Clinical trial NCT04522934: A Pilot Randomized Trial of Pain Neuroscience Education in the Rehabilitation After Arthroscopic Rotator Cuff Repair
Official title: A Pilot Randomized, Controlled Trial of the Effectiveness of Pain Neuroscience Education on Pain Intensity, Patients' Attitudes and Beliefs About Pain, Disability and Quality of Life After Arthroscopic Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Lead sponsor: Universidad Católica del Maule
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to groups by using an online random generator. This procedure was conducted by an external assessor. The allocation concealment strategy included the use of sealed-opaque and consecutively numbered envelopes.
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the effects of a 8-week pain neuroscience education programme compared to a biomedical education programme on the rehabilitation of patients who undergo arthroscopic rotator cuff repair. Outcome measures included pain intensity, patients' attitudes and beliefs about pain, disability and quality of life.

Detailed description: This was a single-blinded, randomized parallel study. Twenty- nine patients who undergo arthroscopic rotator cuff repair took part in a multimodal physiotherapy programme and were allocated to two groups. Patients in the experimental group - PNE (n= 16) received multimodal physiotherapy along with pain neuroscience education, and the control group- PME (n=13) received multimodal physiotherapy along with biomedical education. The multimodal treatment included 1-hour sessions 3 times per week for 8 weeks (24 sessions). In addition, the education component (PNE, PME) consisted of 4 education sessions of 30 minutes duration, on a one-to-one basis, once per week at the start of the programme.

Physiotherapists involved in the delivery of the interventions were previously trained on both, the theoretical and practical aspects related to the protocols of multimodal physiotherapy and specially on the education component.

Outcome measures included pain intensity (pain intensity numerical rating score), catastrophizing, kinesiophobia, disability and quality of life.

Eligibility criteria: Inclusion Criteria:

* People aged 30 to 59 years with shoulder pain for more than three months, with torn rotator cuff repaired by arthroscopy.

Exclusion Criteria:

* Subjects unable to understand, read or speak Spanish, or participated in a programme for psychological management of chronic pain, or presented with generalised pain.

Primary outcomes:
measure: Change Pain intensity: visual analogue scale
timeFrame: From baseline to the end of intervention (8 weeks)
measure: Pain catastrophizing
timeFrame: From baseline to the end of intervention (8 weeks)
measure: Kinesiophobia
timeFrame: From baseline to the end of intervention (8 weeks)
measure: Disability
timeFrame: From baseline to the end end of intervention (8 weeks)
measure: Health-related quality of life: 5-dimension EuroQol questionnaire
timeFrame: From baseline to the end of intervention (8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Hospital de Temuco
state: Araucania
Study officials:
affiliation: Universidad Santo Tomas, Chile
name: Felipe Ponce, BSc
role: PRINCIPAL_INVESTIGATOR
References: