Sacroiliac Joint Somatic DysfunctionNCT05356390
Comparative Effects of Stabilization Exercises and Muscle Energy Techniques in Sacroiliac Joint Pain
A study testing Stabilization exercises and Muscle energy techniques in people with Sacroiliac Joint Somatic Dysfunction, run by Riphah International University at 1 site in Pakistan.
Trial summary
Sacroiliac joint is in pelvis. It links the iliac bone (pelvic) bone to the sacrum. This joint pain is due to hyper mobility or instability of the joint, it may also cause by damage to joint between the spine and hip. This pain is typically felt in the lower back, or hip and may radiate to groin area. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Sacroiliac Joint Somatic Dysfunction
- What is being tested?
- Stabilization exercises and Muscle energy techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 2 May 2022to 5 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both men and women age between 30-50 with positive Laslett's criteria. The Cluster of Laslett is a group of four test used for sacroiliac joint pain, the four tests are:
- Sacroiliac Distraction (Gapping) Test
- Thigh Thrust Test
- Sacroiliac Compression (Squish) Test
- Sacral Thrust test
- If a patient has three or more positive pain provocation tests, and then there is a 59% chance that the patient will have Sacroiliac joint pain.
Who cannot join
- Trochanteric bursitis
- Pelvic bone fracture
- Pelvic implants
- Pregnancy
- Lumbosacral disc herniation
- Sacroiliac joint inflammation
- Inflammatory bowel disease
- Malignancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bakhtawar Amin hospital Multan
Multan Khurd, Punjab Province, 60650
About this study
Official title: Comparative Effects of Stabilization Exercises and Muscle Energy Techniques on Pain and Disability in Sacroiliac Joint Patients
Sacroiliac joint is in pelvis. It links the iliac bone (pelvic) bone to the sacrum. This joint pain is due to hyper mobility or instability of the joint, it may also cause by damage to joint between the spine and hip. This pain is typically felt in the lower back, or hip and may radiate to groin area. The aim of this study will be to compare the effects of stabilization exercises and muscle energy techniques on pain and disability in patients with sacroiliac joint pain.
Read the detailed description
A randomized clinical trial will be conducted at Ibn- e- Siena hospital and research institute Multan and in Bakhtawar Amin hospital Multan through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. After giving common treatment of hot pack and transcutaneous electrical stimulation and assessing pre-treatment patient's condition Group A will be treated with stabilization exercises in which iliopsoas, gluteal and hamstring muscles will be stabilized. Total twelve sessions will be given as three sets three times per week for four weeks. Group B will be treated with muscle energy technique, this is active form of manual therapy in which patient will exert force against physiotherapist force through autogenic inhibition and reciprocal inhibition. (20% patient force against that applied by the physiotherapist and hold contractions for 10 seconds over 5 to 12 repetitions, 3 times per week for 4 weeks). Post-treatment assessment will be done after one month. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using 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. Stabilization exercises and muscle energy techniques will be applied for comparing their effectiveness in patients with sacroiliac joint pain.
- Conditions
- Sacroiliac Joint Somatic Dysfunction
- Being tested
- Stabilization exercises, Muscle energy techniques
- Keywords
- pain, disability physical, muscle strength
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization exercisesOther
Stabilization training is an active form of physical therapy designed to strengthen muscles to support the spine and help prevent lower back pain.
Group A performed stabilization exercises for 4 weeks. In stabilization exercises, floor bridging, heel prop and alternate arm and leg exercises were administered in iliopsoas, gluteal and hamstring groups.
On eligible participants baseline assessment was done,3 sessions were given 3days per week, post intervention assessment was taken at 4th week.
Muscle energy techniquesOther
Muscle Energy Technique (MET) is a is a form of manual therapy, widely used in Osteopathy, that uses a muscle's own energy in the form of gentle isometric contractions to relax the muscles via autogenic or reciprocal inhibition and lengthen the muscle.
Muscle energy techniques were given to group B. These techniques are active form of manual therapy in which patient uses its own energy on request to aid in treatment.
On eligible participants baseline assessment was done,3 sessions were given 3days per week, post intervention assessment was taken at 4th week.
| Study group | Role | What they receive |
|---|---|---|
| Stabilization exercises | Experimental | Group A performed stabilization exercises for 4 weeks. In stabilization exercises, floor bridging, heel prop and alternate arm and leg exercises were administered in iliopsoas, gluteal and hamstring groups. Receives: Other: Stabilization exercises |
| Muscle energy techniques | Active comparator | Muscle energy techniques were given to group B. These techniques are active form of manual therapy in which patient uses its own energy on request to aid in treatment. Receives: Other: Muscle energy techniques |
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) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain.
The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity;
- High test-retest reliability has been (r = 0.96 and 0.95, respectively)
- For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95.
