Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460623
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Brief Title:
Effect of Coccygeal Mobilization in Female With Coccydynia
Sponsor:
Riphah International University
Organization:
Riphah International University
Study Overview
Official Title:
Comparative Effects of External Versus Rectal Coccygeal Mobilization on Symptom Severity Disability Quality of Life in Female With Coccydynia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of the study to evaluate the impact of mobilization on symptom severity disability quality of life in female with Coccydynia
Detailed Description:
In 2024 conducted a study to investigate the efficacy of combining manipulation and exercise in the treatment of coccydynia Forty-six participants were split into two groups an experimental group that received manipulation in addition to exercise and a control group that received exercise only As opposed to the exercise-only group the manipulation groups members showed statistically significant reductions in pain coccydynia symptoms and disability scores at both the 6-month follow-up and immediately following treatment In particular there was a substantial drop in pain Visual Analog Scale scores from baseline to post-treatment p 0001 and these scores persisted at the 6-month follow-up p 0003 The manipulation group significantly reduced its Oswestry Disability Index scores from baseline to post-treatment p 0001 and these scores continued to decline at the 6-month follow-up p 0002 The Paris questionnaire scores for coccydynia symptoms also demonstrated a significant reduction in the manipulation group compared to the exercise-only group p 0007 These results imply that for patients with persistent coccydynia a brief course of intrarectal manipulation combined with exercise can significantly reduce pain and symptoms
In 2023 conducted a single-blind randomized controlled trial study to evaluate the efficacy of adding kinesiotaping versus pelvic floor exercise to conventional therapy in the management of post-colonoscopy coccydynia Forty-two participants aged 25-45 years were randomly assigned to the conventional therapy group CT receiving Piriformis and Iliopsoas muscle stretching exercise clamshell exercise and seat cushioning the CT plus kinesiotaping group CT-KT receiving additional kinesiotaping or the CT plus pelvic floor exercise PFE group CT-PFE executing additional PFE This study concluded thst CT-KT is more effective than CT-PFE in reducing pain associated with coccydynia post-colonoscopy but there is no difference in their effects on functional disability CT-KT is therefore recommended as an alternative treatment option for post-colonoscopy coccydynia
In 2023 looked into the effects of a multimodal therapy approach on postpartum coccydynia in their randomized control experiment 56 females aged 25-35 with a VAS score 6 and more than two childbirths were randomized into two groups the control group n 28 and the intervention group n 28 Heat therapy piriformis and iliopsoas muscle stretching and coccyx and sacroiliac joint mobilization were administered to the intervention group Comparing the treated group to the controls the results showed substantial improvements p005 in pain intensity VAS tenderness algometer and pain-free sitting duration Interestingly after treatment the intervention groups VAS ratings dropped from 687207 to 39137 while the controls values went from 68719 pre-study to 6218 post-study This study offers insights into a helpful treatment plan for pain reduction and recovery indicating that stretching joint mobilization and NSAIDs work well together to address postpartum Coccydynia
In 2023undertook a quality improvement QI study to assess the feasibility acceptability and therapeutic outcomes of transrectal osteopathic manipulative treatment OMT for persistent coccydynia in a primary care context The study treated and evaluated 16 patients with chronic coccydynia in a primary care outpatient clinic using transrectal OMT which included myofascial release and balanced ligamentous tension as well as active patient movement of the head and neck The study indicated that all 16 patients agreed to the OMT intervention with six additionally receiving extra procedural therapy Among the ten patients who only underwent OMT post-treatment scores immediately after one procedure acute model improved significantly as compared to pretreatment levelsThe mean pain scores on a 0-10 numerical rating scale NRS for coccydynia were reduced from 68 12 before treatment to 32 15 immediately after treatment Five patients pain levels at different intervals showed significant improvement with a mean drop to 24 16 The study indicated that transrectal OMT is a realistic and acceptable treatment option for coccydynia with patients reporting satisfaction and improvement
