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Sacroiliac DisorderNCT05052762

Effects of Weighted and Elastic Resistance Training of Gluteus Maximus in Sacroiliac Joint Dysfunction

A study testing Group A: Elastic resisted training for Gluteus Maximus strength and Group B: Weight resisted training for Gluteus Maximus strength in people with Sacroiliac Disorder, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research aims to compare the effect of weighted and elastic resistance training of gluteus maximus in subjects with sacroiliac joint dysfunction. Randomized clinical trials were done. The sample size was 54. Read more about this study

Who is it for?
Ages 20 to 40 years
Conditions the study is for
Sacroiliac Disorder
What is being tested?
Group A: Elastic resisted training for Gluteus Maximus strength and Group B: Weight resisted training for Gluteus Maximus strength
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 sitePakistan
Study dates
1 Aug 2021to 2 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • pain in the SI region for at least 12 weeks (chronic) and had no previous physical therapy treatment
  • SIJ dysfunction confirmed by tests described by McGrath et al.
  • These tests included the SI compression, SI distraction, Squish, and Gaenslen.

Who cannot join

  • Subjects with clinical and imaging evidence of any other spinal or pelvic co-morbidity potentially responsible for pain radiating through the sacroiliac region.
  • True leg length discrepancy [measured from the anterior superior iliac spine (ASIS) to the medial malleolus.
  • Back, pelvis, hip, or knee fracture history or surgery.
  • Having a systemic pathology including inflammatory joint disease
  • Having a musculoskeletal or neurological disease
  • Having taken anti-inflammatory medication

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • King Abdullah Teaching Hospital

    Mānsehra, KPK

Other trials in Pakistan

About this study

Official title: Comparison of the Effect of Weighted and Elastic Resistance Training of Gluteus Maximus in Subjects With Sacroiliac Joint Dysfunction

This research aims to compare the effect of weighted and elastic resistance training of gluteus maximus in subjects with sacroiliac joint dysfunction. Randomized clinical trials were done. The sample size was 54. The subjects were divided into two groups, 27 subjects in the weighted resistance training group and 27 in the elastic resisted training group. The study duration was of 1 year. The sampling technique applied was the non-probability connivance sampling technique. Only 20-40 years of symptomatic subjects with pain in the SI region for at least 12 weeks (chronic) and had no previous physical therapy treatment were included. Tools used in the study are numeric pain scale, dynamometer, and Oswestry disability index. Data was be analyzed through SPSS 21.

Read the detailed description

Sacroiliac joint dysfunction or sacroiliitis are common terms used to describe the pain of the sacroiliac joint. It is usually caused by abnormal motion (i.e. hyper- or hypo-mobile) or mal-alignment of the sacroiliac joint. Sacroiliac joint (SI) dysfunction is a well-documented clinical entity that can cause pain and loss of function, The sacroiliac joint (SIJ) has been implicated as the primary pain source in 10% to 25% of the patients with low back pain. During pregnancy, 20% to 80% of the women experience low back or posterior pelvic pain frequently arising from the SIJ.

The Gluteus maximus is inserted proximally into the sacrum, the dorsal sacral ligaments, the posterior portion of the crest of the ilium, and the sacrotuberous ligament. The muscle fibers run inferiorly and laterally to the distal insertion, where it splits into two components. The upper half of the muscle inserts into the iliotibial tract of the fascia and the lower half into the gluteal tuberosity of the femur. Due to its attachments, the gluteus maximus is primarily involved in hip extension and lateral rotation.

Fischer \& Houtz found in electromyography (EMG) study that the strongest contractions of gluteus maximus occurred with muscle setting by isometric contraction, external rotation, abduction with resistance, and vigorous hyperextension exercises of the thigh and trunk in an erect posture. Weakness of gluteal muscles causes decreased sacroiliac (SI) joint stability in patients with sacroiliac disorders. gluteus maximus muscle, due to its attachments to the sacrum, iliac bones, and sacrotuberous ligament, plays a significant role in the stability of the SI joint. The stabilizing forces applied to the SI joint, therefore, could be compromised with gluteal muscle weakness. In patients with gluteal weakness, shortening of the hamstring muscles, through their common attachments to the ischial tuberosity and sacrotuberous ligament, could compensate for gluteal muscle weakness and contribute to the SI joint stability.

