Segmental StabilizationNCT05075473
SEGMENTAL AND GENERAL STABILIZATION EXERCISES IN CHRONIC LOW BACK PAIN
A study testing Segmental stabilization and Generalized Lumber stabilization exercsies in people with Segmental Stabilization and Generalized Segmental Stabilization Exercises, run by Isra University at 1 site in Pakistan.
Trial summary
Chronic low back pain effects more than 50% of general population. It's prevalence is higher is young adults that are economically active adults. Its significance is often underestimated because usually young adults ignore these initial episodes of low back pain due to their busy life style or life full of… Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Segmental Stabilization, Generalized Segmental Stabilization Exercises
- What is being tested?
- Segmental stabilization and Generalized Lumber stabilization exercsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Mar 2019to 11 Dec 2020
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Both males and females will be included in the study
Who cannot join
- Age limits of subjects will be between 15 to 60
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SEGMENTAL STABILIZATION AND GENERAL LUMBER STABILIZATION EXERCISE IN CHRONIC LOW BACK PAIN
Chronic low back pain effects more than 50% of general population. It's prevalence is higher is young adults that are economically active adults.
Its significance is often underestimated because usually young adults ignore these initial episodes of low back pain due to their busy life style or life full of commitments. Approximately 70% of adults have at least one episode of low back pain during their lifetimes.
Read the detailed description
It will be randomized control trial with 60 patients with chronic low back pain divided into 2 groups. One group will be given segmental stabilization whose purpose is to achieve segmental control over primary stabilizers. Second group will be given just generalized lumber stabilization exercises as it includes close chain exercises with low velocity as well as low load. This study will be conducted in Rehabilitation setup of Benazir Bhutto hospital Rawalpindi and IIRS that is Rehabilitation dept. at Al Nafees medical college and hospital, Islamabad. Non probability Convenience Sampling technique will be utilized
- Being tested
- Segmental stabilization, Generalized Lumber stabilization exercsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental stabilizationOther
Also called Experimental
Physiotherapist will perform activation of multifidus in prone position. It also includes activation of transverse abdominas in crook lying position, in sitting as well as in point kneeling position to re-establish simultaneous contraction of deep muscles synergy.
Generalized Lumber stabilization exercsiesOther
Also called Active comparator
It can by performed by patient him or her self under physiotherapist's assistance. Lumber neutral position is maintained. Bridging in prone as well as supine position will be maintained.
| Study group | Role | What they receive |
|---|---|---|
| Segmental Stabilization | Experimental | Segmental control over the primary stabilizers (TrA, deep multifidus, pelvic floor and diaphram) is maintained. Weight of body is minimized by using drawing in maneuver. Time duration will be of 30 to 40 mins, thrice a week for four weeks. Hot packs will be applied for 10 mins. In starting days, 8 to 10 reps with hold time 5 count. In later days, 12 to 15 reps with hold time increases up till 10 to 15 counts. Receives: Other: Segmental stabilization |
| General lumber stabilization exercises | Active comparator | It includes exercises in closed chain with low velocity as well as low load. Time duration will be of 30 to 40 mins, thrice a week for four weeks. Hot packs will be applied for about 10 mins. In starting days, 8 to 10 reps with hold time 5 count. In later days, 12 to 15 reps with hold time increases up till 10 to 15 counts. Receives: Other: Generalized Lumber stabilization exercsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual analogue scale for Pain 0= no pain, 10= unbearable pain
Measured: 4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.
Oswestry disability Index
It is used to measure permanent functional disability. For each section, total possible score is 5, after completing all 10 sections. sum of all scores will be obtained in the form of percentages.
Measured: 4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.
