NCT05969769

Brief Summary

Coccydynia is common and prevalent among the females and several types of exercises and electrotherapy are advised. Pain can reduced significantly with both short wave diathermy and muscles stretches. There is limited evidence on indirect method like thoracic mobilization techniques to improve coccydynia. This study will determine the effects of thoracic mobilization techniques on coccydynia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

July 23, 2023

Last Update Submit

August 18, 2023

Conditions

Coccyx Disorder

Keywords

Coccyx Disorderthoracic

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

    Changes from the baseline Numeric Pain Rating Scale will be used to assess pain. • The Numeric Pain Rating Scale is an eleven-point measure of pain: the patient rates pain from 0 (no pain) to 10 (worst imaginable pain). The NPRS has shown good responsiveness in shoulder pain.

    8th Week

  • Modified OSWESTRY Low Back pain Index

    Changes from the baseline ODI is a disease specific disability measure is used to establish a level of disability stage on a patient activity status and monitor change over the time. The ODI is made up of 10 questions. Each question is scored from (o-5) m

    8th Week

Study Arms (2)

Experimental Group

ACTIVE COMPARATOR

Sustained Natural Apophyseal Glides will be performed with Muscle Energy Technique and Short Wave Diathermy as experimental group.

Other: Thoracic Sustained Natural Apophyseal Glides

Control Group

ACTIVE COMPARATOR

Short wave diathermy will be given with Muscle Energy Techniques.

Other: Muscle Energy Techniques

Interventions

Thoracic Sustained Natural Apophyseal GlidesOTHER

Sustained Natural Apophyseal Glides 3 sets of 10 reps with 1 min rest btw sets.

Experimental Group
Muscle Energy TechniquesOTHER

Short wave diathermy for 10 to 15 mins Muscle Energy Techniques of following muscles will be performed, Hip flexors muscles, Quadrates lamborum muscles, Erector spinae muscles, Piriformis muscles, PFS technique of METs Isometric hold 5-7 sec, Stretching 15 sec, Rest 30 sec.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed females coccydynia patients.

You may not qualify if:

  • Pregnancy
  • Months past Surgery, fracture or dislocation of coccyx.
  • Malignancy or cyst in the pelvic area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rahman Medical Hospital

Peshawar, KPK, Pakistan

RECRUITING

Study Officials

  • summra andleeb, MS(OMPT)

    riphah internation university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, Phd

CONTACT

03324390125imran.amjad@riphah.edu.pk

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

July 23, 2023

First Posted

August 1, 2023

Study Start

August 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)