NCT05875298

Brief Summary

this study will be conducted to investigate the effect of physical therapy protocol and medication on pain, pressure pain threshold and dysfunction in patients with Chronic Maxillary Sinusitis

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 16, 2023

Last Update Submit

May 16, 2023

Conditions

Keywords

physical therapy protocolchronic maxillary sinusitis

Outcome Measures

Primary Outcomes (3)

  • pain intensity

    by visual analogue scale (VAS) 10 cm line with 2 ends, 0 and 10 ends 0 end means no pain 10 end means the worst pain

    up to four weeks

  • pressure pain threshold

    pressure algometer will be used to measure pressure pain threshold

    up to four weeks

  • functional disability

    Rhinosinusitis Disability Index will be used to assess functional disability in patients with chronic maxillary sinusitis.it consists of 30 items divided between three main domains: physical, functional, and emotional. Responses are provided using a 5-point Likert scale, and scores range from 0 to 150, with higher scores indicating that CRS exerts a greater impact on quality of life

    up to four weeks

Study Arms (3)

physical therapy protocol

EXPERIMENTAL

the patients will receive physical therapy protocol three times a week for four weeks

Other: physical therapy protocol

physical therapy protocol and medical drugs

EXPERIMENTAL

the patients will receive physical therapy protocol three times a week for four weeks and medication twice daily for four weeks

Other: physical therapy protocol and medical drugsOther: medical drugs

medical drugs

ACTIVE COMPARATOR

the patients will receive medical drugs twice daily for four weeks

Other: medical drugs

Interventions

the patients will receive physical therapy protocol in the form of therapeutic ultrasound (pulsed mode n An intensity of 1.7 W/cm² for maxillary, respectively in A frequency of 1.7 MHz in Duration of treatment of ten minutes for each maxillary sinus and five minutes for each side), Hot pack that will be applied eight minutes at each maxillary area and manual drainage technique for maxillary sinus.

physical therapy protocol

the patients will receive physical therapy protocol and medical drugs in the form of therapeutic ultrasound (pulsed mode n An intensity of 1.7 W/cm² for maxillary, respectively in A frequency of 1.7 MHz in Duration of treatment of ten minutes for each maxillary sinus and five minutes for each side), Hot pack that will be applied eight minutes at each maxillary area and manual drainage technique for maxillary sinus. The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray.

physical therapy protocol and medical drugs

The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray.

medical drugsphysical therapy protocol and medical drugs

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients clinically diagnosed by ENT Physician with chronic maxillary sinusitis With a history of 3 months or longer.
  • Age group from 18 to 50 years

You may not qualify if:

  • Local contraindications for face mobilization or massage. (abrasions, skin conditions, broken bones) Medical contraindications. (bacterial infections, conjunctivitis, styes)
  • Duration of onset less than 2 months Headache due to reasons other than chronic sinusitis (TMJD, cervicogenic headache, underlying neurological diseases, anxiety-related, etc)
  • Patients with surgery performed in the past 1 year for maxillary sinusitis Cognition level impairment
  • Metal implants in the face region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelop
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: physical therapy protocol and medication
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

June 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05