Effect of Coccygeal Mobilization in Female With Coccydynia

NCT06460623 | Not Yet Recruiting

• 1 other identifier: REC/RCR&AHS/23/0565
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study to evaluate the impact of mobilization on symptom severity, disability \& quality of life in female with Coccydynia.

Conditions

Coccyx Disorder

Keywords

Coccyx,; Disability; Manipulation

Outcome Measures

Primary Outcomes (3)

• Paris Scale Questionnaire

  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.

  4th week

• DALLAS Pain Questionnaire

  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.

  4th week

• SF-36 Questionnaire in Urdu version

  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)

  4th week

Study Arms (2)

(external coccygeal mobilization+ stretching

EXPERIMENTAL

Patients lying prone received external mobilization as part of the study. Contact was made with the sacrospinous ligament and all soft tissue on the opposite side (e.g., if the coccyx was bent to the right, contact was made on the left). If the coccyx was bent to one side, the slack was taken up and stretched for five minutes. The manipulation group underwent two 5-minute sessions of external manipulation per week over a 5-week period.Burst TENS, which administers bursts of high-frequency pulses at a low frequency (less than 10 Hz), accompanied by a 10-minute application of a hot pack. Furthermore, muscle stretching, targeting the iliopsoas and piriformis, was conducted with a 30-second hold, comprising three sets of five repetitions per set.

Other: external mobilization

internal coccygeal mobilization+ stretching

ACTIVE COMPARATOR

. The investigator inserted the gloved and lubricated index finger of their right hand into the anal passage. The thumb of the investigator's other hand, also gloved but not lubricated, was placed on the dorsum of the coccyx to establish a good grasp between the two fingers. The technique involved distracting the coccyx along its long axis during the initial treatments,to correct alignment using controlled force in the coronal plane. The treatment consisted of two 5-minute sessions of external manipulation per week over a 5-week period.Burst TENS,less than 10 Hz accompanied by a 10-minute application of a hot pack. Furthermore, muscle stretching, targeting the iliopsoas and piriformis, was conducted with a 30-second hold, comprising three sets of five repetitions per set.

Other: rectal coccygeal mobilization

Interventions

external mobilization OTHER

two 5-minute sessions of external manipulation per week over a 5-week period.

(external coccygeal mobilization+ stretching

rectal coccygeal mobilization OTHER

consisted of two 5-minute sessions of external manipulation per week over a 5-week period.

internal coccygeal mobilization+ stretching

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Hafizabad Road

Gujranwala, Punjab Province, 50250, Pakistan

Location

Related Publications (6)

• Nathan ST, Fisher BE, Roberts CS. Coccydynia: a review of pathoanatomy, aetiology, treatment and outcome. J Bone Joint Surg Br. 2010 Dec;92(12):1622-7. doi: 10.1302/0301-620X.92B12.25486.

  PMID: 21119164 BACKGROUND

• Alhomedha G, Citaker S, Gunaydin G, Khan F, Sezer R. Reliability and validation of Turkish version of the Dallas Pain Questionnaire. Agri. 2022 Jan;34(1):16-22. doi: 10.14744/agri.2021.24861.

  PMID: 34988958 BACKGROUND

• Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Zaheer A. Translation, cross-cultural adaptation, and psychometric properties of the Urdu version of Rand Short Form 36-item survey (SF-36) among patients with lumbar radiculopathy. J Bodyw Mov Ther. 2022 Oct;32:176-182. doi: 10.1016/j.jbmt.2022.05.003. Epub 2022 May 18.

  PMID: 36180146 BACKGROUND

• Mohanty PP, Pattnaik M. Effect of stretching of piriformis and iliopsoas in coccydynia. J Bodyw Mov Ther. 2017 Jul;21(3):743-746. doi: 10.1016/j.jbmt.2017.03.024. Epub 2017 Mar 29.

  PMID: 28750995 BACKGROUND

• Lee SH, Yang M, Won HS, Kim YD. Coccydynia: anatomic origin and considerations regarding the effectiveness of injections for pain management. Korean J Pain. 2023 Jul 1;36(3):272-280. doi: 10.3344/kjp.23175.

  PMID: 37394271 BACKGROUND

• Maigne JY, Chatellier G, Faou ML, Archambeau M. The treatment of chronic coccydynia with intrarectal manipulation: a randomized controlled study. Spine (Phila Pa 1976). 2006 Aug 15;31(18):E621-7. doi: 10.1097/01.brs.0000231895.72380.64.

  PMID: 16915077 BACKGROUND

Study Officials

• Hafiza Neelam

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Imran Amjad, PHD

CONTACT

051-5481826; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)