In 2022 conducted a prospective randomized studies to eevaluate the The Efficacy of Extracorporeal Shock Wave Therapy for Chronic Coccydynia Medical records of 34 patients 29 females 5 males who had been treated with ESWT between 2017 and 2018 for chronic coccydynia were evaluated Visual analog scale VAS scores were noted at the initial consultation at each session and during the initial and follow-up at 6 months examinations after the treatment This study concluded that ESWT provided effective pain control
In 2020 conducted a Randomized Clinical Trial on the Effect of Biofeedback on Pain and Quality of Life of Patients with Chronic Coccydynia In this study 30 women were randomized into two groups Both groups were injected with the corticosteroid One group received pelvic floor muscle exercises plus biofeedback while the other group only performed exercises The patients pain was measured using the Visual Analog Scale VAS in the first visit and after 1 2 and 6 months of follow-up as well as Dallas pain and SF-36 quality of life questionnaires before and 2 months after the treatment This study concluded that adding biofeedback to pelvic floor muscle exercises did not lead to any further improvement in the management of chronic coccydynia
In the 2020 aimed to evaluate the effectiveness of transrectal osteopathic manipulative treatment OMT for coccydynia and associated headaches The study involved a 20-year-old female with chronic coccydynia and headaches unresponsive to conventional treatments Following a fall and subsequent injuries during cheerleading the patient experienced persistent pain despite various therapies The transrectal OMT provided immediate and substantial relief in pain and associated symptoms which was sustained over a follow-up period of 26 months This case highlights the potential efficacy of transrectal OMT for coccydynia and suggests the need for further research on this treatment approach
In 2018treated 21 patients with combination therapy Group 1 and 23 with steroid injection alone Group 2 in a trial comparing manual therapy with steroid injection versus single steroid injection for persistent coccydynia With a mean follow-up period of 278 months the average age at the time of treatments was 305 years VAS scores dropped in both groups but the combination therapy groups outcomes were noticeably better Just 174 of Group 2 experienced complete pain alleviation compared to 619 of Group 1 Furthermore whereas Group 2 experienced 739 of reduced VAS scores but continued discomfort only 238 of Group 1 experienced this Group 2 had a relapse rate of 565 while Group 1 had no relapses The results were unaffected by variables including the underlying etiology BMI coccyx morphology or length of symptoms
Limited number of studies have been conducted regarding coccygeal mobilization in females with coccydynia Various methods of treating coccydynia are found in the literature but to our knowledge no research has been performed that compared the effectiveness of these interventions Due to low levels of evidence in the published studiesadditional research is needed regarding the treatment for this painful condition
In 2023 conducted a single-blind randomized controlled trial study to evaluate the efficacy of adding kinesiotaping versus pelvic floor exercise to conventional therapy in the management of post-colonoscopy coccydynia Forty-two participants aged 25-45 years were randomly assigned to the conventional therapy group CT receiving Piriformis and Iliopsoas muscle stretching exercise clamshell exercise and seat cushioning the CT plus kinesiotaping group CT-KT receiving additional kinesiotaping or the CT plus pelvic floor exercise PFE group CT-PFE executing additional PFE This study concluded thst CT-KT is more effective than CT-PFE in reducing pain associated with coccydynia post-colonoscopy but there is no difference in their effects on functional disability CT-KT is therefore recommended as an alternative treatment option for post-colonoscopy coccydynia
In 2023 looked into the effects of a multimodal therapy approach on postpartum coccydynia in their randomized control experiment 56 females aged 25-35 with a VAS score 6 and more than two childbirths were randomized into two groups the control group n 28 and the intervention group n 28 Heat therapy piriformis and iliopsoas muscle stretching and coccyx and sacroiliac joint mobilization were administered to the intervention group Comparing the treated group to the controls the results showed substantial improvements p005 in pain intensity VAS tenderness algometer and pain-free sitting duration Interestingly after treatment the intervention groups VAS ratings dropped from 687207 to 39137 while the controls values went from 68719 pre-study to 6218 post-study This study offers insights into a helpful treatment plan for pain reduction and recovery indicating that stretching joint mobilization and NSAIDs work well together to address postpartum Coccydynia
