- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07645170
Strain Counter-Strain vs Maitland Mobilization for Sacroiliac Joint Pain (SCS-MAITLAND-S)
8. juni 2026 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
34
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Punjab Province
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Faisalābad, Punjab Province, Pakistan, 3800
- The University of Faisalabad
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Intensity
Tidsramme: Baseline and after 4 weeks of treatment (week 4)
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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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Functional Limitation
Tidsramme: 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)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2026
Primær færdiggørelse (Anslået)
24. juni 2026
Studieafslutning (Anslået)
15. juli 2026
Datoer for studieregistrering
Først indsendt
8. juni 2026
Først indsendt, der opfyldte QC-kriterier
8. juni 2026
Først opslået (Faktiske)
12. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- TUF/EIRB/ 208 /26
Plan for individuelle deltagerdata (IPD)
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