Health TrialsbyHealthPanel

The Effectiveness of Dextrose Prolotherapy in Patients With Coccydynia

ConditionCoccydynia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dextrose prolotherapy (DPT)

    Procedure/Surgery

    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.

  • Physiological Saline Injection

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Dextrose ProlotherapyActive comparator 1 intervention
Group B: Physiological SalineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog Scale

Pain intensity during sitting and activity

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

Secondary outcomes

1

Paris Functional Coccydynia Questionnaire

Functional status assessment

Time frame
Before treatment and at the 1st, 3rd, and 6th months after treatment
2

Visual Analog Scale-Global Assesment

Daily living activities and patient global assessment

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul University

Lead sponsor

Source ClinicalTrials.gov
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