The Effectiveness of Dextrose Prolotherapy in Patients With Coccydynia

April 20, 2026 updated by: Ekin Ilke Sen, Istanbul University
In this prospective, randomized, controlled, double-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with coccydynia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be informed verbally and in writing about the purpose, duration, and procedure of the study, and their consent will be obtained by signing the "Informed Consent Form." The study aims to evaluate the effectiveness of dextrose prolotherapy applied in coccydynia. The duration of the study is determined to be approximately one year, and it is planned to include 40 patients who will be randomized by a computer program according to the order of application. Patients who meet the inclusion and exclusion criteria will be randomized into two groups. In the first group, in addition to protection recommendations, three sessions of dextrose prolotherapy will be administered at three-week intervals. In the second group, in addition to protection recommendations, three sessions of a superficial saline-lidocaine combination will be administered at three-week intervals. After the application, patients will be questioned for side effects and complications. The effectiveness of dextrose prolotherapy will be evaluated in comparison with the superficial saline-lidocaine combination group. Patients' medical histories will be taken, and demographic characteristics such as age, gender, height, weight, marital status, education level, and occupation will be recorded, along with medical histories such as comorbidities and previous treatments. In the physical examination, lumbar and sacroiliac tests will be applied, the sacrococcygeal region will be palpated, and the average and maximum levels of pain during activity, at rest, and at night will be assessed using the Visual Analog Scale (0-10 points). Functional status will be evaluated using the Paris Functional Coccydynia Questionnaire. Assessments will be conducted before treatment and at the 1st, 3rd, and 6th months after treatment.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
        • Contact:
        • Sub-Investigator:
          • Serhat Yavuz, MD
        • Sub-Investigator:
          • Yonca Baykut Cicek, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with coccydynia lasting longer than 6 months,
  • Those unresponsive to at least 6 months of conventional conservative treatment methods,
  • Those with coccygeal tenderness on palpation,
  • Patients aged between 18 and 65 years.

Exclusion Criteria:

  • Patients with a history of trauma within the last 3 months or postpartum coccydynia,
  • Those with lesions or infections at the injection site,
  • Those with dislocation or organic bone pathology of the coccyx observed on X-ray imaging,
  • Those with fecal or urinary incontinence,
  • Patients with poorly controlled diabetes mellitus,
  • Those with a history of malignancy,
  • Patients with a bleeding tendency (acquired or hereditary) [INR > 2 in patients using warfarin],
  • Those with a history of myelomeningocele,
  • Those diagnosed with spina bifida,
  • Patients with rheumatologic disease,
  • Those who have undergone coccyx injection or ganglion block within the last 3 months,
  • Patients with severe comorbidities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Dextrose Prolotherapy
Coccyx injection: Using a sterile 27-gauge syringe (dental needle), a total of 10 cc of solution (5 cc of 30% dextrose + 4 cc of physiological saline + 1 cc of 1% lidocaine solution) will be injected perpendicularly to the surface at the previously marked attachment points of the sacrococcygeal-sacro-tuberous ligaments to the sacrum and along the entire coccyx.
Procedure: Dextrose prolotherapy (DPT)
Coccyx injection: Using a sterile 27-gauge syringe (dental needle), a total of 10 cc of solution (5 cc of 30% dextrose + 4 cc of physiological saline + 1 cc of 1% lidocaine solution) will be injected perpendicularly to the surface at the previously marked attachment points of the sacrococcygeal-sacro-tuberous ligaments to the sacrum and along the entire coccyx.
Active Comparator: Physiological Saline
Saline + lidocaine group injection protocol: Using a sterile 30-gauge syringe (insulin needle), a total of 10 cc of solution (5 cc of physiological saline + 5 cc of 1% lidocaine solution) will be injected into the previously marked tendon attachment points on the bone.
Procedure: Physiological Saline Injection
Saline + lidocaine group injection protocol: Using a sterile 30-gauge syringe (insulin needle), a total of 10 cc of solution (5 cc of physiological saline + 5 cc of 1% lidocaine solution) will be injected into the previously marked tendon attachment points on the bone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Before treatment, and at the 1st, 3rd, and 6th months following treatment
Pain intensity during sitting and activity
Before treatment, and at the 1st, 3rd, and 6th months following treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paris Functional Coccydynia Questionnaire
Time Frame: Before treatment and at the 1st, 3rd, and 6th months after treatment
Functional status assessment
Before treatment and at the 1st, 3rd, and 6th months after treatment
Visual Analog Scale-Global Assesment
Time Frame: before treatment, and at the 1st, 3rd, and 6th months following treatment
Daily living activities and patient global assessment
before treatment, and at the 1st, 3rd, and 6th months following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Ekin I Sen, Assoc.Prof., Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2025

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IstanbulU-2022-77979112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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