Coccyx DisorderNCT06754033
Ganglion Impar Block With Physical Therapy vs Caudal Epidural Steroid Injection With PT for Patients With Coccydynia
A study testing Interventional group I and Interventional group II in people with Coccyx Disorder, run by Superior University at 1 site in Pakistan.
Trial summary
The study aims to evaluate the efficacy of two treatment modalities for patients suffering from coccydynia: Ganglion Impar Block (GIB) combined with physical therapy, and Caudal Epidural Steroid Injection (CESI) also accompanied by physical therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coccyx Disorder
- What is being tested?
- Interventional group I and Interventional group II
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients with age 18-65 diagnosed with chronic coccydynia for at least 3 months were recruited.
- Participants who will be willing \& able to adhere to the study protocol.
- Including participants who will be attending follow-up appointments \& completing outcome measures.
- Participants who will be able to understand \& provide written informed consent.
- Participants with a complete screening of other medical conditions and previous medical records.
Who cannot join
- Participants with previous surgery on the coccyx or lumbosacral spine, pregnancy or breastfeeding, history of bleeding disorders or anticoagulant use, active infection, or significant medical condition that could pose a safety risk during the procedures (GIB or CESI) was omitted.
- Patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes.
- Participants with neurological conditions affecting pain perception or sensation were excluded.
- Participants with known allergies to medications used in the study (local anesthetic, steroid for injections) were not part of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ganglion Impar Block With Physical Therapy Versus Caudal Epidural Steroid Injection With Physical Therapy for Patients With Coccydynia
The study aims to evaluate the efficacy of two treatment modalities for patients suffering from coccydynia: Ganglion Impar Block (GIB) combined with physical therapy, and Caudal Epidural Steroid Injection (CESI) also accompanied by physical therapy. Coccydynia, characterized by pain in the coccygeal region, can significantly impair daily functioning and quality of life.
Read the detailed description
Participants were assessed using various outcome measures, including the SF-12, Oswestry Disability Index (ODI), and Numeric Pain Rating Scale (NPRS). Data collection will occur at baseline and through four follow-up points over 16 weeks, allowing for a comprehensive evaluation of both immediate and long-term treatment effects. By comparing these two interventions, the study seeks to determine which approach yields superior results in alleviating pain and improving functional outcomes for patients with coccydynia, thereby contributing valuable insights into the management of this condition.
- Conditions
- Coccyx Disorder
- Being tested
- Interventional group I, Interventional group II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional group IDiagnostic test
Intervention Details: Participants in this arm will receive a Ganglion Impar Block, a minimally invasive injection aimed at blocking pain signals from the coccyx region (Ganglion Impar Block using Triamcinolone Acetate (40 mg) and Bupivacaine (0.25%) administered with a 22G Spinal Needle under Fluoroscopic Guidance). Participants in this arm will receive a Ganglion Impar Block, a minimally invasive procedure involving the administration of Triamcinolone Acetate (a corticosteroid) and Bupivacaine (a local anesthetic). This is intended to block pain signals originating from the coccyx region. The procedure will be conducted under fluoroscopic guidance to ensure precise delivery. The injection will be complemented by a structured physical therapy program, including heat therapy, ultrasound, posture training, core strengthening exercises, and mobility activities to improve pain relief and functional capacity.
Interventional group IICombination product
Intervention Details: Participants in this arm will receive a Caudal Epidural Steroid Injection Caudal Epidural Steroid Injection using Triamcinolone Acetate (40 mg), Bupivacaine (0.25%), and Normal Saline (6 mL) administered with a 22G Spinal Needle under Fluoroscopic Guidance), designed to deliver anti-inflammatory medication directly to the epidural space, thereby reducing inflammation and pain. This will also be paired with a tailored physical therapy program, focusing on similar modalities as in Arm 1, including heat therapy, ultrasound, posture training, and strengthening exercises. The objective is to enhance pain relief and functional recovery in the context of coccydynia.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group I | Experimental | Not described Receives: Diagnostic Test: Interventional group I |
| Interventional group II | Active comparator | Not described Receives: Combination Product: Interventional group II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Used as the primary outcome measure. Participants will rate their pain intensity on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. This measure will assess changes in pain levels from baseline through various follow-up points.
