Biomechanical Risk Factors of Cervical Pain in Pregnant Women

NCT06741605 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005381
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the biomechanical risk factors for neck pain in pregnant women.

Conditions

Cervical Pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  The VAS will be used to assess cervical pain for each pregnant woman. It is a pain rating scale, whose scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and "worst pain" on the right end of the scale (10 cm).

  2 months

• Measurement of trigger points

  Pressure algometer will be used to assess the trigger points of the neck muscles of each pregnant woman in the study. It will be placed perpendicularly to the fibers of the upper trapezius muscle, bilaterally, exactly over the myofascial trigger points. These points were pressed until the pain is reported, and the value displayed on the equipment's display will be recorded in kg/cm2.

  2 months

Secondary Outcomes (7)

• Measurement of craniovertebral angle (CVA)

  2 months

• Measurement of cervical flexion range of motion (ROM)

  2 months

• Measurement of cervical extension range of motion (ROM)

  2 months

• Measurement of cervical lateral flexion range of motion (ROM)

  2 months

• Measurement of cervical rotation range of motion (ROM)

  2 months

Study Arms (1)

Pregnant women with cervical pain

Pregnant women with cervical pain in their third trimester will be assessed to investigate the relationship between biomechanical risk factors and neck pain in pregnant women.

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

They will be selected from the departments of obstetrics and gynecology at Sinhout Hospital and Minya Elkamh Central Hospital, El-Sharqia Governorate, Egypt.

You may qualify if:

• Pregnant women in their third trimester suffering from cervical pain.
• They have experienced cervical pain starting during pregnancy.
• They reported no neck pain or neck-related disorders during the previous year and were screened for the absence of cervical pathology during a physical examination.

You may not qualify if:

• Objective signs of structural pathology on physical examination, including but not limited to shoulder bursitis, impingement, tendonitis, fracture, cervical nerve or disc impairment, radiculopathy, or loss of upper extremity sensory or motor function.
• Acute injury of the neck or shoulders (\<12 weeks before the study).
• History of fibromyalgia or musculoskeletal pain present in more than 4 body regions concurrently.
• Self-reported systemic illness, including cancer, rheumatic, cardiovascular, or neurological disease
• Untreated psychiatric condition
• Previous surgery involving the cervical spine or shoulders
• Uncontrolled hypertension (resting systolic blood pressure \>150 mm Hg, or diastolic blood pressure \>90 mm Hg).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Doaa Ahmed Fadel

Zagazig, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hossam Hussien, Professor

  Al-Azhar University

  STUDY DIRECTOR

• Doaa Osman, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Doaa Fadel, Master

CONTACT

+201013791440; doaaahmedfadel@gmail.com

Amira Nagy, PHD

CONTACT

+201021177871; Amira.nagy@rochetmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: December 20, 2024
• Primary Completion: February 20, 2025
• Study Completion: March 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

EG (1)