Effects of Primal Reflex Release Technique on Pain, Range of Motion and Quality of Life in Post Colonoscopy Coccydynia

NCT07438483 | Completed

• 1 other identifier: REC/RCR & AHS/24/01114
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The study was conducted to determine the effects of primal reflex release technique on pain, range of motion and quality of life in post colonoscopy coccydynia

Conditions

Disability and Pain Around the Coccyx; Diagnosed With Coccydynia

Keywords

Post-colonoscopy Coccydynia; Primal reflex release technique; Pain around coccyx; Numeric Pain Rating Scale

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rate Scale (NPRS)

  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)

  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

Study Arms (2)

Primal reflex release technique

EXPERIMENTAL

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: Primal Reflex Release Technique

Standardized Physiotherapy Treatment

OTHER

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.

Other: Standardized Physiotherapy Treatment

Interventions

Primal Reflex Release Technique OTHER

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.

Also known as: Experimental

Primal reflex release technique

Standardized Physiotherapy Treatment OTHER

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international university

Lahore, Punjab Province, Pakistan

Location

Related Publications (10)

• Iams JJAPTRM. When reflexes rule: A new paradigm in understanding why some patients don't get well. 2005;16(3):41.

  BACKGROUND

• Bertoti DBJ. Functional neurorehabilitation: through the life span. 2004.

  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

• 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.

  PMID: 23212432 BACKGROUND

• Izci EK, Keskin F. Coccygectomy for coccygodynia: A single-center experience. Medicine (Baltimore). 2023 Jun 2;102(22):e33606. doi: 10.1097/MD.0000000000033606.

  PMID: 37266613 BACKGROUND

• 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.

  PMID: 21597433 BACKGROUND

• 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.

  PMID: 14753797 BACKGROUND

• 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.

  PMID: 16394915 BACKGROUND

• Schapiro SJTAJoS. Low back and rectal pain from an orthopedic and proctologic viewpoint with a review of 180 cases. 1950;79(1):117-28.

  BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Shanza Mahmood, MS-OMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 46 patients were assessed for eligibility criteria by using non-probability consecutive random sampling technique. The participants were randomly allocated into two groups: Group A and Group B. Both groups received standardized as common treatment. Group A received PRRT of coccygeal area and pelvic for three times per week for a total of four weeks. Group B received standardized physiotherapy treatment three times per week for four weeks.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: January 6, 2025
• Primary Completion: October 10, 2025
• Study Completion: November 2, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)