NCT07645170

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Feb 2026Jul 2026

Study Start

First participant enrolled

February 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2026

Expected
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Sacroiliac jointmanual therapystrain counter-strainMaitland mobilizationphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity

    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)

Secondary Outcomes (1)

  • Change in Functional Limitation

    Baseline and after 4 weeks of treatment (week 4)

Study Arms (2)

Strain Counter-Strain Group

EXPERIMENTAL

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.

Procedure: Strain Counter-Strain Technique

Maitland Mobilization Group

ACTIVE COMPARATOR

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.

Procedure: Maitland Mobilization

Interventions

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.

Strain Counter-Strain Group

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.

Maitland Mobilization Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants are blinded to which technique they receive as both are manual therapy applied in prone lying. Outcome assessors are blinded to group allocation. The treating therapist cannot be blinded due to the nature of manual therapy interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Rehabilitation Sciences

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 12, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 24, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations