NCT05076136

Brief Summary

The SIJ has long been considered an important source of low back pain because of the empirical finding that treatment targeting the SIJ can relieve pain.This study was be a Randomized Clinical Trail conducted at Riphah Rehabilitation Centre Lahore. The study was be completed within the time duration of Six months. Purposive sampling technique was be used. Sample size is calculated by using the G power 3.1. The sample size of 64 patients was be taken in this study to find the comparison of regional manual therapy and standard physiotherapy intervention in females with sacroiliac joint pain. Patients was be divided into two groups.. Patients was be divided into two groups. Group A was be treated with regional manual therapy. In regional manual therapy patients was be given mobilization to lumber region and SIJ, pelvic floor exercises and core strengthening exercises and Group B was be treated with standard physiotherapy in which patients was be given SIJ mobilization and Straight leg raise. Both groups was receive transcutaneous electrical nerve stimulator and heating pad as a common treatment protocol. Numeric pain rating scale (NPRS) and oswestry low back disability questionnaire was be used as Data collecting tools. Two session of treatment per week for eight weeks was be given. Data was be analyzed on SPSS 21.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

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

November 24, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
Last Updated

October 13, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

September 29, 2021

Last Update Submit

September 29, 2021

Conditions

Sacroiliac; Sprain (Strain)

Outcome Measures

Primary Outcomes (2)

  • NPRS

    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.

    Eight week

  • Oswestry low back disability questionnaire

    The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools

    Eight week

Study Arms (2)

Regional treatment

EXPERIMENTAL

Group A was given regional treatment with baseline treatment protocol

Other: Regional treatment

Standard physiotherapy treatment

ACTIVE COMPARATOR

Group B was given standard physiotherapy treatment with baseline protocol

Other: Standard physiotherapy treatment

Interventions

Regional treatmentOTHER

In reginal treatment patients were given physiotherapy exercises and manual therapies on hip joint as well as on surrounding areas of hip joint such as lumber area and sacroiliac joint.

Regional treatment
Standard physiotherapy treatmentOTHER

In this treatment patients were given just hip joint mobilizations and quadriceps and hamstrings stretching.

Standard physiotherapy treatment

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females with sacroiliac joint pain
  • Age: 20 to 50 years

You may not qualify if:

  • Patients withany red flag signs i.etumor, fracture, metabolic diseases, rheumatoid arthritis, prolonged history of steroids use, etc.
  • Females with sciatica
  • Females with radiating pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bajwa hospital

Lahore, Punjab Province, 57000, Pakistan

Location

Related Publications (3)

  • Forst SL, Wheeler MT, Fortin JD, Vilensky JA. The sacroiliac joint: anatomy, physiology and clinical significance. Pain Physician. 2006 Jan;9(1):61-7.

    PMID: 16700283BACKGROUND

  • 5. Merskey H, Bogduk N. Classification of Chronic Pain:Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. 2nd ed. Seattle, WA: IASP Press; 1994.

    BACKGROUND

  • 7. Solonen KA: The sacroiliac joint in the light of anatomical, roentgenological and clinical studies. Acta Orthop Scand 1957;27(suppl):1-127 Fortin JD, Dwyer AP, West S, et al: Sacroiliac joint: pain referral maps upon applying a newinjection/arthrography technique: part 1, asymptomatic volunteers. Spine 1994; 19(13):1475-1482

    BACKGROUND

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Tasneem Shahzadi, Mphil

    Riphah international university Lahore

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 13, 2021

Study Start

November 24, 2019

Primary Completion

October 10, 2020

Study Completion

November 10, 2020

Last Updated

October 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)