Clinical trial NCT02839785: Analgesia and Physiotherapy in Children With Cerebral Palsy (ANTALKINECP)
Official title: Analgesia and Physiotherapy in Children With Cerebral Palsy (ANTALKINECP): Double Blind Cross-over Placebo Controlled Study of Ibuprofen in Children With Cerebral Palsy Undergoing Physiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Physiotherapy
Children
Ibuprofen
Pain
Anxiety
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 3
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: SPARCLE 1 and 2 studies followed a cohort of 818 children with cerebral palsy (CP) between 8 and 12 (SPARCLE 1) and 13 and 18 years old (SPARCLE 2) interviewed at home. The prevalence of pain in these populations was respectively 60 and 69% while it is about 35% in typically developed children of the same age.

The main location of the pain for 60% of children with CP was the lower limbs, caused by musculoskeletal pain and movement (for those who can) and therapeutic procedures. In SPARCLE 2, 50% of the children complained about pain during physical therapy.

If the pain is part of the management of physiotherapy, a recent review showed that for a condition such as chronic back pain, the level of evidence of the effectiveness of physiotherapy techniques in reducing pain is low. The effectiveness of these techniques would include higher efficacy on anxiety than pain itself.

Despite significant involvement of physiotherapists in the management of pain, the focus on pain should increase, in particular taking into account the procedural/induced pain (caused by treatment).

In addition to drugs, physical methods (analgesic therapy) or psychotherapy are used to reduce the pain of children during medical procedures. For the latter most of them require the presence of two individuals to provide the therapy. This is unsuited for out-patient care provided to the majority of children with CP.

Non steroid anti-inflammatory drug (NSAIDs), are first recommended, alone or in combination with the treatment of several indications in child pain (migraine, postoperative pain, etc.). Ibuprofen is commonly used in children during painful procedures and represented the 4th molecule among prescribed per os analgesic drugs in 2008 in the United States.


Eligibility criteria: Inclusion Criteria:

* Cerebral palsy hemiplegic diplegic or tetraplegic spastic or not.
* Children who feel pain during the pre-screening physiotherapy session with a VAS score above 2.
* Aged 6 to 17 years of both gender.
* Ability to express his/her pain and to measure its intensity with VAS.
* Informed and signed (parents, investigator and child if possible).

Exclusion Criteria:

* Lack of physiotherapy.
* Analgesic treatment already available or stopped in the last month.
* Scheduled surgery procedure or botulinum toxin injection during the period of the assessment of pain (around 5 month)
* The last botulinum toxin injection in two months before the inclusion
* Child who feel pain with EVA score superior or equal to 4 at the time of the inclusion outside the sessions of physiotherapy
* Child unable to cooperate.
* Severe infection or instable vital functions.
* Hypersensitivity to ibuprofen or any of the constituents in the product.
* History of allergy or asthma triggered by taking ibuprofen or substances of near activity such as other NSAIDs and aspirin.
* Allergy to other component of treatment.
* History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
* Active gastrointestinal ulcer.
* Severe hepatic failure.
* Severe renal failure.
* Uncontrolled severe cardiac failure.
* Systemic Lupus Erythematosus.
* Regular intake of ibuprofen

Randomisation Criteria:

• Child who feel pain during the physiotherapy session with a mean VAS score above 3 during the screening phase.

Primary outcomes:
measure: Reduction of at least 20% of the average VAS between the run-in phase and the treatment phase (placebo and ibuprofen)
timeFrame: 5 months
Secondary outcomes:
measure: Pain
timeFrame: 5 months
measure: Anxiety
timeFrame: 5 months
measure: Quality of life
timeFrame: 5 months
measure: Incidence of adverse events
timeFrame: 5 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Hôpital Morvan - CHRU Brest
city: Saint-Maurice
country: France
facility: Hopitaux de Saint-Maurice
city: Trevou-Treguignec
country: France
facility: Ch Lannion-Trestel
Study officials:
affiliation: University hospital of Brest
name: Sylvain Brochard, Dr
role: PRINCIPAL_INVESTIGATOR
References: