Sacroiliac Joint Somatic DysfunctionNCT05347537
Effects of Mulligan's Mobilization With and Without Clamshell Exercises in Sacroiliac Joint Dysfunction
A study testing Mulligan mobilization and clamshell exercise in people with Sacroiliac Joint Somatic Dysfunction and Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Sacroiliac joint dysfunction is the changing of joint structure (ligaments, muscles and cartilage) that cause impairments and movement restrictions. It is one of the primary sources of low back pain among female population and often misdiagnosed. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Sacroiliac Joint Somatic Dysfunction, Pain, Disability Physical
- What is being tested?
- Mulligan mobilization and clamshell exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Apr 2022to 15 Oct 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female between the ages of 20 to 50 years with positive Leslett's criteria.
- Sacroiliac pain of sub-acute level with the duration of 4 weeks
Who cannot join
- Spondylosis
- Lumbar canal stenosis
- Spondylolisthesis
- Pervious spinal surgery
- Congenital postural deformities and
- Lumbar disc herniation
- Pelvic bone fractures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Fatima memorial hospital - Physical therapy clinic
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Mulligan's Mobilization With and Without Clamshell Exercise on Pain, Disability and Quality of Life in Patients With Sacroiliac Joint Dysfunction
Sacroiliac joint dysfunction is the changing of joint structure (ligaments, muscles and cartilage) that cause impairments and movement restrictions. It is one of the primary sources of low back pain among female population and often misdiagnosed. Almost 15-30% patients are suffering from sacroiliac joint dysfunction who presented with the complaint of low back pain. The aim of the study is to determine the effect of mulligan's mobilization with and without clamshell exercise on pain, disability and quality of life in patients with sacroiliac joint dysfunction.
Read the detailed description
A Randomized controlled trial will be conducted at Fatima Memorial Hospital Physiotherapy Clinic \& Boston Physiotherapy and wellness Clinic through consecutive sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A \& group B. Group A will be treated with only mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise. Group B will be treated with mulligan's mobilization with movement and clamshell exercises. Outcome measures will be conducted through pain, disability and quality of life questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Being tested
- Mulligan mobilization, clamshell exercise
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan mobilizationOther
Mulligan Mobilization designed to reduce pain and improve the patient's range of motion. Mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise.
clamshell exerciseOther
As a general exercise, the clamshell can help strengthen your medial glutes, bringing more power and stability to your hips. This group treated with mulligan's mobilization with movement and clamshell exercises.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan mobilization | Experimental | Group A will be treated with only mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise. Receives: Other: Mulligan mobilization |
| Mulligan mobilization with clamshell exercise | Active comparator | Group B will be treated with mulligan's mobilization with movement and clamshell exercises. Receives: Other: clamshell exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. NPRS
Patient level of pain was assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain"
Measured: follow up at 6th week
2. Oswestry Disability index (NDI)
It comprises 10 items, 7 related with daily activities, 2 related to pain , 1 related to concentration. Each item scores from 0 to 5. Total score is expressed as percentage with higher scores related to greater disability.
Measured: follow up at 6th week
Euro Quality of life (EQ-5D)
Quality of life will be checked by Euro Quality of life (EQ-5D) Health Related Quality of Life Question.
Measured: follow up at 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start27 Apr 2022
- Primary completion27 Sep 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac Joint Somatic 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samrood Akram, Mphill, Principal investigator, Riphah International University, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347537
- Sponsor's protocol ID
- REC/Lhr/22/0114 Rahat
- Status last verified
- Nov 2022
- First submitted
- 21 Apr 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Added MAN, de Freitas DG, Kasawara KT, Martin RL, Fukuda TY. STRENGTHENING THE GLUTEUS MAXIMUS IN SUBJECTS WITH SACROILIAC DYSFUNCTION. Int J Sports Phys Ther. 2018 Feb;13(1):114-120.
PubMed 29484248Ramirez C, Sanchez L, Oliveira B. Prevalence of sacroiliac joint dysfunction and sacroiliac pain provocation tests in people with low back pain. Annals of Physical and Rehabilitation Medicine. 2018;61:e152.
Sarkar M, Goyal M, Samuel AJ. Comparing the Effectiveness of the Muscle Energy Technique and Kinesiotaping in Mechanical Sacroiliac Joint Dysfunction: A Non-blinded, Two-Group, Pretest-Posttest Randomized Clinical Trial Protocol. Asian Spine J. 2021 Feb;15(1):54-63. doi: 10.31616/asj.2019.0300. Epub 2020 Jan 30.
