NCT06108960

Brief Summary

The aim of the study is to compare the effects of pelvic stabilization exercises and proprioceptive neuromuscular facilitation on pain, disability and functional leg length in patients with anterior innominate iliosacral dysfunction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 8, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 25, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

Anterior innominate Iliosacral DysfunctionFunctional leg lengthPelvic Stabilization ExerciseProprioceptive Neuromuscular FacilitationDisability

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale NPRS

    Change from baseline the NPRS is a self-reporting or clinician-administered measuring tool that has extreme values ranging from "no pain" to "severe pain", on either horizontal or vertical line of scale. Numeric Rating Scale (NRS-11), which is an eleven-point scale in which the end points are the extremes of no pain at all (score of 0) and the worst pain the patient has ever experienced (score of 10).

    8 week

  • Modified Oswestry low back pain disability Questionnaire

    Change from baseline this questionnaire has been designed to give information as to how back pain has affected the ability to manage in everyday life. It consists of total of 10 questions which are scored as follow: This scale consists of 10 items in the form of activities of daily living with each item scoring from 0 to 5 where 0 is no difficulty in performing that activity and 5 inability to do that activity.

    8 week

  • Measurement of Functional Leg length: (Tape Method):

    Change from baseline the true leg length measurement or spinomalleolar distance (acceptable validity and reliability \[intraclass correlation coefficient (ICC3,3) range 0.98 - 0.99\] in measuring LLD) was used to assess the leg length of the subjects. A measuring tape will then use to measure from the apex of anterior superior iliac spine (ASIS) to the distal end of the medial malleolus in each leg and recorded in millimeter (mm). The following is the classification of the level of LLD: mild (\< 30 mm), moderate (30 - 60 mm) and severe (\> 60 mm).

    8 week

Study Arms (2)

Proprioceptive neuromuscular facilitation

EXPERIMENTAL

The patients will be positioned in supine lying and then contract relax will be performed on affected side of pelvis first in D1 pattern (anterior elevation and posterior depression) 3 times with 10 sec contractions and 5 sec relaxations in 1 set. Then in D2 pattern (posterior elevation and anterior depression) 3 times with 10 sec contractions and 5 sec relaxations in 1 set. 3 set of each diagonal pattern to be performed in 1 treatment session alternatively. Treatment will be given for a period of 4 days a week for 8 weeks

Other: Proprioceptive neuromuscular facilitation

Pelvic stabilization exercises

EXPERIMENTAL

All participants will receive training programs for the eight levels of training from static to dynamic conditions. The practiced therapy method will first taught by a physical therapist with a verbal explanation and visual aids (such as photographs) in each group. The therapist will supervise all stages of the exercise therapy to ensure the patients correctly performed the exercises. The supervised exercise intervention will be conducted 3 days a week for 8 weeks.

Other: Pelvic stabilization exercises

Interventions

Group A (Proprioceptive neuromuscular facilitation.) will be treated with Proprioceptive neuromuscular facilitation, before applying exercise, Hot pack will be applied for 15 minutes. (8 weeks, 4 sessions per week) The patients will be positioned in supine lying and then contract relax will be performed on affected side of pelvis first in D1 pattern (anterior elevation and posterior depression) 3 times with 10 sec contractions and 5 sec relaxations in 1 set. Then in D2 pattern (posterior elevation and anterior depression) 3 times with 10 sec contractions and 5 sec relaxations in 1 set. 3 set of each diagonal pattern to be performed in 1 treatment session alternatively. Treatment will be given for a period of 4 days a week for 8 weeks

Proprioceptive neuromuscular facilitation

Group B (Pelvic stabilization exercises) will be treated with Pelvic Stabilization Exercise, before applying exercise we will apply Hot pack for 15minutes (8 weeks, 3 sessions per week). All participants will receive training programs for the eight levels of training from static to dynamic conditions. The practiced therapy method will first be taught by a physical therapist with a verbal explanation and visual aids (such as photographs) in each group. The therapist will supervise all stages of the exercise therapy to ensure the patients correctly performed the exercises. The supervised exercise intervention will be conducted 3 days a week for 8 weeks.

