Low Back Pain, Post PartumNCT06303401
Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises in Post Partum Low Back Pain
A study testing SI joint thrust manipulation and pelvic stabilization exercises in people with Low Back Pain, Post Partum, run by Riphah International University at 1 site in Pakistan.
Trial summary
compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Low Back Pain, Post Partum
- What is being tested?
- SI joint thrust manipulation and pelvic stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Sep 2023to 30 Aug 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
- No healthy volunteers
- Adult
Who may be able to join
- age 20-40 years
- Postpartum women (after 6 weeks)(3, 12)
- Postpartum LBP patient
- Patient pain increased by provocation test i.e. Faber test, High thrust test and Gaenslen test
Who cannot join
- C-section
- inflammatory or malignant type of pain
- Neurological deficit
- Severe trauma
- Pelvic fracture
- Osteoporosis, spinal stenosis, spondylolysis, spondoloesthesisi
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Lady Reading Hospital and Shahab Orthopedic & General Hospital
Peshawar, KPK, 25000
Asmar Fatima, MS OMPT, 03336195644, asmar.fatima@riphah.edu.pk
Gull alay, MS OMPT*
About this study
Official title: Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises on Pain and Disability Among Patients With Post-Partum Low Back Pain.
compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain.
Read the detailed description
Patients fulfilling the inclusion criteria will be divided into 2 groups i.e. Group A and Group B. Patients in Group A will receive thrust manipulation technique and Group B will receive pelvic stabilization exercises, heating pad will be given to both groups. Patients will be treated 3 times per week for 4 consecutive weeks. Patient will be evaluated at baseline, midline and at end of 4th week. Pain, functional status and disability will be evaluated after every 3 sessions.
- Conditions
- Low Back Pain, Post Partum
- Being tested
- SI joint thrust manipulation, pelvic stabilization exercises
- 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.
SI joint thrust manipulationOther
experimental group given the thrust manipulation along with heating pad. 3 sessions per week will be given for 4 weeks. The pain measure by using NPRS, functional status and disability through ODI will be evaluated.
after every 3 sessions.
pelvic stabilization exercisesOther
Heating pad for 10- 15 mints Pelvic stabilization exercises include Bridging (3 sets x 10 reps with 10 secs hold) Pelvic Tilt exercise(3 sets x 10 reps with 10 secs hold) Bird-Dog Exercise (3 sets x 10 reps with 10 secs hold) clamshell Exercise (3 sets x 10 reps with 10 secs hold) .3 sessions per week will be given for 4 weeks. The pain using NPRS , functional status and disability will be evaluated by using ODI after every 3 sessions.
| Study group | Role | What they receive |
|---|---|---|
| SI joint thrust Manipulation | Experimental | The patient was supine and the therapist stood contralateral to the side which was to be manipulated. The patient was passively moved into side bending toward the side to be manipulated. The therapist passively rotated the patient, and then delivered a quick thrust to the Anterior Superior Iliac Spine (ASIS) in a posterior and inferior direction Receives: Other: SI joint thrust manipulation |
| Pelvic Stabilization Exercises | Active comparator | Heating pad for 10- 15 mints Pelvic stabilization exercises. Bridging (3 sets x 10 reps with 10 secs hold), Pelvic Tilt exercise (3 sets x 10 reps with 10 secs hold), Bird-Dog Exercise (3 sets x 10 reps with 10 secs hold), clamshell Exercise (3 sets x 10 reps with 10 secs hold). Receives: Other: pelvic stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale: the patient rates pain from 0 (no pain) to 10 (worst imaginable pain).
Measured: 4th week
Modified Oswestry Disability Index (ODI)
The ODI is a disease specific disability measure is used to establish a level of disability stage on a patient activity status and monitor change over the time. The ODI is made up of 10 questions. Each question is scored from (o-5) minimum to maximum.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start27 Sep 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Aug 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 Pain, Post PartumStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asmar Fatima, MS OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303401
- Sponsor's protocol ID
- REC/MS-PT/01787 Gullalay
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises on Pain and Disability Among Patients With Post-Partum Low Back Pain.
- ClinicalTrials.gov ID
- NCT06303401
- Acronym / sponsor ID
- REC/MS-PT/01787 Gullalay
- Conditions
- Low Back Pain, Post Partum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 12 Mar 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.
compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain.
Detailed description
Patients fulfilling the inclusion criteria will be divided into 2 groups i.e. Group A and Group B. Patients in Group A will receive thrust manipulation technique and Group B will receive pelvic stabilization exercises, heating pad will be given to both groups. Patients will be treated 3 times per week for 4 consecutive weeks. Patient will be evaluated at baseline, midline and at end of 4th week. Pain, functional status and disability will be evaluated after every 3 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SI joint thrust Manipulation | Experimental | Other: SI joint thrust manipulationThe patient was supine and the therapist stood contralateral to the side which was to be manipulated. The patient was passively moved into side bending toward the side to be manipulated. The therapist passively rotated the patient, and then delivered a quick thrust to the Anterior Superior Iliac Spine (ASIS) in a posterior and inferior direction |
| Pelvic Stabilization Exercises | Active comparator | Other: pelvic stabilization exercisesHeating pad for 10- 15 mints Pelvic stabilization exercises. Bridging (3 sets x 10 reps with 10 secs hold), Pelvic Tilt exercise (3 sets x 10 reps with 10 secs hold), Bird-Dog Exercise (3 sets x 10 reps with 10 secs hold), clamshell Exercise (3 sets x 10 reps with 10 secs hold). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 20-40 years
- Postpartum women (after 6 weeks)(3, 12)
- Postpartum LBP patient
- Patient pain increased by provocation test i.e. Faber test, High thrust test and Gaenslen test
Key exclusion criteria (6 listed)
- C-section
- inflammatory or malignant type of pain
- Neurological deficit
- Severe trauma
- Pelvic fracture
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 |
|---|---|---|
| SI joint thrust manipulationexperimental group given the thrust manipulation along with heating pad. 3 sessions per week will be given for 4 weeks. The pain measure by using NPRS, functional status and disability through ODI will be evaluated. after every 3 sessions. | Other | SI joint thrust Manipulation |
| pelvic stabilization exercisesHeating pad for 10- 15 mints Pelvic stabilization exercises include Bridging (3 sets x 10 reps with 10 secs hold) Pelvic Tilt exercise(3 sets x 10 reps with 10 secs hold) Bird-Dog Exercise (3 sets x 10 reps with 10 secs hold) clamshell Exercise (3 sets x 10 reps with 10 secs hold) .3 sessions per week will be given for 4 weeks. The pain using NPRS , functional status and disability will be evaluated by using ODI after every 3 sessions. | Other | Pelvic Stabilization Exercises |
Primary outcome
Numeric pain rating scale (NPRS)
Time frame: 4th week
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale: the patient rates pain from 0 (no pain) to 10 (worst imaginable pain).
Modified Oswestry Disability Index (ODI)
Time frame: 4th week
The ODI is a disease specific disability measure is used to establish a level of disability stage on a patient activity status and monitor change over the time. The ODI is made up of 10 questions. Each question is scored from (o-5) minimum to maximum.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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.
Asmar Fatima, MS OMPT 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 SI joint thrust manipulation and pelvic stabilization exercises in people with Low Back Pain, Post Partum, 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 4 inclusion and 6 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 12 Mar 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?
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?
Numeric pain rating scale (NPRS) (time frame: 4th week). 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 12 Mar 2024.