause-eg, a vertebral fracture, malignancy, or infection. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greatest risk of reporting low back pain.Hyper lordosis creates a characteristic C-shaped curve in the lower back, or lumbar region, where the spine curves inward just above the buttocks. It often occurs as a result of poor posture or a lack of exercise. Hyperlordosis can cause muscle tightening and stiffness in the lower back. It can also damage the spine and soft tissues in the lumbar region. Hyperlordosis leads to excessive curvature of the spine in the lower back, causing the abdomen and buttocks to appear more prominent in profile view. People with hyperlordosis may experience mild to severe lower back pain, which may worsen with movement.
Various conservative treatments are used to treat hyperlordosis and low back pain due to hyperlordosis. Most commonly used are the manual therapy techniques that employ William's protocol and hold relax stretching of iliopsoas muscle at lumbar spine. This study will be randomized control trial used to compare the effects of William protocol and hold relax stretching of iliopsoas muscle in subjects with hyperlordosis and low back pain. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre assessment will be done using LUMBAR SPINE QUESTIONNAIRE as subjective measurements and NPRS as objective measurements. Subjects in one group will be treated using William's protocol and the other one will be treated with hold relax stretching of iliopsoas muscle. Each subject will receive 08 treatment sessions with 02 treatment sessions per week. Post treatment reading for NPRS and lumbar spine questionnaire will be recorded after every week.
Detailed description
Hyper lordosis is a condition in which there is an excessive spine curvature in the lower back. Hyper lordosis is a very common symptom. It occurs in high-income, middle-income, and low-income countries and all age groups from children to the elderly population Only a small proportion of people have a well understood pathological cause-eg, a vertebral fracture, malignancy, or infection. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greatest risk of reporting low back pain.Hyper lordosis creates a characteristic C-shaped curve in the lower back, or lumbar region, where the spine curves inward just above the buttocks. It often occurs as a result of poor posture or a lack of exercise. Hyperlordosis can cause muscle tightening and stiffness in the lower back. It can also damage the spine and soft tissues in the lumbar region. Hyperlordosis leads to excessive curvature of the spine in the lower back, causing the abdomen and buttocks to appear more prominent in profile view. People with hyperlordosis may experience mild to severe lower back pain, which may worsen with movement.
Various conservative treatments are used to treat hyperlordosis and low back pain due to hyperlordosis. Most commonly used are the manual therapy techniques that employ William's protocol and hold relax stretching of iliopsoas muscle at lumbar spine. This study will be randomized control trial used to compare the effects of William protocol and hold relax stretching of iliopsoas muscle in subjects with hyperlordosis and low back pain. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre assessment will be done using LUMBAR SPINE QUESTIONNAIRE as subjective measurements and NPRS as objective measurements. Subjects in one group will be treated using William's protocol and the other one will be treated with hold relax stretching of iliopsoas muscle. Each subject will receive 08 treatment sessions with 02 treatment sessions per week. Post treatment reading for NPRS and lumbar spine questionnaire will be recorded after every week.Various conservative treatments are used to treat hyperlordosis and low back pain due to hyperlordosis. Most commonly used are the manual therapy techniques that employ William's protocol and hold relax stretching of iliopsoas muscle at lumbar spine. This study will be randomized control trial used to compare the effects of William protocol and hold relax stretching of iliopsoas muscle in subjects with hyperlordosis and low back pain. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre assessment will be done using LUMBAR SPINE QUESTIONNAIRE as subjective measurements and NPRS as objective measurements. Subjects in one group will be treated using William's protocol and the other one will be treated with hold relax stretching of iliopsoas muscle. Each subject will receive 08 treatment sessions with 02 treatment sessions per week. Post treatment reading for NPRS and lumbar spine questionnaire will be recorded after every week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOLD RELAX STRETCHING OF ILIOPSOAS | Experimental | Other: HOLD RELAX STRETCHING OF ILIOPSOAS10-second isometric contraction of iliopsoas muscle (HR), 10-second rest, 20-second static stretch, 5 repetitions. The stretching exercise was performed 2 times a week for 8 weeks. |
| • WILLIAM'S PROTOCOL | Experimental | Other: WILLIAM'S PROTOCOL* Pelvic tilt * Single Knee to chest * Double knee to chest * Partial sit-up * Hamstring stretch * Hip Flexor stretch * Squat * Each group performed special trainings for 8 weeks, 2 sessions per week; each session took about 1 hour. Duration of each exercise was 8 to 10 seconds in each set. Protocols were started with 1 set of 10 repetitions at starting baseline and by improving performance and patients' compatibility with trainings, all eventually finished with 3 sets of 20 repetitions at the end of protocols. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 21-40 years
- Hyperlordosis Angle
- Females having increased lordotic curve
- Pain perceived anywhere in the region of lumbar spine from L1 to l5.
- Limitation of lumbar spine range of motion.
Key exclusion criteria (4 listed)
- Any red flags including tumors, fractures.
- Spinal canal stenosis
- Rheumatoid arthritis
- Osteoporosis
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 |
|---|---|---|
| HOLD RELAX STRETCHING OF ILIOPSOAS10 second isometric contraction of iliopsoas muscle (HR), 10-second rest, 20 second static stretch, 5 repetitions. • The stretching exercise was performed 2 times a week for 8 weeks. 10 second isometric contraction of iliopsoas muscle (HR), 10-second rest, 20 second static stretch, 5 repetitions. The stretching exercise was performed 2 times a week for 8 weeks. | Other | HOLD RELAX STRETCHING OF ILIOPSOAS |
| WILLIAM'S PROTOCOLPelvic tilt Single Knee to chest Double knee to chest Partial sit-up Hamstring stretch Hip Flexor stretch Squat Each group performed special trainings for 8 weeks, 2 sessions per week; each session took about 1 hour. Duration of each exercise was 8 to 10 seconds in each set. Protocols were started with 1 set of 10 repetitions at starting baseline and by improving performance and patients' compatibility with trainings, all eventually finished with 3 sets of 20 repetitions at the end of protocols. | Other | • WILLIAM'S PROTOCOL |
Primary outcome
pain assessment
Time frame: 8 weeks
The NRS for pain is a unidimensional measure of pain intensity in adults including those with chronic pain due to rheumatic diseases. Although various iterations exist, the most commonly used is the 11-item NRS
lordatic angle
Time frame: 8 weeks
2- Flexicurve ruler: The angle of lumbar lordosis will be measured with a flexible ruler. The subject remained in the normal standing posture while lordatic angle was measured
low back pain
Time frame: 8 weeks
3- Lumbar spine questionnaire (LSQ): It is used for the assessment of low back pain. It contains various items and patients will be asked relevant questions and answers will be noted and written
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- 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.
Hafiza Mehjabeen, MSWHPT 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 HOLD RELAX STRETCHING OF ILIOPSOAS and WILLIAM'S PROTOCOL in people with Hyperlordosis, 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 4 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 7 Sep 2022. 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?
pain assessment (time frame: 8 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?
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 7 Sep 2022.