Effects of Pubic Symphysis Manipulation in Patients With Sacroiliac Joint Dysfunction

NCT06656208 | Completed DMC

• 1 other identifier: RiphahIUMalihaFatima
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research is to determine the effect of Pubic Symphysis manipulation on pain, disability and fear avoidance behavior in patients with sacroiliac joint dysfunction. Randomized controlled trials was done at Pakistan Railway Hospital. The sample size was 44. The subjects will be divided into Control group and Experimental group. Each group will be having 22 participants. Study duration was of 12 months. Sampling technique applied was non probability connivance sampling technique. Subject included in the study will be female with presence of back pain for ≥6 months, Unilateral back pain, Age 25-60 years, Postpartum women, Patient with pubic tenderness. Tools used in the study are NPRS, Oswestry Disability Index and FABQ. Data will be analyzed using SPSS version 26.

Conditions

Sacroiliac Joint Dysfunction

Keywords

Sacroiliac joint dysfunction; Symphysis pubis dysfunction (SPD); Pubic symphysis manipulation (PSM); Low back pain; Disability; Pubic malalignment

Outcome Measures

Primary Outcomes (2)

• Numeric pain rating scale

  The NPRS is a self-reported, or clinician administered, measurement tool to measure pain intensity consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain'. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form.

  baseline to 6th day

• Fear Avoidance Belief Questionnaire (FABQ)

  his scale is used to measure fear avoidance behavior in patients due to pain. It consists of 16 items and patients rate their agreement with each statement on a 7- point Likert scale (0 = completely disagree, 6 = completely agree). The original factor analysis revealed two sub-scales: the work sub-scale (FABQ w) with 7 questions (maximum score = 42) and the physical activity sub-scale (FABQ pa) with 4 questions (maximum score = 24). A higher score indicates more strongly held fear avoidance beliefs.

  baseline to 6th day

Secondary Outcomes (1)

• Oswestry Disability Index (ODI)

  baseline to 6th day

Study Arms (2)

Experimental Group

EXPERIMENTAL

Pubic symphysis manipulation with 5 repetitions hold for 10 sec and ask the patient to apply max. Contraction and then relax. Whereas, the therapist applies a rapid stretch to a new barrier and is held for 10 seconds. SIJ mobilizations will be given with 30 Oscillations per set for 15 seconds, 3 sets on effected side along with

Other: Pubic symphysis manipulation

Control Group

ACTIVE COMPARATOR

SIJ mobilizations will be given with 30 Oscillations per set for 15 seconds, 3 sets on effected side.

Other: Traditional sacroiliac treatment

Interventions

Pubic symphysis manipulation OTHER

Manipulation was applied in the crook lying position with 5 repetitions hold for 10 sec and ask the patient to apply max. Contraction in Abduction and then relax. Whereas, the therapist applies a rapid stretch to a new barrier and is held for 10 seconds.

Experimental Group

Traditional sacroiliac treatment OTHER

Mobilization was applied in prone lying position on sacroiliac joint, 30 Oscillations per set for 15 seconds, 3 sets on effected side.

Control Group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Gender Eligibility Details: Female are prone to SIJ Dysfunction than male, due to pregnancy, joint pain and obesity
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female gender
• Age 25-60 years
• Presence of back pain for ≥6 months
• Postpartum women
• Patient with pubic tenderness
• Patient with pubic symphysis asymmetry
• Unilateral back pain
• Participants had 2 positive test out of four test, Sacroiliac distraction test, Sacroiliac compression test, thigh thrust test, sacral thrust test.

You may not qualify if:

• Participants underwent surgical approaches
• History of fracture
• Patients suffering from pubic neuralgia and osteitis pubis
• SIJ or Hip joint pathology
• Arthritides
• Adductor strain

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, 26054, Pakistan

Location

MeSH Terms

Conditions

Pelvic Girdle Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Back Pain

Study Officials

• Maliha Fatima, MS-OMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: October 10, 2024
• Primary Completion: January 25, 2025
• Study Completion: April 16, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)