International physical activity questionnaire
It is used to measure to physical activity of a person
Measured: Only one reading is required that is the baseline reading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start26 Mar 2019
- Primary completion11 Nov 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Segmental StabilizationStudies 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
- Sequential
- Model description
- 44 patients with chronic low back pain, distributed randomly in to two groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Summaiya Zaman, Mphil, Principal investigator, Isra Institute of rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075473
- Sponsor's protocol ID
- 1703-MPHIL-OPT/008
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 12 Oct 2021
- 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 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEGMENTAL STABILIZATION AND GENERAL LUMBER STABILIZATION EXERCISE IN CHRONIC LOW BACK PAIN
- ClinicalTrials.gov ID
- NCT05075473
- Acronym / sponsor ID
- 1703-MPHIL-OPT/008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 12 Oct 2021 (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.
Chronic low back pain effects more than 50% of general population. It's prevalence is higher is young adults that are economically active adults.
Its significance is often underestimated because usually young adults ignore these initial episodes of low back pain due to their busy life style or life full of commitments. Approximately 70% of adults have at least one episode of low back pain during their lifetimes.
Detailed description
It will be randomized control trial with 60 patients with chronic low back pain divided into 2 groups. One group will be given segmental stabilization whose purpose is to achieve segmental control over primary stabilizers. Second group will be given just generalized lumber stabilization exercises as it includes close chain exercises with low velocity as well as low load. This study will be conducted in Rehabilitation setup of Benazir Bhutto hospital Rawalpindi and IIRS that is Rehabilitation dept. at Al Nafees medical college and hospital, Islamabad. Non probability Convenience Sampling technique will be utilized
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 44 patients with chronic low back pain, distributed randomly in to two groups.
| Arm | Type | Receives |
|---|---|---|
| Segmental Stabilization | Experimental | Other: Segmental stabilizationSegmental control over the primary stabilizers (TrA, deep multifidus, pelvic floor and diaphram) is maintained. Weight of body is minimized by using drawing in maneuver. Time duration will be of 30 to 40 mins, thrice a week for four weeks. Hot packs will be applied for 10 mins. In starting days, 8 to 10 reps with hold time 5 count. In later days, 12 to 15 reps with hold time increases up till 10 to 15 counts. |
| General lumber stabilization exercises | Active comparator | Other: Generalized Lumber stabilization exercsiesIt includes exercises in closed chain with low velocity as well as low load. Time duration will be of 30 to 40 mins, thrice a week for four weeks. Hot packs will be applied for about 10 mins. In starting days, 8 to 10 reps with hold time 5 count. In later days, 12 to 15 reps with hold time increases up till 10 to 15 counts. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Both males and females will be included in the study
Key exclusion criteria (1 listed)
- Age limits of subjects will be between 15 to 60
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 |
|---|---|---|
| Segmental stabilizationAlso: ExperimentalPhysiotherapist will perform activation of multifidus in prone position. It also includes activation of transverse abdominas in crook lying position, in sitting as well as in point kneeling position to re-establish simultaneous contraction of deep muscles synergy. | Other | Segmental Stabilization |
| Generalized Lumber stabilization exercsiesAlso: Active comparatorIt can by performed by patient him or her self under physiotherapist's assistance. Lumber neutral position is maintained. Bridging in prone as well as supine position will be maintained. | Other | General lumber stabilization exercises |
Primary outcome
VAS
Time frame: 4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.
Visual analogue scale for Pain 0= no pain, 10= unbearable pain
Oswestry disability Index
Time frame: 4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.
It is used to measure permanent functional disability. For each section, total possible score is 5, after completing all 10 sections. sum of all scores will be obtained in the form of percentages.
International physical activity questionnaire
Time frame: Only one reading is required that is the baseline reading.
It is used to measure to physical activity of a person
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 12 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Segmental Stabilization
Recruiting
Core Endurance Versus Segmental Stabilization Exercise in Recreational Athletes With Low Back Pain
Low Back Pain, Athletic Injuries
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.
Dr. Summaiya Zaman, Mphil principal investigator
Isra Institute of rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Segmental stabilization and Generalized Lumber stabilization exercsies in people with Segmental Stabilization and Generalized Segmental Stabilization Exercises, run by Isra 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 1 inclusion and 1 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 12 Oct 2021. 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?
VAS (time frame: 4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.). 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 12 Oct 2021.