PubMed 31992024Bashir MS, Noor R, Hadian MR, Olyaei G. Pattern of changes in latissimus dorsi, gluteus maximus, internal oblique and transverse abdominus muscle thickness among individuals with sacroiliac joint dysfunction. Pak J Med Sci. 2019;35(3):818-823. doi: 10.12669/pjms.35.3.62.
PubMed 31258601Jeong S-G, Cynn H-S, Lee J-H, Choi S, Kim D. Effect of modified clamshell exercise on gluteus medius, quadratus lumborum and anterior hip flexor in participants with gluteus medius weakness. Journal of the Korean Society of Physical Medicine. 2019;14(2):9-19.
Ribeiro S, Heggannavar A, Metgud S. Effect of mulligans mobilization versus manipulation, along with mulligans taping in anterior innominate dysfunction-A randomized clinical trial. Indian Journal of Physical Therapy and Research. 2019;1(1):17.
Kaur H, Sharma M, Hazari A. Effectiveness of Maitland Mobilization and Mulligan Mobilization in Sacroiliac Joint Dysfunction: A Comparative Study. Critical Reviews™ in Physical and Rehabilitation Medicine. 2019;31(2).
Sanika V, Prem V, Karvannan H. Comparison of Glutues Maximus Activation to Flexion Bias Exercises Along with MET Technique in Subjects with Anterior Rotated Sacroiliac Joint Dysfunction-a Randomised Controlled Trial. Int J Ther Massage Bodywork. 2021 Mar 1;14(1):30-38. eCollection 2021 Mar.
PubMed 33654504Javadov A, Ketenci A, Aksoy C. The Efficiency of Manual Therapy and Sacroiliac and Lumbar Exercises in Patients with Sacroiliac Joint Dysfunction Syndrome. Pain Physician. 2021 May;24(3):223-233.
PubMed 33988941Saleh HM, Ibrahim AH, Yosef AO, Sedhom MG. EFFECT OF RADIAL EXTRA CORPOREAL SHOCK WAVE THERAPY VERSUS MULLIGAN MOBILIZATION ON SACROILIAC JOINT DYSFUNCTION. Journal of Critical Reviews. 2020;7(19):8055-9.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mulligan's Mobilization With and Without Clamshell Exercise on Pain, Disability and Quality of Life in Patients With Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT05347537
- Acronym / sponsor ID
- REC/Lhr/22/0114 Rahat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 26 Apr 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.
Sacroiliac joint dysfunction is the changing of joint structure (ligaments, muscles and cartilage) that cause impairments and movement restrictions. It is one of the primary sources of low back pain among female population and often misdiagnosed. Almost 15-30% patients are suffering from sacroiliac joint dysfunction who presented with the complaint of low back pain. The aim of the study is to determine the effect of mulligan's mobilization with and without clamshell exercise on pain, disability and quality of life in patients with sacroiliac joint dysfunction.
Detailed description
A Randomized controlled trial will be conducted at Fatima Memorial Hospital Physiotherapy Clinic \& Boston Physiotherapy and wellness Clinic through consecutive sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A \& group B. Group A will be treated with only mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise. Group B will be treated with mulligan's mobilization with movement and clamshell exercises. Outcome measures will be conducted through pain, disability and quality of life questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulligan mobilization | Experimental | Other: Mulligan mobilizationGroup A will be treated with only mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise. |
| Mulligan mobilization with clamshell exercise | Active comparator | Other: clamshell exerciseGroup B will be treated with mulligan's mobilization with movement and clamshell exercises. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female between the ages of 20 to 50 years with positive Leslett's criteria.
- Sacroiliac pain of sub-acute level with the duration of 4 weeks
Key exclusion criteria (7 listed)
- Spondylosis
- Lumbar canal stenosis
- Spondylolisthesis
- Pervious spinal surgery
- Congenital postural deformities and
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 mobilizationMulligan Mobilization designed to reduce pain and improve the patient's range of motion. Mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise. | Other | Mulligan mobilization |
| clamshell exerciseAs a general exercise, the clamshell can help strengthen your medial glutes, bringing more power and stability to your hips. This group treated with mulligan's mobilization with movement and clamshell exercises. | Other | Mulligan mobilization with clamshell exercise |
Primary outcome
1. NPRS
Time frame: follow up at 6th week
Patient level of pain was assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain"
2. Oswestry Disability index (NDI)
Time frame: follow up at 6th week
It comprises 10 items, 7 related with daily activities, 2 related to pain , 1 related to concentration. Each item scores from 0 to 5. Total score is expressed as percentage with higher scores related to greater disability.
