Lower Crossed SyndromeNCT05973695
Effects of Clamshell Versus Gluteal Bridge Exercises
A study testing clamshell exercise and Gluteal Bridge exercises in people with Lower Crossed Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Gluteal amnesia is a "condition" where the individual is believed to have lost the ability to contract their gluteal muscles - generally the gluteus maximus, though some report it as the gluteus medius. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lower Crossed Syndrome
- What is being tested?
- clamshell exercise and Gluteal Bridge exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Oct 2023to 10 Mar 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Female between the ages of 20 to 40 years
- Prolonged sitting hours >4 hours.
- Examination- Symptoms provoked by low back movement.
- Positive Gluteal strength test
- Positive SLR for hamstring tightness
- Positive Thomas test for Rectus femoris tightness.
Who cannot join
- • Osteoporosis
- Malignancy
- Vertebral fractures
- Pervious or scheduled surgery
- Trauma
- Pregnancy
- Psychological conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Clamshell Versus Gluteal Bridge Exercises on Low Back Pain, Gluteal Strength and Disability Due to Prolonged Sitting in Females With Gluteal Amnesia
Gluteal amnesia is a "condition" where the individual is believed to have lost the ability to contract their gluteal muscles - generally the gluteus maximus, though some report it as the gluteus medius. This can take many different names, such as "dead butt", "sleeping glutes", or glutes that are "turned off".Since the gluteus medius normally helps stabilize the pelvis, gluteal amnesia can lead to lower back pain and hip pain, as well as knee and ankle issues, as the body tries to compensate for the imbalance.
Read the detailed description
A Randomized controlled trial will be conducted at Jinnah Hospital Physiotherapy Clinic \& Boston Physiotherapy and wellness Clinic through consecutive sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A \& group B. Group A will be treated with clamshell exercises at the frequency of 3 sets with 10 repetitions 3 times/ week with baseline treatment. Group B will be treated with gluteal bridge and baseline treatment. Baseline treatment for both groups will be given Hot pack at low back for 10 minutes and Quadriceps and hamstring stretching 3 times with 30 seconds hold. Outcome measures will be conducted through pain, disability and quality of life questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro -Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Lower Crossed Syndrome
- Being tested
- clamshell exercise, Gluteal Bridge exercises
- Keywords
- gluteal weakness, disability, pain, gluteal amnesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clamshell exerciseOther
For clamshell exercises, Lie on your side with your knees slightly bent and with one leg on top of the other. Keep your feet together and lift your top knee until its parallel with your hip. Lower your knee back to the initial position, repeat, and then switch sides. In 1st week 1 sets 10 repetitions. In 2nd week 2 sets of 10 repetitions. In 3rd and 4th week and onwards 3 sets of 10 repetitions
Gluteal Bridge exercisesOther
Start flat on your back with your legs bent at a 90-degree angle and feet placed flat on the ground. Make sure your toes are turned outward at 45-degree angles and your knees are facing in the same direction as your toes. Drive d
| Study group | Role | What they receive |
|---|---|---|
| Group A: Clamshell Exercise | Active comparator | Group A will be treated with baseline treatment and clamshell exercises. Lie on your side with your knees slightly bent and with one leg on top of the other. Keep your feet together and lift your top knee until its parallel with your hip. Lower your knee back to the initial position, repeat, and then switch sides. In 1st week 1 sets 10 repetitions. In 2nd week 2 sets of 10 repetitions. In 3rd and 4th week and onwards 3 sets of 10 repetitions. Receives: Other: clamshell exercise |
| Group B: Gluteal Bridge exercise | Active comparator | Group B will be treated with baseline treatment and Gluteal Bridge exercises. Start flat on your back with your legs bent at a 90-degree angle and feet placed flat on the ground. Make sure your toes are turned outward at 45-degree angles and your knees are facing in the same direction as your toes. Drive down through your feet and push your hips up. You should feel this variation fatiguing the outer portion of your thighs. Make sure you keep your knees over your toes throughout the entire movement. Don't let them move forward over the toes. In a controlled motion, let your hips sink back down toward the ground. This completes 1 repetition. Perform 3 sets of 15 repetitions, or 3 rounds of a 30-second hold. Receives: Other: Gluteal Bridge exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating scale (NPRS)
The numerical Pain Rating scale (NPRS) assesses the pain in the gluteal region.
Pain is assessed using a Numeric pain rating (NPRS). The scale ranges from 0 to 10. 0 indicates "no pain", and 10 indicates "worst Pain.
mild pain score 1 to 3 moderate pain score 4 to 7 severe pain score with interference with functioning. 8 to 10
Measured: upto 4 weeks
Oswestry disability score
Oswestry Disability score is used to measure low back disability.
Each ten item is scored from 0 to 5, and the total is added and multiplied by 2. Therefore, the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability caused by LBP.
Oswestry Disability Index will evaluate disability for disability. This questionnaire will be used to assess disability. It comprises 10 items, 7 related to daily activities, 2 related to pain, and 1 related to concentration. Each item scores from 0 to 5. The total score is expressed as a percentage with higher scores related to more significant disability
Measured: upto 4 weeks
Quality of Life EQ-5D
EQ-5D Health-Related Quality of Life Question checked the quality of life of the patients.
Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each with five severity levels described by statements appropriate to that dimension.
The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine'). This is used to obtain a respondent's stated preference values, not to record their own health state.
