- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438483
Effects of Primal Reflex Release Technique on Pain, Range of Motion and Quality of Life in Post Colonoscopy Coccydynia
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age group 18-65 year (26)
- Both gender (male and female)
- Diagnosed with coccydynia post colonoscopy.
- Pain in and around the coccyx area without palpation, radiation and tenderness.
- No history of significant trauma to the coccyx.
- Difficulty in pain-free sitting for long duration.
Exclusion Criteria:
- Diabetes mellitus
- Any malignancy
- Active infection
- Cyst or cancer in the pelvic region.
- Previous coccygeal surgery or trauma.
- Pregnancy or breastfeeding.
- Major ligament injuries in the pelvic region.
- Neurological disorders affecting pain perception.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Primal reflex release technique
Primal Reflex Release Techniques (3 sets of 10 repetitions) that includes the initial assessment to evaluate pain and Rom . PRRT techniques of coccygeal area and pelvic (10-15 minutes) And post treatment evaluation to reassess. |
Primal Reflex Release Techniques (3 sets of 10 repetitions) that includes the initial assessment to evaluate pain and Rom.
PRRT techniques of coccygeal area and pelvic (10-15 minutes) And post treatment evaluation to reassess.
Other Names:
|
|
Other: Standardized Physiotherapy Treatment
Standardized Physiotherapy treatment was included hot pack for 10 minutes, Hip flexors and pelvic muscles stretching for 3 times with 30 seconds and core stability exercises of pelvic tilts and bridges for 2 sets of 10 seconds. Both groups came thrice per week for a total of 4 weeks. Pre and post treatment values of both groups were analyzed. |
Standardized Physiotherapy treatment was included hot pack for 10 minutes, Hip flexors and pelvic muscles stretching for 3 times with 30 seconds and core stability exercises of pelvic tilts and bridges for 2 sets of 10 seconds.
Both groups came thrice per week for a total of 4 weeks.
Pre and post treatment values of both groups were analyzed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rate Scale (NPRS)
Time Frame: From enrollment to the end of treatment in 10 months
|
Patient's pain was summarized using numerical scale.
It has numbers from 0 to 10.
Where 0 is equal to "no pain" and 10 is equal to "worst pain".
This scale has high test-retest reliability of r = 0.96 and 0.95, respectively.
|
From enrollment to the end of treatment in 10 months
|
|
Manual Muscle Testing (MMT)
Time Frame: From enrollment to the end of treatment in 10 months
|
Manual muscle testing was used to assess muscle strength.
Which can be scored using a 0-10 points using Kendal 10-point muscle strength scale.
MMT is the most commonly used method for documenting impairments in muscle strength in both spine and periphery with a kappa value 0.88.
|
From enrollment to the end of treatment in 10 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shanza Mahmood, MS-OMPT, Riphah International University
Publications and helpful links
General Publications
- 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.
- Fogel GR, Cunningham PY 3rd, Esses SI. Coccygodynia: evaluation and management. J Am Acad Orthop Surg. 2004 Jan-Feb;12(1):49-54. doi: 10.5435/00124635-200401000-00007.
- Iams JJAPTRM. When reflexes rule: A new paradigm in understanding why some patients don't get well. 2005;16(3):41.
- Bertoti DBJ. Functional neurorehabilitation: through the life span. 2004.
- Emerson SS, Speece AJ 3rd. Manipulation of the coccyx with anesthesia for the management of coccydynia. J Am Osteopath Assoc. 2012 Dec;112(12):805-7.
- Izci EK, Keskin F. Coccygectomy for coccygodynia: A single-center experience. Medicine (Baltimore). 2023 Jun 2;102(22):e33606. doi: 10.1097/MD.0000000000033606.
- Maigne JY, Pigeau I, Aguer N, Doursounian L, Chatellier G. Chronic coccydynia in adolescents. A series of 53 patients. Eur J Phys Rehabil Med. 2011 Jun;47(2):245-51.
- Pennekamp PH, Kraft CN, Stutz A, Wallny T, Schmitt O, Diedrich O. Coccygectomy for coccygodynia: does pathogenesis matter? J Trauma. 2005 Dec;59(6):1414-9. doi: 10.1097/01.ta.0000195878.50928.3c.
- Schapiro SJTAJoS. Low back and rectal pain from an orthopedic and proctologic viewpoint with a review of 180 cases. 1950;79(1):117-28.
- Lirette LS, Chaiban G, Tolba R, Eissa HJOJ. Coccydynia: an overview of the anatomy, etiology, and treatment of coccyx pain. 2014;14(1):84-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/RCR & AHS/24/01114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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