NCT05052762

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

September 13, 2021

Last Update Submit

August 10, 2022

Conditions

Keywords

gluteus maximusElastic resistance trainingweighted resistance training

Outcome Measures

Primary Outcomes (3)

  • 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.

    5th week

  • 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.

    5th week

  • 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

    5th week

Study Arms (2)

Group A: Elastic resisted training for Gluteus Maximus strength.

EXPERIMENTAL

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 and weight-bearing hip extension are added.

Other: Group A: Elastic resisted training for Gluteus Maximus strength

Group B: Weight resisted training for Gluteus Maximus strength

EXPERIMENTAL

Prone hip extension with knee flexion against weighted resistance

Other: Group B: Weight resisted training for Gluteus Maximus strength

Interventions

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 A: Elastic resisted training for Gluteus Maximus strength.

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.

Group B: Weight resisted training for Gluteus Maximus strength

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdullah Teaching Hospital

Mānsehra, KPK, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 26957096BACKGROUND
  • 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.

    PMID: 27494053BACKGROUND
  • 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.

    PMID: 29484248BACKGROUND
  • 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.

    BACKGROUND

Study Officials

  • Aisha Razzaq, MSPT-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 22, 2021

Study Start

August 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 2, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations