Low Back PainNCT06399549
Effects of Dead Bug vs. Mc Gill Exercises on Pain, QOL and Core Stability in Patient With Chronic Nonspecific LBP
A study testing Dead bug exercise and The McGill Curl Up in people with Low Back Pain, run by Superior University at 1 site in Pakistan.
Trial summary
Low back pain is one of the most common conditions for which patients are sent to physiotherapy clinics. 84% of people have experienced it at least once in their lifetime, and over 50% have experienced it more than once, according to research. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Dead bug exercise and The McGill Curl Up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Mar 2024to 30 Jul 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 30-50 years
- Patient with the history of 3 months nonspecific low back pain
- Pain intensity (3-7) according to VAS score
Who cannot join
- Spinal stenosis
- Neurological dysfunction
- Systemic disease
- Pregnancy
- Infections
- Carcinoma
- Any fracture or deformity
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sir Ganga Ram Hospital Physiotherapy department , Mozang
Lahore, Punjab Province
About this study
Official title: Effects of Dead Bug vs. Mc Gill Exercises on Pain, Quality of Life and Core Stability in Patient With Chronic Nonspecific Low Back Pain
Low back pain is one of the most common conditions for which patients are sent to physiotherapy clinics. 84% of people have experienced it at least once in their lifetime, and over 50% have experienced it more than once, according to research. However, diagnosis and, in particular, the provision of specialized back pain therapy remain difficult.
Read the detailed description
This study aims to compare the effects of dead bug vs. Mc Gill exercises on pain, quality of life and core stability in patient with chronic nonspecific low back pain. It will be a randomized clinical trial study. The sample size of study will be 44 participants (22 in each group). Data will be collected from Azra Naheed Hospital. Data will be collected within 6 months after approval of synopsis. Group A will follow dead bug exercises and Group B will follow Mc Gill exercises (Curl up, Side Bridge and Bird Dog). The patients in both groups will be performed the corresponding exercises 3 days a week and 10 repetitions of each exercise for a period of 6 weeks and a rest interval of 2 minutes between exercises. The exercises will be taught to the patients at the end of the first session in both groups. The data will be analyzed using SPSS version 24 for Windows software. Statistical significance will be set at P ≤ 0.05. Normality of data will be assessed through Kolmogorov-smirnov test. Difference between pre-treatment and post-treatment readings will be calculated using Paired sample t-test for parametric data. For non-parametric data Wilcoxon test will be used. Independent sample t test will be used for parametric data and Mann Whitney test will be used for non parametric data.
- Conditions
- Low Back Pain
- Being tested
- Dead bug exercise, The McGill Curl Up
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dead bug exerciseDiagnostic test
the participant in supine, lying on a mat with shoulders, hip joints and knees flexed to 90°. With the lumbopelvic region being maintained in the neutral position, the participant will be instructed to draw in the abdomen, lower two contra lateral limbs (opposite arm and leg) toward the floor, hold for the stipulated time, then return to starting position. The same movement will be repeated with the opposite limbs. In the DBG, both pairs of limbs will be moved an equal number of times withinthe stipulated time. The patients in both groups will perform the corresponding exercises 3 days a week for a period of 3 weeks and a rest interval of 2 minutes between exercises along with conventional physiotherapy exercises.
The McGill Curl UpDiagnostic test
Lie down on your back. Extend one leg and bend the knee of the other leg. The Side Bridge. Lie on your side, with your forearm on the floor and elbow underneath your shoulder.
The Bird Dog. Assume a hands-and-knees position on the floor. The patients in both groups will perform the corresponding exercises 3 days a week for a period of 3 weeks and a rest interval of 2 minutes between exercises along with conventional physiotherapy exercises. The exercise program includes a warm-up session of five exercises (awareness of the back, pelvic tilt, lumbar rotation, arm movements, whole-body movement in standing), well-known exercises targeting the muscles of the back extensors, abdominals, lateral buttocks, trunk rotators, posterior buttocks, leg muscles, oblique abdominals (e.g. the plank, diagonal arm and leg lift), as well as exercises for flexibility. The exercises will be taught to the patients at the end of the first session in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Dead bug exercise | Experimental | Not described Receives: Diagnostic Test: Dead bug exercise |
| The McGill Curl Up | Experimental | Not described Receives: Diagnostic Test: The McGill Curl Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
VA
Visual Analogue Scale (VAS) is one of the pain rating scales 10 for worse and 0 for no pain
Measured: 6 Months
Secondary outcomes (1)
SF36
The Short Form 36 Health Survey (SF-36) is a commonly used scale to assess HRQoL. Thirty-six questions divided into 8 dimensions. Higher scores are associated with better HRQOL. The SF-36 health-related quality of life questionnaire is well applied to assess the quality of life due to its reliability or validity.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start9 Mar 2024
- Primary completion16 Apr 2024
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Superior 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399549
- Sponsor's protocol ID
- DPT/Batch-Fall19/561
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 3 May 2024
- 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 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dead Bug vs. Mc Gill Exercises on Pain, Quality of Life and Core Stability in Patient With Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT06399549
- Acronym / sponsor ID
- DPT/Batch-Fall19/561
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 3 May 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.
