NCT04717401

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 8, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

January 1, 2021

Last Update Submit

March 7, 2022

Conditions

Keywords

Strain-counterstrainMuscle energy technique

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Functional disability via the Oswestry Disability Index ( ODI):

    15 minutes

Study Arms (2)

Strain-counterstrain Group A

EXPERIMENTAL

Strain Counterstrain (SCS) is a passive positional technique which aims to relieve musculoskeletal pain and dysfunction by indirect manipulation .

Procedure: Strain-Counterstrain

Muscle Energy Technique Group B

EXPERIMENTAL

MET is a gentle manual therapy for the restricted mobility of the spine and extremities and is an active procedure in which the corrective force is regulated by the patient, not the clinician. This technique requires the patient to perform voluntary muscle contractions of varying intensity, in a specific direction, while the clinician uses a counter-force that does not allow movement to occur The physiological mechanism underlying SCS is unknown though. It has hypothesized that muscle tone inhibition occurs by stimulation of the target muscle's Golgi tendon organ by physical approximation of muscle origin and insertion.

Procedure: Muscle Energy Technique

Interventions

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

Also known as: Positional Release
Strain-counterstrain Group A

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

Muscle Energy Technique Group B

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female patients aged from 20 years to 60 years.
  • Positive Fortin's sign (pain around PSIS and sacral sulcus).
  • Positive three posterior provocation tests of four including Thigh thrust test, Compression test, Distraction Test, and Patrick test.
  • Pain in lower back below level L5 vertebra and buttocks.
  • Self-reported disability due to SIJ pain on the Oswestry Disability Index (ODI) scores at least 30%.

You may not qualify if:

  • Acute injury or fracture of the lower limb and spine.
  • Systemic diseases such as Rheumatoid arthritis (R.A) or ankylosing spondylitis.
  • Previous major lumbar or hip surgery.
  • Pregnancy or delivery for less than 6 months ago.
  • Lumbar stenosis or spondylolisthesis or disc disease.
  • Congenital spinal deformity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warraq Central hospital

Giza, Egypt

Location

Study Officials

  • Bassem G El- Nahaas, Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients will be assigned randomly to the 2 groups by using opaque, sealed envelopes, containing the name of one of each groups (SCS or MET). A colleague who will be not participating in recruiting, treating or evaluating participants will select the envelopes. After the initial assessment but before the first therapy session, group allocation will be carried out.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy

Study Record Dates

First Submitted

January 1, 2021

First Posted

January 22, 2021

Study Start

August 8, 2020

Primary Completion

June 30, 2021

Study Completion

September 30, 2021

Last Updated

March 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations