Coccyx InjuryNCT05753514
Radial Extracorporeal Shockwave Therapy (rESWT) for Coccydynia: a Quasi-experimental Case Series
A study testing ESWT in people with Coccyx Injury, run by Barts & The London NHS Trust.
Trial summary
The aim of this study was to assess whether a pain-adapted protocol of rESWT is effective in treating coccydynia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coccyx Injury
- What is being tested?
- ESWT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- VAS pain level ≥6
- Diagnosis of coccydynia (persistent pain in the coccygeal area consistent with coccydynia)
Who cannot join
- Age <18 years
- Local or systemic neurological disease
- Rheumatological disease
- Malignant disease
- Previous spinal surgery or spinal disease
- Coagulopathies
Show all 9Show fewer
- Pregnancy
- VAS pain level <6
- Recent (≤6 weeks) trauma to the coccyx
About this study
The aim of this study was to assess whether a pain-adapted protocol of rESWT is effective in treating coccydynia.
- Conditions
- Coccyx Injury
- Being tested
- ESWT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWTOther
ESWT
| Study group | Role | What they receive |
|---|---|---|
| ESWT | Experimental | Effect of ESWT in alleviating pain Receives: Other: ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of coccydynia
Management of coccydynia (pain in the coccyx). The main presenting symptom is pain. its management is the primary goal of treatment. The pain VAS was used to monitor patient response and clinical improvement throughout treatment, with patients ranking the severity of their pain at rest, between "no pain" (0) and "worst imaginable pain" (10). Patients were asked their pain level before treatment at each session; although, this did not form part of our formal data collection. Treatment continued until patients reported a VAS pain level ≤3, at which point they were discharged from the clinic.
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 posted3 Mar 2023
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coccyx InjuryStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kabir Singh Lota, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753514
- Sponsor's protocol ID
- 2016-09
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Extracorporeal Shockwave Therapy (rESWT) for Coccydynia: a Quasi-experimental Case Series
- ClinicalTrials.gov ID
- NCT05753514
- Acronym / sponsor ID
- 2016-09
- Conditions
- Coccyx Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Mar 2023 (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 aim of this study was to assess whether a pain-adapted protocol of rESWT is effective in treating coccydynia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESWT | Experimental | Other: ESWTEffect of ESWT in alleviating pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- VAS pain level ≥6
- Diagnosis of coccydynia (persistent pain in the coccygeal area consistent with coccydynia)
Key exclusion criteria (9 listed)
- Age <18 years
- Local or systemic neurological disease
- Rheumatological disease
- Malignant disease
- Previous spinal surgery or spinal disease
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 |
|---|---|---|
| ESWTESWT | Other | ESWT |
Primary outcome
Management of coccydynia
Time frame: 12 months
Management of coccydynia (pain in the coccyx). The main presenting symptom is pain. its management is the primary goal of treatment. The pain VAS was used to monitor patient response and clinical improvement throughout treatment, with patients ranking the severity of their pain at rest, between "no pain" (0) and "worst imaginable pain" (10). Patients were asked their pain level before treatment at each session; although, this did not form part of our formal data collection. Treatment continued until patients reported a VAS pain level ≤3, at which point they were discharged from the clinic.
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 31 Mar 2023.
- Individual participant dataSharing planned: Yes
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.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT in people with Coccyx Injury, run by Barts & The London NHS Trust.
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 3 inclusion and 9 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Management of coccydynia (time frame: 12 months). 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 Mar 2023.