Pelvic stabilization exercises

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient within ages of 25 and 45 years.
  • Both male and female participants will be included.
  • Episode of Lumbopelvic pain within the previous 6 weeks with pain radiating till the knee and associated groin pain.
  • Pain and tenderness at SIJ
  • The diagnostic criteria for SJD were five clinical tests Compression, Distraction, sacral thrust, thigh thrust and Gaenslen test (patient with a minimum of 3 positive results among the 5 provocation tests)
  • Positive Special test for Anterior Innominate Dysfunction (Standing flexion test, Seated flexion test, Supine to sit test and Gillet test)
  • NPRS = 3 to 6

You may not qualify if:

  • Any other medical/systemic illness relevant to lower back and lower extremity
  • Previous major surgery for lower back and lower extremity
  • SLR Less than 45°
  • Pain radiating past the knee
  • Pregnant and lactating females
  • Had been diagnosed by physician with a diagnosis other than SIJD
  • Receiving manual therapy for the sacroiliac joint in the past 3 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex

Lahore, Punjab Province, 55201, Pakistan

RECRUITING

Related Publications (22)

  • Brolinson PG, Kozar AJ, Cibor G. Sacroiliac joint dysfunction in athletes. Curr Sports Med Rep. 2003 Feb;2(1):47-56. doi: 10.1249/00149619-200302000-00009.

    PMID: 12831676BACKGROUND
  • ASAD F, HAFEEZ S, SAEED S, RIAZ S, KHAN RR, AWAN AB. Comparison of Post Isometric Relaxation of Gluteus Maximus and Static Stretching of Hip Flexors on Pain and Functional Status in Patients with Anterior Innominate Dysfunction.

    BACKGROUND
  • Timm KE. Sacroiliac joint dysfunction in elite rowers. J Orthop Sports Phys Ther. 1999 May;29(5):288-93. doi: 10.2519/jospt.1999.29.5.288.

    PMID: 10342566BACKGROUND
  • Oldreive WLJJoM, Therapy M. A critical review of the literature on tests of the sacroiliac joint. 1995;3(4):157-61.

    BACKGROUND
  • Vaidya A, Babu VS, Mungikar S, Dobhal SJIJHS. Comparison between muscle energy technique and Mulligan's mobilization with movement in patients with anterior innominate iliosacral dysfunction. 2019;1(9).

    BACKGROUND
  • Shaw J, editor The role of the sacroiliac joint as a cause of low back pain and dysfunction. The First Interdisciplinary World Congress on Low Back Pain and its Relation to the Sacroiliac Joint, San Diego, CA; 1992.

    BACKGROUND
  • Wallin D, Ekblom B, Grahn R, Nordenborg T. Improvement of muscle flexibility. A comparison between two techniques. Am J Sports Med. 1985 Jul-Aug;13(4):263-8. doi: 10.1177/036354658501300409.

    PMID: 4025678BACKGROUND
  • Ribeiro S, Heggannavar A, Metgud SJIJoPT, Research. Effect of mulligans mobilization versus manipulation, along with mulligans taping in anterior innominate dysfunction-A randomized clinical trial. 2019;1(1):17.

    BACKGROUND
  • Akram H, Bashir MS, Zia A, Noor R, Shakeel A. Comparison of muscle energy technique and mobilization with movement to reduce pain and improve functional status in subjects with anterior innominate ilio-sacral dysfunction. J Bodyw Mov Ther. 2024 Oct;40:1336-1341. doi: 10.1016/j.jbmt.2022.11.003. Epub 2022 Dec 5.