Measured: 12 Months
Oswestry Disability Index (ODI)
The Oswestry Disability Index will serve as the secondary outcome measure. This questionnaire evaluates the degree of disability experienced by participants due to their pain, focusing on various aspects of daily living and functional capacity. Additionally, the SF-12 health survey will be used to measure the overall health-related quality of life, providing further insights into the impact of the interventions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Feb 2024
- Primary completion1 Aug 2024
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coccyx DisorderStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754033
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/766
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ganglion Impar Block With Physical Therapy Versus Caudal Epidural Steroid Injection With Physical Therapy for Patients With Coccydynia
- ClinicalTrials.gov ID
- NCT06754033
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/766
- Conditions
- Coccyx Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 31 Dec 2024 (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 aims to evaluate the efficacy of two treatment modalities for patients suffering from coccydynia: Ganglion Impar Block (GIB) combined with physical therapy, and Caudal Epidural Steroid Injection (CESI) also accompanied by physical therapy. Coccydynia, characterized by pain in the coccygeal region, can significantly impair daily functioning and quality of life.
Detailed description
Participants were assessed using various outcome measures, including the SF-12, Oswestry Disability Index (ODI), and Numeric Pain Rating Scale (NPRS). Data collection will occur at baseline and through four follow-up points over 16 weeks, allowing for a comprehensive evaluation of both immediate and long-term treatment effects. By comparing these two interventions, the study seeks to determine which approach yields superior results in alleviating pain and improving functional outcomes for patients with coccydynia, thereby contributing valuable insights into the management of this condition.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group I | Experimental | Diagnostic Test: Interventional group I |
| Interventional group II | Active comparator | Combination Product: Interventional group II |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with age 18-65 diagnosed with chronic coccydynia for at least 3 months were recruited.
- Participants who will be willing \& able to adhere to the study protocol.
- Including participants who will be attending follow-up appointments \& completing outcome measures.
- Participants who will be able to understand \& provide written informed consent.
- Participants with a complete screening of other medical conditions and previous medical records.
Key exclusion criteria (4 listed)
- Participants with previous surgery on the coccyx or lumbosacral spine, pregnancy or breastfeeding, history of bleeding disorders or anticoagulant use, active infection, or significant medical condition that could pose a safety risk during the procedures (GIB or CESI) was omitted.
- Patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes.
- Participants with neurological conditions affecting pain perception or sensation were excluded.
- Participants with known allergies to medications used in the study (local anesthetic, steroid for injections) were not part of the study.
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 |
|---|---|---|
| Interventional group IIntervention Details: Participants in this arm will receive a Ganglion Impar Block, a minimally invasive injection aimed at blocking pain signals from the coccyx region (Ganglion Impar Block using Triamcinolone Acetate (40 mg) and Bupivacaine (0.25%) administered with a 22G Spinal Needle under Fluoroscopic Guidance). Participants in this arm will receive a Ganglion Impar Block, a minimally invasive procedure involving the administration of Triamcinolone Acetate (a corticosteroid) and Bupivacaine (a local anesthetic). This is intended to block pain signals originating from the coccyx region. The procedure will be conducted under fluoroscopic guidance to ensure precise delivery. The injection will be complemented by a structured physical therapy program, including heat therapy, ultrasound, posture training, core strengthening exercises, and mobility activities to improve pain relief and functional capacity. | Diagnostic test | Interventional group I |
| Interventional group IIIntervention Details: Participants in this arm will receive a Caudal Epidural Steroid Injection Caudal Epidural Steroid Injection using Triamcinolone Acetate (40 mg), Bupivacaine (0.25%), and Normal Saline (6 mL) administered with a 22G Spinal Needle under Fluoroscopic Guidance), designed to deliver anti-inflammatory medication directly to the epidural space, thereby reducing inflammation and pain. This will also be paired with a tailored physical therapy program, focusing on similar modalities as in Arm 1, including heat therapy, ultrasound, posture training, and strengthening exercises. The objective is to enhance pain relief and functional recovery in the context of coccydynia. | Combination product | Interventional group II |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 12 Months
Used as the primary outcome measure. Participants will rate their pain intensity on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. This measure will assess changes in pain levels from baseline through various follow-up points.
Oswestry Disability Index (ODI)
Time frame: 12 months
The Oswestry Disability Index will serve as the secondary outcome measure. This questionnaire evaluates the degree of disability experienced by participants due to their pain, focusing on various aspects of daily living and functional capacity. Additionally, the SF-12 health survey will be used to measure the overall health-related quality of life, providing further insights into the impact of the interventions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Coccyx Disorder
RecruitingPhase 3
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Coccyx Disorder, Neuropathic Pain
Not yet recruiting
Effect of Pelvic Floor Muscles Down Training on Postpartum Coccydynia
Tailbone Disorders
RecruitingObservational study
Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in Coccygodygnia
Coccyx Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional group I and Interventional group II in people with Coccyx Disorder, run by Superior University at 1 site in Pakistan.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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 Rating Scale (NPRS) (time frame: 12 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?
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 31 Dec 2024.