Low back pain is one of the most common conditions for which patients are sent to physiotherapy clinics. 84% of people have experienced it at least once in their lifetime, and over 50% have experienced it more than once, according to research. However, diagnosis and, in particular, the provision of specialized back pain therapy remain difficult.
Detailed description
This study aims to compare the effects of dead bug vs. Mc Gill exercises on pain, quality of life and core stability in patient with chronic nonspecific low back pain. It will be a randomized clinical trial study. The sample size of study will be 44 participants (22 in each group). Data will be collected from Azra Naheed Hospital. Data will be collected within 6 months after approval of synopsis. Group A will follow dead bug exercises and Group B will follow Mc Gill exercises (Curl up, Side Bridge and Bird Dog). The patients in both groups will be performed the corresponding exercises 3 days a week and 10 repetitions of each exercise for a period of 6 weeks and a rest interval of 2 minutes between exercises. The exercises will be taught to the patients at the end of the first session in both groups. The data will be analyzed using SPSS version 24 for Windows software. Statistical significance will be set at P ≤ 0.05. Normality of data will be assessed through Kolmogorov-smirnov test. Difference between pre-treatment and post-treatment readings will be calculated using Paired sample t-test for parametric data. For non-parametric data Wilcoxon test will be used. Independent sample t test will be used for parametric data and Mann Whitney test will be used for non parametric data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dead bug exercise | Experimental | Diagnostic Test: Dead bug exercise |
| The McGill Curl Up | Experimental | Diagnostic Test: The McGill Curl Up |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 30-50 years
- Patient with the history of 3 months nonspecific low back pain
- Pain intensity (3-7) according to VAS score
Key exclusion criteria (7 listed)
- Spinal stenosis
- Neurological dysfunction
- Systemic disease
- Pregnancy
- Infections
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 |
|---|---|---|
| Dead bug exercisethe participant in supine, lying on a mat with shoulders, hip joints and knees flexed to 90°. With the lumbopelvic region being maintained in the neutral position, the participant will be instructed to draw in the abdomen, lower two contra lateral limbs (opposite arm and leg) toward the floor, hold for the stipulated time, then return to starting position. The same movement will be repeated with the opposite limbs. In the DBG, both pairs of limbs will be moved an equal number of times withinthe stipulated time. The patients in both groups will perform the corresponding exercises 3 days a week for a period of 3 weeks and a rest interval of 2 minutes between exercises along with conventional physiotherapy exercises. | Diagnostic test | Dead bug exercise |
| The McGill Curl UpLie down on your back. Extend one leg and bend the knee of the other leg. The Side Bridge. Lie on your side, with your forearm on the floor and elbow underneath your shoulder. The Bird Dog. Assume a hands-and-knees position on the floor. The patients in both groups will perform the corresponding exercises 3 days a week for a period of 3 weeks and a rest interval of 2 minutes between exercises along with conventional physiotherapy exercises. The exercise program includes a warm-up session of five exercises (awareness of the back, pelvic tilt, lumbar rotation, arm movements, whole-body movement in standing), well-known exercises targeting the muscles of the back extensors, abdominals, lateral buttocks, trunk rotators, posterior buttocks, leg muscles, oblique abdominals (e.g. the plank, diagonal arm and leg lift), as well as exercises for flexibility. The exercises will be taught to the patients at the end of the first session in both groups. | Diagnostic test | The McGill Curl Up |
Primary outcome
VA
Time frame: 6 Months
Visual Analogue Scale (VAS) is one of the pain rating scales 10 for worse and 0 for no pain
1 secondary outcome
SF36
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dead bug exercise and The McGill Curl Up in people with Low Back Pain, run by Superior 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 3 May 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?
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?
VA (time frame: 6 Months). 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 3 May 2024.