Euro Quality of life (EQ-5D)
Time frame: follow up at 6th week
Quality of life will be checked by Euro Quality of life (EQ-5D) Health Related Quality of Life Question.
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 9 Nov 2022.
- Background: PubMed 29484248Added MAN, de Freitas DG, Kasawara KT, Martin RL, Fukuda TY. STRENGTHENING THE GLUTEUS MAXIMUS IN SUBJECTS WITH SACROILIAC DYSFUNCTION. Int J Sports Phys Ther. 2018 Feb;13(1):114-120.
- BackgroundRamirez C, Sanchez L, Oliveira B. Prevalence of sacroiliac joint dysfunction and sacroiliac pain provocation tests in people with low back pain. Annals of Physical and Rehabilitation Medicine. 2018;61:e152.
- Background: PubMed 31992024Sarkar M, Goyal M, Samuel AJ. Comparing the Effectiveness of the Muscle Energy Technique and Kinesiotaping in Mechanical Sacroiliac Joint Dysfunction: A Non-blinded, Two-Group, Pretest-Posttest Randomized Clinical Trial Protocol. Asian Spine J. 2021 Feb;15(1):54-63. doi: 10.31616/asj.2019.0300. Epub 2020 Jan 30.
- Background: PubMed 31258601Bashir MS, Noor R, Hadian MR, Olyaei G. Pattern of changes in latissimus dorsi, gluteus maximus, internal oblique and transverse abdominus muscle thickness among individuals with sacroiliac joint dysfunction. Pak J Med Sci. 2019;35(3):818-823. doi: 10.12669/pjms.35.3.62.
- BackgroundJeong S-G, Cynn H-S, Lee J-H, Choi S, Kim D. Effect of modified clamshell exercise on gluteus medius, quadratus lumborum and anterior hip flexor in participants with gluteus medius weakness. Journal of the Korean Society of Physical Medicine. 2019;14(2):9-19.
- BackgroundRibeiro S, Heggannavar A, Metgud S. Effect of mulligans mobilization versus manipulation, along with mulligans taping in anterior innominate dysfunction-A randomized clinical trial. Indian Journal of Physical Therapy and Research. 2019;1(1):17.
- BackgroundKaur H, Sharma M, Hazari A. Effectiveness of Maitland Mobilization and Mulligan Mobilization in Sacroiliac Joint Dysfunction: A Comparative Study. Critical Reviews™ in Physical and Rehabilitation Medicine. 2019;31(2).
- Background: PubMed 33654504Sanika V, Prem V, Karvannan H. Comparison of Glutues Maximus Activation to Flexion Bias Exercises Along with MET Technique in Subjects with Anterior Rotated Sacroiliac Joint Dysfunction-a Randomised Controlled Trial. Int J Ther Massage Bodywork. 2021 Mar 1;14(1):30-38. eCollection 2021 Mar.
- Background: PubMed 33988941Javadov A, Ketenci A, Aksoy C. The Efficiency of Manual Therapy and Sacroiliac and Lumbar Exercises in Patients with Sacroiliac Joint Dysfunction Syndrome. Pain Physician. 2021 May;24(3):223-233.
- BackgroundSaleh HM, Ibrahim AH, Yosef AO, Sedhom MG. EFFECT OF RADIAL EXTRA CORPOREAL SHOCK WAVE THERAPY VERSUS MULLIGAN MOBILIZATION ON SACROILIAC JOINT DYSFUNCTION. Journal of Critical Reviews. 2020;7(19):8055-9.
- 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.
Samrood Akram, Mphill principal investigator
Riphah International University, Lahore
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 clamshell exercise in people with Sacroiliac Joint Somatic Dysfunction and Pain, 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 2 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: finished, as of the sponsor's last update on 9 Nov 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?
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?
1. NPRS (time frame: follow up at 6th week). 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?
On the ClinicalTrials.gov record for NCT05347537, which also lists 10 linked publications.
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 9 Nov 2022.