CoccydyniaNCT06109077
Comparative Effects of Levator Ani Release and Post Isometric Relaxation Among Patients With Coccydynia
A study testing Levator ani release and Post isometric relaxion in people with Coccydynia, run by Riphah International University at 1 site in Pakistan.
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 Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Coccydynia
- What is being tested?
- Levator ani release and Post isometric relaxion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 8 May 2023to 8 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender
- Age between 20-40 years
- Drivers
- Office workers
- Computer users
- Both gender
Show all 10Show fewer
- Age between 20-40 years
- Drivers
- Office workers
- Computer users
Who cannot join
- Neurological disorders,
- Bone deficits,
- Vascular abnormalities,
- Rheumatoid arthritis
- Ankylosing spondylitis
- Fracture
- Tumor
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ittefaq
Lahore, Punjab Province, 54700
Humera Mubashar, Ms(OMPT), 03084157979, Humera.mubashar@riphah.edu.pk
Hafiz Muhammad Amir Hanif, MS(OMPT)
About this study
Official title: Comparative Effects of Levator Ani Release and Post Isometric Relaxation on Pain, Disability, and Quality of Life Among Patients With Coccydynia
To compare the effects of levator ani release and post isometric relaxation on pain, disability and quality of life among patients with coccydynia
Read the 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.
- Conditions
- Coccydynia
- Being tested
- Levator ani release, Post isometric relaxion
- Keywords
- Coccydynia, levator ani, pain, post isometric relaxation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levator ani releaseOther
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 relaxionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Levator ani release | Experimental | Participants will receive levator ani release exercise Receives: Other: Levator ani release |
| Post isometric relaxion | Experimental | Participants will receive post isometric relaxion exercise Receives: Other: Post isometric relaxion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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%.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start8 May 2023
- Primary completion8 Dec 2023 (estimated)
- Study completion8 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CoccydyniaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Humera Mubashar, Ms, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109077
- Sponsor's protocol ID
- REC/RCR & AHS/23/0143
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24688338Tague 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.
PubMed 21541925Lawson JO. Pelvic anatomy. I. Pelvic floor muscles. Ann R Coll Surg Engl. 1974 May;54(5):244-52. No abstract available.
PubMed 4829749Enck 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.
PubMed 17055294Slattengren AH, Nissly T, Blustin J, Bader A, Westfall E. Best uses of osteopathic manipulation. J Fam Pract. 2017 Dec;66(12):743-747.
PubMed 29202144Mosaad 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.
PubMed 37545928
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Levator Ani Release and Post Isometric Relaxation on Pain, Disability, and Quality of Life Among Patients With Coccydynia
- ClinicalTrials.gov ID
- NCT06109077
- Acronym / sponsor ID
- REC/RCR & AHS/23/0143
- Conditions
- Coccydynia
- Keywords
- Coccydynia, levator ani, pain, post isometric relaxation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 8 Dec 2023 (estimated)
- Study completion
- 8 Jan 2024 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levator ani release | Experimental | Other: Levator ani releaseParticipants will receive levator ani release exercise |
| Post isometric relaxion | Experimental | Other: Post isometric relaxionParticipants will receive post isometric relaxion exercise |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Both gender
- Age between 20-40 years
- Drivers
- Office workers
- Computer users
Key exclusion criteria (7 listed)
- Neurological disorders,
- Bone deficits,
- Vascular abnormalities,
- Rheumatoid arthritis
- Ankylosing spondylitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levator ani releasePatients will be treated with levator ani release exercises for pain (3 sets with 10 repetitions 3 times per week for 6 weeks). | Other | Levator ani release |
| Post isometric relaxionPatients 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 | Other | Post isometric relaxion |
Primary outcome
Pain (NPRS)
Time frame: 4th week
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.
Dallas pain questionnaire (DPQ)
Time frame: 4th week
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.
Oswestry disability index (ODI)
Time frame: 4th week
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%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 24688338Lirette 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.
- Background: PubMed 21541925Tague 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.
- Background: PubMed 4829749Lawson JO. Pelvic anatomy. I. Pelvic floor muscles. Ann R Coll Surg Engl. 1974 May;54(5):244-52. No abstract available.
- BackgroundEnck 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
- Background: PubMed 17055294Enck 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.
- Background: PubMed 29202144Slattengren AH, Nissly T, Blustin J, Bader A, Westfall E. Best uses of osteopathic manipulation. J Fam Pract. 2017 Dec;66(12):743-747.
- Background: PubMed 37545928Mosaad 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.
- Individual participant dataSharing planned: No
Related trials for Coccydynia
Recruiting
Shock Wave Therapy Versus High-Intensity Laser Therapy for Coccydynia (Tailbone Pain)
Coccydynia, Coccygodynia
Recruiting
Conventional vs Pulsed RF in Coccydynia
Back Pain
RecruitingPhase 3
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Coccyx Disorder, Neuropathic Pain
Not yet recruitingObservational study
Alexithymia, Pain Intensity, Quality of Life, and Psychological Symptoms in Chronic Coccydynia Patients Scheduled for Ganglion Impar Block
Coccydynia, Chronic Pain
RecruitingObservational study
Evaluation of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia
Chronic Coccydynia, Alexithymia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Humera Mubashar, Ms principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levator ani release and Post isometric relaxion in people with Coccydynia, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (NPRS) (time frame: 4th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06109077, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.