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 posted3 Aug 2023
- Study start5 Oct 2023
- Primary completion8 Mar 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Crossed SyndromeStudies of the same condition, open and under way.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samrood Akram, Mphil, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973695
- Sponsor's protocol ID
- REC/RCR & AHS/23/0128 UMIA
- Status last verified
- Apr 2024
- First submitted
- 27 Jun 2023
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clamshell Versus Gluteal Bridge Exercises on Low Back Pain, Gluteal Strength and Disability Due to Prolonged Sitting in Females With Gluteal Amnesia
- ClinicalTrials.gov ID
- NCT05973695
- Acronym / sponsor ID
- REC/RCR & AHS/23/0128 UMIA
- Conditions
- Lower Crossed Syndrome
- Keywords
- gluteal weakness, disability, pain, gluteal amnesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 3 Aug 2023 (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.
Gluteal amnesia is a "condition" where the individual is believed to have lost the ability to contract their gluteal muscles - generally the gluteus maximus, though some report it as the gluteus medius. This can take many different names, such as "dead butt", "sleeping glutes", or glutes that are "turned off".Since the gluteus medius normally helps stabilize the pelvis, gluteal amnesia can lead to lower back pain and hip pain, as well as knee and ankle issues, as the body tries to compensate for the imbalance.
Detailed description
A Randomized controlled trial will be conducted at Jinnah Hospital Physiotherapy Clinic \& Boston Physiotherapy and wellness Clinic through consecutive sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A \& group B. Group A will be treated with clamshell exercises at the frequency of 3 sets with 10 repetitions 3 times/ week with baseline treatment. Group B will be treated with gluteal bridge and baseline treatment. Baseline treatment for both groups will be given Hot pack at low back for 10 minutes and Quadriceps and hamstring stretching 3 times with 30 seconds hold. Outcome measures will be conducted through pain, disability and quality of life questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro -Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
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: Clamshell Exercise | Active comparator | Other: clamshell exerciseGroup A will be treated with baseline treatment and clamshell exercises. Lie on your side with your knees slightly bent and with one leg on top of the other. Keep your feet together and lift your top knee until its parallel with your hip. Lower your knee back to the initial position, repeat, and then switch sides. In 1st week 1 sets 10 repetitions. In 2nd week 2 sets of 10 repetitions. In 3rd and 4th week and onwards 3 sets of 10 repetitions. |
| Group B: Gluteal Bridge exercise | Active comparator | Other: Gluteal Bridge exercisesGroup B will be treated with baseline treatment and Gluteal Bridge exercises. Start flat on your back with your legs bent at a 90-degree angle and feet placed flat on the ground. Make sure your toes are turned outward at 45-degree angles and your knees are facing in the same direction as your toes. Drive down through your feet and push your hips up. You should feel this variation fatiguing the outer portion of your thighs. Make sure you keep your knees over your toes throughout the entire movement. Don't let them move forward over the toes. In a controlled motion, let your hips sink back down toward the ground. This completes 1 repetition. Perform 3 sets of 15 repetitions, or 3 rounds of a 30-second hold. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Female between the ages of 20 to 40 years
Key exclusion criteria (7 listed)
- • 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 |
|---|---|---|
| clamshell exerciseFor clamshell exercises, Lie on your side with your knees slightly bent and with one leg on top of the other. Keep your feet together and lift your top knee until its parallel with your hip. Lower your knee back to the initial position, repeat, and then switch sides. In 1st week 1 sets 10 repetitions. In 2nd week 2 sets of 10 repetitions. In 3rd and 4th week and onwards 3 sets of 10 repetitions | Other | Group A: Clamshell Exercise |
| Gluteal Bridge exercisesStart flat on your back with your legs bent at a 90-degree angle and feet placed flat on the ground. Make sure your toes are turned outward at 45-degree angles and your knees are facing in the same direction as your toes. Drive d | Other | Group B: Gluteal Bridge exercise |
Primary outcome
Numerical Pain Rating scale (NPRS)
Time frame: upto 4 weeks
The numerical Pain Rating scale (NPRS) assesses the pain in the gluteal region. Pain is assessed using a Numeric pain rating (NPRS). The scale ranges from 0 to 10. 0 indicates "no pain", and 10 indicates "worst Pain. mild pain score 1 to 3 moderate pain score 4 to 7 severe pain score with interference with functioning. 8 to 10
Oswestry disability score
Time frame: upto 4 weeks
Oswestry Disability score is used to measure low back disability. Each ten item is scored from 0 to 5, and the total is added and multiplied by 2. Therefore, the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability caused by LBP. Oswestry Disability Index will evaluate disability for disability. This questionnaire will be used to assess disability. It comprises 10 items, 7 related to daily activities, 2 related to pain, and 1 related to concentration. Each item scores from 0 to 5. The total score is expressed as a percentage with higher scores related to more significant disability
Quality of Life EQ-5D
Time frame: upto 4 weeks
EQ-5D Health-Related Quality of Life Question checked the quality of life of the patients. Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each with five severity levels described by statements appropriate to that dimension. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine'). This is used to obtain a respondent's stated preference values, not to record their own health state.
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 30 Apr 2024.
- 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.
Samrood Akram, Mphil 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 clamshell exercise and Gluteal Bridge exercises in people with Lower Crossed 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 30 Apr 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?
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 30 Apr 2024.