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- Essai clinique NCT07645170
Strain Counter-Strain vs Maitland Mobilization for Sacroiliac Joint Pain (SCS-MAITLAND-S)
17 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
34
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Punjab Province
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Faisalābad, Punjab Province, Pakistan, 3800
- The University of Faisalabad
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Pain Intensity
Délai: 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.
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Baseline and after 4 weeks of treatment (week 4)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Functional Limitation
Délai: 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.
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Baseline and after 4 weeks of treatment (week 4)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 février 2026
Achèvement primaire (Réel)
24 juillet 2026
Achèvement de l'étude (Estimé)
15 août 2026
Dates d'inscription aux études
Première soumission
8 juin 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 août 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- TUF/EIRB/ 208 /26
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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