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Clinical Trials/NCT06460623
NCT06460623Not yet recruitingNot Applicable

Comparative Effects of External Versus Rectal Coccygeal Mobilization on Symptom Severity, Disability & Quality of Life in Female With Coccydynia

Riphah International University2 sites in 1 country34 target enrollmentStarted: June 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
34
Locations
2
Primary Endpoint
SF-36 Questionnaire in Urdu version

Study Overview

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 group's 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 < 0.001), and these scores persisted at the 6-month follow-up (p = 0.003). The manipulation group significantly reduced its Oswestry Disability Index scores from baseline to post-treatment (p < 0.001), and these scores continued to decline at the 6-month follow-up (p = 0.002). The Paris questionnaire scores for coccydynia symptoms also demonstrated a significant reduction in the manipulation group compared to the exercise-only group (p = 0.007). 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 (p<0.05) in pain intensity (VAS), tenderness (algometer), and pain-free sitting duration. Interestingly, after treatment, the intervention group's VAS ratings dropped from 6.87±2.07 to 3.9±1.37, while the controls' values went from 6.87±1.9 (pre-study) to 6.2±1.8 (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 2023,undertook 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 levels.The mean pain scores on a 0-10 numerical rating scale (NRS) for coccydynia were reduced from 6.8 ± 1.2 before treatment to 3.2 ± 1.5 immediately after treatment. Five patients' pain levels at different intervals showed significant improvement, with a mean drop to 2.4 ± 1.6. 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 .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
35 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient with coccygeal pain for more than 3 months
  • Diagnosed patients of Coccydynia.
  • Pain from the pericoccygeal soft tissues
  • Pelvic floor muscle spasm, referred pain from lumbar pathology.

Exclusion Criteria

  • Patient with local infection (inflammatory bowel disease or psoriasis)
  • Patient who undergone cocygectomy, sacroccygeal joint fusion, bleeding disorder and pregnancy.
  • Spinal surgery
  • Fracture of coccyx
  • Having any psychological issue

Outcomes

Primary Outcomes

SF-36 Questionnaire in Urdu version

Time Frame: 4th week

The SF-36-U is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health. SF-36-U presented good to excellent test-retest reliability for all eight domains (ICC2,1 = 0.75-0.92. Internal consistency for all domains (Cronbach's alpha = 0.73- 0.90)

Paris Scale Questionnaire

Time Frame: 4th week

The Paris Questionnaire was specifically designed for coccydynia. It covers, specifically, the functional aspects of the pain, which are not assessed by the other two questionnaires. It explores the pain when sitting (and differs, in this respect, from the VAS, which only measures the intensity of the pain), when passing from sitting to standing (very specific of coccydynia with radiologic findings), when walking and at night (pain on these occasions is frequent in severe coccydynia), and when traveling (the most sensitive detector of coccygeal pain). This set of three questionnaires offers a correct representation of the pain impact in chronic coccydynia.

DALLAS Pain Questionnaire

Time Frame: 4th week

The Dallas Pain Questionnaire (DPQ), which is a 16-item visual analog tool was developed by Lawlis, McCoy, and Selby (appendix) for the purpose of evaluating subject's cognitions about the percentage that chronic pain affects four aspects of the patients' lives: 1) daily activities including pain and intensity, personal care, lifting, walking, sitting, standing, and sleeping; 2) work and leisure activities including social life, travelling, and vocational; 3) anxiety-depression and 4) social interest that includes interpersonal relationship, social support, and punishing responses. Each question asks the responder to rate their experience with different activities using a percentage scale from 0% to 100%. Retest reliability of DALLAS Pain Questionnaire is 0.970.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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