Measured: follow up at 4th week
Modified Oswestry disability index
This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life. Please answer by checking ONE box in each section for the statement which best applies to you. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5.
Measured: follow up at 4th week
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 start2 May 2022
- Primary completion30 Sep 2022
- Study completion5 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- samrood Akram, MPhil, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356390
- Sponsor's protocol ID
- REC/Lhr/22/0107 Sana
- Status last verified
- Nov 2022
- First submitted
- 28 Apr 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho HJ, Kwak DS. Movement of the sacroiliac joint: Anatomy, systematic review, and biomechanical considerations. Proc Inst Mech Eng H. 2021 Mar;235(3):357-364. doi: 10.1177/0954411920978021. Epub 2020 Nov 30.
PubMed 33256545Sasaki T, Kurosawa D, Murakami E, Watanabe T. Physical therapeutic options for residual sacrotuberous ligament pain after treatment of sacroiliac joint dysfunction. J Phys Ther Sci. 2021 Sep;33(9):646-652. doi: 10.1589/jpts.33.646. Epub 2021 Sep 1.
PubMed 34539068Rashbaum RF, Ohnmeiss DD, Lindley EM, Kitchel SH, Patel VV. Sacroiliac Joint Pain and Its Treatment. Clin Spine Surg. 2016 Mar;29(2):42-8. doi: 10.1097/BSD.0000000000000359.
PubMed 26889985Barros G, McGrath L, Gelfenbeyn M. Sacroiliac Joint Dysfunction in Patients With Low Back Pain. Fed Pract. 2019 Aug;36(8):370-375.
PubMed 31456628Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
PubMed 23253394Ahmed UA, Maharaj SS, Van Oosterwijck J. Effects of dynamic stabilization exercises and muscle energy technique on selected biopsychosocial outcomes for patients with chronic non-specific low back pain: a double-blind randomized controlled trial. Scand J Pain. 2021 Feb 24;21(3):495-511. doi: 10.1515/sjpain-2020-0133. Print 2021 Jul 27.
PubMed 33641272Sanika 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 33654504Garcia-Penalver UJ, Palop-Montoro MV, Manzano-Sanchez D. Effectiveness of the Muscle Energy Technique versus Osteopathic Manipulation in the Treatment of Sacroiliac Joint Dysfunction in Athletes. Int J Environ Res Public Health. 2020 Jun 22;17(12):4490. doi: 10.3390/ijerph17124490.
PubMed 32580480Sarkar 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 31992024Vaseghnia A, Shadmehr A, Attarbashi Moghadam B, Olyaei G, Hadian Rasanani DM-R, Khazaeipour Z. Effects of Muscle Energy Technique on Daily Activities and Lumbar Stiffness in Women With Sacroiliac Joint Dysfunction: A Randomized Controlled Clinical Trial Study. Journal of Modern Rehabilitation. 2019;13:23-30.
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
- Comparative Effects of Stabilization Exercises and Muscle Energy Techniques on Pain and Disability in Sacroiliac Joint Patients
- ClinicalTrials.gov ID
- NCT05356390
- Acronym / sponsor ID
- REC/Lhr/22/0107 Sana
- Conditions
- Sacroiliac Joint Somatic Dysfunction
- Keywords
- pain, disability physical, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- 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.
Sacroiliac joint is in pelvis. It links the iliac bone (pelvic) bone to the sacrum. This joint pain is due to hyper mobility or instability of the joint, it may also cause by damage to joint between the spine and hip. This pain is typically felt in the lower back, or hip and may radiate to groin area. The aim of this study will be to compare the effects of stabilization exercises and muscle energy techniques on pain and disability in patients with sacroiliac joint pain.
Detailed description
A randomized clinical trial will be conducted at Ibn- e- Siena hospital and research institute Multan and in Bakhtawar Amin hospital Multan through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. After giving common treatment of hot pack and transcutaneous electrical stimulation and assessing pre-treatment patient's condition Group A will be treated with stabilization exercises in which iliopsoas, gluteal and hamstring muscles will be stabilized. Total twelve sessions will be given as three sets three times per week for four weeks. Group B will be treated with muscle energy technique, this is active form of manual therapy in which patient will exert force against physiotherapist force through autogenic inhibition and reciprocal inhibition. (20% patient force against that applied by the physiotherapist and hold contractions for 10 seconds over 5 to 12 repetitions, 3 times per week for 4 weeks). Post-treatment assessment will be done after one month. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using 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. Stabilization exercises and muscle energy techniques will be applied for comparing their effectiveness in patients with sacroiliac joint pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization exercises | Experimental | Other: Stabilization exercisesGroup A performed stabilization exercises for 4 weeks. In stabilization exercises, floor bridging, heel prop and alternate arm and leg exercises were administered in iliopsoas, gluteal and hamstring groups. |
| Muscle energy techniques | Active comparator | Other: Muscle energy techniquesMuscle energy techniques were given to group B. These techniques are active form of manual therapy in which patient uses its own energy on request to aid in treatment. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both men and women age between 30-50 with positive Laslett's criteria. The Cluster of Laslett is a group of four test used for sacroiliac joint pain, the four tests are:
- If a patient has three or more positive pain provocation tests, and then there is a 59% chance that the patient will have Sacroiliac joint pain.
Key exclusion criteria (8 listed)
- Trochanteric bursitis
- Pelvic bone fracture
- Pelvic implants
- Pregnancy
- Lumbosacral disc herniation
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 |
|---|---|---|
| Stabilization exercisesStabilization training is an active form of physical therapy designed to strengthen muscles to support the spine and help prevent lower back pain. Group A performed stabilization exercises for 4 weeks. In stabilization exercises, floor bridging, heel prop and alternate arm and leg exercises were administered in iliopsoas, gluteal and hamstring groups. On eligible participants baseline assessment was done,3 sessions were given 3days per week, post intervention assessment was taken at 4th week. | Other | Stabilization exercises |
| Muscle energy techniquesMuscle Energy Technique (MET) is a is a form of manual therapy, widely used in Osteopathy, that uses a muscle's own energy in the form of gentle isometric contractions to relax the muscles via autogenic or reciprocal inhibition and lengthen the muscle. Muscle energy techniques were given to group B. These techniques are active form of manual therapy in which patient uses its own energy on request to aid in treatment. On eligible participants baseline assessment was done,3 sessions were given 3days per week, post intervention assessment was taken at 4th week. | Other | Muscle energy techniques |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: follow up at 4th week
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain. The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity; * High test-retest reliability has been (r = 0.96 and 0.95, respectively) * For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95.
Modified Oswestry disability index
Time frame: follow up at 4th week
This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life. Please answer by checking ONE box in each section for the statement which best applies to you. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5.
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 33256545Cho HJ, Kwak DS. Movement of the sacroiliac joint: Anatomy, systematic review, and biomechanical considerations. Proc Inst Mech Eng H. 2021 Mar;235(3):357-364. doi: 10.1177/0954411920978021. Epub 2020 Nov 30.
- Background: PubMed 34539068Sasaki T, Kurosawa D, Murakami E, Watanabe T. Physical therapeutic options for residual sacrotuberous ligament pain after treatment of sacroiliac joint dysfunction. J Phys Ther Sci. 2021 Sep;33(9):646-652. doi: 10.1589/jpts.33.646. Epub 2021 Sep 1.
- Background: PubMed 26889985Rashbaum RF, Ohnmeiss DD, Lindley EM, Kitchel SH, Patel VV. Sacroiliac Joint Pain and Its Treatment. Clin Spine Surg. 2016 Mar;29(2):42-8. doi: 10.1097/BSD.0000000000000359.
- Background: PubMed 31456628Barros G, McGrath L, Gelfenbeyn M. Sacroiliac Joint Dysfunction in Patients With Low Back Pain. Fed Pract. 2019 Aug;36(8):370-375.
- Background: PubMed 23253394Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
- Background: PubMed 33641272Ahmed UA, Maharaj SS, Van Oosterwijck J. Effects of dynamic stabilization exercises and muscle energy technique on selected biopsychosocial outcomes for patients with chronic non-specific low back pain: a double-blind randomized controlled trial. Scand J Pain. 2021 Feb 24;21(3):495-511. doi: 10.1515/sjpain-2020-0133. Print 2021 Jul 27.
- 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 32580480Garcia-Penalver UJ, Palop-Montoro MV, Manzano-Sanchez D. Effectiveness of the Muscle Energy Technique versus Osteopathic Manipulation in the Treatment of Sacroiliac Joint Dysfunction in Athletes. Int J Environ Res Public Health. 2020 Jun 22;17(12):4490. doi: 10.3390/ijerph17124490.
- 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.
- BackgroundVaseghnia A, Shadmehr A, Attarbashi Moghadam B, Olyaei G, Hadian Rasanani DM-R, Khazaeipour Z. Effects of Muscle Energy Technique on Daily Activities and Lumbar Stiffness in Women With Sacroiliac Joint Dysfunction: A Randomized Controlled Clinical Trial Study. Journal of Modern Rehabilitation. 2019;13:23-30.
- 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, MPhil 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 Stabilization exercises and Muscle energy techniques in people with Sacroiliac Joint Somatic 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 6 inclusion and 8 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?
Numeric Pain Rating Scale (NPRS) (time frame: follow up at 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?
On the ClinicalTrials.gov record for NCT05356390, 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.