Botox injektion in the hip joint for pain relief and diagnosis of pain lokalisation. To seeifthe pain comes from the hipjoint or from the surrounding structures and tissue.

Botox injektion in the hip joint for pain relief and diagnosis of pain lokalisation. - Botox injektion in the hip joint for pain relief and diagnosis of pain lokalisation.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004488-33-DK

Enrollment

Registered

2019-12-01

Start date

2020-01-30

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hip pain 6 month after operation with periacetabular osteotomi for dysplastic hip. MedDRA version: 20.0 Level: LLT Classification code 10063175 Term: Hip dysplasia System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10033432 Term: Pain in hip System Organ Class: 100000004859

Interventions

Trade Name: Botox Product Name: Botox Pharmaceutical Form: Concentrate and solvent for solution for injection CAS Number: 93384-43-1 Current Sponsor code: BOTULINUM TOXIN TYPE A Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Dysplastic hip patients with hip pain 6 month after periacetabular osteotomy with ease of pain after intraarticular injection of lidocaine. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Neuromuscular disease Allergi to Botox, lidocaine or NaCl Bodymass index above 35 Patients who can not be expected to meet at the controls and report the effect.

Design outcomes

Primary

Measure	Time frame
Main Objective: Pain measured on VAS score scale 1,2 and 6 weeks after intraarticular injection of Botox in the painfull hipjoint. Change of Hagos and iHOT 12 score 6 from day 0 to 6 weeks after intraarticular injection of Botox in the painfull hipjoint. ;Secondary Objective: Change of Hagos and iHOT 12 score 6 from day 0 to 6 weeks after intraarticular injection of Botox in the painfull hipjoint. Registation of side effects. Registation of numberog patients with pain relief;Primary end point(s): Pain measured as VAS score 1,2and 6 weeks after the intraarticular injection of Botox in the painfull hip. Change in Hagos and iHOT 12 score 6 weeks after intraarticular injection of Botox n the hip. ;Timepoint(s) of evaluation of this end point: Pain measured as VAS score 1,2and 6 weeks after the intraarticular injection of Botox in the painfull hip. Change in Hagos and iHOT 12 score 6 weeks after intraarticular injection of Botox n the hip.	—

Measure

Time frame

Main Objective: Pain measured on VAS score scale 1,2 and 6 weeks after intraarticular injection of Botox in the painfull hipjoint. Change of Hagos and iHOT 12 score 6 from day 0 to 6 weeks after intraarticular injection of Botox in the painfull hipjoint. ;Secondary Objective: Change of Hagos and iHOT 12 score 6 from day 0 to 6 weeks after intraarticular injection of Botox in the painfull hipjoint. Registation of side effects. Registation of numberog patients with pain relief;Primary end point(s): Pain measured as VAS score 1,2and 6 weeks after the intraarticular injection of Botox in the painfull hip. Change in Hagos and iHOT 12 score 6 weeks after intraarticular injection of Botox n the hip. ;Timepoint(s) of evaluation of this end point: Pain measured as VAS score 1,2and 6 weeks after the intraarticular injection of Botox in the painfull hip. Change in Hagos and iHOT 12 score 6 weeks after intraarticular injection of Botox n the hip.

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Secondary

Measure	Time frame
Secondary end point(s): Change in Hagos and iHOT 12 score 6 weeks after intraarticular injection of Botox n the hip. Side effects of the treatment until 6 month after the injection of Botox in the painfull hip. Number of patient with effect after 6 weeks. ;Timepoint(s) of evaluation of this end point: Change in Hagos and iHOT 12 score 6 weeks after intraarticular injection of Botox n the hip. Side effects of the treatment until 6 month after the injection of Botox in the painfull hip. Number of patient with effect after 6 weeks.	—

Measure

Time frame

Secondary end point(s): Change in Hagos and iHOT 12 score 6 weeks after intraarticular injection of Botox n the hip. Side effects of the treatment until 6 month after the injection of Botox in the painfull hip. Number of patient with effect after 6 weeks. ;Timepoint(s) of evaluation of this end point: Change in Hagos and iHOT 12 score 6 weeks after intraarticular injection of Botox n the hip. Side effects of the treatment until 6 month after the injection of Botox in the painfull hip. Number of patient with effect after 6 weeks.

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Countries

Denmark

Contacts

Public ContactRøntgen og skanning

Silkeborg Regionshospital

nb@dadlnet.dk+4578417500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026