    PMID: 39593454BACKGROUND
  • Kumar AJN. The Effectiveness of Gluteus Maximus Activation and Kinesio Taping along with Muscle Energy Technique on Pain, Alignment and Functional Activities in Subject with Anterior Innominate Rotation Dysfunction. 2022;20(12):3650-

    BACKGROUND
  • Singh K, Arora L, Arora RJIJoP. Effect of proprioceptive neuromuscular facilitation (PNF) in improving sensorimotor function in patients with diabetic neuropathy affecting lower limbs. 2016:332-6.

    BACKGROUND
  • Kamali F, Zamanlou M, Ghanbari A, Alipour A, Bervis S. Comparison of manipulation and stabilization exercises in patients with sacroiliac joint dysfunction patients: A randomized clinical trial. J Bodyw Mov Ther. 2019 Jan;23(1):177-182. doi: 10.1016/j.jbmt.2018.01.014. Epub 2018 Jan 31.

    PMID: 30691749BACKGROUND
  • Sharma P. Effect of Proprioceptive Neuromuscular Facilitation (PNF) in Improving Muscle Control in Patient with Sacroiliac Joint Dysfunction: A Case Report. International Journal of Recent Advances in Multidisciplinary Topics. 2021;2(3):1-4.

    BACKGROUND
  • Altaim SASIT, Shafique SJJoIIMCQ. Maitland's Mobilization versus Mulligan's Mobilization Technique to Treat Anterior/Posterior Innominate Dysfunctions.81.

    BACKGROUND
  • Kahl C, Cleland JAJPtr. Visual analogue scale, numeric pain rating scale and the McGill pain Questionnaire: an overview of psychometric properties. 2005;10(2):123-8.

    BACKGROUND
  • Al-Hadidi F, Bsisu I, AlRyalat SA, Al-Zu'bi B, Bsisu R, Hamdan M, Kanaan T, Yasin M, Samarah O. Association between mobile phone use and neck pain in university students: A cross-sectional study using numeric rating scale for evaluation of neck pain. PLoS One. 2019 May 20;14(5):e0217231. doi: 10.1371/journal.pone.0217231. eCollection 2019.

    PMID: 31107910BACKGROUND
  • Bashir FJIMM. Diagnosis and manipulative therapy of sacroiliac joint disorder. 2011;33(3):115-9.

    BACKGROUND
  • Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther. 2001 Feb;81(2):776-88. doi: 10.1093/ptj/81.2.776.

    PMID: 11175676BACKGROUND
  • Sakulsriprasert P, Vachalathiti R, Vongsirinavarat M, Kantasorn J. Cross-cultural adaptation of modified Oswestry Low Back Pain Disability Questionnaire to Thai and its reliability. J Med Assoc Thai. 2006 Oct;89(10):1694-701.

    PMID: 17128846BACKGROUND
  • Wiangkham T, Rinrit P, Choprateep M, Thamrongthanakul R, Chidnok WJCMJ. Correlation between leg length discrepancy and asymptomatic sacroiliac joint dysfunction in young males. 2022;66(1):15-21.

    BACKGROUND
  • Farahmand B, Ebrahimi Takamjani E, Yazdi HR, Saeedi H, Kamali M, Bagherzadeh Cham M. A systematic review on the validity and reliability of tape measurement method in leg length discrepancy. Med J Islam Repub Iran. 2019 May 26;33:46. doi: 10.34171/mjiri.33.46. eCollection 2019.

    PMID: 31456970BACKGROUND
  • Ehsani F, Sahebi N, Shanbehzadeh S, Arab AM, ShahAli S. Stabilization exercise affects function of transverse abdominis and pelvic floor muscles in women with postpartum lumbo-pelvic pain: a double-blinded randomized clinical trial study. Int Urogynecol J. 2020 Jan;31(1):197-204. doi: 10.1007/s00192-019-03877-1. Epub 2019 Apr 23.

    PMID: 31016337BACKGROUND

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Faiza Amjad, M.Phil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

October 25, 2023

First Posted

October 31, 2023

Study Start

May 8, 2023

Primary Completion

December 1, 2023

Study Completion

January 8, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations