Radiculopathy LumbarNCT06749574
Effectiveness of Stability Ball Training, Dead Bug Exercises, and Their Combination on Reducing Specific Low Back Pain
A study testing stability ball exercises, dead bug exercise and Combined Groupo in people with Radiculopathy Lumbar, run by Superior University at 1 site in Pakistan.
Trial summary
This study is a single-blinded, randomized controlled trial (RCT) focused on individuals aged 30 to 50 with acute specific low back pain (lumbar radiculopathy). Participants will be divided into three groups: one performing stability ball exercises, one doing dead bug exercises, and the third group combining both… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiculopathy Lumbar
- What is being tested?
- stability ball exercises, dead bug exercise and Combined Groupo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2024to 2 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- participants aged 30 to 50 years with a specific diagnosis of acute lumbar radiculopathy lasting less than three months but severe enough to impair daily activities were included in the study.
- They were required to provide informed consent and agree to adhere to the study procedures,
- including attending sessions and completing evaluations. Eligibility was limited to those without other physical conditions, such as joint replacements or fractures,
- that could interfere with the ability to perform stability ball or dead bug exercises. Individuals who had participated in similar therapeutic exercises, such as stability ball training or core strengthening, within the last six months were excluded to ensure the results reflected the intervention's impact rather than prior training effects.
Who cannot join
- included participants with severe musculoskeletal or cardiovascular disorders, such as spinal surgery, herniated discs, scoliosis, fractures, or osteoarthritis, due to the potential risks associated with exercise.
- Pregnant women were excluded as balance-related activities, like stability ball exercises, could pose safety concerns. Individuals using pain medications, particularly opioids or muscle relaxants, were excluded to avoid interference with exercise performance or altered pain perception.
- Participants who had undergone back surgery within the last six months, or those currently undergoing other physical therapy or treatments for back pain, such as physiotherapy or chiropractic care, in the previous month were also excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sheikh Zayed Hosp and Alara Health Care Clinic
Lahore, Punjab Province
About this study
This study is a single-blinded, randomized controlled trial (RCT) focused on individuals aged 30 to 50 with acute specific low back pain (lumbar radiculopathy). Participants will be divided into three groups: one performing stability ball exercises, one doing dead bug exercises, and the third group combining both types of exercises.
Read the detailed description
The study aims to assess the effectiveness of these regimens in reducing pain and improving quality of life. The trial will be conducted at Sheikh Zayed Hospital and Alara Health Care Clinic, with simple random sampling used to assign participants. The study will run for 6 months, with follow-up assessments at 1, 4, and 8 weeks.
- Conditions
- Radiculopathy Lumbar
- Being tested
- stability ball exercises, dead bug exercise, Combined Groupo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stability ball exercisesDiagnostic test
articipants in the first group performed stability ball exercises designed to enhance balance, core stability, they were introduced to the stability ball with instructions on maintaining proper posture, alignment, and safety to prevent injuries. The program included exercises such as the Stability ball bridging, stability ball bird dog and stability ball pelvic tilts were included to activate the lower abdominal muscles and glutes through gentle, controlled movements
dead bug exerciseDiagnostic test
The second group focused on dead bug exercises, Participants performed exercises such as extending one arm and the opposite leg while lying on their backs, ensuring their spine remained neutral and their lower back stayed pressed into the floor. Variations included alternating opposite arm and leg movements and holding the extended position to increase the challenge and enhance core stability. These exercises were performed slowly to maintain control and improve movement precision over the eight-week period
Combined GroupoCombination product
The third group combined stability ball and dead bug exercises for a comprehensive training approach targeting both core stability and balance. Participants alternated between dead bug exercises, which required controlled arm and leg extensions while lying on their backs, and stability ball exercises such as the ball with bridging and bird dog. Throughout the eight weeks, participants were encouraged to maintain proper posture, alignment, and a neutral spine during all activities to ensure safety and effectiveness
| Study group | Role | What they receive |
|---|---|---|
| Stability ball Training | Active comparator | Not described Receives: Diagnostic Test: stability ball exercises |
| Dead bug training: | Experimental | Not described Receives: Diagnostic Test: dead bug exercise |
| Combined Group | Active comparator | Not described Receives: Combination Product: Combined Groupo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The VAS (Visual Analog Scale) is used for pain assessment. It consists of a vertical line, with the words 'No pain' at the bottom end corresponding to a VAS of 0, and 'Worst pain possible' at the top end corresponding to a VAS of 10.
Measured: 12 Months
SF-12 (Short Form 12-Item Health Survey)
widely used questionnaire designed to assess health-related quality of life. It is a concise version of the SF-36, retaining 12 carefully selected questions that measure physical and mental health domains. The SF-12 evaluates eight health components: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional health problems, and mental health.Responses from the SF-12 are used to generate two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These scores provide a quantitative measure of an individual's physical and mental well-being, respectively. The PCS focuses on physical health aspects like mobility and pain, while the MCS emphasizes emotional health and social functioning.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start15 Feb 2024
- Primary completion10 Jul 2024
- Study completion2 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy LumbarStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 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
- NCT06749574
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/774
- Status last verified
- Feb 2025
- First submitted
- 19 Dec 2024
- Last updated
- 4 Feb 2025
- 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Stability Ball Training, Dead Bug Exercises, and Their Combination on Reducing Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06749574
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/774
- Conditions
- Radiculopathy Lumbar
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 27 Dec 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.
