Sacroiliac Joint Somatic DysfunctionNCT04717401
Comparison Between Strain-counterstrain and Muscle Energy Technique in Sacroiliac Joint Dysfunction
A study testing Strain-Counterstrain and Muscle Energy Technique in people with Sacroiliac Joint Somatic Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
Examine the effect of strain-counter strain (SCS) versus muscle energy technique (MET) on pain pressure threshold (PPT), functional disability, and the innominate angle tilt with SIJ dysfunction. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Sacroiliac Joint Somatic Dysfunction
- What is being tested?
- Strain-Counterstrain and Muscle Energy Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Aug 2020to 30 Sep 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients aged from 20 years to 60 years.
- Positive Fortin's sign (pain around PSIS and sacral sulcus).
- Positive three posterior provocation tests of four including Thigh thrust test, Compression test, Distraction Test, and Patrick test.
- Pain in lower back below level L5 vertebra and buttocks.
- Self-reported disability due to SIJ pain on the Oswestry Disability Index (ODI) scores at least 30%.
Who cannot join
- Acute injury or fracture of the lower limb and spine.
- Systemic diseases such as Rheumatoid arthritis (R.A) or ankylosing spondylitis.
- Previous major lumbar or hip surgery.
- Pregnancy or delivery for less than 6 months ago.
- Lumbar stenosis or spondylolisthesis or disc disease.
- Congenital spinal deformity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strain-Counterstrain Versus Muscle Energy Technique In Sacroiliac Joint Dysfunction
Examine the effect of strain-counter strain (SCS) versus muscle energy technique (MET) on pain pressure threshold (PPT), functional disability, and the innominate angle tilt with SIJ dysfunction.
Read the detailed description
Sacroiliac joint dysfunction (SIJD) can be cured with medical and physical therapy interventions. Standard physical therapy techniques include manual joint mobilization, manipulation, bracing, massage, patient education, aerobic training, general exercise, and electrotherapies such as heat, ultrasound, and transcutaneous electric nerve stimulation(TENS). In the physiotherapy context, an effective treatment strategy for unappreciated SIJD is needed. Currently, there are no guidelines or appropriate management plans for this dysfunction, physicians usually refer to it as low back pain alone, and physiotherapists treat the pain as low back pain (LBP). However, appropriate medical intervention or physical therapy may be carried out if the diagnosis is accurate. Furthermore, only a few studies tried to compare the effects of the various treatment approaches.
Strain-counterstain (SCS) consider an excellent choice for building patient thrust as the patient is held passively in a pain-free position. SCS can facilitate treatment for the patient who has experienced pain during a treatment session by using other manual therapy techniques such as manipulation and MET or specific core stability exercises to enhance force closure of SIJ.
SCS allows normalization of the tone of tight muscles involved in SIJ dysfunction which allows a significant improvement in recruitment of weak muscles, especially the gluteal group. SCS has shown its effectiveness in reducing pain or palpation tenderness over different musculoskeletal disorders such as acute/ chronic LBP, mechanical neck pain, and masseter trigger points.
SCS affects local circulations which lead to more nutrient supply, metabolic waste removal, and reverse ischemia that can manifest as painful tender points (TPs) or sustain dysfunction. Current literature lacks consensus on mechanisms, contributing factors, and treatment of SIJ dysfunction.
MET was advocated for the treatment of muscle imbalances in the lumbopelvic region, such as pelvic asymmetry. The theory behind MET assumes that the technique is used to correct asymmetry by targeting hamstring or hip flexor contractions on the painful side of the lower back and move the innominate in the proper direction. It is important to note, however, that evidence indicates that non-symptomatic individuals have also been shown to have pelvic asymmetries.
While manual therapy is a helpful tool for LBP care, few studies have focused on the efficacy of SIJD. There is limited evidence concerning the efficacy of SCS and MET in SIJ dysfunction. According to investigators' knowledge, there is no study to investigate the effectiveness of SCS on SIJ dysfunction patients in comparison to muscle energy technique.
