NCT04790500

Brief Summary

The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

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

October 14, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

March 7, 2021

Last Update Submit

September 17, 2021

Conditions

Sacroiliac Joint Dysfunction

Keywords

MobilizationMuscle energy techniquePostpartumSacroiliac joint pain

Outcome Measures

Primary Outcomes (2)

  • Numeric pain rating scale

    o The 11-point (numeric pain rating scale) NPRS will use to capture the patient's level of pain. The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.'' Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the 3 ratings or any single rating may be used to represent the patient's level of pain. Numeric pain scales have been shown to be reliable and valid. The reliability of numeric pain rating scale is 0.74

    4th week

  • Modified Oswestry disability index

    It is a self-report questionnaire of a patient's perceived disability based on 10 areas of pain and daily activities (pain intensity, personal hygiene, lifting, walking, sitting, standing, sleeping, sexual activity, social activity and travelling). Each section is scored on a6-point scale (0-5), with 0 representing no limitation and 5 representing maximal limitation. The subscales combined add up to a total maximal score of 50. The score is then doubled and interpreted as a percentage of the patient-perceived disability (the higher the score, the greater the disability). In cases where patients did not answer all the 10 sections, the sum score of the answered sections were divided by the number of completed sections. The reliability of modified oswestry disability index is 0.88.

    4th week

Study Arms (2)

Group A

ACTIVE COMPARATOR

mobilization technique

Other: mobilization technique

Group B

EXPERIMENTAL

muscle energy technique

Other: muscle energy technique

Interventions

mobilization techniqueOTHER

Mobilization of sacroiliac joint which will increase the range of motion and reduction in pain and improvement in functional limitation.

Group A
muscle energy techniqueOTHER

Muscle energy technique it is known as active muscular relaxation technique. It helps in lengthening the shorten muscle and increasing range of restricted muscles

Group B

Eligibility Criteria

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

You may qualify if:

  • year having unilateral back pain around or on sacral sulcus,
  • Positive posterior pain provocation test for Sacroiliac joint dysfunction,
  • Low back pain within six weeks of delivery
  • Pain while sitting down, lying on the ipsilateral side of pain, or climbing stairs.
  • Local tenderness of the posterior aspect of the sacroiliac joint
  • Pain is usually localized over the buttock.
  • Sharp, stabbing, and/or shooting pain which extends down the posterior thigh usually not past the knee.
  • C-section

You may not qualify if:

  • Neurological deficit
  • Spinal tumors
  • Scoliosis,
  • Underwent spinal surgery and prolapsed
  • Intervertebral disc with or without radiculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan railway hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Officials

  • Anam Aftab, Phd*

    Riphah college of rehabilitation and allied health sciences - Rawalpindi

    PRINCIPAL INVESTIGATOR

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

March 7, 2021

First Posted

March 10, 2021

Study Start

October 14, 2020

Primary Completion

August 20, 2021

Study Completion

August 20, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)