SACROILIAC JOINT DYSFUNCTIONNCT05356650
Mulligan's Mobilization and Proprioceptive Neuromuscular Facilitation Technique in Sacroiliac Joint Dysfunction
A study testing Mulligan Mobilization and PNF in people with SACROILIAC JOINT DYSFUNCTION, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will aim to compare the effects of mulligan mobilization and PNF on pain and disability with patients of SIJ dysfunction and will be helpful for clinical physiotherapist to choose more effective treatment protocol for patients as there are fewer researches on comparison of these techniques. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- SACROILIAC JOINT DYSFUNCTION
- What is being tested?
- Mulligan Mobilization and PNF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2022to 15 Sep 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20 to 35 years
- Both genders
- Subjects with positive provocation test ( Faber's test\Patricks test, Gaenslen test, distraction test, compression test, sacral thrust test)
- Subjects with positive innominate test ( Stork Test\Gillet Test)
- Subjects who agree to fill the informed consent
Who cannot join
- Pregnant women
- Presence of neurological signs
- Patient with ankylosis spondylosis.
- Patient has been diagnosed by disease other than SIJ dysfunction
- Patients having any congenital posture problem or previous surgery
- SLR less than 45 degree
- Patient having any mental problem or reduced cognitive ability
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Govt. Hospital DHQ
Jhang, Punjab Province, 38000
Nosheen Manzoor, 03236877879, Nosheenmanzoor_444@yahoo.com
Aisha Waseem
About this study
Official title: Comparative Effects of Mulligan's Mobilization and Proprioceptive Neuromuscular Facilitation Technique on Pain and Disability in Patients With Sacroiliac Joint Dysfunction: A Randomised Controlled Trail
This study will aim to compare the effects of mulligan mobilization and PNF on pain and disability with patients of SIJ dysfunction and will be helpful for clinical physiotherapist to choose more effective treatment protocol for patients as there are fewer researches on comparison of these techniques.
Read the detailed description
The sacroiliac joint dysfunction syndrome (SIJDS) is an ongoing controversial issue and an important source of low back pain (LBP). It has been emphasized in many studies that the pathologies of sacroiliac joint (SIJ) are a source of pain in the lumbar spine and hip region. The prevalence of SIJDS in patients with chronic mechanical LBP is between 15 and 30% SIJD is a condition in which pain arises from the sacroiliac joint and is caused by the abnormal movement of ilium around the sacrum and abnormal function of the SIJ structures, like ligaments, muscles, capsules. The prevalence of SIJP has been stated to be up to 75% in LBP patients.
Physiotherapy techniques are used to correct SIJ mal-alignment manually by restoring the normal function and balance of lumbar and pelvic muscles and ligaments. Mulligan described the positional fault theory in which articular mal-alignment leads to altered kinematics and eventual dysfunction(2). Proprioceptive neuromuscular facilitation (PNF) is a form of flexibility exercises used to resolve muscle shortening and strain.
- Conditions
- SACROILIAC JOINT DYSFUNCTION
- Being tested
- Mulligan Mobilization, PNF
- Keywords
- Mulligan Mobilization, Proprioceptive Neuromuscular Facilitation, Contract Relax, Sacroiliac joint Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan MobilizationOther
The patient will be in a prone position. With one hand, the physiotherapist will fix the sacrum and place the fingers of her other hand under the anterior superior iliac spine. The therapist then pull the ilium on the sacrum and will instruct the patient to do press-ups. Treatment will be given with frequency of 3 sets with 10 repetitions on sacroiliac joint 3 times a week for 6 weeks
PNFOther
PNF stretching will be performed using contract-relax techniques of agonists in supine, prone and side-lying. Contract-relax will be applied with a 6-second contraction with 80% force of the maximal isometric contraction on the muscles (iliopsoas, hamstrings and gluteal muscles) and will be followed by a 15-second passive static stretching in the opposite direction of that muscles. Three sets of stretching of each muscle will be performed for each position with the frequency of 3 times a week for 6 weeks.