- Conditions
- Sacroiliac Joint Somatic Dysfunction
- Being tested
- Strain-Counterstrain, Muscle Energy Technique
- Keywords
- Strain-counterstrain, Muscle energy technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strain-CounterstrainProcedure or surgery
Also called Positional Release
Strain-counterstrain will be applied to four muscle which are . Tender point of each muscle will be identified then the muscle will be positioned passively in the most relaxed position which will be held for 90 sec. This procedure will repeated 3 times for each muscle
Muscle Energy TechniqueProcedure or surgery
Muscle energy technique will be applied to four muscles which are quadratus Lumborum, iliacus, piriform and erector spinae. Each muscle will be positioned passively in stretched position the patient asked to push against the therapist isometrically while holding breath for 5-10sec. After exhalation, the muscle will be moved into a new barrier. This procedure will repeated 3 times for each muscle
| Study group | Role | What they receive |
|---|---|---|
| Strain-counterstrain Group A | Experimental | Strain Counterstrain (SCS) is a passive positional technique which aims to relieve musculoskeletal pain and dysfunction by indirect manipulation . Receives: Procedure: Strain-Counterstrain |
| Muscle Energy Technique Group B | Experimental | MET is a gentle manual therapy for the restricted mobility of the spine and extremities and is an active procedure in which the corrective force is regulated by the patient, not the clinician. This technique requires the patient to perform voluntary muscle contractions of varying intensity, in a specific direction, while the clinician uses a counter-force that does not allow movement to occur The physiological mechanism underlying SCS is unknown though. It has hypothesized that muscle tone inhibition occurs by stimulation of the target muscle's Golgi tendon organ by physical approximation of muscle origin and insertion. Receives: Procedure: Muscle Energy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Pressure Threshold(PPT) via Digital Pressure Algometer (Wagner Model FDIX)
The algometry (Wagner model FDIX) is an analogue mechanical pressure dynamometer with half circular compression rubber tip (1 cm²). The dial ranges from 2.0 to 20.0 kg (kilogram-force). The value of the kilogram-force is equal to a kilogram per square centimeter. PPT will be considered abnormal when it is equal to 3.0 kg or less Two measure points will be marked 2 cm cranially (first point) and 2 cm laterally (second point) from reference point located 1 cm medially and caudally from the posterior superior iliac spine (PSIS) which shows the most painful points in SIJ patients. Anatomically, the first point is related to the attachment of gluteus maximus to the iliac crest while the second point is related to the erector spinae muscle and posterior sacroiliac ligament.
Measured: 10 minutes
Pelvic tilting via Palpation Meter (PALM)
Palpation Meter (PALM) was developed to measure pelvic torsion, pelvic tilting and leg length discrepancy (LLD). The body of the PALM contains a bubble level in a semi-circular arc with one-degree gradations that range from zero degree to thirty degrees on either side of the midline. The caliper arms are placed in bony landmarks and the degree of deviation from horizontal is read from the inclinometer
Measured: 15 minutes
Secondary outcomes (1)
Functional disability via the Oswestry Disability Index ( ODI):
Oswestry Disability Index (ODI) ODI is a validated and well-accepted measure of disability due to lower back pain without distinguishing between different causes of back pain. ODI focused on details of LBP concerning standing, walking, sitting, lifting, daily activity and socially. It is consists of ten questions, each question has a score between 0 and 5.
The scoring is calculated by dividing total score by the maximum score and multiplied by 100 to give a percentage which indicates the level of disability related to spinal disorder ( 0-20% minimal, 20%-40% moderate, 40%-60% severe, 60%-80% crippled and 80%-100% patient are confined to bed)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start8 Aug 2020
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint Somatic DysfunctionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karima Abdelaty Hassan, Cairo University
- Investigators
- Bassem G El- Nahaas, Professor, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717401
- Sponsor's protocol ID
- sacroiliac dysfunction
- Status last verified
- Mar 2022
- First submitted
- 1 Jan 2021
- Last updated
- 8 Mar 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain-Counterstrain Versus Muscle Energy Technique In Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT04717401
- Acronym / sponsor ID
- sacroiliac dysfunction
- Conditions
- Sacroiliac Joint Somatic Dysfunction
- Keywords
- Strain-counterstrain, Muscle energy technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 22 Jan 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.
Examine the effect of strain-counter strain (SCS) versus muscle energy technique (MET) on pain pressure threshold (PPT), functional disability, and the innominate angle tilt with SIJ dysfunction.
Detailed description
Sacroiliac joint dysfunction (SIJD) can be cured with medical and physical therapy interventions. Standard physical therapy techniques include manual joint mobilization, manipulation, bracing, massage, patient education, aerobic training, general exercise, and electrotherapies such as heat, ultrasound, and transcutaneous electric nerve stimulation(TENS). In the physiotherapy context, an effective treatment strategy for unappreciated SIJD is needed. Currently, there are no guidelines or appropriate management plans for this dysfunction, physicians usually refer to it as low back pain alone, and physiotherapists treat the pain as low back pain (LBP). However, appropriate medical intervention or physical therapy may be carried out if the diagnosis is accurate. Furthermore, only a few studies tried to compare the effects of the various treatment approaches.
Strain-counterstain (SCS) consider an excellent choice for building patient thrust as the patient is held passively in a pain-free position. SCS can facilitate treatment for the patient who has experienced pain during a treatment session by using other manual therapy techniques such as manipulation and MET or specific core stability exercises to enhance force closure of SIJ.
SCS allows normalization of the tone of tight muscles involved in SIJ dysfunction which allows a significant improvement in recruitment of weak muscles, especially the gluteal group. SCS has shown its effectiveness in reducing pain or palpation tenderness over different musculoskeletal disorders such as acute/ chronic LBP, mechanical neck pain, and masseter trigger points.
SCS affects local circulations which lead to more nutrient supply, metabolic waste removal, and reverse ischemia that can manifest as painful tender points (TPs) or sustain dysfunction. Current literature lacks consensus on mechanisms, contributing factors, and treatment of SIJ dysfunction.
MET was advocated for the treatment of muscle imbalances in the lumbopelvic region, such as pelvic asymmetry. The theory behind MET assumes that the technique is used to correct asymmetry by targeting hamstring or hip flexor contractions on the painful side of the lower back and move the innominate in the proper direction. It is important to note, however, that evidence indicates that non-symptomatic individuals have also been shown to have pelvic asymmetries.
While manual therapy is a helpful tool for LBP care, few studies have focused on the efficacy of SIJD. There is limited evidence concerning the efficacy of SCS and MET in SIJ dysfunction. According to investigators' knowledge, there is no study to investigate the effectiveness of SCS on SIJ dysfunction patients in comparison to muscle energy technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strain-counterstrain Group A | Experimental | Procedure: Strain-CounterstrainStrain Counterstrain (SCS) is a passive positional technique which aims to relieve musculoskeletal pain and dysfunction by indirect manipulation . |
| Muscle Energy Technique Group B | Experimental | Procedure: Muscle Energy TechniqueMET is a gentle manual therapy for the restricted mobility of the spine and extremities and is an active procedure in which the corrective force is regulated by the patient, not the clinician. This technique requires the patient to perform voluntary muscle contractions of varying intensity, in a specific direction, while the clinician uses a counter-force that does not allow movement to occur The physiological mechanism underlying SCS is unknown though. It has hypothesized that muscle tone inhibition occurs by stimulation of the target muscle's Golgi tendon organ by physical approximation of muscle origin and insertion. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female patients aged from 20 years to 60 years.
- Positive Fortin's sign (pain around PSIS and sacral sulcus).
- Positive three posterior provocation tests of four including Thigh thrust test, Compression test, Distraction Test, and Patrick test.
- Pain in lower back below level L5 vertebra and buttocks.
- Self-reported disability due to SIJ pain on the Oswestry Disability Index (ODI) scores at least 30%.
Key exclusion criteria (6 listed)
- Acute injury or fracture of the lower limb and spine.
- Systemic diseases such as Rheumatoid arthritis (R.A) or ankylosing spondylitis.
- Previous major lumbar or hip surgery.
- Pregnancy or delivery for less than 6 months ago.
- Lumbar stenosis or spondylolisthesis or disc disease.
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 |
|---|---|---|
| Strain-CounterstrainAlso: Positional ReleaseStrain-counterstrain will be applied to four muscle which are . Tender point of each muscle will be identified then the muscle will be positioned passively in the most relaxed position which will be held for 90 sec. This procedure will repeated 3 times for each muscle | Procedure or surgery | Strain-counterstrain Group A |
| Muscle Energy TechniqueMuscle energy technique will be applied to four muscles which are quadratus Lumborum, iliacus, piriform and erector spinae. Each muscle will be positioned passively in stretched position the patient asked to push against the therapist isometrically while holding breath for 5-10sec. After exhalation, the muscle will be moved into a new barrier. This procedure will repeated 3 times for each muscle | Procedure or surgery | Muscle Energy Technique Group B |
Primary outcome
Pain Pressure Threshold(PPT) via Digital Pressure Algometer (Wagner Model FDIX)
Time frame: 10 minutes
The algometry (Wagner model FDIX) is an analogue mechanical pressure dynamometer with half circular compression rubber tip (1 cm²). The dial ranges from 2.0 to 20.0 kg (kilogram-force). The value of the kilogram-force is equal to a kilogram per square centimeter. PPT will be considered abnormal when it is equal to 3.0 kg or less Two measure points will be marked 2 cm cranially (first point) and 2 cm laterally (second point) from reference point located 1 cm medially and caudally from the posterior superior iliac spine (PSIS) which shows the most painful points in SIJ patients. Anatomically, the first point is related to the attachment of gluteus maximus to the iliac crest while the second point is related to the erector spinae muscle and posterior sacroiliac ligament.
Pelvic tilting via Palpation Meter (PALM)
Time frame: 15 minutes
Palpation Meter (PALM) was developed to measure pelvic torsion, pelvic tilting and leg length discrepancy (LLD). The body of the PALM contains a bubble level in a semi-circular arc with one-degree gradations that range from zero degree to thirty degrees on either side of the midline. The caliper arms are placed in bony landmarks and the degree of deviation from horizontal is read from the inclinometer
1 secondary outcome
Functional disability via the Oswestry Disability Index ( ODI):
Time frame: 15 minutes
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 8 Mar 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.
Bassem G El- Nahaas, Professor study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strain-Counterstrain and Muscle Energy Technique in people with Sacroiliac Joint Somatic Dysfunction, run by Cairo University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 8 Mar 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 Egypt. 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?
Pain Pressure Threshold(PPT) via Digital Pressure Algometer (Wagner Model FDIX) (time frame: 10 minutes). 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 8 Mar 2022.