A relationship between the gluteus maximus and the SI joint has been investigated in particular. Anatomical studies suggest that the gluteus maximus, with muscle fibers perpendicular to the joint surfaces, can help to stabilize the SI joint. Furthermore, it was discovered that activating the gluteus maximus increased compressive force across the SI joint. Individuals with SI joint dysfunction have abnormal gluteus maximus recruitment during weight-bearing exercises. As a result, it is hypothesized that gluteus maximus weakness can be linked to incorrect loading of the SI joint and be a cause of the impairments associated with SI joint dysfunction.

Hip extension exercise is the general clinical method for improving the weakened muscle strength of the hip extensors. These exercises are often used to strengthen the gluteus maximus and is also recommended for patients with pain in the lower back, pelvis, or hip. The gluteus maximus contributes to the postural alignments, core stability, and functional abilities that are important for normal gait. A weakness of the gluteus maximus can cause an abnormal gait cycle that can affect the gait mechanics at both hip and knee joints. In particular, gluteus maximus exercise is important for patients who have low back pain and lower extremity injuries. Patients with low back pain show reduced activity of the gluteus maximus. Early activation of the hamstring muscles and spinal erector, as well as delayed or decreased activation of the gluteal muscles, are considered indications of faulty muscle activation.

Studies have assessed methods for selective strengthening of the gluteus maximus. Prone hip extension (PHE) exercise is generally used to activate and strengthen the gluteus maximus selectively. Active prone hip extension with knee flexion is a common exercise employed to optimize gluteus maximus activation because this position causes active insufficiency of the hamstring. A previous study reported that PHE exercise is the most effective method for activating the gluteal muscles when subjects extend their hip with 30° abduction. Other studies have suggested that an abdominal drawing-in maneuver (ADIM) with prone hip extension is useful for the selective activation of the gluteus maximus from the erector spinae and hamstring.

A correction of the abnormal pattern is recommended to reduce the stress on the spine and hip joint. In a clinical setting, the ADIM is used during hip extension to prevent abnormal motion of the pelvis and lumbar., and the degree of knee extension affects the gluteus maximus activity. When the level of knee extension is increased, the activity of the gluteus maximus decreases, and the hamstring activity increases. Previous studies compared the muscle activities of the hamstring and gluteus maximus during prone hip extension with ADIM. The following were applied during active prone hip extension exercises: knee flexion, knee extension, hip external rotation with knee flexion, and hip external rotation with knee extension. In addition, eleven different exercises of the gluteus maximus used in therapeutic exercises were compared.

Although a wide variety of different exercises are advocated train and condition gluteus maximus and surrounding musculature, there are no specific guidelines for gluteus maximus strengthening with SI joint dysfunction using best evidence-based practice. This study aims to find out whether the weighted and elastic resistance training of gluteus maximus provides better results in subjects with SIJ dysfunction.

Being tested
Group A: Elastic resisted training for Gluteus Maximus strength, Group B: Weight resisted training for Gluteus Maximus strength
Keywords
gluteus maximus, Elastic resistance training, weighted resistance training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A: Elastic resisted training for Gluteus Maximus strengthOther

    Subjects attended physical therapy two times per week for a total of 10 visits. In the first five sessions, subjects performed the following exercises to strengthen the gluteus maximus: bilateral bridge, unilateral bridge, and non-weight-bearing hip extension in prone with the knee flexed at 90 degrees. In the next five sessions, abduction and external rotation in a quadruped ("fire hydrant" exercise) and weight-bearing hip extension (known as "deadlift" exercise) are added. Each exercise was performed for 10 repetitions. Elastic resistance was Added to the fire hydrant, hip extension in prone and deadlift exercises to allow each subject to perform at a 10-repetition maximum. The resistance for each subject was adjusted weekly as needed. The exercise program was performed under direct supervision only during the physical therapy sessions.

  • Group B: Weight resisted training for Gluteus Maximus strengthOther

    Subjects attended p two times per week for a total of 10 visits. The participants performed PHEKF in 90° knee flexion with 30° hip abduction and 10° hip extension to increase the muscle activity of the gluteus maximus. In the prone position, the participant performed 10° hip extension until the posterior knee reached the horizontal bar. The participants maintained 90° knee flexion with 30° hip abduction and 10° hip extension in the prone position against the resistance. Sandbags (3 kg) will be used to provide resistance on the ankle through a rope and pulley. Each subject performed three sets with three repetitions of five seconds each. 1-minute break is allowed between each set.

Study groups in NCT05052762
Study groupRoleWhat they receive
Group A: Elastic resisted training for Gluteus Maximus strength.Experimentalbilateral bridge, unilateral bridge, and non-weight-bearing hip extension in prone with the knee flexed at 90 degrees. In the next five sessions, abduction and external rotation in a quadruped and weight-bearing hip extension are added.
Receives: Other: Group A: Elastic resisted training for Gluteus Maximus strength
Group B: Weight resisted training for Gluteus Maximus strengthExperimentalProne hip extension with knee flexion against weighted resistance
Receives: Other: Group B: Weight resisted training for Gluteus Maximus strength

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gluteus maximus strength with a dynamometer

    hand held dynamometer is placed over gluteus maximus in position of hip extension ad knee flexion and asked the patient to contract for three seconds against resistance nad record reading.

    Measured: 5th week

  2. Oswestry disability index

    This questionnaire consists of 10 sections describing the pain and its impact. Each section scores from 0 to 5, 0 being no pain and 5 being severe pain. The domains include pain intensity, personal care, lifting, sitting, walking, standing, sleeping, travel, social life, and change in the degree of pain.

    Measured: 5th week

  3. Numeric Pain Rating Scale

    this is scale for measuring pain. it is 11 point scale with 0 at no pain and 10 at max pain

    Measured: 5th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2021
  2. Study start1 Aug 2021
  3. Primary completion30 Jun 2022
  4. Study completion2 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05052762
Sponsor's protocol ID
REC/01070 Aiman Mazhar
Status last verified
Aug 2022
First submitted
13 Sep 2021
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lingutla KK, Pollock R, Ahuja S. Sacroiliac joint fusion for low back pain: a systematic review and meta-analysis. Eur Spine J. 2016 Jun;25(6):1924-31. doi: 10.1007/s00586-016-4490-8. Epub 2016 Mar 8.

    PubMed 26957096
  • Selkowitz DM, Beneck GJ, Powers CM. Comparison of Electromyographic Activity of the Superior and Inferior Portions of the Gluteus Maximus Muscle During Common Therapeutic Exercises. J Orthop Sports Phys Ther. 2016 Sep;46(9):794-9. doi: 10.2519/jospt.2016.6493. Epub 2016 Aug 5.

    PubMed 27494053
  • Added MAN, de Freitas DG, Kasawara KT, Martin RL, Fukuda TY. STRENGTHENING THE GLUTEUS MAXIMUS IN SUBJECTS WITH SACROILIAC DYSFUNCTION. Int J Sports Phys Ther. 2018 Feb;13(1):114-120.

    PubMed 29484248
  • Bae C-H, Choe Y-W, Kim M-K. Effects of Different External Loads on the Activities of the Gluteus Maximus and Biceps Femoris during Prone Hip Extension in Healthy Young Men. Korean Society of Physical Medicine. 2020;15(2):1-9.

Questions about this trial

What is this clinical trial studying?

A study testing Group A: Elastic resisted training for Gluteus Maximus strength and Group B: Weight resisted training for Gluteus Maximus strength in people with Sacroiliac Disorder, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gluteus maximus strength with a dynamometer (time frame: 5th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05052762, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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