Comparative Effects of Levator Ani Release and Post Isometric Relaxation Among Patients With Coccydynia
1 other identifier
interventional
46
1 country
1
Brief Summary
To compare the effects of levator ani release and post isometric relaxation on pain, disability and quality of life among patients with coccydynia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
May 8, 2023
CompletedFirst Submitted
Initial submission to the registry
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2024
CompletedOctober 31, 2023
October 1, 2023
7 months
October 25, 2023
October 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pain (NPRS)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain.
4th week
Dallas pain questionnaire (DPQ)
A condition-specific impairment questionnaire as well as pain and satisfaction indicators such self-assessment pain ratings are needed for the evaluation of low back pain (LBP). The 16-item Dallas Pain Questionnaire (DPQ) was created to assess patients' perceptions of the extent to which four parts of their lives are affected by chronic pain. It is simple to comprehend, can be answered in 3 to 5 minutes, and can be scored in under a minute.
4th week
Oswestry disability index (ODI)
The ODI comprises of ten items that examine several activities of daily life (such as lifting, walking, and travelling) and measures the limitations of a patient's performance in comparison to that of a fit individual. On a six-point scale, from 0 to 5, each item is scored. By adding together the values of each individual item, dividing that total by the range of potential scores, and multiplying that result by 100, one can approximate the overall ODI score. Higher scores imply greater levels of disability on the scale of 0 to 100%.
4th week
Study Arms (2)
Levator ani release
EXPERIMENTALParticipants will receive levator ani release exercise
Post isometric relaxion
EXPERIMENTALParticipants will receive post isometric relaxion exercise
Interventions
Patients will be treated with levator ani release exercises for pain (3 sets with 10 repetitions 3 times per week for 6 weeks).
Patients will be treated with Post isometric relaxation exercise and hold contractions for 10 seconds over 5 to 12 repetitions, 3 times per week for 6 weeks
Eligibility Criteria
You may qualify if:
- Both gender
- Age between 20-40 years
- Drivers
- Office workers
- Computer users
- Both gender
- Age between 20-40 years
- Drivers
- Office workers
- Computer users
You may not qualify if:
- Neurological disorders,
- Bone deficits,
- Vascular abnormalities,
- Rheumatoid arthritis
- Ankylosing spondylitis
- Fracture
- Tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ittefaq
Lahore, Punjab Province, 54700, Pakistan
Related Publications (6)
Lirette LS, Chaiban G, Tolba R, Eissa H. Coccydynia: an overview of the anatomy, etiology, and treatment of coccyx pain. Ochsner J. 2014 Spring;14(1):84-7.
PMID: 24688338BACKGROUNDTague RG. Fusion of coccyx to sacrum in humans: prevalence, correlates, and effect on pelvic size, with obstetrical and evolutionary implications. Am J Phys Anthropol. 2011 Jul;145(3):426-37. doi: 10.1002/ajpa.21518. Epub 2011 May 3.
PMID: 21541925BACKGROUNDLawson JO. Pelvic anatomy. I. Pelvic floor muscles. Ann R Coll Surg Engl. 1974 May;54(5):244-52. No abstract available.
PMID: 4829749BACKGROUNDSlattengren AH, Nissly T, Blustin J, Bader A, Westfall E. Best uses of osteopathic manipulation. J Fam Pract. 2017 Dec;66(12):743-747.
PMID: 29202144BACKGROUNDEnck P, Vodusek DB. Electromyography of pelvic floor muscles. J Electromyogr Kinesiol. 2006 Dec;16(6):568-77. doi: 10.1016/j.jelekin.2006.08.007. Epub 2006 Oct 18.
PMID: 17055294BACKGROUNDMosaad EH, Mohamed AY, Fawzy AA, Mohamed MH. The effect of adding kinesiotaping versus pelvic floor exercise to conventional therapy in the management of post-colonoscopy coccydynia: a single-blind randomized controlled trial. Afr Health Sci. 2023 Mar;23(1):575-583. doi: 10.4314/ahs.v23i1.60.
PMID: 37545928BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Humera Mubashar, Ms
Riphah International University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single blinding
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2023
First Posted
October 31, 2023
Study Start
May 8, 2023
Primary Completion
December 8, 2023
Study Completion
January 8, 2024
Last Updated
October 31, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share