Comparative Effects of Levator Ani Release and Post Isometric Relaxation Among Patients With Coccydynia

Coccydynia Clinical Trial

Official title:

Comparative Effects of Levator Ani Release and Post Isometric Relaxation on Pain, Disability, and Quality of Life Among Patients With Coccydynia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109077
• Other study ID #: REC/RCR & AHS/23/0143
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: January 8, 2024

Study information

• Verified date: October 2023
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effects of levator ani release and post isometric relaxation on pain, disability and quality of life among patients with coccydynia

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: January 8, 2024
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Coccydynia

Intervention

Other:
• Levator ani release
Patients will be treated with levator ani release exercises for pain (3 sets with 10 repetitions 3 times per week for 6 weeks).
• Post isometric relaxion
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

Locations

Country	Name	City	State
Pakistan	Ittefaq	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

Enck P, Vodušek DB. Electromyography of pelvic floor muscles. Journal of Electromyography and Kinesiology. 2006;16(6):568-77. 6. Slattengren AH, Nissly T, Blustin J, Bader A, Westfall E. Best uses of osteopathic manipulation. Journal of Family Practice. 2017;66(12):743-8

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. — View Citation

Lawson JO. Pelvic anatomy. I. Pelvic floor muscles. Ann R Coll Surg Engl. 1974 May;54(5):244-52. No abstract available. — View 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. — View 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. — View 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. — View Citation

Tague 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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