In 2023undertook a quality improvement QI study to assess the feasibility acceptability and therapeutic outcomes of transrectal osteopathic manipulative treatment OMT for persistent coccydynia in a primary care context The study treated and evaluated 16 patients with chronic coccydynia in a primary care outpatient clinic using transrectal OMT which included myofascial release and balanced ligamentous tension as well as active patient movement of the head and neck The study indicated that all 16 patients agreed to the OMT intervention with six additionally receiving extra procedural therapy Among the ten patients who only underwent OMT post-treatment scores immediately after one procedure acute model improved significantly as compared to pretreatment levelsThe mean pain scores on a 0-10 numerical rating scale NRS for coccydynia were reduced from 68 12 before treatment to 32 15 immediately after treatment Five patients pain levels at different intervals showed significant improvement with a mean drop to 24 16 The study indicated that transrectal OMT is a realistic and acceptable treatment option for coccydynia with patients reporting satisfaction and improvement
In 2022 conducted a prospective randomized studies to eevaluate the The Efficacy of Extracorporeal Shock Wave Therapy for Chronic Coccydynia Medical records of 34 patients 29 females 5 males who had been treated with ESWT between 2017 and 2018 for chronic coccydynia were evaluated Visual analog scale VAS scores were noted at the initial consultation at each session and during the initial and follow-up at 6 months examinations after the treatment This study concluded that ESWT provided effective pain control
In 2020 conducted a Randomized Clinical Trial on the Effect of Biofeedback on Pain and Quality of Life of Patients with Chronic Coccydynia In this study 30 women were randomized into two groups Both groups were injected with the corticosteroid One group received pelvic floor muscle exercises plus biofeedback while the other group only performed exercises The patients pain was measured using the Visual Analog Scale VAS in the first visit and after 1 2 and 6 months of follow-up as well as Dallas pain and SF-36 quality of life questionnaires before and 2 months after the treatment This study concluded that adding biofeedback to pelvic floor muscle exercises did not lead to any further improvement in the management of chronic coccydynia
In the 2020 aimed to evaluate the effectiveness of transrectal osteopathic manipulative treatment OMT for coccydynia and associated headaches The study involved a 20-year-old female with chronic coccydynia and headaches unresponsive to conventional treatments Following a fall and subsequent injuries during cheerleading the patient experienced persistent pain despite various therapies The transrectal OMT provided immediate and substantial relief in pain and associated symptoms which was sustained over a follow-up period of 26 months This case highlights the potential efficacy of transrectal OMT for coccydynia and suggests the need for further research on this treatment approach
In 2018treated 21 patients with combination therapy Group 1 and 23 with steroid injection alone Group 2 in a trial comparing manual therapy with steroid injection versus single steroid injection for persistent coccydynia With a mean follow-up period of 278 months the average age at the time of treatments was 305 years VAS scores dropped in both groups but the combination therapy groups outcomes were noticeably better Just 174 of Group 2 experienced complete pain alleviation compared to 619 of Group 1 Furthermore whereas Group 2 experienced 739 of reduced VAS scores but continued discomfort only 238 of Group 1 experienced this Group 2 had a relapse rate of 565 while Group 1 had no relapses The results were unaffected by variables including the underlying etiology BMI coccyx morphology or length of symptoms
Limited number of studies have been conducted regarding coccygeal mobilization in females with coccydynia Various methods of treating coccydynia are found in the literature but to our knowledge no research has been performed that compared the effectiveness of these interventions Due to low levels of evidence in the published studiesadditional research is needed regarding the treatment for this painful condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None