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Anterior Innominate Iliosacral DysfunctionNCT06108960

Pelvic Stabilization Exercises & (PNF) on Pain, Disability & Functional Leg Length

A study testing Proprioceptive neuromuscular facilitation and Pelvic stabilization exercises in people with Anterior Innominate Iliosacral Dysfunction, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 45 years
What is being tested?
Proprioceptive neuromuscular facilitation and Pelvic stabilization exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 sitePakistan
Study dates
8 May 2023to 8 Jan 2024
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 25 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Imran Amjad, PHD contact

03324390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Sehat Medical Complex

    Lahore, Punjab Province, 55201

    Faiza Amjad, M.Phil, 03338013182, faiza.amjad@riphah.edu.pk

    Maham Ali, MS-OMPT

    Recruiting

Other trials in Pakistan

About this study

Official title: Comparison of Pelvic Stabilization Exercises and Proprioceptive Neuromuscular Facilitation on Pain, Disability and Functional Leg Length in Patients With Anterior Innominate Iliosacral Dysfunction.

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.

Read the detailed description

Illiosacral Dysfunction is accompanied by an abnormal movement of the ilium in relation to the sacrum, most commonly classified as either anterior or posterior innominate dysfunction. One of the unrecognized causes of low back and pelvic pain, as well as source of pain to proximal lower extremity is sacroiliac joint (SIJ) which arises from L5, S1 and in particular if there was an associated groin pain. There is a strong consensus on the effects of stabilization exercises in patients with chronic LBP, also some evidence for its benefits in patients with SJD. 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 rotation dysfunction.

A total of 26 patients with Anterior innominate iliosacral dysfunction will be included in the study. Ethical approval will be taken from ethical committee of Riphah Internatinal University Lahore. Non-probability convenience sampling technique will be used to divide participants into group. Sample size is twenty-six. After taking informed consent and maintaining the confidentiality of individual participant, both groups will be treated with baseline treatment via the application of Hot pack. Group A will be treated with Proprioceptive neuromuscular facilitation and Group B will be treated with Pelvic Stabilization Exercises for eight weeks. Outcome measuring tools for pain (Numeric Pain Rating Scale), Functional Disability (Modified Oswestry low back pain disability Questionnaire) and Functional Leg length (Tape Method) will be noted pre, 4th week and post treatment. Data will be Analyzed by SPSS version 29. Descriptive statistics will be used for demographics. The normality of the data will be assessed by Shapiro-Wilk test. If the data is normally distributed parametric test i.e., T-Test will be used for inter group difference while Paired Sample T-Test will be used for intra group pre and post treatment difference. If the data is not normally distributed a nonparametric test i.e., Mann-Whitney test will be used.

Being tested
Proprioceptive neuromuscular facilitation, Pelvic stabilization exercises
Keywords
Anterior innominate Iliosacral Dysfunction, Functional leg length, Pelvic Stabilization Exercise, Proprioceptive Neuromuscular Facilitation, Disability

What participants receive

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

  • Proprioceptive neuromuscular facilitationOther

    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

  • Pelvic stabilization exercisesOther

    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.

Study groups in NCT06108960
Study groupRoleWhat they receive
Proprioceptive neuromuscular facilitationExperimentalThe 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
Receives: Other: Proprioceptive neuromuscular facilitation
Pelvic stabilization exercisesExperimentalAll 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.
Receives: Other: Pelvic stabilization exercises

What is being measured

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

  1. 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).

    Measured: 8 week

  2. 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.

    Measured: 8 week

  3. 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).

    Measured: 8 week

Timeline

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

  1. First posted31 Oct 2023
  2. Study start8 May 2023
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion8 Jan 2024 (estimated)

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
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06108960
Sponsor's protocol ID
REC/RCR & AHS/23/0159
Status last verified
Oct 2023
First submitted
25 Oct 2023
Last updated
31 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12831676
  • 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.

  • 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.

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

  • 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).

  • 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.

  • 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.

    PubMed 4025678
  • 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.

  • 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.

    PubMed 39593454
  • 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-

  • 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.

  • 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.

    PubMed 30691749
  • 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.

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

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Proprioceptive neuromuscular facilitation and Pelvic stabilization exercises in people with Anterior Innominate Iliosacral Dysfunction, 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?

Results are not available in the source record.

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

Contact Imran Amjad, PHD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale NPRS (time frame: 8 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 NCT06108960, which also lists 22 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 31 Oct 2023.

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