- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07645170
Strain Counter-Strain vs Maitland Mobilization for Sacroiliac Joint Pain (SCS-MAITLAND-S)
8. Juni 2026 aktualisiert von: Dr Waqar Younas, University of Faisalabad
Comparative Effects of Strain Counter-Strain Versus Maitland Mobilization Technique (Grade II and III) for Reducing Pain and Functional Limitation in Patients With Sacroiliac Joint Dysfunction
This randomized clinical trial compares two manual therapy techniques for treating sacroiliac joint dysfunction, a condition that causes lower back and buttock pain.
The two techniques are strain counter-strain, an indirect positional release method, and Maitland mobilization grades II and III, a direct joint oscillation technique.
Thirty-four participants aged 20 to 40 years with confirmed sacroiliac joint dysfunction will be randomly assigned to receive either strain counter-strain or Maitland mobilization three times per week for four weeks.
Both groups will also receive a 10-minute moist hot pack before each treatment.
Pain will be measured using the Numeric Pain Rating Scale and functional limitation using the Modified Oswestry Disability Index at baseline and after four weeks.
The study aims to determine which technique is more effective for reducing pain and improving function in this patient population.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is a double-blind, parallel-group, randomized clinical trial to be conducted at three hospitals in Faisalabad, Pakistan: National Hospital Faisalabad, Health 360 Faisalabad, and Madinah Teaching Hospital Faisalabad.
The study duration is six months following synopsis approval.
A total of 34 participants will be enrolled using simple random sampling.
Inclusion criteria include: age 20 to 40 years, both males and females, pain at the sacroiliac joint region below L5 radiating to buttocks or back of thigh for at least 8 weeks, baseline pain intensity of 3 or more on the Numeric Pain Rating Scale, Modified Oswestry Disability Index score of at least 30 percent, and at least three positive provocation tests out of five (Gaenslen test, distraction test, compression test, thigh thrust test, and sacral thrust test).
Exclusion criteria include: recent lumbar or hip surgery, lumbar or pelvic fracture, infectious conditions such as bone tumors or tuberculosis, inflammatory joint diseases such as rheumatoid arthritis or ankylosing spondylitis, and refusal to provide informed consent.
Participants will be randomly assigned to two groups of 17 each.
Group A will receive strain counter-strain technique targeting the quadratus lumborum, piriformis, and erector spinae muscles.
The therapist will position the patient comfortably for 90 seconds per muscle, repeated three times per muscle, for three sets per session.
Group B will receive Maitland mobilization grades II and III applied to the sacrum.
Grade II will be used in week one and early week two for pain reduction, using 3 to 4 sets of 30-second oscillations.
Grade III will be introduced by the end of week two and used primarily in weeks three and four for 40-second sets to improve mobility.
Both groups will receive a 10-minute moist hot pack to the gluteal area before each treatment.
Treatments will be delivered three times per week for four weeks.
Outcome measures will be assessed at baseline and after completion of the fourth week.
The Numeric Pain Rating Scale is an 11-point scale from 0 (no pain) to 10 (worst possible pain).
The Modified Oswestry Disability Index contains ten sections each scored 0 to 5, converted to a percentage where higher scores indicate greater disability.
Data will be analyzed using SPSS version 20.
Between-group comparisons will be conducted using independent t-tests for normally distributed data or Mann-Whitney U tests for non-normal data.
Within-group comparisons will use paired t-tests or Wilcoxon signed-rank tests.
Statistical significance will be set at p less than 0.05.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
34
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Punjab Province
-
Faisalābad, Punjab Province, Pakistan, 3800
- the University of Faisalabad
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Age 20 to 40 years, including both males and females
- Pain at the level of the sacroiliac joint region below L5 and radiating to the buttocks or back of thigh
- Pain duration of 8 weeks or longer
- Baseline pain intensity of 3 or greater on the Numeric Pain Rating Scale
- Modified Oswestry Disability Index score of at least 30 percent
- At least 3 positive provocation tests out of 5: Gaenslen test, distraction test, compression test, thigh thrust test, and sacral thrust test
- Willing and able to provide written informed consent
Exclusion Criteria:
- Age below 19 years or above 40 years
- Recent lumbar or hip surgery within the past 6 months
- Lumbar or pelvic fracture
- Infectious conditions including bone tumors, nerve root irritation, and tuberculosis of the spine or hip
- Pre-diagnosed inflammatory joint diseases including rheumatoid arthritis and ankylosing spondylitis
- Any condition that contraindicates manual therapy
- Pregnancy (if applicable - you may want to add this, as SIJ pain is common in pregnancy but manual therapy protocols may differ)
- Unable or unwilling to provide informed consent
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Strain Counter-Strain Group
Participants in this arm receive strain counter-strain technique applied to the quadratus lumborum, piriformis, and erector spinae muscles.
The therapist places the patient in a comfortable position for each corresponding muscle for 90 seconds, repeated three times per muscle, for three sets per session.
Treatment is delivered three times per week for four weeks.
Each session begins with a 10-minute moist hot pack to the gluteal area.
|
Strain counter-strain is an indirect manual therapy technique based on the proprioceptive hypothesis of somatic dysfunction.
The therapist identifies tender points in the quadratus lumborum, piriformis, and erector spinae muscles.
The patient is then placed in a comfortable position that reduces tension in the targeted muscle.
This position is maintained for 90 seconds, after which the therapist passively returns the patient to the starting position.
The procedure is repeated three times per muscle, with three sets per session.
Treatment is provided three times per week for four weeks.
A 10-minute moist hot pack is applied to the gluteal area before the technique begins.
|
|
Aktiver Komparator: Maitland Mobilization Group
Participants in this arm receive Maitland mobilization grades II and III applied to the sacrum in prone lying.
Grade II is used in week one and early week two using 3 to 4 sets of 30-second oscillations.
Grade III is introduced by the end of week two and used primarily in weeks three and four for 40-second sets to improve mobility.
Treatment is delivered three times per week for four weeks.
Each session begins with a 10-minute moist hot pack to the gluteal area.
|
Maitland mobilization is a manual therapy technique using passive oscillatory motions to treat joint pain and stiffness.
The patient is positioned in prone lying.
The therapist places hands centrally on the upper sacrum and applies pressure in a postero-anterior direction.
Grade II (large amplitude, low intensity) is used for pain reduction in week one and early week two, with 3 to 4 sets of 30-second oscillations at 2 to 3 Hz.
Grade III (large amplitude, high intensity) is introduced by the end of week two to improve stiffness and function, using 40-second sets at 2 to 3 Hz through weeks three and four.
One Grade II session is added in week four to maintain pain relief.
Treatment is provided three times per week for four weeks.
A 10-minute moist hot pack is applied to the gluteal area before mobilization begins.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Pain Intensity
Zeitfenster: Baseline and after 4 weeks of treatment (week 4)
|
Pain intensity is measured using the Numeric Pain Rating Scale (NPRS), an 11-point scale from 0 (no pain) to 10 (worst possible pain).
Participants rate their current pain level at the sacroiliac joint region.
The scale is administered by a blinded outcome assessor.
|
Baseline and after 4 weeks of treatment (week 4)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Functional Limitation
Zeitfenster: Baseline and after 4 weeks of treatment (week 4)
|
Functional limitation is measured using the Modified Oswestry Disability Index (MODI) questionnaire.
The MODI contains ten sections covering activities of daily living: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking.
Each section is scored from 0 to 5, with total score converted to a percentage.
Higher percentages indicate greater disability.
Scores are classified as: minimal disability (0 to 20 percent), moderate disability (21 to 40 percent), severe disability (41 to 60 percent), crippled (61 to 80 percent), and bed-bound or exaggerated symptoms (81 to 100 percent).
The questionnaire is administered by a blinded outcome assessor.
|
Baseline and after 4 weeks of treatment (week 4)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Februar 2026
Primärer Abschluss (Geschätzt)
24. Juni 2026
Studienabschluss (Geschätzt)
15. Juli 2026
Studienanmeldedaten
Zuerst eingereicht
8. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juni 2026
Zuerst gepostet (Tatsächlich)
12. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- TUF/EIRB/ 208 /26
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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