Patient will be in supine, prone, side lying. Both groups will receive a baseline treatment (Moist Heat Pack for 10 minutes and 10 minutes of Ultrasound (0.75 MHz, continuous wave)
| Study group | Role | What they receive |
|---|---|---|
| Mulligan Mobilization | Experimental | Treatment will be given with frequency of 3 sets with 10 repetitions on sacroiliac joint 3 times a week for 6 weeks Receives: Other: Mulligan Mobilization |
| PNF Technique | Experimental | Three sets of stretching of each muscle will be performed for each position with the frequency of 3 times a week for 6 weeks. Receives: Other: PNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating scale
The most common validated tool for assessment of pain in clinical tests is the numeric pain rating score (NPRS), a 10-point scale where 0 indicates no pain and 10 indicates severe pain
Measured: 3 months
Modified Oswestry Disability Questionnaire
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The questionnaire consists of 10 items addressing different aspects of function. Each item is scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start15 Apr 2022
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SACROILIAC JOINT DYSFUNCTIONStudies 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
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nosheen Manzoor, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356650
- Sponsor's protocol ID
- REC/Lhr/22/0109 Aisha
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 2 May 2022
- 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Mulligan's Mobilization and Proprioceptive Neuromuscular Facilitation Technique on Pain and Disability in Patients With Sacroiliac Joint Dysfunction: A Randomised Controlled Trail
- ClinicalTrials.gov ID
- NCT05356650
- Acronym / sponsor ID
- REC/Lhr/22/0109 Aisha
- Conditions
- SACROILIAC JOINT DYSFUNCTION
- Keywords
- Mulligan Mobilization, Proprioceptive Neuromuscular Facilitation, Contract Relax, Sacroiliac joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 2 May 2022 (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 will aim to compare the effects of mulligan mobilization and PNF on pain and disability with patients of SIJ dysfunction and will be helpful for clinical physiotherapist to choose more effective treatment protocol for patients as there are fewer researches on comparison of these techniques.
Detailed description
The sacroiliac joint dysfunction syndrome (SIJDS) is an ongoing controversial issue and an important source of low back pain (LBP). It has been emphasized in many studies that the pathologies of sacroiliac joint (SIJ) are a source of pain in the lumbar spine and hip region. The prevalence of SIJDS in patients with chronic mechanical LBP is between 15 and 30% SIJD is a condition in which pain arises from the sacroiliac joint and is caused by the abnormal movement of ilium around the sacrum and abnormal function of the SIJ structures, like ligaments, muscles, capsules. The prevalence of SIJP has been stated to be up to 75% in LBP patients.
Physiotherapy techniques are used to correct SIJ mal-alignment manually by restoring the normal function and balance of lumbar and pelvic muscles and ligaments. Mulligan described the positional fault theory in which articular mal-alignment leads to altered kinematics and eventual dysfunction(2). Proprioceptive neuromuscular facilitation (PNF) is a form of flexibility exercises used to resolve muscle shortening and strain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulligan Mobilization | Experimental | Other: Mulligan MobilizationTreatment will be given with frequency of 3 sets with 10 repetitions on sacroiliac joint 3 times a week for 6 weeks |
| PNF Technique | Experimental | Other: PNFThree sets of stretching of each muscle will be performed for each position with the frequency of 3 times a week for 6 weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20 to 35 years
Key exclusion criteria (7 listed)
- Pregnant women
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 |
|---|---|---|
| Mulligan MobilizationThe patient will be in a prone position. With one hand, the physiotherapist will fix the sacrum and place the fingers of her other hand under the anterior superior iliac spine. The therapist then pull the ilium on the sacrum and will instruct the patient to do press-ups. Treatment will be given with frequency of 3 sets with 10 repetitions on sacroiliac joint 3 times a week for 6 weeks | Other | Mulligan Mobilization |
| PNFPNF stretching will be performed using contract-relax techniques of agonists in supine, prone and side-lying. Contract-relax will be applied with a 6-second contraction with 80% force of the maximal isometric contraction on the muscles (iliopsoas, hamstrings and gluteal muscles) and will be followed by a 15-second passive static stretching in the opposite direction of that muscles. Three sets of stretching of each muscle will be performed for each position with the frequency of 3 times a week for 6 weeks. Patient will be in supine, prone, side lying. Both groups will receive a baseline treatment (Moist Heat Pack for 10 minutes and 10 minutes of Ultrasound (0.75 MHz, continuous wave) | Other | PNF Technique |
Primary outcome
Numeric Pain Rating scale
Time frame: 3 months
The most common validated tool for assessment of pain in clinical tests is the numeric pain rating score (NPRS), a 10-point scale where 0 indicates no pain and 10 indicates severe pain
Modified Oswestry Disability Questionnaire
Time frame: 3 months
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The questionnaire consists of 10 items addressing different aspects of function. Each item is scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- 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.
Nosheen Manzoor 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 Mulligan Mobilization and PNF in people with SACROILIAC JOINT DYSFUNCTION, 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 5 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 2 May 2022. 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 Nosheen Manzoor (03236877879, nosheen.manzoor@riphahfsd.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 (time frame: 3 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 2 May 2022.