A Pilot Randomized Trial of Pain Neuroscience Education in the Rehabilitation After Arthroscopic Rotator Cuff Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-26

Study Completion Date

2019-01-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rotator Cuff Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The assessor responsible for the outcome measures was blinded to the subjetc´s treatment assignment. The assessor was not present in the room while the treatment was delivered. He returned once the treatment was completed to perform the measurements.

Study Groups

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Pain Neuroscience Education

Patients received 24 sessions, in a 8-week period, of multimodal physiotherapy along with four sessions of pain neuroscience education.

Group Type EXPERIMENTAL

Pain Neuroscience Education

Intervention Type BEHAVIORAL

Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of pain neuroscience education. The latter was focused on the influence of psychosocial factors in the experience of pain, differences between acute and chronic pain and central-peripheral awareness.

Biomedical Education

Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy along with four sessions of biomedical education.

Group Type ACTIVE_COMPARATOR

Biomedical Education

Intervention Type BEHAVIORAL

Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of biomedical education. The latter was focused on the anatomy and pathomechanics of the shoulder.

Interventions

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Pain Neuroscience Education

Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of pain neuroscience education. The latter was focused on the influence of psychosocial factors in the experience of pain, differences between acute and chronic pain and central-peripheral awareness.

Intervention Type BEHAVIORAL

Biomedical Education

Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of biomedical education. The latter was focused on the anatomy and pathomechanics of the shoulder.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No