The Effectiveness of Dextrose Prolotherapy in Patients With Coccydynia

NCT07552298 | Recruiting

• 1 other identifier: IstanbulU-2022-77979112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, randomized, controlled, double-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with coccydynia.

Conditions

Coccydynia

Keywords

prolotherapy; coccydynia

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  Pain intensity during sitting and activity

  Before treatment, and at the 1st, 3rd, and 6th months following treatment

Secondary Outcomes (2)

• Paris Functional Coccydynia Questionnaire

  Before treatment and at the 1st, 3rd, and 6th months after treatment

• Visual Analog Scale-Global Assesment

  before treatment, and at the 1st, 3rd, and 6th months following treatment

Study Arms (2)

Dextrose Prolotherapy

ACTIVE COMPARATOR

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)

Physiological Saline

ACTIVE COMPARATOR

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

Interventions

Dextrose prolotherapy (DPT) PROCEDURE

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.

Dextrose Prolotherapy

Physiological Saline Injection PROCEDURE

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.

Physiological Saline

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

• Ekin I Sen, Assoc.Prof.

  Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ekin I Sen, Assoc.Prof.

CONTACT

+902124142000; ekinozgorgu@gmail.com

Serhat Yavuz

CONTACT

serhatyavz@gmail.com

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 27, 2026
• Study Start: June 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: April 27, 2026

Record last verified: 2025-11

Locations

TU (1)