This study is a single-blinded, randomized controlled trial (RCT) focused on individuals aged 30 to 50 with acute specific low back pain (lumbar radiculopathy). Participants will be divided into three groups: one performing stability ball exercises, one doing dead bug exercises, and the third group combining both types of exercises.
Detailed description
The study aims to assess the effectiveness of these regimens in reducing pain and improving quality of life. The trial will be conducted at Sheikh Zayed Hospital and Alara Health Care Clinic, with simple random sampling used to assign participants. The study will run for 6 months, with follow-up assessments at 1, 4, and 8 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stability ball Training | Active comparator | Diagnostic Test: stability ball exercises |
| Dead bug training: | Experimental | Diagnostic Test: dead bug exercise |
| Combined Group | Active comparator | Combination Product: Combined Groupo |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- participants aged 30 to 50 years with a specific diagnosis of acute lumbar radiculopathy lasting less than three months but severe enough to impair daily activities were included in the study.
- They were required to provide informed consent and agree to adhere to the study procedures,
- including attending sessions and completing evaluations. Eligibility was limited to those without other physical conditions, such as joint replacements or fractures,
- that could interfere with the ability to perform stability ball or dead bug exercises. Individuals who had participated in similar therapeutic exercises, such as stability ball training or core strengthening, within the last six months were excluded to ensure the results reflected the intervention's impact rather than prior training effects.
Key exclusion criteria (3 listed)
- included participants with severe musculoskeletal or cardiovascular disorders, such as spinal surgery, herniated discs, scoliosis, fractures, or osteoarthritis, due to the potential risks associated with exercise.
- Pregnant women were excluded as balance-related activities, like stability ball exercises, could pose safety concerns. Individuals using pain medications, particularly opioids or muscle relaxants, were excluded to avoid interference with exercise performance or altered pain perception.
- Participants who had undergone back surgery within the last six months, or those currently undergoing other physical therapy or treatments for back pain, such as physiotherapy or chiropractic care, in the previous month were also excluded
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 |
|---|---|---|
| stability ball exercisesarticipants in the first group performed stability ball exercises designed to enhance balance, core stability, they were introduced to the stability ball with instructions on maintaining proper posture, alignment, and safety to prevent injuries. The program included exercises such as the Stability ball bridging, stability ball bird dog and stability ball pelvic tilts were included to activate the lower abdominal muscles and glutes through gentle, controlled movements | Diagnostic test | Stability ball Training |
| dead bug exerciseThe second group focused on dead bug exercises, Participants performed exercises such as extending one arm and the opposite leg while lying on their backs, ensuring their spine remained neutral and their lower back stayed pressed into the floor. Variations included alternating opposite arm and leg movements and holding the extended position to increase the challenge and enhance core stability. These exercises were performed slowly to maintain control and improve movement precision over the eight-week period | Diagnostic test | Dead bug training: |
| Combined GroupoThe third group combined stability ball and dead bug exercises for a comprehensive training approach targeting both core stability and balance. Participants alternated between dead bug exercises, which required controlled arm and leg extensions while lying on their backs, and stability ball exercises such as the ball with bridging and bird dog. Throughout the eight weeks, participants were encouraged to maintain proper posture, alignment, and a neutral spine during all activities to ensure safety and effectiveness | Combination product | Combined Group |
Primary outcome
Visual Analog Scale
Time frame: 12 Months
The VAS (Visual Analog Scale) is used for pain assessment. It consists of a vertical line, with the words 'No pain' at the bottom end corresponding to a VAS of 0, and 'Worst pain possible' at the top end corresponding to a VAS of 10.
SF-12 (Short Form 12-Item Health Survey)
Time frame: 12 Months
widely used questionnaire designed to assess health-related quality of life. It is a concise version of the SF-36, retaining 12 carefully selected questions that measure physical and mental health domains. The SF-12 evaluates eight health components: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional health problems, and mental health.Responses from the SF-12 are used to generate two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These scores provide a quantitative measure of an individual's physical and mental well-being, respectively. The PCS focuses on physical health aspects like mobility and pain, while the MCS emphasizes emotional health and social functioning.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Radiculopathy Lumbar
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Tecar Therapy in Patients With Lumbar Radiculopathy
Lumbar Radiculopathy
Not yet recruitingObservational study
Clinical and MRI Factors Associated With Procedural Difficulty in Lumbar TFESI
Radiculopathy Lumbar
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 stability ball exercises, dead bug exercise and Combined Groupo in people with Radiculopathy Lumbar, 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Scale (time frame: 12 Months). The study lists 2 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 4 Feb 2025; AzTrials last refreshed its copy on 1 Nov 2026.