Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04717401
Other study ID # sacroiliac dysfunction
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2020
Est. completion date September 30, 2021

Study information

Verified date March 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date September 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: 1. Male and female patients aged from 20 years to 60 years. 2. Positive Fortin's sign (pain around PSIS and sacral sulcus). 3. Positive three posterior provocation tests of four including Thigh thrust test, Compression test, Distraction Test, and Patrick test. 4. Pain in lower back below level L5 vertebra and buttocks. 5. Self-reported disability due to SIJ pain on the Oswestry Disability Index (ODI) scores at least 30%. Exclusion Criteria: 1. Acute injury or fracture of the lower limb and spine. 2. Systemic diseases such as Rheumatoid arthritis (R.A) or ankylosing spondylitis. 3. Previous major lumbar or hip surgery. 4. Pregnancy or delivery for less than 6 months ago. 5. Lumbar stenosis or spondylolisthesis or disc disease. 6. Congenital spinal deformity.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Strain-Counterstrain
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 Technique
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

Locations

Country Name City State
Egypt Warraq Central hospital Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 10 minutes
Primary 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 15 minutes
Secondary 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)
15 minutes
See also
  Status Clinical Trial Phase
Completed NCT05181579 - Efficacy of Manual Therapy and Sacroiliac Joint Injection in Sacroiliac Joint Dysfunction N/A
Withdrawn NCT03230279 - Sacroiliac Joint Fusion Comparison Study N/A
Recruiting NCT01311479 - Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction N/A
Completed NCT05356390 - Comparative Effects of Stabilization Exercises and Muscle Energy Techniques in Sacroiliac Joint Pain N/A
Recruiting NCT05432453 - The Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction
Active, not recruiting NCT03507049 - Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain N/A
Not yet recruiting NCT05404451 - Comparison of Mulligan Mobilization Technique and Mckenzie Exercises Among Patient With Sacroilliac Joint Dysfunction N/A
Withdrawn NCT04534829 - Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Radiofrequency Ablation Phase 3
Completed NCT04519840 - Diastasis Recti Abdominis Association With Sacroiliac Joint and Pelvic Floor Dysfunction in Postpartum C-section Women
Recruiting NCT04829513 - Exercise and Two Different Kinesiotape Applications in Patients With Sacroiliac Joint Dysfunction
Terminated NCT04218838 - Comparison of CornerLoc SI Joint Stabilization and Steroid Injections for Sacroiliac Joint Dysfunction N/A
Completed NCT05347537 - Effects of Mulligan's Mobilization With and Without Clamshell Exercises in Sacroiliac Joint Dysfunction N/A
Recruiting NCT04381208 - Medical Record, Physical and Neurological Data That Orient to the Diagnosis of Sacroiliac Joint Dysfunction
Recruiting NCT05944861 - Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections N/A