Clinical trial NCT06109077: Comparative Effects of Levator Ani Release and Post Isometric Relaxation Among Patients With Coccydynia
Official title: Comparative Effects of Levator Ani Release and Post Isometric Relaxation on Pain, Disability, and Quality of Life Among Patients With Coccydynia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coccydynia
Keywords: Coccydynia
levator ani
pain
post isometric relaxation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Coccygodynia, also known as coccalgia, coccygeal neuralgia, or tailbone pain, is the word used to describe the pain symptoms that develop in the coccyx region. The discomfort is typically brought on while the person is sitting down, but it can also start when the person stands up. The majority of instances get well within a few weeks to months, but for certain people, the pain might last longer and have an adverse effect on quality of life. Due to the complexity of coccygeal pain in these people, management can be challenging.

The aim of the study is to compare effects of levator ani release exercises and post isometric in patients with coccydynia. A randomized control trial will be conducted at Jinnah hospital Lahore through convenience sampling technique on 46 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with levator ani release exercises and Group B will be treated with post isometric relaxation techniques. Outcome measure will be conducted through pain and disability questionnaire at baseline and after 4 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria: Inclusion Criteria:•

* Both gender
* Age between 20-40 years
* Drivers
* Office workers
* Computer users
* Both gender
* Age between 20-40 years
* Drivers
* Office workers
* Computer users

Exclusion Criteria:

* Neurological disorders,
* Bone deficits,
* Vascular abnormalities,
* Rheumatoid arthritis
* Ankylosing spondylitis
* Fracture
* Tumor

Primary outcomes:
measure: Pain (NPRS)
timeFrame: 4th week
measure: Dallas pain questionnaire (DPQ)
timeFrame: 4th week
measure: Oswestry disability index (ODI)
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ittefaq
state: Punjab
Study officials:
affiliation: Riphah International University
name: Humera Mubashar, Ms
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: Lawson JO. Pelvic anatomy. I. Pelvic floor muscles. Ann R Coll Surg Engl. 1974 May;54(5):244-52. No abstract available.
citation: Slattengren AH, Nissly T, Blustin J, Bader A, Westfall E. Best uses of osteopathic manipulation. J Fam Pract. 2017 Dec;66(12):743-747.
citation: Enck 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.
citation: Mosaad 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.