Disability and Pain Around the CoccyxNCT07438483

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

A study testing Primal Reflex Release Technique and Standardized Physiotherapy Treatment in people with Disability and Pain Around the Coccyx and Diagnosed With Coccydynia, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Disability and Pain Around the Coccyx, Diagnosed With Coccydynia
What is being tested?: Primal Reflex Release Technique and Standardized Physiotherapy Treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 sitePakistan
Study dates: 6 Jan 2025to 2 Nov 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Riphah international university
Lahore, Punjab Province

Other trials in Pakistan

About this study

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
Being tested: Primal Reflex Release Technique, Standardized Physiotherapy Treatment
Keywords: Post-colonoscopy Coccydynia, Primal reflex release technique, Pain around coccyx, Numeric Pain Rating Scale

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Primal Reflex Release TechniqueOther
Also called 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.
Standardized Physiotherapy TreatmentOther
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.

Study groups in NCT07438483
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Standardized Physiotherapy Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: From enrollment to the end of treatment in 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 20252 Nov 2025

First posted27 Feb 2026
Study start6 Jan 2025
Primary completion10 Oct 2025
Study completion2 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Disability and Pain Around the CoccyxStudies of the same condition, open and under way.
More trials run by Riphah International UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07438483
Sponsor's protocol ID: REC/RCR & AHS/24/01114
Status last verified: Feb 2026
First submitted: 23 Feb 2026
Last updated: 27 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
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.
PubMed 16915077
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.
PubMed 23212432
Izci EK, Keskin F. Coccygectomy for coccygodynia: A single-center experience. Medicine (Baltimore). 2023 Jun 2;102(22):e33606. doi: 10.1097/MD.0000000000033606.
PubMed 37266613
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.
PubMed 21597433
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.
PubMed 14753797
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.
PubMed 16394915
SCHAPIRO S. Low back and rectal pain from an orthopedic and proctologic viewpoint; with a review of 180 cases. Am J Surg. 1950 Jan;79(1):117-28, illust. doi: 10.1016/0002-9610(50)90202-9. No abstract available.
PubMed 15399361
Lirette LS, Chaiban G, Tolba R, Eissa H. Coccydynia: an overview of the anatomy, etiology, and treatment of coccyx pain. Ochsner J. 2014 Spring;14(1):84-7.
PubMed 24688338

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Primal Reflex Release Technique on Pain, Range of Motion and Quality of Life in Post Colonoscopy Coccydynia
ClinicalTrials.gov ID: NCT07438483
Acronym / sponsor ID: REC/RCR & AHS/24/01114
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 6 Jan 2025 (actual)
Primary completion: 10 Oct 2025 (actual)
Study completion: 2 Nov 2025 (actual)
First posted: 27 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Primal reflex release technique	Experimental	Other: Primal Reflex Release TechniquePrimal 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.
Standardized Physiotherapy Treatment	Other	Other: Standardized Physiotherapy TreatmentStandardized 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (8 listed)

Diabetes mellitus
Any malignancy
Active infection
Cyst or cancer in the pelvic region.
Previous coccygeal surgery or trauma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Primal Reflex Release TechniqueAlso: ExperimentalPrimal 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 TreatmentStandardized 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

Primary outcome

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
BackgroundIams JJAPTRM. When reflexes rule: A new paradigm in understanding why some patients don't get well. 2005;16(3):41.
BackgroundBertoti DBJ. Functional neurorehabilitation: through the life span. 2004.
Background: PubMed 16915077Maigne 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.
Background: PubMed 23212432Emerson 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.
Background: PubMed 37266613Izci EK, Keskin F. Coccygectomy for coccygodynia: A single-center experience. Medicine (Baltimore). 2023 Jun 2;102(22):e33606. doi: 10.1097/MD.0000000000033606.
Background: PubMed 21597433Maigne 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.
Background: PubMed 14753797Fogel 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.
Background: PubMed 16394915Pennekamp 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.
Background: PubMed 15399361SCHAPIRO S. Low back and rectal pain from an orthopedic and proctologic viewpoint; with a review of 180 cases. Am J Surg. 1950 Jan;79(1):117-28, illust. doi: 10.1016/0002-9610(50)90202-9. No abstract available.
Background: PubMed 24688338Lirette LS, Chaiban G, Tolba R, Eissa H. Coccydynia: an overview of the anatomy, etiology, and treatment of coccyx pain. Ochsner J. 2014 Spring;14(1):84-7.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shanza Mahmood, MS-OMPT principal investigator

Riphah International University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rate Scale (NPRS) (time frame: From enrollment to the end of treatment in 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07438483, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.